NDC properties for "tobramycin 300 MG per 5 ML Inhalation Solution" (RxCUI 348719)
About this data
The tables show NDC propoerties for tobramycin 300 MG per 5 ML Inhalation Solution with the RxCUI 348719
This product uses publicly available data from the U.S. National Library of Medicine (NLM), National Institutes of Health, Department of Health and Human Services; NLM is not responsible for the product and does not endorse or recommend this or any other product
Details for tobramycin 300 MG per 5 ML Inhalation Solution (RxCUI 348719)
| ANDA | ANDA091589 |
|---|---|
| ANDA | ANDA201422 |
| ANDA | ANDA205501 |
| ANDA | ANDA207080 |
| ANDA | ANDA207136 |
| ANDA | ANDA208964 |
| ANDA | ANDA210871 |
| ANDA | ANDA212848 |
| ANDA | ANDA214478 |
| ANDA | ANDA217344 |
| MMSL_CODE | BD6531 |
| MMSL_CODE | CD6531 |
| RxCUI | 348719 |
| SNOMEDCT | 1264525006 |
| SPL_SET_ID | 0aa5859e-cd80-49c0-881b-47f39d1f1d01 |
| SPL_SET_ID | 15f9c0cd-7dbf-4a91-9961-14f1dd000343 |
| SPL_SET_ID | 3d044738-a715-fdee-7849-521e8981e6ec |
| SPL_SET_ID | 5563e8af-c6c9-42a2-974d-7d364a47f00a |
| SPL_SET_ID | 7803ac83-1250-451b-8ad8-2c0a343c3031 |
| SPL_SET_ID | 845e3328-fffa-44eb-b78a-3607c05fdd55 |
| SPL_SET_ID | 9d8b7b6c-3072-48e9-87c8-51160b9df9bc |
| SPL_SET_ID | be8368d7-bfd0-47e8-8d69-ac5f4a4851ed |
| SPL_SET_ID | c452e428-0d8f-4f35-b98f-5aa3b814cb49 |
| SPL_SET_ID | c5f65e5b-c851-45da-a0e8-215d9a4e6ad3 |
| SPL_SET_ID | dad13445-f591-4829-96f9-1598ba03dff8 |
| SPL_SET_ID | e5bbf589-d066-c89a-c40f-cbeb6f98c5b5 |
| SPL_SET_ID | e8205898-0162-4e6c-bcf1-87cb074ab9ae |
| SPL_SET_ID | f2f8bf02-57f8-4d34-937a-32411fc6bfba |
| SPL_SET_ID | fd871ae7-9083-4e57-aacb-f584c1390db9 |
| VUID | 4005552 |
| VUID | 4033969 |
| Prescribable Synonym | tobramycin 300 MG in 5 ML Inhalation Solution |
| RXNAV_STR | tobramycin 60 MG/ML Inhalation Solution |
| RxNorm Name | tobramycin 60 MG/ML Inhalation Solution |
| RxNorm Synonym | tobramycin 300 MG per 5 ML Inhalation Solution |
| Related queries | Interactions (for RxCUI 348719) |
NDC Properties
NDC Item 00093408563
| NDC 9 | 0093-4085 |
|---|---|
| NDC 10 | 0093-4085-63 |
| NDC Item | 00093408563 |
| Packaging | 56 AMPULE in 1 CARTON (0093-4085-63) / 5 mL in 1 AMPULE |
| ANDA | ANDA091589 |
| FDA SPL set id | 861925 |
| Labeler | Teva Pharmaceuticals USA, Inc. |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2013-11-19 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 0093-4085 |
NDC Item 00781717156
| NDC 9 | 0781-7171 |
|---|---|
| NDC 10 | 0781-7171-56 |
| NDC Item | 00781717156 |
| Packaging | 56 AMPULE in 1 CARTON (0781-7171-56) / 5 mL in 1 AMPULE (0781-7171-75) |
| FDA SPL set id | 132419 |
| Labeler | Sandoz Inc |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | NDA AUTHORIZED GENERIC |
| Marketing effective time low | 2014-07-09 |
| Marketing status | COMPLETED |
| NDA_AUTHORIZED_GENERIC | NDA050753 |
| Related queries | Properties for NDC 9 0781-7171 |
NDC Item 00781717175
| NDC 9 | 0781-7171 |
|---|---|
| NDC 10 | 0781-7171-75 |
| NDC Item | 00781717175 |
| Packaging | 5 mL in 1 AMPULE |
| FDA SPL set id | 132419 |
| Labeler | Sandoz Inc |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | NDA AUTHORIZED GENERIC |
| Marketing effective time low | 2014-07-09 |
| Marketing status | COMPLETED |
| NDA_AUTHORIZED_GENERIC | NDA050753 |
| Related queries | Properties for NDC 9 0781-7171 |
NDC Item 16714011902
| NDC 9 | 16714-119 |
|---|---|
| NDC 10 | 16714-119-02 |
| NDC Item | 16714011902 |
| Packaging | 5 mL in 1 AMPULE |
| ANDA | ANDA207080 |
| FDA SPL set id | 842222 |
| Labeler | NorthStar RxLLC |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2020-05-21 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 16714-119 |
NDC Item 16714011903
| NDC 9 | 16714-119 |
|---|---|
| NDC 10 | 16714-119-03 |
| NDC Item | 16714011903 |
| Packaging | 14 POUCH in 1 CARTON (16714-119-03) / 4 AMPULE in 1 POUCH / 5 mL in 1 AMPULE (16714-119-02) |
| ANDA | ANDA207080 |
| FDA SPL set id | 842222 |
| Labeler | NorthStar RxLLC |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2020-05-21 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 16714-119 |
NDC Item 17478034038
| NDC 9 | 17478-340 |
|---|---|
| NDC 10 | 17478-340-38 |
| NDC Item | 17478034038 |
| Packaging | 14 POUCH in 1 CARTON (17478-340-38) / 4 AMPULE in 1 POUCH / 5 mL in 1 AMPULE |
| ANDA | ANDA201422 |
| FDA SPL set id | 656792 |
| Labeler | Akorn Operating Company LLC (dba Akorn) |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 17478-340 |
NDC Item 42571040809
| NDC 9 | 42571-408 |
|---|---|
| NDC 10 | 42571-408-09 |
| NDC Item | 42571040809 |
| Packaging | 5 mL in 1 AMPULE |
| ANDA | ANDA217344 |
| FDA SPL set id | 812408 |
| Labeler | Micro Labs Limited |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2024-01-01 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 42571-408 |
NDC Item 42571040819
| NDC 9 | 42571-408 |
|---|---|
| NDC 10 | 42571-408-19 |
| NDC Item | 42571040819 |
| Packaging | 4 in 1 POUCH |
| ANDA | ANDA217344 |
| FDA SPL set id | 812408 |
| Labeler | Micro Labs Limited |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2024-01-01 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 42571-408 |
NDC Item 42571040892
| NDC 9 | 42571-408 |
|---|---|
| NDC 10 | 42571-408-92 |
| NDC Item | 42571040892 |
| Packaging | 14 POUCH in 1 CARTON (42571-408-92) / 4 AMPULE in 1 POUCH (42571-408-19) / 5 mL in 1 AMPULE (42571-408-09) |
| ANDA | ANDA217344 |
| FDA SPL set id | 812408 |
| Labeler | Micro Labs Limited |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2024-01-01 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 42571-408 |
NDC Item 43598060504
| NDC 9 | 43598-605 |
|---|---|
| NDC 10 | 43598-605-04 |
| NDC Item | 43598060504 |
| ANDA | ANDA207080 |
| FDA SPL set id | 706735 |
| Labeler | Dr. Reddy's Laboratories Inc. |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2019-05-14 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 43598-605 |
NDC Item 43598060511
| NDC 9 | 43598-605 |
|---|---|
| NDC 10 | 43598-605-11 |
| NDC Item | 43598060511 |
| ANDA | ANDA207080 |
| FDA SPL set id | 706735 |
| Labeler | Dr. Reddy's Laboratories Inc. |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2019-05-14 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 43598-605 |
NDC Item 43598060556
| NDC 9 | 43598-605 |
|---|---|
| NDC 10 | 43598-605-56 |
| NDC Item | 43598060556 |
| Packaging | 14 POUCH in 1 CARTON (43598-605-56) / 4 AMPULE in 1 POUCH (43598-605-04) / 5 mL in 1 AMPULE |
| ANDA | ANDA207080 |
| FDA SPL set id | 706735 |
| Labeler | Dr. Reddy's Laboratories Inc. |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2019-05-14 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 43598-605 |
NDC Item 43598060558
| NDC 9 | 43598-605 |
|---|---|
| NDC 10 | 43598-605-58 |
| NDC Item | 43598060558 |
| Packaging | 56 POUCH in 1 CARTON (43598-605-58) / 1 AMPULE in 1 POUCH (43598-605-11) / 5 mL in 1 AMPULE |
| ANDA | ANDA207080 |
| FDA SPL set id | 706735 |
| Labeler | Dr. Reddy's Laboratories Inc. |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2019-05-14 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 43598-605 |
NDC Item 47335017148
| NDC 9 | 47335-171 |
|---|---|
| NDC 10 | 47335-171-48 |
| NDC Item | 47335017148 |
| Packaging | 4 in 1 POUCH |
| Packaging | 5 mL in 1 AMPULE |
| ANDA | ANDA207136 |
| COLORTEXT | YELLOW(Colourless to light yellow) |
| Color | C48330 __ |
| FDA SPL set id | 707885 |
| Labeler | Sun Pharmaceutical Industries, Inc. |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2020-02-28 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 47335-171 |
NDC Item 47335017149
| NDC 9 | 47335-171 |
|---|---|
| NDC 10 | 47335-171-49 |
| NDC Item | 47335017149 |
| Packaging | 14 POUCH in 1 CARTON (47335-171-49) / 4 AMPULE in 1 POUCH (47335-171-48) / 5 mL in 1 AMPULE |
| ANDA | ANDA207136 |
| COLORTEXT | YELLOW(Colourless to light yellow) |
| Color | C48330 __ |
| FDA SPL set id | 707885 |
| Labeler | Sun Pharmaceutical Industries, Inc. |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2020-02-28 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 47335-171 |
NDC Item 59651012904
| NDC 9 | 59651-129 |
|---|---|
| NDC 10 | 59651-129-04 |
| NDC Item | 59651012904 |
| Packaging | 4 in 1 POUCH |
| Packaging | 5 mL in 1 AMPULE |
| ANDA | ANDA210871 |
| FDA SPL set id | 710977 |
| Labeler | Aurobindo Pharma Limited |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2021-01-22 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 59651-129 |
NDC Item 59651012956
| NDC 9 | 59651-129 |
|---|---|
| NDC 10 | 59651-129-56 |
| NDC Item | 59651012956 |
| Packaging | 14 POUCH in 1 CARTON (59651-129-56) / 4 AMPULE in 1 POUCH (59651-129-04) / 5 mL in 1 AMPULE |
| ANDA | ANDA210871 |
| FDA SPL set id | 710977 |
| Labeler | Aurobindo Pharma Limited |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2021-01-22 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 59651-129 |
NDC Item 60687073179
| NDC 9 | 60687-731 |
|---|---|
| NDC 10 | 60687-731-79 |
| NDC Item | 60687073179 |
| Packaging | 1 in 1 POUCH |
| Packaging | 5 mL in 1 AMPULE |
| ANDA | ANDA207136 |
| COLORTEXT | yellow(Colourless to light yellow) |
| Color | C48330 __ |
| FDA SPL set id | 786945 |
| Labeler | American Health Packaging |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2024-05-19 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 60687-731 |
NDC Item 60687073183
| NDC 9 | 60687-731 |
|---|---|
| NDC 10 | 60687-731-83 |
| NDC Item | 60687073183 |
| Packaging | 30 POUCH in 1 CARTON (60687-731-83) / 1 AMPULE in 1 POUCH (60687-731-79) / 5 mL in 1 AMPULE |
| ANDA | ANDA207136 |
| COLORTEXT | yellow(Colourless to light yellow) |
| Color | C48330 __ |
| FDA SPL set id | 786945 |
| Labeler | American Health Packaging |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2024-05-19 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 60687-731 |
NDC Item 65162091446
| NDC 9 | 65162-914 |
|---|---|
| NDC 10 | 65162-914-46 |
| NDC Item | 65162091446 |
| Packaging | 56 AMPULE in 1 CARTON (65162-914-46) / 5 mL in 1 AMPULE |
| ANDA | ANDA205501 |
| COLORTEXT | yellow(clear, slightly yellow) |
| Color | C48330 __ |
| FDA SPL set id | 824547 |
| Labeler | Amneal Pharmaceuticals LLC |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2014-07-13 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 65162-914 |
NDC Item 67877067869
| NDC 9 | 67877-678 |
|---|---|
| NDC 10 | 67877-678-69 |
| NDC Item | 67877067869 |
| Packaging | 5 mL in 1 AMPULE |
| Packaging | 7 in 1 POUCH |
| ANDA | ANDA212848 |
| FDA SPL set id | 762146 |
| Labeler | Ascend Laboratories, LLC |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2021-04-02 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 67877-678 |
NDC Item 67877067870
| NDC 9 | 67877-678 |
|---|---|
| NDC 10 | 67877-678-70 |
| NDC Item | 67877067870 |
| Packaging | 56 POUCH in 1 CARTON (67877-678-70) / 7 AMPULE in 1 POUCH (67877-678-69) / 5 mL in 1 AMPULE |
| ANDA | ANDA212848 |
| FDA SPL set id | 762146 |
| Labeler | Ascend Laboratories, LLC |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2021-04-02 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 67877-678 |
NDC Item 68180096204
| NDC 9 | 68180-962 |
|---|---|
| NDC 10 | 68180-962-04 |
| NDC Item | 68180096204 |
| Packaging | 4 in 1 POUCH |
| Packaging | 5 mL in 1 AMPULE |
| ANDA | ANDA208964 |
| FDA SPL set id | 779846 |
| Labeler | Lupin Pharmaceuticals, Inc. |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2018-06-12 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 68180-962 |
NDC Item 68180096256
| NDC 9 | 68180-962 |
|---|---|
| NDC 10 | 68180-962-56 |
| NDC Item | 68180096256 |
| Packaging | 56 POUCH in 1 CARTON (68180-962-56) / 4 AMPULE in 1 POUCH / 5 mL in 1 AMPULE |
| ANDA | ANDA208964 |
| FDA SPL set id | 779846 |
| Labeler | Lupin Pharmaceuticals, Inc. |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2018-06-12 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 68180-962 |
NDC Item 70644089999
| NDC 9 | 70644-899 |
|---|---|
| NDC 10 | 70644-899-99 |
| NDC Item | 70644089999 |
| Packaging | 14 POUCH in 1 CARTON (70644-899-99) / 4 AMPULE in 1 POUCH / 5 mL in 1 AMPULE |
| FDA SPL set id | 849478 |
| Labeler | Genericus, Inc. |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | NDA AUTHORIZED GENERIC |
| Marketing effective time low | 2016-07-11 |
| Marketing status | ACTIVE |
| NDA_AUTHORIZED_GENERIC | NDA205433 |
| Related queries | Properties for NDC 9 70644-899 |
NDC Item 70756060444
| NDC 9 | 70756-604 |
|---|---|
| NDC 10 | 70756-604-44 |
| NDC Item | 70756060444 |
| Packaging | 4 in 1 POUCH |
| Packaging | 5 mL in 1 AMPULE |
| ANDA | ANDA214478 |
| FDA SPL set id | 805293 |
| Labeler | Lifestar Pharma LLC |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2023-06-30 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 70756-604 |
NDC Item 70756060456
| NDC 9 | 70756-604 |
|---|---|
| NDC 10 | 70756-604-56 |
| NDC Item | 70756060456 |
| Packaging | 14 POUCH in 1 CARTON (70756-604-56) / 4 AMPULE in 1 POUCH (70756-604-44) / 5 mL in 1 AMPULE |
| ANDA | ANDA214478 |
| FDA SPL set id | 805293 |
| Labeler | Lifestar Pharma LLC |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2023-06-30 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 70756-604 |
NDC Item 72603043004
| NDC 9 | 72603-430 |
|---|---|
| NDC 10 | 72603-430-04 |
| NDC Item | 72603043004 |
| Packaging | 4 in 1 POUCH |
| Packaging | 5 mL in 1 AMPULE |
| ANDA | ANDA214478 |
| FDA SPL set id | 801097 |
| Labeler | NorthStar RxLLC |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2024-08-01 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 72603-430 |
NDC Item 72603043056
| NDC 9 | 72603-430 |
|---|---|
| NDC 10 | 72603-430-56 |
| NDC Item | 72603043056 |
| Packaging | 14 POUCH in 1 CARTON (72603-430-56) / 4 AMPULE in 1 POUCH (72603-430-04) / 5 mL in 1 AMPULE |
| ANDA | ANDA214478 |
| FDA SPL set id | 801097 |
| Labeler | NorthStar RxLLC |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2024-08-01 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 72603-430 |
NDC Item 76204002956
| NDC 9 | 76204-029 |
|---|---|
| NDC 10 | 76204-029-56 |
| NDC Item | 76204002956 |
| Packaging | 14 POUCH in 1 CARTON (76204-029-56) / 4 AMPULE in 1 POUCH / 5 mL in 1 AMPULE |
| ANDA | ANDA201422 |
| FDA SPL set id | 866956 |
| Labeler | Ritedose Pharmaceuticals, LLC |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2025-03-25 |
| Marketing status | active |
| Related queries | Properties for NDC 9 76204-029 |
NDC Item 00093408563
| NDC 9 | 0093-4085 |
|---|---|
| NDC 10 | 0093-4085-63 |
| NDC Item | 00093408563 |
| Packaging | 56 AMPULE in 1 CARTON (0093-4085-63) / 5 mL in 1 AMPULE |
| ANDA | ANDA091589 |
| FDA SPL set id | 861925 |
| Labeler | Teva Pharmaceuticals USA, Inc. |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2013-11-19 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 0093-4085 |
NDC Item 00781717156
| NDC 9 | 0781-7171 |
|---|---|
| NDC 10 | 0781-7171-56 |
| NDC Item | 00781717156 |
| Packaging | 56 AMPULE in 1 CARTON (0781-7171-56) / 5 mL in 1 AMPULE (0781-7171-75) |
| FDA SPL set id | 132419 |
| Labeler | Sandoz Inc |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | NDA AUTHORIZED GENERIC |
| Marketing effective time low | 2014-07-09 |
| Marketing status | COMPLETED |
| NDA_AUTHORIZED_GENERIC | NDA050753 |
| Related queries | Properties for NDC 9 0781-7171 |
NDC Item 00781717175
| NDC 9 | 0781-7171 |
|---|---|
| NDC 10 | 0781-7171-75 |
| NDC Item | 00781717175 |
| Packaging | 5 mL in 1 AMPULE |
| FDA SPL set id | 132419 |
| Labeler | Sandoz Inc |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | NDA AUTHORIZED GENERIC |
| Marketing effective time low | 2014-07-09 |
| Marketing status | COMPLETED |
| NDA_AUTHORIZED_GENERIC | NDA050753 |
| Related queries | Properties for NDC 9 0781-7171 |
NDC Item 16714011902
| NDC 9 | 16714-119 |
|---|---|
| NDC 10 | 16714-119-02 |
| NDC Item | 16714011902 |
| Packaging | 5 mL in 1 AMPULE |
| ANDA | ANDA207080 |
| FDA SPL set id | 842222 |
| Labeler | NorthStar RxLLC |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2020-05-21 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 16714-119 |
NDC Item 16714011903
| NDC 9 | 16714-119 |
|---|---|
| NDC 10 | 16714-119-03 |
| NDC Item | 16714011903 |
| Packaging | 14 POUCH in 1 CARTON (16714-119-03) / 4 AMPULE in 1 POUCH / 5 mL in 1 AMPULE (16714-119-02) |
| ANDA | ANDA207080 |
| FDA SPL set id | 842222 |
| Labeler | NorthStar RxLLC |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2020-05-21 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 16714-119 |
NDC Item 17478034038
| NDC 9 | 17478-340 |
|---|---|
| NDC 10 | 17478-340-38 |
| NDC Item | 17478034038 |
| Packaging | 14 POUCH in 1 CARTON (17478-340-38) / 4 AMPULE in 1 POUCH / 5 mL in 1 AMPULE |
| ANDA | ANDA201422 |
| FDA SPL set id | 656792 |
| Labeler | Akorn Operating Company LLC (dba Akorn) |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 17478-340 |
NDC Item 42571040809
| NDC 9 | 42571-408 |
|---|---|
| NDC 10 | 42571-408-09 |
| NDC Item | 42571040809 |
| Packaging | 5 mL in 1 AMPULE |
| ANDA | ANDA217344 |
| FDA SPL set id | 812408 |
| Labeler | Micro Labs Limited |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2024-01-01 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 42571-408 |
NDC Item 42571040819
| NDC 9 | 42571-408 |
|---|---|
| NDC 10 | 42571-408-19 |
| NDC Item | 42571040819 |
| Packaging | 4 in 1 POUCH |
| ANDA | ANDA217344 |
| FDA SPL set id | 812408 |
| Labeler | Micro Labs Limited |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2024-01-01 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 42571-408 |
NDC Item 42571040892
| NDC 9 | 42571-408 |
|---|---|
| NDC 10 | 42571-408-92 |
| NDC Item | 42571040892 |
| Packaging | 14 POUCH in 1 CARTON (42571-408-92) / 4 AMPULE in 1 POUCH (42571-408-19) / 5 mL in 1 AMPULE (42571-408-09) |
| ANDA | ANDA217344 |
| FDA SPL set id | 812408 |
| Labeler | Micro Labs Limited |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2024-01-01 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 42571-408 |
NDC Item 43598060504
| NDC 9 | 43598-605 |
|---|---|
| NDC 10 | 43598-605-04 |
| NDC Item | 43598060504 |
| ANDA | ANDA207080 |
| FDA SPL set id | 706735 |
| Labeler | Dr. Reddy's Laboratories Inc. |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2019-05-14 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 43598-605 |
NDC Item 43598060511
| NDC 9 | 43598-605 |
|---|---|
| NDC 10 | 43598-605-11 |
| NDC Item | 43598060511 |
| ANDA | ANDA207080 |
| FDA SPL set id | 706735 |
| Labeler | Dr. Reddy's Laboratories Inc. |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2019-05-14 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 43598-605 |
NDC Item 43598060556
| NDC 9 | 43598-605 |
|---|---|
| NDC 10 | 43598-605-56 |
| NDC Item | 43598060556 |
| Packaging | 14 POUCH in 1 CARTON (43598-605-56) / 4 AMPULE in 1 POUCH (43598-605-04) / 5 mL in 1 AMPULE |
| ANDA | ANDA207080 |
| FDA SPL set id | 706735 |
| Labeler | Dr. Reddy's Laboratories Inc. |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2019-05-14 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 43598-605 |
NDC Item 43598060558
| NDC 9 | 43598-605 |
|---|---|
| NDC 10 | 43598-605-58 |
| NDC Item | 43598060558 |
| Packaging | 56 POUCH in 1 CARTON (43598-605-58) / 1 AMPULE in 1 POUCH (43598-605-11) / 5 mL in 1 AMPULE |
| ANDA | ANDA207080 |
| FDA SPL set id | 706735 |
| Labeler | Dr. Reddy's Laboratories Inc. |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2019-05-14 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 43598-605 |
NDC Item 47335017148
| NDC 9 | 47335-171 |
|---|---|
| NDC 10 | 47335-171-48 |
| NDC Item | 47335017148 |
| Packaging | 4 in 1 POUCH |
| Packaging | 5 mL in 1 AMPULE |
| ANDA | ANDA207136 |
| COLORTEXT | YELLOW(Colourless to light yellow) |
| Color | C48330 __ |
| FDA SPL set id | 707885 |
| Labeler | Sun Pharmaceutical Industries, Inc. |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2020-02-28 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 47335-171 |
NDC Item 47335017149
| NDC 9 | 47335-171 |
|---|---|
| NDC 10 | 47335-171-49 |
| NDC Item | 47335017149 |
| Packaging | 14 POUCH in 1 CARTON (47335-171-49) / 4 AMPULE in 1 POUCH (47335-171-48) / 5 mL in 1 AMPULE |
| ANDA | ANDA207136 |
| COLORTEXT | YELLOW(Colourless to light yellow) |
| Color | C48330 __ |
| FDA SPL set id | 707885 |
| Labeler | Sun Pharmaceutical Industries, Inc. |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2020-02-28 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 47335-171 |
NDC Item 59651012904
| NDC 9 | 59651-129 |
|---|---|
| NDC 10 | 59651-129-04 |
| NDC Item | 59651012904 |
| Packaging | 4 in 1 POUCH |
| Packaging | 5 mL in 1 AMPULE |
| ANDA | ANDA210871 |
| FDA SPL set id | 710977 |
| Labeler | Aurobindo Pharma Limited |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2021-01-22 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 59651-129 |
NDC Item 59651012956
| NDC 9 | 59651-129 |
|---|---|
| NDC 10 | 59651-129-56 |
| NDC Item | 59651012956 |
| Packaging | 14 POUCH in 1 CARTON (59651-129-56) / 4 AMPULE in 1 POUCH (59651-129-04) / 5 mL in 1 AMPULE |
| ANDA | ANDA210871 |
| FDA SPL set id | 710977 |
| Labeler | Aurobindo Pharma Limited |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2021-01-22 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 59651-129 |
NDC Item 60687073179
| NDC 9 | 60687-731 |
|---|---|
| NDC 10 | 60687-731-79 |
| NDC Item | 60687073179 |
| Packaging | 1 in 1 POUCH |
| Packaging | 5 mL in 1 AMPULE |
| ANDA | ANDA207136 |
| COLORTEXT | yellow(Colourless to light yellow) |
| Color | C48330 __ |
| FDA SPL set id | 786945 |
| Labeler | American Health Packaging |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2024-05-19 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 60687-731 |
NDC Item 60687073183
| NDC 9 | 60687-731 |
|---|---|
| NDC 10 | 60687-731-83 |
| NDC Item | 60687073183 |
| Packaging | 30 POUCH in 1 CARTON (60687-731-83) / 1 AMPULE in 1 POUCH (60687-731-79) / 5 mL in 1 AMPULE |
| ANDA | ANDA207136 |
| COLORTEXT | yellow(Colourless to light yellow) |
| Color | C48330 __ |
| FDA SPL set id | 786945 |
| Labeler | American Health Packaging |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2024-05-19 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 60687-731 |
NDC Item 65162091446
| NDC 9 | 65162-914 |
|---|---|
| NDC 10 | 65162-914-46 |
| NDC Item | 65162091446 |
| Packaging | 56 AMPULE in 1 CARTON (65162-914-46) / 5 mL in 1 AMPULE |
| ANDA | ANDA205501 |
| COLORTEXT | yellow(clear, slightly yellow) |
| Color | C48330 __ |
| FDA SPL set id | 824547 |
| Labeler | Amneal Pharmaceuticals LLC |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2014-07-13 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 65162-914 |
NDC Item 67877067869
| NDC 9 | 67877-678 |
|---|---|
| NDC 10 | 67877-678-69 |
| NDC Item | 67877067869 |
| Packaging | 5 mL in 1 AMPULE |
| Packaging | 7 in 1 POUCH |
| ANDA | ANDA212848 |
| FDA SPL set id | 762146 |
| Labeler | Ascend Laboratories, LLC |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2021-04-02 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 67877-678 |
NDC Item 67877067870
| NDC 9 | 67877-678 |
|---|---|
| NDC 10 | 67877-678-70 |
| NDC Item | 67877067870 |
| Packaging | 56 POUCH in 1 CARTON (67877-678-70) / 7 AMPULE in 1 POUCH (67877-678-69) / 5 mL in 1 AMPULE |
| ANDA | ANDA212848 |
| FDA SPL set id | 762146 |
| Labeler | Ascend Laboratories, LLC |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2021-04-02 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 67877-678 |
NDC Item 68180096204
| NDC 9 | 68180-962 |
|---|---|
| NDC 10 | 68180-962-04 |
| NDC Item | 68180096204 |
| Packaging | 4 in 1 POUCH |
| Packaging | 5 mL in 1 AMPULE |
| ANDA | ANDA208964 |
| FDA SPL set id | 779846 |
| Labeler | Lupin Pharmaceuticals, Inc. |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2018-06-12 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 68180-962 |
NDC Item 68180096256
| NDC 9 | 68180-962 |
|---|---|
| NDC 10 | 68180-962-56 |
| NDC Item | 68180096256 |
| Packaging | 56 POUCH in 1 CARTON (68180-962-56) / 4 AMPULE in 1 POUCH / 5 mL in 1 AMPULE |
| ANDA | ANDA208964 |
| FDA SPL set id | 779846 |
| Labeler | Lupin Pharmaceuticals, Inc. |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2018-06-12 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 68180-962 |
NDC Item 70644089999
| NDC 9 | 70644-899 |
|---|---|
| NDC 10 | 70644-899-99 |
| NDC Item | 70644089999 |
| Packaging | 14 POUCH in 1 CARTON (70644-899-99) / 4 AMPULE in 1 POUCH / 5 mL in 1 AMPULE |
| FDA SPL set id | 849478 |
| Labeler | Genericus, Inc. |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | NDA AUTHORIZED GENERIC |
| Marketing effective time low | 2016-07-11 |
| Marketing status | ACTIVE |
| NDA_AUTHORIZED_GENERIC | NDA205433 |
| Related queries | Properties for NDC 9 70644-899 |
NDC Item 70756060444
| NDC 9 | 70756-604 |
|---|---|
| NDC 10 | 70756-604-44 |
| NDC Item | 70756060444 |
| Packaging | 4 in 1 POUCH |
| Packaging | 5 mL in 1 AMPULE |
| ANDA | ANDA214478 |
| FDA SPL set id | 805293 |
| Labeler | Lifestar Pharma LLC |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2023-06-30 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 70756-604 |
NDC Item 70756060456
| NDC 9 | 70756-604 |
|---|---|
| NDC 10 | 70756-604-56 |
| NDC Item | 70756060456 |
| Packaging | 14 POUCH in 1 CARTON (70756-604-56) / 4 AMPULE in 1 POUCH (70756-604-44) / 5 mL in 1 AMPULE |
| ANDA | ANDA214478 |
| FDA SPL set id | 805293 |
| Labeler | Lifestar Pharma LLC |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2023-06-30 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 70756-604 |
NDC Item 72603043004
| NDC 9 | 72603-430 |
|---|---|
| NDC 10 | 72603-430-04 |
| NDC Item | 72603043004 |
| Packaging | 4 in 1 POUCH |
| Packaging | 5 mL in 1 AMPULE |
| ANDA | ANDA214478 |
| FDA SPL set id | 801097 |
| Labeler | NorthStar RxLLC |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2024-08-01 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 72603-430 |
NDC Item 72603043056
| NDC 9 | 72603-430 |
|---|---|
| NDC 10 | 72603-430-56 |
| NDC Item | 72603043056 |
| Packaging | 14 POUCH in 1 CARTON (72603-430-56) / 4 AMPULE in 1 POUCH (72603-430-04) / 5 mL in 1 AMPULE |
| ANDA | ANDA214478 |
| FDA SPL set id | 801097 |
| Labeler | NorthStar RxLLC |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2024-08-01 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 72603-430 |
NDC Item 76204002956
| NDC 9 | 76204-029 |
|---|---|
| NDC 10 | 76204-029-56 |
| NDC Item | 76204002956 |
| Packaging | 14 POUCH in 1 CARTON (76204-029-56) / 4 AMPULE in 1 POUCH / 5 mL in 1 AMPULE |
| ANDA | ANDA201422 |
| FDA SPL set id | 866956 |
| Labeler | Ritedose Pharmaceuticals, LLC |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2025-03-25 |
| Marketing status | active |
| Related queries | Properties for NDC 9 76204-029 |
NDC Item 00093408563
| NDC 9 | 0093-4085 |
|---|---|
| NDC 10 | 0093-4085-63 |
| NDC Item | 00093408563 |
| Packaging | 56 AMPULE in 1 CARTON (0093-4085-63) / 5 mL in 1 AMPULE |
| ANDA | ANDA091589 |
| FDA SPL set id | 861925 |
| Labeler | Teva Pharmaceuticals USA, Inc. |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2013-11-19 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 0093-4085 |
NDC Item 00781717156
| NDC 9 | 0781-7171 |
|---|---|
| NDC 10 | 0781-7171-56 |
| NDC Item | 00781717156 |
| Packaging | 56 AMPULE in 1 CARTON (0781-7171-56) / 5 mL in 1 AMPULE (0781-7171-75) |
| FDA SPL set id | 132419 |
| Labeler | Sandoz Inc |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | NDA AUTHORIZED GENERIC |
| Marketing effective time low | 2014-07-09 |
| Marketing status | COMPLETED |
| NDA_AUTHORIZED_GENERIC | NDA050753 |
| Related queries | Properties for NDC 9 0781-7171 |
NDC Item 00781717175
| NDC 9 | 0781-7171 |
|---|---|
| NDC 10 | 0781-7171-75 |
| NDC Item | 00781717175 |
| Packaging | 5 mL in 1 AMPULE |
| FDA SPL set id | 132419 |
| Labeler | Sandoz Inc |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | NDA AUTHORIZED GENERIC |
| Marketing effective time low | 2014-07-09 |
| Marketing status | COMPLETED |
| NDA_AUTHORIZED_GENERIC | NDA050753 |
| Related queries | Properties for NDC 9 0781-7171 |
NDC Item 16714011902
| NDC 9 | 16714-119 |
|---|---|
| NDC 10 | 16714-119-02 |
| NDC Item | 16714011902 |
| Packaging | 5 mL in 1 AMPULE |
| ANDA | ANDA207080 |
| FDA SPL set id | 842222 |
| Labeler | NorthStar RxLLC |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2020-05-21 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 16714-119 |
NDC Item 16714011903
| NDC 9 | 16714-119 |
|---|---|
| NDC 10 | 16714-119-03 |
| NDC Item | 16714011903 |
| Packaging | 14 POUCH in 1 CARTON (16714-119-03) / 4 AMPULE in 1 POUCH / 5 mL in 1 AMPULE (16714-119-02) |
| ANDA | ANDA207080 |
| FDA SPL set id | 842222 |
| Labeler | NorthStar RxLLC |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2020-05-21 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 16714-119 |
NDC Item 17478034038
| NDC 9 | 17478-340 |
|---|---|
| NDC 10 | 17478-340-38 |
| NDC Item | 17478034038 |
| Packaging | 14 POUCH in 1 CARTON (17478-340-38) / 4 AMPULE in 1 POUCH / 5 mL in 1 AMPULE |
| ANDA | ANDA201422 |
| FDA SPL set id | 656792 |
| Labeler | Akorn Operating Company LLC (dba Akorn) |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 17478-340 |
NDC Item 42571040809
| NDC 9 | 42571-408 |
|---|---|
| NDC 10 | 42571-408-09 |
| NDC Item | 42571040809 |
| Packaging | 5 mL in 1 AMPULE |
| ANDA | ANDA217344 |
| FDA SPL set id | 812408 |
| Labeler | Micro Labs Limited |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2024-01-01 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 42571-408 |
NDC Item 42571040819
| NDC 9 | 42571-408 |
|---|---|
| NDC 10 | 42571-408-19 |
| NDC Item | 42571040819 |
| Packaging | 4 in 1 POUCH |
| ANDA | ANDA217344 |
| FDA SPL set id | 812408 |
| Labeler | Micro Labs Limited |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2024-01-01 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 42571-408 |
NDC Item 42571040892
| NDC 9 | 42571-408 |
|---|---|
| NDC 10 | 42571-408-92 |
| NDC Item | 42571040892 |
| Packaging | 14 POUCH in 1 CARTON (42571-408-92) / 4 AMPULE in 1 POUCH (42571-408-19) / 5 mL in 1 AMPULE (42571-408-09) |
| ANDA | ANDA217344 |
| FDA SPL set id | 812408 |
| Labeler | Micro Labs Limited |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2024-01-01 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 42571-408 |
NDC Item 43598060504
| NDC 9 | 43598-605 |
|---|---|
| NDC 10 | 43598-605-04 |
| NDC Item | 43598060504 |
| ANDA | ANDA207080 |
| FDA SPL set id | 706735 |
| Labeler | Dr. Reddy's Laboratories Inc. |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2019-05-14 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 43598-605 |
NDC Item 43598060511
| NDC 9 | 43598-605 |
|---|---|
| NDC 10 | 43598-605-11 |
| NDC Item | 43598060511 |
| ANDA | ANDA207080 |
| FDA SPL set id | 706735 |
| Labeler | Dr. Reddy's Laboratories Inc. |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2019-05-14 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 43598-605 |
NDC Item 43598060556
| NDC 9 | 43598-605 |
|---|---|
| NDC 10 | 43598-605-56 |
| NDC Item | 43598060556 |
| Packaging | 14 POUCH in 1 CARTON (43598-605-56) / 4 AMPULE in 1 POUCH (43598-605-04) / 5 mL in 1 AMPULE |
| ANDA | ANDA207080 |
| FDA SPL set id | 706735 |
| Labeler | Dr. Reddy's Laboratories Inc. |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2019-05-14 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 43598-605 |
NDC Item 43598060558
| NDC 9 | 43598-605 |
|---|---|
| NDC 10 | 43598-605-58 |
| NDC Item | 43598060558 |
| Packaging | 56 POUCH in 1 CARTON (43598-605-58) / 1 AMPULE in 1 POUCH (43598-605-11) / 5 mL in 1 AMPULE |
| ANDA | ANDA207080 |
| FDA SPL set id | 706735 |
| Labeler | Dr. Reddy's Laboratories Inc. |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2019-05-14 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 43598-605 |
NDC Item 47335017148
| NDC 9 | 47335-171 |
|---|---|
| NDC 10 | 47335-171-48 |
| NDC Item | 47335017148 |
| Packaging | 4 in 1 POUCH |
| Packaging | 5 mL in 1 AMPULE |
| ANDA | ANDA207136 |
| COLORTEXT | YELLOW(Colourless to light yellow) |
| Color | C48330 __ |
| FDA SPL set id | 707885 |
| Labeler | Sun Pharmaceutical Industries, Inc. |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2020-02-28 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 47335-171 |
NDC Item 47335017149
| NDC 9 | 47335-171 |
|---|---|
| NDC 10 | 47335-171-49 |
| NDC Item | 47335017149 |
| Packaging | 14 POUCH in 1 CARTON (47335-171-49) / 4 AMPULE in 1 POUCH (47335-171-48) / 5 mL in 1 AMPULE |
| ANDA | ANDA207136 |
| COLORTEXT | YELLOW(Colourless to light yellow) |
| Color | C48330 __ |
| FDA SPL set id | 707885 |
| Labeler | Sun Pharmaceutical Industries, Inc. |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2020-02-28 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 47335-171 |
NDC Item 59651012904
| NDC 9 | 59651-129 |
|---|---|
| NDC 10 | 59651-129-04 |
| NDC Item | 59651012904 |
| Packaging | 4 in 1 POUCH |
| Packaging | 5 mL in 1 AMPULE |
| ANDA | ANDA210871 |
| FDA SPL set id | 710977 |
| Labeler | Aurobindo Pharma Limited |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2021-01-22 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 59651-129 |
NDC Item 59651012956
| NDC 9 | 59651-129 |
|---|---|
| NDC 10 | 59651-129-56 |
| NDC Item | 59651012956 |
| Packaging | 14 POUCH in 1 CARTON (59651-129-56) / 4 AMPULE in 1 POUCH (59651-129-04) / 5 mL in 1 AMPULE |
| ANDA | ANDA210871 |
| FDA SPL set id | 710977 |
| Labeler | Aurobindo Pharma Limited |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2021-01-22 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 59651-129 |
NDC Item 60687073179
| NDC 9 | 60687-731 |
|---|---|
| NDC 10 | 60687-731-79 |
| NDC Item | 60687073179 |
| Packaging | 1 in 1 POUCH |
| Packaging | 5 mL in 1 AMPULE |
| ANDA | ANDA207136 |
| COLORTEXT | yellow(Colourless to light yellow) |
| Color | C48330 __ |
| FDA SPL set id | 786945 |
| Labeler | American Health Packaging |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2024-05-19 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 60687-731 |
NDC Item 60687073183
| NDC 9 | 60687-731 |
|---|---|
| NDC 10 | 60687-731-83 |
| NDC Item | 60687073183 |
| Packaging | 30 POUCH in 1 CARTON (60687-731-83) / 1 AMPULE in 1 POUCH (60687-731-79) / 5 mL in 1 AMPULE |
| ANDA | ANDA207136 |
| COLORTEXT | yellow(Colourless to light yellow) |
| Color | C48330 __ |
| FDA SPL set id | 786945 |
| Labeler | American Health Packaging |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2024-05-19 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 60687-731 |
NDC Item 65162091446
| NDC 9 | 65162-914 |
|---|---|
| NDC 10 | 65162-914-46 |
| NDC Item | 65162091446 |
| Packaging | 56 AMPULE in 1 CARTON (65162-914-46) / 5 mL in 1 AMPULE |
| ANDA | ANDA205501 |
| COLORTEXT | yellow(clear, slightly yellow) |
| Color | C48330 __ |
| FDA SPL set id | 824547 |
| Labeler | Amneal Pharmaceuticals LLC |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2014-07-13 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 65162-914 |
NDC Item 67877067869
| NDC 9 | 67877-678 |
|---|---|
| NDC 10 | 67877-678-69 |
| NDC Item | 67877067869 |
| Packaging | 5 mL in 1 AMPULE |
| Packaging | 7 in 1 POUCH |
| ANDA | ANDA212848 |
| FDA SPL set id | 762146 |
| Labeler | Ascend Laboratories, LLC |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2021-04-02 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 67877-678 |
NDC Item 67877067870
| NDC 9 | 67877-678 |
|---|---|
| NDC 10 | 67877-678-70 |
| NDC Item | 67877067870 |
| Packaging | 56 POUCH in 1 CARTON (67877-678-70) / 7 AMPULE in 1 POUCH (67877-678-69) / 5 mL in 1 AMPULE |
| ANDA | ANDA212848 |
| FDA SPL set id | 762146 |
| Labeler | Ascend Laboratories, LLC |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2021-04-02 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 67877-678 |
NDC Item 68180096204
| NDC 9 | 68180-962 |
|---|---|
| NDC 10 | 68180-962-04 |
| NDC Item | 68180096204 |
| Packaging | 4 in 1 POUCH |
| Packaging | 5 mL in 1 AMPULE |
| ANDA | ANDA208964 |
| FDA SPL set id | 779846 |
| Labeler | Lupin Pharmaceuticals, Inc. |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2018-06-12 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 68180-962 |
NDC Item 68180096256
| NDC 9 | 68180-962 |
|---|---|
| NDC 10 | 68180-962-56 |
| NDC Item | 68180096256 |
| Packaging | 56 POUCH in 1 CARTON (68180-962-56) / 4 AMPULE in 1 POUCH / 5 mL in 1 AMPULE |
| ANDA | ANDA208964 |
| FDA SPL set id | 779846 |
| Labeler | Lupin Pharmaceuticals, Inc. |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2018-06-12 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 68180-962 |
NDC Item 70644089999
| NDC 9 | 70644-899 |
|---|---|
| NDC 10 | 70644-899-99 |
| NDC Item | 70644089999 |
| Packaging | 14 POUCH in 1 CARTON (70644-899-99) / 4 AMPULE in 1 POUCH / 5 mL in 1 AMPULE |
| FDA SPL set id | 849478 |
| Labeler | Genericus, Inc. |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | NDA AUTHORIZED GENERIC |
| Marketing effective time low | 2016-07-11 |
| Marketing status | ACTIVE |
| NDA_AUTHORIZED_GENERIC | NDA205433 |
| Related queries | Properties for NDC 9 70644-899 |
NDC Item 70756060444
| NDC 9 | 70756-604 |
|---|---|
| NDC 10 | 70756-604-44 |
| NDC Item | 70756060444 |
| Packaging | 4 in 1 POUCH |
| Packaging | 5 mL in 1 AMPULE |
| ANDA | ANDA214478 |
| FDA SPL set id | 805293 |
| Labeler | Lifestar Pharma LLC |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2023-06-30 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 70756-604 |
NDC Item 70756060456
| NDC 9 | 70756-604 |
|---|---|
| NDC 10 | 70756-604-56 |
| NDC Item | 70756060456 |
| Packaging | 14 POUCH in 1 CARTON (70756-604-56) / 4 AMPULE in 1 POUCH (70756-604-44) / 5 mL in 1 AMPULE |
| ANDA | ANDA214478 |
| FDA SPL set id | 805293 |
| Labeler | Lifestar Pharma LLC |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2023-06-30 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 70756-604 |
NDC Item 72603043004
| NDC 9 | 72603-430 |
|---|---|
| NDC 10 | 72603-430-04 |
| NDC Item | 72603043004 |
| Packaging | 4 in 1 POUCH |
| Packaging | 5 mL in 1 AMPULE |
| ANDA | ANDA214478 |
| FDA SPL set id | 801097 |
| Labeler | NorthStar RxLLC |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2024-08-01 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 72603-430 |
NDC Item 72603043056
| NDC 9 | 72603-430 |
|---|---|
| NDC 10 | 72603-430-56 |
| NDC Item | 72603043056 |
| Packaging | 14 POUCH in 1 CARTON (72603-430-56) / 4 AMPULE in 1 POUCH (72603-430-04) / 5 mL in 1 AMPULE |
| ANDA | ANDA214478 |
| FDA SPL set id | 801097 |
| Labeler | NorthStar RxLLC |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2024-08-01 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 72603-430 |
NDC Item 76204002956
| NDC 9 | 76204-029 |
|---|---|
| NDC 10 | 76204-029-56 |
| NDC Item | 76204002956 |
| Packaging | 14 POUCH in 1 CARTON (76204-029-56) / 4 AMPULE in 1 POUCH / 5 mL in 1 AMPULE |
| ANDA | ANDA201422 |
| FDA SPL set id | 866956 |
| Labeler | Ritedose Pharmaceuticals, LLC |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2025-03-25 |
| Marketing status | active |
| Related queries | Properties for NDC 9 76204-029 |
NDC Item 00093408563
| NDC 9 | 0093-4085 |
|---|---|
| NDC 10 | 0093-4085-63 |
| NDC Item | 00093408563 |
| Packaging | 56 AMPULE in 1 CARTON (0093-4085-63) / 5 mL in 1 AMPULE |
| ANDA | ANDA091589 |
| FDA SPL set id | 861925 |
| Labeler | Teva Pharmaceuticals USA, Inc. |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2013-11-19 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 0093-4085 |
NDC Item 00781717156
| NDC 9 | 0781-7171 |
|---|---|
| NDC 10 | 0781-7171-56 |
| NDC Item | 00781717156 |
| Packaging | 56 AMPULE in 1 CARTON (0781-7171-56) / 5 mL in 1 AMPULE (0781-7171-75) |
| FDA SPL set id | 132419 |
| Labeler | Sandoz Inc |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | NDA AUTHORIZED GENERIC |
| Marketing effective time low | 2014-07-09 |
| Marketing status | COMPLETED |
| NDA_AUTHORIZED_GENERIC | NDA050753 |
| Related queries | Properties for NDC 9 0781-7171 |
NDC Item 00781717175
| NDC 9 | 0781-7171 |
|---|---|
| NDC 10 | 0781-7171-75 |
| NDC Item | 00781717175 |
| Packaging | 5 mL in 1 AMPULE |
| FDA SPL set id | 132419 |
| Labeler | Sandoz Inc |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | NDA AUTHORIZED GENERIC |
| Marketing effective time low | 2014-07-09 |
| Marketing status | COMPLETED |
| NDA_AUTHORIZED_GENERIC | NDA050753 |
| Related queries | Properties for NDC 9 0781-7171 |
NDC Item 16714011902
| NDC 9 | 16714-119 |
|---|---|
| NDC 10 | 16714-119-02 |
| NDC Item | 16714011902 |
| Packaging | 5 mL in 1 AMPULE |
| ANDA | ANDA207080 |
| FDA SPL set id | 842222 |
| Labeler | NorthStar RxLLC |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2020-05-21 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 16714-119 |
NDC Item 16714011903
| NDC 9 | 16714-119 |
|---|---|
| NDC 10 | 16714-119-03 |
| NDC Item | 16714011903 |
| Packaging | 14 POUCH in 1 CARTON (16714-119-03) / 4 AMPULE in 1 POUCH / 5 mL in 1 AMPULE (16714-119-02) |
| ANDA | ANDA207080 |
| FDA SPL set id | 842222 |
| Labeler | NorthStar RxLLC |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2020-05-21 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 16714-119 |
NDC Item 17478034038
| NDC 9 | 17478-340 |
|---|---|
| NDC 10 | 17478-340-38 |
| NDC Item | 17478034038 |
| Packaging | 14 POUCH in 1 CARTON (17478-340-38) / 4 AMPULE in 1 POUCH / 5 mL in 1 AMPULE |
| ANDA | ANDA201422 |
| FDA SPL set id | 656792 |
| Labeler | Akorn Operating Company LLC (dba Akorn) |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 17478-340 |
NDC Item 42571040809
| NDC 9 | 42571-408 |
|---|---|
| NDC 10 | 42571-408-09 |
| NDC Item | 42571040809 |
| Packaging | 5 mL in 1 AMPULE |
| ANDA | ANDA217344 |
| FDA SPL set id | 812408 |
| Labeler | Micro Labs Limited |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2024-01-01 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 42571-408 |
NDC Item 42571040819
| NDC 9 | 42571-408 |
|---|---|
| NDC 10 | 42571-408-19 |
| NDC Item | 42571040819 |
| Packaging | 4 in 1 POUCH |
| ANDA | ANDA217344 |
| FDA SPL set id | 812408 |
| Labeler | Micro Labs Limited |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2024-01-01 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 42571-408 |
NDC Item 42571040892
| NDC 9 | 42571-408 |
|---|---|
| NDC 10 | 42571-408-92 |
| NDC Item | 42571040892 |
| Packaging | 14 POUCH in 1 CARTON (42571-408-92) / 4 AMPULE in 1 POUCH (42571-408-19) / 5 mL in 1 AMPULE (42571-408-09) |
| ANDA | ANDA217344 |
| FDA SPL set id | 812408 |
| Labeler | Micro Labs Limited |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2024-01-01 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 42571-408 |
NDC Item 43598060504
| NDC 9 | 43598-605 |
|---|---|
| NDC 10 | 43598-605-04 |
| NDC Item | 43598060504 |
| ANDA | ANDA207080 |
| FDA SPL set id | 706735 |
| Labeler | Dr. Reddy's Laboratories Inc. |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2019-05-14 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 43598-605 |
NDC Item 43598060511
| NDC 9 | 43598-605 |
|---|---|
| NDC 10 | 43598-605-11 |
| NDC Item | 43598060511 |
| ANDA | ANDA207080 |
| FDA SPL set id | 706735 |
| Labeler | Dr. Reddy's Laboratories Inc. |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2019-05-14 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 43598-605 |
NDC Item 43598060556
| NDC 9 | 43598-605 |
|---|---|
| NDC 10 | 43598-605-56 |
| NDC Item | 43598060556 |
| Packaging | 14 POUCH in 1 CARTON (43598-605-56) / 4 AMPULE in 1 POUCH (43598-605-04) / 5 mL in 1 AMPULE |
| ANDA | ANDA207080 |
| FDA SPL set id | 706735 |
| Labeler | Dr. Reddy's Laboratories Inc. |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2019-05-14 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 43598-605 |
NDC Item 43598060558
| NDC 9 | 43598-605 |
|---|---|
| NDC 10 | 43598-605-58 |
| NDC Item | 43598060558 |
| Packaging | 56 POUCH in 1 CARTON (43598-605-58) / 1 AMPULE in 1 POUCH (43598-605-11) / 5 mL in 1 AMPULE |
| ANDA | ANDA207080 |
| FDA SPL set id | 706735 |
| Labeler | Dr. Reddy's Laboratories Inc. |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2019-05-14 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 43598-605 |
NDC Item 47335017148
| NDC 9 | 47335-171 |
|---|---|
| NDC 10 | 47335-171-48 |
| NDC Item | 47335017148 |
| Packaging | 4 in 1 POUCH |
| Packaging | 5 mL in 1 AMPULE |
| ANDA | ANDA207136 |
| COLORTEXT | YELLOW(Colourless to light yellow) |
| Color | C48330 __ |
| FDA SPL set id | 707885 |
| Labeler | Sun Pharmaceutical Industries, Inc. |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2020-02-28 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 47335-171 |
NDC Item 47335017149
| NDC 9 | 47335-171 |
|---|---|
| NDC 10 | 47335-171-49 |
| NDC Item | 47335017149 |
| Packaging | 14 POUCH in 1 CARTON (47335-171-49) / 4 AMPULE in 1 POUCH (47335-171-48) / 5 mL in 1 AMPULE |
| ANDA | ANDA207136 |
| COLORTEXT | YELLOW(Colourless to light yellow) |
| Color | C48330 __ |
| FDA SPL set id | 707885 |
| Labeler | Sun Pharmaceutical Industries, Inc. |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2020-02-28 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 47335-171 |
NDC Item 59651012904
| NDC 9 | 59651-129 |
|---|---|
| NDC 10 | 59651-129-04 |
| NDC Item | 59651012904 |
| Packaging | 4 in 1 POUCH |
| Packaging | 5 mL in 1 AMPULE |
| ANDA | ANDA210871 |
| FDA SPL set id | 710977 |
| Labeler | Aurobindo Pharma Limited |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2021-01-22 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 59651-129 |
NDC Item 59651012956
| NDC 9 | 59651-129 |
|---|---|
| NDC 10 | 59651-129-56 |
| NDC Item | 59651012956 |
| Packaging | 14 POUCH in 1 CARTON (59651-129-56) / 4 AMPULE in 1 POUCH (59651-129-04) / 5 mL in 1 AMPULE |
| ANDA | ANDA210871 |
| FDA SPL set id | 710977 |
| Labeler | Aurobindo Pharma Limited |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2021-01-22 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 59651-129 |
NDC Item 60687073179
| NDC 9 | 60687-731 |
|---|---|
| NDC 10 | 60687-731-79 |
| NDC Item | 60687073179 |
| Packaging | 1 in 1 POUCH |
| Packaging | 5 mL in 1 AMPULE |
| ANDA | ANDA207136 |
| COLORTEXT | yellow(Colourless to light yellow) |
| Color | C48330 __ |
| FDA SPL set id | 786945 |
| Labeler | American Health Packaging |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2024-05-19 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 60687-731 |
NDC Item 60687073183
| NDC 9 | 60687-731 |
|---|---|
| NDC 10 | 60687-731-83 |
| NDC Item | 60687073183 |
| Packaging | 30 POUCH in 1 CARTON (60687-731-83) / 1 AMPULE in 1 POUCH (60687-731-79) / 5 mL in 1 AMPULE |
| ANDA | ANDA207136 |
| COLORTEXT | yellow(Colourless to light yellow) |
| Color | C48330 __ |
| FDA SPL set id | 786945 |
| Labeler | American Health Packaging |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2024-05-19 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 60687-731 |
NDC Item 65162091446
| NDC 9 | 65162-914 |
|---|---|
| NDC 10 | 65162-914-46 |
| NDC Item | 65162091446 |
| Packaging | 56 AMPULE in 1 CARTON (65162-914-46) / 5 mL in 1 AMPULE |
| ANDA | ANDA205501 |
| COLORTEXT | yellow(clear, slightly yellow) |
| Color | C48330 __ |
| FDA SPL set id | 824547 |
| Labeler | Amneal Pharmaceuticals LLC |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2014-07-13 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 65162-914 |
NDC Item 67877067869
| NDC 9 | 67877-678 |
|---|---|
| NDC 10 | 67877-678-69 |
| NDC Item | 67877067869 |
| Packaging | 5 mL in 1 AMPULE |
| Packaging | 7 in 1 POUCH |
| ANDA | ANDA212848 |
| FDA SPL set id | 762146 |
| Labeler | Ascend Laboratories, LLC |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2021-04-02 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 67877-678 |
NDC Item 67877067870
| NDC 9 | 67877-678 |
|---|---|
| NDC 10 | 67877-678-70 |
| NDC Item | 67877067870 |
| Packaging | 56 POUCH in 1 CARTON (67877-678-70) / 7 AMPULE in 1 POUCH (67877-678-69) / 5 mL in 1 AMPULE |
| ANDA | ANDA212848 |
| FDA SPL set id | 762146 |
| Labeler | Ascend Laboratories, LLC |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2021-04-02 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 67877-678 |
NDC Item 68180096204
| NDC 9 | 68180-962 |
|---|---|
| NDC 10 | 68180-962-04 |
| NDC Item | 68180096204 |
| Packaging | 4 in 1 POUCH |
| Packaging | 5 mL in 1 AMPULE |
| ANDA | ANDA208964 |
| FDA SPL set id | 779846 |
| Labeler | Lupin Pharmaceuticals, Inc. |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2018-06-12 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 68180-962 |
NDC Item 68180096256
| NDC 9 | 68180-962 |
|---|---|
| NDC 10 | 68180-962-56 |
| NDC Item | 68180096256 |
| Packaging | 56 POUCH in 1 CARTON (68180-962-56) / 4 AMPULE in 1 POUCH / 5 mL in 1 AMPULE |
| ANDA | ANDA208964 |
| FDA SPL set id | 779846 |
| Labeler | Lupin Pharmaceuticals, Inc. |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2018-06-12 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 68180-962 |
NDC Item 70644089999
| NDC 9 | 70644-899 |
|---|---|
| NDC 10 | 70644-899-99 |
| NDC Item | 70644089999 |
| Packaging | 14 POUCH in 1 CARTON (70644-899-99) / 4 AMPULE in 1 POUCH / 5 mL in 1 AMPULE |
| FDA SPL set id | 849478 |
| Labeler | Genericus, Inc. |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | NDA AUTHORIZED GENERIC |
| Marketing effective time low | 2016-07-11 |
| Marketing status | ACTIVE |
| NDA_AUTHORIZED_GENERIC | NDA205433 |
| Related queries | Properties for NDC 9 70644-899 |
NDC Item 70756060444
| NDC 9 | 70756-604 |
|---|---|
| NDC 10 | 70756-604-44 |
| NDC Item | 70756060444 |
| Packaging | 4 in 1 POUCH |
| Packaging | 5 mL in 1 AMPULE |
| ANDA | ANDA214478 |
| FDA SPL set id | 805293 |
| Labeler | Lifestar Pharma LLC |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2023-06-30 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 70756-604 |
NDC Item 70756060456
| NDC 9 | 70756-604 |
|---|---|
| NDC 10 | 70756-604-56 |
| NDC Item | 70756060456 |
| Packaging | 14 POUCH in 1 CARTON (70756-604-56) / 4 AMPULE in 1 POUCH (70756-604-44) / 5 mL in 1 AMPULE |
| ANDA | ANDA214478 |
| FDA SPL set id | 805293 |
| Labeler | Lifestar Pharma LLC |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2023-06-30 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 70756-604 |
NDC Item 72603043004
| NDC 9 | 72603-430 |
|---|---|
| NDC 10 | 72603-430-04 |
| NDC Item | 72603043004 |
| Packaging | 4 in 1 POUCH |
| Packaging | 5 mL in 1 AMPULE |
| ANDA | ANDA214478 |
| FDA SPL set id | 801097 |
| Labeler | NorthStar RxLLC |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2024-08-01 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 72603-430 |
NDC Item 72603043056
| NDC 9 | 72603-430 |
|---|---|
| NDC 10 | 72603-430-56 |
| NDC Item | 72603043056 |
| Packaging | 14 POUCH in 1 CARTON (72603-430-56) / 4 AMPULE in 1 POUCH (72603-430-04) / 5 mL in 1 AMPULE |
| ANDA | ANDA214478 |
| FDA SPL set id | 801097 |
| Labeler | NorthStar RxLLC |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2024-08-01 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 72603-430 |
NDC Item 76204002956
| NDC 9 | 76204-029 |
|---|---|
| NDC 10 | 76204-029-56 |
| NDC Item | 76204002956 |
| Packaging | 14 POUCH in 1 CARTON (76204-029-56) / 4 AMPULE in 1 POUCH / 5 mL in 1 AMPULE |
| ANDA | ANDA201422 |
| FDA SPL set id | 866956 |
| Labeler | Ritedose Pharmaceuticals, LLC |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2025-03-25 |
| Marketing status | active |
| Related queries | Properties for NDC 9 76204-029 |
NDC Item 00093408563
| NDC 9 | 0093-4085 |
|---|---|
| NDC 10 | 0093-4085-63 |
| NDC Item | 00093408563 |
| Packaging | 56 AMPULE in 1 CARTON (0093-4085-63) / 5 mL in 1 AMPULE |
| ANDA | ANDA091589 |
| FDA SPL set id | 861925 |
| Labeler | Teva Pharmaceuticals USA, Inc. |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2013-11-19 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 0093-4085 |
NDC Item 00781717156
| NDC 9 | 0781-7171 |
|---|---|
| NDC 10 | 0781-7171-56 |
| NDC Item | 00781717156 |
| Packaging | 56 AMPULE in 1 CARTON (0781-7171-56) / 5 mL in 1 AMPULE (0781-7171-75) |
| FDA SPL set id | 132419 |
| Labeler | Sandoz Inc |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | NDA AUTHORIZED GENERIC |
| Marketing effective time low | 2014-07-09 |
| Marketing status | COMPLETED |
| NDA_AUTHORIZED_GENERIC | NDA050753 |
| Related queries | Properties for NDC 9 0781-7171 |
NDC Item 00781717175
| NDC 9 | 0781-7171 |
|---|---|
| NDC 10 | 0781-7171-75 |
| NDC Item | 00781717175 |
| Packaging | 5 mL in 1 AMPULE |
| FDA SPL set id | 132419 |
| Labeler | Sandoz Inc |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | NDA AUTHORIZED GENERIC |
| Marketing effective time low | 2014-07-09 |
| Marketing status | COMPLETED |
| NDA_AUTHORIZED_GENERIC | NDA050753 |
| Related queries | Properties for NDC 9 0781-7171 |
NDC Item 16714011902
| NDC 9 | 16714-119 |
|---|---|
| NDC 10 | 16714-119-02 |
| NDC Item | 16714011902 |
| Packaging | 5 mL in 1 AMPULE |
| ANDA | ANDA207080 |
| FDA SPL set id | 842222 |
| Labeler | NorthStar RxLLC |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2020-05-21 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 16714-119 |
NDC Item 16714011903
| NDC 9 | 16714-119 |
|---|---|
| NDC 10 | 16714-119-03 |
| NDC Item | 16714011903 |
| Packaging | 14 POUCH in 1 CARTON (16714-119-03) / 4 AMPULE in 1 POUCH / 5 mL in 1 AMPULE (16714-119-02) |
| ANDA | ANDA207080 |
| FDA SPL set id | 842222 |
| Labeler | NorthStar RxLLC |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2020-05-21 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 16714-119 |
NDC Item 17478034038
| NDC 9 | 17478-340 |
|---|---|
| NDC 10 | 17478-340-38 |
| NDC Item | 17478034038 |
| Packaging | 14 POUCH in 1 CARTON (17478-340-38) / 4 AMPULE in 1 POUCH / 5 mL in 1 AMPULE |
| ANDA | ANDA201422 |
| FDA SPL set id | 656792 |
| Labeler | Akorn Operating Company LLC (dba Akorn) |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 17478-340 |
NDC Item 42571040809
| NDC 9 | 42571-408 |
|---|---|
| NDC 10 | 42571-408-09 |
| NDC Item | 42571040809 |
| Packaging | 5 mL in 1 AMPULE |
| ANDA | ANDA217344 |
| FDA SPL set id | 812408 |
| Labeler | Micro Labs Limited |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2024-01-01 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 42571-408 |
NDC Item 42571040819
| NDC 9 | 42571-408 |
|---|---|
| NDC 10 | 42571-408-19 |
| NDC Item | 42571040819 |
| Packaging | 4 in 1 POUCH |
| ANDA | ANDA217344 |
| FDA SPL set id | 812408 |
| Labeler | Micro Labs Limited |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2024-01-01 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 42571-408 |
NDC Item 42571040892
| NDC 9 | 42571-408 |
|---|---|
| NDC 10 | 42571-408-92 |
| NDC Item | 42571040892 |
| Packaging | 14 POUCH in 1 CARTON (42571-408-92) / 4 AMPULE in 1 POUCH (42571-408-19) / 5 mL in 1 AMPULE (42571-408-09) |
| ANDA | ANDA217344 |
| FDA SPL set id | 812408 |
| Labeler | Micro Labs Limited |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2024-01-01 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 42571-408 |
NDC Item 43598060504
| NDC 9 | 43598-605 |
|---|---|
| NDC 10 | 43598-605-04 |
| NDC Item | 43598060504 |
| ANDA | ANDA207080 |
| FDA SPL set id | 706735 |
| Labeler | Dr. Reddy's Laboratories Inc. |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2019-05-14 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 43598-605 |
NDC Item 43598060511
| NDC 9 | 43598-605 |
|---|---|
| NDC 10 | 43598-605-11 |
| NDC Item | 43598060511 |
| ANDA | ANDA207080 |
| FDA SPL set id | 706735 |
| Labeler | Dr. Reddy's Laboratories Inc. |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2019-05-14 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 43598-605 |
NDC Item 43598060556
| NDC 9 | 43598-605 |
|---|---|
| NDC 10 | 43598-605-56 |
| NDC Item | 43598060556 |
| Packaging | 14 POUCH in 1 CARTON (43598-605-56) / 4 AMPULE in 1 POUCH (43598-605-04) / 5 mL in 1 AMPULE |
| ANDA | ANDA207080 |
| FDA SPL set id | 706735 |
| Labeler | Dr. Reddy's Laboratories Inc. |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2019-05-14 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 43598-605 |
NDC Item 43598060558
| NDC 9 | 43598-605 |
|---|---|
| NDC 10 | 43598-605-58 |
| NDC Item | 43598060558 |
| Packaging | 56 POUCH in 1 CARTON (43598-605-58) / 1 AMPULE in 1 POUCH (43598-605-11) / 5 mL in 1 AMPULE |
| ANDA | ANDA207080 |
| FDA SPL set id | 706735 |
| Labeler | Dr. Reddy's Laboratories Inc. |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2019-05-14 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 43598-605 |
NDC Item 47335017148
| NDC 9 | 47335-171 |
|---|---|
| NDC 10 | 47335-171-48 |
| NDC Item | 47335017148 |
| Packaging | 4 in 1 POUCH |
| Packaging | 5 mL in 1 AMPULE |
| ANDA | ANDA207136 |
| COLORTEXT | YELLOW(Colourless to light yellow) |
| Color | C48330 __ |
| FDA SPL set id | 707885 |
| Labeler | Sun Pharmaceutical Industries, Inc. |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2020-02-28 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 47335-171 |
NDC Item 47335017149
| NDC 9 | 47335-171 |
|---|---|
| NDC 10 | 47335-171-49 |
| NDC Item | 47335017149 |
| Packaging | 14 POUCH in 1 CARTON (47335-171-49) / 4 AMPULE in 1 POUCH (47335-171-48) / 5 mL in 1 AMPULE |
| ANDA | ANDA207136 |
| COLORTEXT | YELLOW(Colourless to light yellow) |
| Color | C48330 __ |
| FDA SPL set id | 707885 |
| Labeler | Sun Pharmaceutical Industries, Inc. |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2020-02-28 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 47335-171 |
NDC Item 59651012904
| NDC 9 | 59651-129 |
|---|---|
| NDC 10 | 59651-129-04 |
| NDC Item | 59651012904 |
| Packaging | 4 in 1 POUCH |
| Packaging | 5 mL in 1 AMPULE |
| ANDA | ANDA210871 |
| FDA SPL set id | 710977 |
| Labeler | Aurobindo Pharma Limited |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2021-01-22 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 59651-129 |
NDC Item 59651012956
| NDC 9 | 59651-129 |
|---|---|
| NDC 10 | 59651-129-56 |
| NDC Item | 59651012956 |
| Packaging | 14 POUCH in 1 CARTON (59651-129-56) / 4 AMPULE in 1 POUCH (59651-129-04) / 5 mL in 1 AMPULE |
| ANDA | ANDA210871 |
| FDA SPL set id | 710977 |
| Labeler | Aurobindo Pharma Limited |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2021-01-22 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 59651-129 |
NDC Item 60687073179
| NDC 9 | 60687-731 |
|---|---|
| NDC 10 | 60687-731-79 |
| NDC Item | 60687073179 |
| Packaging | 1 in 1 POUCH |
| Packaging | 5 mL in 1 AMPULE |
| ANDA | ANDA207136 |
| COLORTEXT | yellow(Colourless to light yellow) |
| Color | C48330 __ |
| FDA SPL set id | 786945 |
| Labeler | American Health Packaging |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2024-05-19 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 60687-731 |
NDC Item 60687073183
| NDC 9 | 60687-731 |
|---|---|
| NDC 10 | 60687-731-83 |
| NDC Item | 60687073183 |
| Packaging | 30 POUCH in 1 CARTON (60687-731-83) / 1 AMPULE in 1 POUCH (60687-731-79) / 5 mL in 1 AMPULE |
| ANDA | ANDA207136 |
| COLORTEXT | yellow(Colourless to light yellow) |
| Color | C48330 __ |
| FDA SPL set id | 786945 |
| Labeler | American Health Packaging |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2024-05-19 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 60687-731 |
NDC Item 65162091446
| NDC 9 | 65162-914 |
|---|---|
| NDC 10 | 65162-914-46 |
| NDC Item | 65162091446 |
| Packaging | 56 AMPULE in 1 CARTON (65162-914-46) / 5 mL in 1 AMPULE |
| ANDA | ANDA205501 |
| COLORTEXT | yellow(clear, slightly yellow) |
| Color | C48330 __ |
| FDA SPL set id | 824547 |
| Labeler | Amneal Pharmaceuticals LLC |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2014-07-13 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 65162-914 |
NDC Item 67877067869
| NDC 9 | 67877-678 |
|---|---|
| NDC 10 | 67877-678-69 |
| NDC Item | 67877067869 |
| Packaging | 5 mL in 1 AMPULE |
| Packaging | 7 in 1 POUCH |
| ANDA | ANDA212848 |
| FDA SPL set id | 762146 |
| Labeler | Ascend Laboratories, LLC |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2021-04-02 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 67877-678 |
NDC Item 67877067870
| NDC 9 | 67877-678 |
|---|---|
| NDC 10 | 67877-678-70 |
| NDC Item | 67877067870 |
| Packaging | 56 POUCH in 1 CARTON (67877-678-70) / 7 AMPULE in 1 POUCH (67877-678-69) / 5 mL in 1 AMPULE |
| ANDA | ANDA212848 |
| FDA SPL set id | 762146 |
| Labeler | Ascend Laboratories, LLC |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2021-04-02 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 67877-678 |
NDC Item 68180096204
| NDC 9 | 68180-962 |
|---|---|
| NDC 10 | 68180-962-04 |
| NDC Item | 68180096204 |
| Packaging | 4 in 1 POUCH |
| Packaging | 5 mL in 1 AMPULE |
| ANDA | ANDA208964 |
| FDA SPL set id | 779846 |
| Labeler | Lupin Pharmaceuticals, Inc. |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2018-06-12 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 68180-962 |
NDC Item 68180096256
| NDC 9 | 68180-962 |
|---|---|
| NDC 10 | 68180-962-56 |
| NDC Item | 68180096256 |
| Packaging | 56 POUCH in 1 CARTON (68180-962-56) / 4 AMPULE in 1 POUCH / 5 mL in 1 AMPULE |
| ANDA | ANDA208964 |
| FDA SPL set id | 779846 |
| Labeler | Lupin Pharmaceuticals, Inc. |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2018-06-12 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 68180-962 |
NDC Item 70644089999
| NDC 9 | 70644-899 |
|---|---|
| NDC 10 | 70644-899-99 |
| NDC Item | 70644089999 |
| Packaging | 14 POUCH in 1 CARTON (70644-899-99) / 4 AMPULE in 1 POUCH / 5 mL in 1 AMPULE |
| FDA SPL set id | 849478 |
| Labeler | Genericus, Inc. |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | NDA AUTHORIZED GENERIC |
| Marketing effective time low | 2016-07-11 |
| Marketing status | ACTIVE |
| NDA_AUTHORIZED_GENERIC | NDA205433 |
| Related queries | Properties for NDC 9 70644-899 |
NDC Item 70756060444
| NDC 9 | 70756-604 |
|---|---|
| NDC 10 | 70756-604-44 |
| NDC Item | 70756060444 |
| Packaging | 4 in 1 POUCH |
| Packaging | 5 mL in 1 AMPULE |
| ANDA | ANDA214478 |
| FDA SPL set id | 805293 |
| Labeler | Lifestar Pharma LLC |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2023-06-30 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 70756-604 |
NDC Item 70756060456
| NDC 9 | 70756-604 |
|---|---|
| NDC 10 | 70756-604-56 |
| NDC Item | 70756060456 |
| Packaging | 14 POUCH in 1 CARTON (70756-604-56) / 4 AMPULE in 1 POUCH (70756-604-44) / 5 mL in 1 AMPULE |
| ANDA | ANDA214478 |
| FDA SPL set id | 805293 |
| Labeler | Lifestar Pharma LLC |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2023-06-30 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 70756-604 |
NDC Item 72603043004
| NDC 9 | 72603-430 |
|---|---|
| NDC 10 | 72603-430-04 |
| NDC Item | 72603043004 |
| Packaging | 4 in 1 POUCH |
| Packaging | 5 mL in 1 AMPULE |
| ANDA | ANDA214478 |
| FDA SPL set id | 801097 |
| Labeler | NorthStar RxLLC |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2024-08-01 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 72603-430 |
NDC Item 72603043056
| NDC 9 | 72603-430 |
|---|---|
| NDC 10 | 72603-430-56 |
| NDC Item | 72603043056 |
| Packaging | 14 POUCH in 1 CARTON (72603-430-56) / 4 AMPULE in 1 POUCH (72603-430-04) / 5 mL in 1 AMPULE |
| ANDA | ANDA214478 |
| FDA SPL set id | 801097 |
| Labeler | NorthStar RxLLC |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2024-08-01 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 72603-430 |
NDC Item 76204002956
| NDC 9 | 76204-029 |
|---|---|
| NDC 10 | 76204-029-56 |
| NDC Item | 76204002956 |
| Packaging | 14 POUCH in 1 CARTON (76204-029-56) / 4 AMPULE in 1 POUCH / 5 mL in 1 AMPULE |
| ANDA | ANDA201422 |
| FDA SPL set id | 866956 |
| Labeler | Ritedose Pharmaceuticals, LLC |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2025-03-25 |
| Marketing status | active |
| Related queries | Properties for NDC 9 76204-029 |
NDC Item 00093408563
| NDC 9 | 0093-4085 |
|---|---|
| NDC 10 | 0093-4085-63 |
| NDC Item | 00093408563 |
| Packaging | 56 AMPULE in 1 CARTON (0093-4085-63) / 5 mL in 1 AMPULE |
| ANDA | ANDA091589 |
| FDA SPL set id | 861925 |
| Labeler | Teva Pharmaceuticals USA, Inc. |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2013-11-19 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 0093-4085 |
NDC Item 00781717156
| NDC 9 | 0781-7171 |
|---|---|
| NDC 10 | 0781-7171-56 |
| NDC Item | 00781717156 |
| Packaging | 56 AMPULE in 1 CARTON (0781-7171-56) / 5 mL in 1 AMPULE (0781-7171-75) |
| FDA SPL set id | 132419 |
| Labeler | Sandoz Inc |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | NDA AUTHORIZED GENERIC |
| Marketing effective time low | 2014-07-09 |
| Marketing status | COMPLETED |
| NDA_AUTHORIZED_GENERIC | NDA050753 |
| Related queries | Properties for NDC 9 0781-7171 |
NDC Item 00781717175
| NDC 9 | 0781-7171 |
|---|---|
| NDC 10 | 0781-7171-75 |
| NDC Item | 00781717175 |
| Packaging | 5 mL in 1 AMPULE |
| FDA SPL set id | 132419 |
| Labeler | Sandoz Inc |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | NDA AUTHORIZED GENERIC |
| Marketing effective time low | 2014-07-09 |
| Marketing status | COMPLETED |
| NDA_AUTHORIZED_GENERIC | NDA050753 |
| Related queries | Properties for NDC 9 0781-7171 |
NDC Item 16714011902
| NDC 9 | 16714-119 |
|---|---|
| NDC 10 | 16714-119-02 |
| NDC Item | 16714011902 |
| Packaging | 5 mL in 1 AMPULE |
| ANDA | ANDA207080 |
| FDA SPL set id | 842222 |
| Labeler | NorthStar RxLLC |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2020-05-21 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 16714-119 |
NDC Item 16714011903
| NDC 9 | 16714-119 |
|---|---|
| NDC 10 | 16714-119-03 |
| NDC Item | 16714011903 |
| Packaging | 14 POUCH in 1 CARTON (16714-119-03) / 4 AMPULE in 1 POUCH / 5 mL in 1 AMPULE (16714-119-02) |
| ANDA | ANDA207080 |
| FDA SPL set id | 842222 |
| Labeler | NorthStar RxLLC |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2020-05-21 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 16714-119 |
NDC Item 17478034038
| NDC 9 | 17478-340 |
|---|---|
| NDC 10 | 17478-340-38 |
| NDC Item | 17478034038 |
| Packaging | 14 POUCH in 1 CARTON (17478-340-38) / 4 AMPULE in 1 POUCH / 5 mL in 1 AMPULE |
| ANDA | ANDA201422 |
| FDA SPL set id | 656792 |
| Labeler | Akorn Operating Company LLC (dba Akorn) |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 17478-340 |
NDC Item 42571040809
| NDC 9 | 42571-408 |
|---|---|
| NDC 10 | 42571-408-09 |
| NDC Item | 42571040809 |
| Packaging | 5 mL in 1 AMPULE |
| ANDA | ANDA217344 |
| FDA SPL set id | 812408 |
| Labeler | Micro Labs Limited |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2024-01-01 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 42571-408 |
NDC Item 42571040819
| NDC 9 | 42571-408 |
|---|---|
| NDC 10 | 42571-408-19 |
| NDC Item | 42571040819 |
| Packaging | 4 in 1 POUCH |
| ANDA | ANDA217344 |
| FDA SPL set id | 812408 |
| Labeler | Micro Labs Limited |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2024-01-01 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 42571-408 |
NDC Item 42571040892
| NDC 9 | 42571-408 |
|---|---|
| NDC 10 | 42571-408-92 |
| NDC Item | 42571040892 |
| Packaging | 14 POUCH in 1 CARTON (42571-408-92) / 4 AMPULE in 1 POUCH (42571-408-19) / 5 mL in 1 AMPULE (42571-408-09) |
| ANDA | ANDA217344 |
| FDA SPL set id | 812408 |
| Labeler | Micro Labs Limited |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2024-01-01 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 42571-408 |
NDC Item 43598060504
| NDC 9 | 43598-605 |
|---|---|
| NDC 10 | 43598-605-04 |
| NDC Item | 43598060504 |
| ANDA | ANDA207080 |
| FDA SPL set id | 706735 |
| Labeler | Dr. Reddy's Laboratories Inc. |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2019-05-14 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 43598-605 |
NDC Item 43598060511
| NDC 9 | 43598-605 |
|---|---|
| NDC 10 | 43598-605-11 |
| NDC Item | 43598060511 |
| ANDA | ANDA207080 |
| FDA SPL set id | 706735 |
| Labeler | Dr. Reddy's Laboratories Inc. |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2019-05-14 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 43598-605 |
NDC Item 43598060556
| NDC 9 | 43598-605 |
|---|---|
| NDC 10 | 43598-605-56 |
| NDC Item | 43598060556 |
| Packaging | 14 POUCH in 1 CARTON (43598-605-56) / 4 AMPULE in 1 POUCH (43598-605-04) / 5 mL in 1 AMPULE |
| ANDA | ANDA207080 |
| FDA SPL set id | 706735 |
| Labeler | Dr. Reddy's Laboratories Inc. |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2019-05-14 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 43598-605 |
NDC Item 43598060558
| NDC 9 | 43598-605 |
|---|---|
| NDC 10 | 43598-605-58 |
| NDC Item | 43598060558 |
| Packaging | 56 POUCH in 1 CARTON (43598-605-58) / 1 AMPULE in 1 POUCH (43598-605-11) / 5 mL in 1 AMPULE |
| ANDA | ANDA207080 |
| FDA SPL set id | 706735 |
| Labeler | Dr. Reddy's Laboratories Inc. |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2019-05-14 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 43598-605 |
NDC Item 47335017148
| NDC 9 | 47335-171 |
|---|---|
| NDC 10 | 47335-171-48 |
| NDC Item | 47335017148 |
| Packaging | 4 in 1 POUCH |
| Packaging | 5 mL in 1 AMPULE |
| ANDA | ANDA207136 |
| COLORTEXT | YELLOW(Colourless to light yellow) |
| Color | C48330 __ |
| FDA SPL set id | 707885 |
| Labeler | Sun Pharmaceutical Industries, Inc. |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2020-02-28 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 47335-171 |
NDC Item 47335017149
| NDC 9 | 47335-171 |
|---|---|
| NDC 10 | 47335-171-49 |
| NDC Item | 47335017149 |
| Packaging | 14 POUCH in 1 CARTON (47335-171-49) / 4 AMPULE in 1 POUCH (47335-171-48) / 5 mL in 1 AMPULE |
| ANDA | ANDA207136 |
| COLORTEXT | YELLOW(Colourless to light yellow) |
| Color | C48330 __ |
| FDA SPL set id | 707885 |
| Labeler | Sun Pharmaceutical Industries, Inc. |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2020-02-28 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 47335-171 |
NDC Item 59651012904
| NDC 9 | 59651-129 |
|---|---|
| NDC 10 | 59651-129-04 |
| NDC Item | 59651012904 |
| Packaging | 4 in 1 POUCH |
| Packaging | 5 mL in 1 AMPULE |
| ANDA | ANDA210871 |
| FDA SPL set id | 710977 |
| Labeler | Aurobindo Pharma Limited |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2021-01-22 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 59651-129 |
NDC Item 59651012956
| NDC 9 | 59651-129 |
|---|---|
| NDC 10 | 59651-129-56 |
| NDC Item | 59651012956 |
| Packaging | 14 POUCH in 1 CARTON (59651-129-56) / 4 AMPULE in 1 POUCH (59651-129-04) / 5 mL in 1 AMPULE |
| ANDA | ANDA210871 |
| FDA SPL set id | 710977 |
| Labeler | Aurobindo Pharma Limited |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2021-01-22 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 59651-129 |
NDC Item 60687073179
| NDC 9 | 60687-731 |
|---|---|
| NDC 10 | 60687-731-79 |
| NDC Item | 60687073179 |
| Packaging | 1 in 1 POUCH |
| Packaging | 5 mL in 1 AMPULE |
| ANDA | ANDA207136 |
| COLORTEXT | yellow(Colourless to light yellow) |
| Color | C48330 __ |
| FDA SPL set id | 786945 |
| Labeler | American Health Packaging |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2024-05-19 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 60687-731 |
NDC Item 60687073183
| NDC 9 | 60687-731 |
|---|---|
| NDC 10 | 60687-731-83 |
| NDC Item | 60687073183 |
| Packaging | 30 POUCH in 1 CARTON (60687-731-83) / 1 AMPULE in 1 POUCH (60687-731-79) / 5 mL in 1 AMPULE |
| ANDA | ANDA207136 |
| COLORTEXT | yellow(Colourless to light yellow) |
| Color | C48330 __ |
| FDA SPL set id | 786945 |
| Labeler | American Health Packaging |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2024-05-19 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 60687-731 |
NDC Item 65162091446
| NDC 9 | 65162-914 |
|---|---|
| NDC 10 | 65162-914-46 |
| NDC Item | 65162091446 |
| Packaging | 56 AMPULE in 1 CARTON (65162-914-46) / 5 mL in 1 AMPULE |
| ANDA | ANDA205501 |
| COLORTEXT | yellow(clear, slightly yellow) |
| Color | C48330 __ |
| FDA SPL set id | 824547 |
| Labeler | Amneal Pharmaceuticals LLC |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2014-07-13 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 65162-914 |
NDC Item 67877067869
| NDC 9 | 67877-678 |
|---|---|
| NDC 10 | 67877-678-69 |
| NDC Item | 67877067869 |
| Packaging | 5 mL in 1 AMPULE |
| Packaging | 7 in 1 POUCH |
| ANDA | ANDA212848 |
| FDA SPL set id | 762146 |
| Labeler | Ascend Laboratories, LLC |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2021-04-02 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 67877-678 |
NDC Item 67877067870
| NDC 9 | 67877-678 |
|---|---|
| NDC 10 | 67877-678-70 |
| NDC Item | 67877067870 |
| Packaging | 56 POUCH in 1 CARTON (67877-678-70) / 7 AMPULE in 1 POUCH (67877-678-69) / 5 mL in 1 AMPULE |
| ANDA | ANDA212848 |
| FDA SPL set id | 762146 |
| Labeler | Ascend Laboratories, LLC |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2021-04-02 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 67877-678 |
NDC Item 68180096204
| NDC 9 | 68180-962 |
|---|---|
| NDC 10 | 68180-962-04 |
| NDC Item | 68180096204 |
| Packaging | 4 in 1 POUCH |
| Packaging | 5 mL in 1 AMPULE |
| ANDA | ANDA208964 |
| FDA SPL set id | 779846 |
| Labeler | Lupin Pharmaceuticals, Inc. |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2018-06-12 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 68180-962 |
NDC Item 68180096256
| NDC 9 | 68180-962 |
|---|---|
| NDC 10 | 68180-962-56 |
| NDC Item | 68180096256 |
| Packaging | 56 POUCH in 1 CARTON (68180-962-56) / 4 AMPULE in 1 POUCH / 5 mL in 1 AMPULE |
| ANDA | ANDA208964 |
| FDA SPL set id | 779846 |
| Labeler | Lupin Pharmaceuticals, Inc. |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2018-06-12 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 68180-962 |
NDC Item 70644089999
| NDC 9 | 70644-899 |
|---|---|
| NDC 10 | 70644-899-99 |
| NDC Item | 70644089999 |
| Packaging | 14 POUCH in 1 CARTON (70644-899-99) / 4 AMPULE in 1 POUCH / 5 mL in 1 AMPULE |
| FDA SPL set id | 849478 |
| Labeler | Genericus, Inc. |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | NDA AUTHORIZED GENERIC |
| Marketing effective time low | 2016-07-11 |
| Marketing status | ACTIVE |
| NDA_AUTHORIZED_GENERIC | NDA205433 |
| Related queries | Properties for NDC 9 70644-899 |
NDC Item 70756060444
| NDC 9 | 70756-604 |
|---|---|
| NDC 10 | 70756-604-44 |
| NDC Item | 70756060444 |
| Packaging | 4 in 1 POUCH |
| Packaging | 5 mL in 1 AMPULE |
| ANDA | ANDA214478 |
| FDA SPL set id | 805293 |
| Labeler | Lifestar Pharma LLC |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2023-06-30 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 70756-604 |
NDC Item 70756060456
| NDC 9 | 70756-604 |
|---|---|
| NDC 10 | 70756-604-56 |
| NDC Item | 70756060456 |
| Packaging | 14 POUCH in 1 CARTON (70756-604-56) / 4 AMPULE in 1 POUCH (70756-604-44) / 5 mL in 1 AMPULE |
| ANDA | ANDA214478 |
| FDA SPL set id | 805293 |
| Labeler | Lifestar Pharma LLC |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2023-06-30 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 70756-604 |
NDC Item 72603043004
| NDC 9 | 72603-430 |
|---|---|
| NDC 10 | 72603-430-04 |
| NDC Item | 72603043004 |
| Packaging | 4 in 1 POUCH |
| Packaging | 5 mL in 1 AMPULE |
| ANDA | ANDA214478 |
| FDA SPL set id | 801097 |
| Labeler | NorthStar RxLLC |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2024-08-01 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 72603-430 |
NDC Item 72603043056
| NDC 9 | 72603-430 |
|---|---|
| NDC 10 | 72603-430-56 |
| NDC Item | 72603043056 |
| Packaging | 14 POUCH in 1 CARTON (72603-430-56) / 4 AMPULE in 1 POUCH (72603-430-04) / 5 mL in 1 AMPULE |
| ANDA | ANDA214478 |
| FDA SPL set id | 801097 |
| Labeler | NorthStar RxLLC |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2024-08-01 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 72603-430 |
NDC Item 76204002956
| NDC 9 | 76204-029 |
|---|---|
| NDC 10 | 76204-029-56 |
| NDC Item | 76204002956 |
| Packaging | 14 POUCH in 1 CARTON (76204-029-56) / 4 AMPULE in 1 POUCH / 5 mL in 1 AMPULE |
| ANDA | ANDA201422 |
| FDA SPL set id | 866956 |
| Labeler | Ritedose Pharmaceuticals, LLC |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2025-03-25 |
| Marketing status | active |
| Related queries | Properties for NDC 9 76204-029 |
NDC Item 00093408563
| NDC 9 | 0093-4085 |
|---|---|
| NDC 10 | 0093-4085-63 |
| NDC Item | 00093408563 |
| Packaging | 56 AMPULE in 1 CARTON (0093-4085-63) / 5 mL in 1 AMPULE |
| ANDA | ANDA091589 |
| FDA SPL set id | 861925 |
| Labeler | Teva Pharmaceuticals USA, Inc. |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2013-11-19 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 0093-4085 |
NDC Item 00781717156
| NDC 9 | 0781-7171 |
|---|---|
| NDC 10 | 0781-7171-56 |
| NDC Item | 00781717156 |
| Packaging | 56 AMPULE in 1 CARTON (0781-7171-56) / 5 mL in 1 AMPULE (0781-7171-75) |
| FDA SPL set id | 132419 |
| Labeler | Sandoz Inc |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | NDA AUTHORIZED GENERIC |
| Marketing effective time low | 2014-07-09 |
| Marketing status | COMPLETED |
| NDA_AUTHORIZED_GENERIC | NDA050753 |
| Related queries | Properties for NDC 9 0781-7171 |
NDC Item 00781717175
| NDC 9 | 0781-7171 |
|---|---|
| NDC 10 | 0781-7171-75 |
| NDC Item | 00781717175 |
| Packaging | 5 mL in 1 AMPULE |
| FDA SPL set id | 132419 |
| Labeler | Sandoz Inc |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | NDA AUTHORIZED GENERIC |
| Marketing effective time low | 2014-07-09 |
| Marketing status | COMPLETED |
| NDA_AUTHORIZED_GENERIC | NDA050753 |
| Related queries | Properties for NDC 9 0781-7171 |
NDC Item 16714011902
| NDC 9 | 16714-119 |
|---|---|
| NDC 10 | 16714-119-02 |
| NDC Item | 16714011902 |
| Packaging | 5 mL in 1 AMPULE |
| ANDA | ANDA207080 |
| FDA SPL set id | 842222 |
| Labeler | NorthStar RxLLC |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2020-05-21 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 16714-119 |
NDC Item 16714011903
| NDC 9 | 16714-119 |
|---|---|
| NDC 10 | 16714-119-03 |
| NDC Item | 16714011903 |
| Packaging | 14 POUCH in 1 CARTON (16714-119-03) / 4 AMPULE in 1 POUCH / 5 mL in 1 AMPULE (16714-119-02) |
| ANDA | ANDA207080 |
| FDA SPL set id | 842222 |
| Labeler | NorthStar RxLLC |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2020-05-21 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 16714-119 |
NDC Item 17478034038
| NDC 9 | 17478-340 |
|---|---|
| NDC 10 | 17478-340-38 |
| NDC Item | 17478034038 |
| Packaging | 14 POUCH in 1 CARTON (17478-340-38) / 4 AMPULE in 1 POUCH / 5 mL in 1 AMPULE |
| ANDA | ANDA201422 |
| FDA SPL set id | 656792 |
| Labeler | Akorn Operating Company LLC (dba Akorn) |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 17478-340 |
NDC Item 42571040809
| NDC 9 | 42571-408 |
|---|---|
| NDC 10 | 42571-408-09 |
| NDC Item | 42571040809 |
| Packaging | 5 mL in 1 AMPULE |
| ANDA | ANDA217344 |
| FDA SPL set id | 812408 |
| Labeler | Micro Labs Limited |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2024-01-01 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 42571-408 |
NDC Item 42571040819
| NDC 9 | 42571-408 |
|---|---|
| NDC 10 | 42571-408-19 |
| NDC Item | 42571040819 |
| Packaging | 4 in 1 POUCH |
| ANDA | ANDA217344 |
| FDA SPL set id | 812408 |
| Labeler | Micro Labs Limited |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2024-01-01 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 42571-408 |
NDC Item 42571040892
| NDC 9 | 42571-408 |
|---|---|
| NDC 10 | 42571-408-92 |
| NDC Item | 42571040892 |
| Packaging | 14 POUCH in 1 CARTON (42571-408-92) / 4 AMPULE in 1 POUCH (42571-408-19) / 5 mL in 1 AMPULE (42571-408-09) |
| ANDA | ANDA217344 |
| FDA SPL set id | 812408 |
| Labeler | Micro Labs Limited |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2024-01-01 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 42571-408 |
NDC Item 43598060504
| NDC 9 | 43598-605 |
|---|---|
| NDC 10 | 43598-605-04 |
| NDC Item | 43598060504 |
| ANDA | ANDA207080 |
| FDA SPL set id | 706735 |
| Labeler | Dr. Reddy's Laboratories Inc. |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2019-05-14 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 43598-605 |
NDC Item 43598060511
| NDC 9 | 43598-605 |
|---|---|
| NDC 10 | 43598-605-11 |
| NDC Item | 43598060511 |
| ANDA | ANDA207080 |
| FDA SPL set id | 706735 |
| Labeler | Dr. Reddy's Laboratories Inc. |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2019-05-14 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 43598-605 |
NDC Item 43598060556
| NDC 9 | 43598-605 |
|---|---|
| NDC 10 | 43598-605-56 |
| NDC Item | 43598060556 |
| Packaging | 14 POUCH in 1 CARTON (43598-605-56) / 4 AMPULE in 1 POUCH (43598-605-04) / 5 mL in 1 AMPULE |
| ANDA | ANDA207080 |
| FDA SPL set id | 706735 |
| Labeler | Dr. Reddy's Laboratories Inc. |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2019-05-14 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 43598-605 |
NDC Item 43598060558
| NDC 9 | 43598-605 |
|---|---|
| NDC 10 | 43598-605-58 |
| NDC Item | 43598060558 |
| Packaging | 56 POUCH in 1 CARTON (43598-605-58) / 1 AMPULE in 1 POUCH (43598-605-11) / 5 mL in 1 AMPULE |
| ANDA | ANDA207080 |
| FDA SPL set id | 706735 |
| Labeler | Dr. Reddy's Laboratories Inc. |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2019-05-14 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 43598-605 |
NDC Item 47335017148
| NDC 9 | 47335-171 |
|---|---|
| NDC 10 | 47335-171-48 |
| NDC Item | 47335017148 |
| Packaging | 4 in 1 POUCH |
| Packaging | 5 mL in 1 AMPULE |
| ANDA | ANDA207136 |
| COLORTEXT | YELLOW(Colourless to light yellow) |
| Color | C48330 __ |
| FDA SPL set id | 707885 |
| Labeler | Sun Pharmaceutical Industries, Inc. |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2020-02-28 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 47335-171 |
NDC Item 47335017149
| NDC 9 | 47335-171 |
|---|---|
| NDC 10 | 47335-171-49 |
| NDC Item | 47335017149 |
| Packaging | 14 POUCH in 1 CARTON (47335-171-49) / 4 AMPULE in 1 POUCH (47335-171-48) / 5 mL in 1 AMPULE |
| ANDA | ANDA207136 |
| COLORTEXT | YELLOW(Colourless to light yellow) |
| Color | C48330 __ |
| FDA SPL set id | 707885 |
| Labeler | Sun Pharmaceutical Industries, Inc. |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2020-02-28 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 47335-171 |
NDC Item 59651012904
| NDC 9 | 59651-129 |
|---|---|
| NDC 10 | 59651-129-04 |
| NDC Item | 59651012904 |
| Packaging | 4 in 1 POUCH |
| Packaging | 5 mL in 1 AMPULE |
| ANDA | ANDA210871 |
| FDA SPL set id | 710977 |
| Labeler | Aurobindo Pharma Limited |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2021-01-22 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 59651-129 |
NDC Item 59651012956
| NDC 9 | 59651-129 |
|---|---|
| NDC 10 | 59651-129-56 |
| NDC Item | 59651012956 |
| Packaging | 14 POUCH in 1 CARTON (59651-129-56) / 4 AMPULE in 1 POUCH (59651-129-04) / 5 mL in 1 AMPULE |
| ANDA | ANDA210871 |
| FDA SPL set id | 710977 |
| Labeler | Aurobindo Pharma Limited |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2021-01-22 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 59651-129 |
NDC Item 60687073179
| NDC 9 | 60687-731 |
|---|---|
| NDC 10 | 60687-731-79 |
| NDC Item | 60687073179 |
| Packaging | 1 in 1 POUCH |
| Packaging | 5 mL in 1 AMPULE |
| ANDA | ANDA207136 |
| COLORTEXT | yellow(Colourless to light yellow) |
| Color | C48330 __ |
| FDA SPL set id | 786945 |
| Labeler | American Health Packaging |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2024-05-19 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 60687-731 |
NDC Item 60687073183
| NDC 9 | 60687-731 |
|---|---|
| NDC 10 | 60687-731-83 |
| NDC Item | 60687073183 |
| Packaging | 30 POUCH in 1 CARTON (60687-731-83) / 1 AMPULE in 1 POUCH (60687-731-79) / 5 mL in 1 AMPULE |
| ANDA | ANDA207136 |
| COLORTEXT | yellow(Colourless to light yellow) |
| Color | C48330 __ |
| FDA SPL set id | 786945 |
| Labeler | American Health Packaging |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2024-05-19 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 60687-731 |
NDC Item 65162091446
| NDC 9 | 65162-914 |
|---|---|
| NDC 10 | 65162-914-46 |
| NDC Item | 65162091446 |
| Packaging | 56 AMPULE in 1 CARTON (65162-914-46) / 5 mL in 1 AMPULE |
| ANDA | ANDA205501 |
| COLORTEXT | yellow(clear, slightly yellow) |
| Color | C48330 __ |
| FDA SPL set id | 824547 |
| Labeler | Amneal Pharmaceuticals LLC |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2014-07-13 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 65162-914 |
NDC Item 67877067869
| NDC 9 | 67877-678 |
|---|---|
| NDC 10 | 67877-678-69 |
| NDC Item | 67877067869 |
| Packaging | 5 mL in 1 AMPULE |
| Packaging | 7 in 1 POUCH |
| ANDA | ANDA212848 |
| FDA SPL set id | 762146 |
| Labeler | Ascend Laboratories, LLC |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2021-04-02 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 67877-678 |
NDC Item 67877067870
| NDC 9 | 67877-678 |
|---|---|
| NDC 10 | 67877-678-70 |
| NDC Item | 67877067870 |
| Packaging | 56 POUCH in 1 CARTON (67877-678-70) / 7 AMPULE in 1 POUCH (67877-678-69) / 5 mL in 1 AMPULE |
| ANDA | ANDA212848 |
| FDA SPL set id | 762146 |
| Labeler | Ascend Laboratories, LLC |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2021-04-02 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 67877-678 |
NDC Item 68180096204
| NDC 9 | 68180-962 |
|---|---|
| NDC 10 | 68180-962-04 |
| NDC Item | 68180096204 |
| Packaging | 4 in 1 POUCH |
| Packaging | 5 mL in 1 AMPULE |
| ANDA | ANDA208964 |
| FDA SPL set id | 779846 |
| Labeler | Lupin Pharmaceuticals, Inc. |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2018-06-12 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 68180-962 |
NDC Item 68180096256
| NDC 9 | 68180-962 |
|---|---|
| NDC 10 | 68180-962-56 |
| NDC Item | 68180096256 |
| Packaging | 56 POUCH in 1 CARTON (68180-962-56) / 4 AMPULE in 1 POUCH / 5 mL in 1 AMPULE |
| ANDA | ANDA208964 |
| FDA SPL set id | 779846 |
| Labeler | Lupin Pharmaceuticals, Inc. |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2018-06-12 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 68180-962 |
NDC Item 70644089999
| NDC 9 | 70644-899 |
|---|---|
| NDC 10 | 70644-899-99 |
| NDC Item | 70644089999 |
| Packaging | 14 POUCH in 1 CARTON (70644-899-99) / 4 AMPULE in 1 POUCH / 5 mL in 1 AMPULE |
| FDA SPL set id | 849478 |
| Labeler | Genericus, Inc. |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | NDA AUTHORIZED GENERIC |
| Marketing effective time low | 2016-07-11 |
| Marketing status | ACTIVE |
| NDA_AUTHORIZED_GENERIC | NDA205433 |
| Related queries | Properties for NDC 9 70644-899 |
NDC Item 70756060444
| NDC 9 | 70756-604 |
|---|---|
| NDC 10 | 70756-604-44 |
| NDC Item | 70756060444 |
| Packaging | 4 in 1 POUCH |
| Packaging | 5 mL in 1 AMPULE |
| ANDA | ANDA214478 |
| FDA SPL set id | 805293 |
| Labeler | Lifestar Pharma LLC |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2023-06-30 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 70756-604 |
NDC Item 70756060456
| NDC 9 | 70756-604 |
|---|---|
| NDC 10 | 70756-604-56 |
| NDC Item | 70756060456 |
| Packaging | 14 POUCH in 1 CARTON (70756-604-56) / 4 AMPULE in 1 POUCH (70756-604-44) / 5 mL in 1 AMPULE |
| ANDA | ANDA214478 |
| FDA SPL set id | 805293 |
| Labeler | Lifestar Pharma LLC |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2023-06-30 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 70756-604 |
NDC Item 72603043004
| NDC 9 | 72603-430 |
|---|---|
| NDC 10 | 72603-430-04 |
| NDC Item | 72603043004 |
| Packaging | 4 in 1 POUCH |
| Packaging | 5 mL in 1 AMPULE |
| ANDA | ANDA214478 |
| FDA SPL set id | 801097 |
| Labeler | NorthStar RxLLC |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2024-08-01 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 72603-430 |
NDC Item 72603043056
| NDC 9 | 72603-430 |
|---|---|
| NDC 10 | 72603-430-56 |
| NDC Item | 72603043056 |
| Packaging | 14 POUCH in 1 CARTON (72603-430-56) / 4 AMPULE in 1 POUCH (72603-430-04) / 5 mL in 1 AMPULE |
| ANDA | ANDA214478 |
| FDA SPL set id | 801097 |
| Labeler | NorthStar RxLLC |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2024-08-01 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 72603-430 |
NDC Item 76204002956
| NDC 9 | 76204-029 |
|---|---|
| NDC 10 | 76204-029-56 |
| NDC Item | 76204002956 |
| Packaging | 14 POUCH in 1 CARTON (76204-029-56) / 4 AMPULE in 1 POUCH / 5 mL in 1 AMPULE |
| ANDA | ANDA201422 |
| FDA SPL set id | 866956 |
| Labeler | Ritedose Pharmaceuticals, LLC |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2025-03-25 |
| Marketing status | active |
| Related queries | Properties for NDC 9 76204-029 |
NDC Item 00093408563
| NDC 9 | 0093-4085 |
|---|---|
| NDC 10 | 0093-4085-63 |
| NDC Item | 00093408563 |
| Packaging | 56 AMPULE in 1 CARTON (0093-4085-63) / 5 mL in 1 AMPULE |
| ANDA | ANDA091589 |
| FDA SPL set id | 861925 |
| Labeler | Teva Pharmaceuticals USA, Inc. |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2013-11-19 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 0093-4085 |
NDC Item 00781717156
| NDC 9 | 0781-7171 |
|---|---|
| NDC 10 | 0781-7171-56 |
| NDC Item | 00781717156 |
| Packaging | 56 AMPULE in 1 CARTON (0781-7171-56) / 5 mL in 1 AMPULE (0781-7171-75) |
| FDA SPL set id | 132419 |
| Labeler | Sandoz Inc |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | NDA AUTHORIZED GENERIC |
| Marketing effective time low | 2014-07-09 |
| Marketing status | COMPLETED |
| NDA_AUTHORIZED_GENERIC | NDA050753 |
| Related queries | Properties for NDC 9 0781-7171 |
NDC Item 00781717175
| NDC 9 | 0781-7171 |
|---|---|
| NDC 10 | 0781-7171-75 |
| NDC Item | 00781717175 |
| Packaging | 5 mL in 1 AMPULE |
| FDA SPL set id | 132419 |
| Labeler | Sandoz Inc |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | NDA AUTHORIZED GENERIC |
| Marketing effective time low | 2014-07-09 |
| Marketing status | COMPLETED |
| NDA_AUTHORIZED_GENERIC | NDA050753 |
| Related queries | Properties for NDC 9 0781-7171 |
NDC Item 16714011902
| NDC 9 | 16714-119 |
|---|---|
| NDC 10 | 16714-119-02 |
| NDC Item | 16714011902 |
| Packaging | 5 mL in 1 AMPULE |
| ANDA | ANDA207080 |
| FDA SPL set id | 842222 |
| Labeler | NorthStar RxLLC |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2020-05-21 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 16714-119 |
NDC Item 16714011903
| NDC 9 | 16714-119 |
|---|---|
| NDC 10 | 16714-119-03 |
| NDC Item | 16714011903 |
| Packaging | 14 POUCH in 1 CARTON (16714-119-03) / 4 AMPULE in 1 POUCH / 5 mL in 1 AMPULE (16714-119-02) |
| ANDA | ANDA207080 |
| FDA SPL set id | 842222 |
| Labeler | NorthStar RxLLC |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2020-05-21 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 16714-119 |
NDC Item 17478034038
| NDC 9 | 17478-340 |
|---|---|
| NDC 10 | 17478-340-38 |
| NDC Item | 17478034038 |
| Packaging | 14 POUCH in 1 CARTON (17478-340-38) / 4 AMPULE in 1 POUCH / 5 mL in 1 AMPULE |
| ANDA | ANDA201422 |
| FDA SPL set id | 656792 |
| Labeler | Akorn Operating Company LLC (dba Akorn) |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 17478-340 |
NDC Item 42571040809
| NDC 9 | 42571-408 |
|---|---|
| NDC 10 | 42571-408-09 |
| NDC Item | 42571040809 |
| Packaging | 5 mL in 1 AMPULE |
| ANDA | ANDA217344 |
| FDA SPL set id | 812408 |
| Labeler | Micro Labs Limited |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2024-01-01 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 42571-408 |
NDC Item 42571040819
| NDC 9 | 42571-408 |
|---|---|
| NDC 10 | 42571-408-19 |
| NDC Item | 42571040819 |
| Packaging | 4 in 1 POUCH |
| ANDA | ANDA217344 |
| FDA SPL set id | 812408 |
| Labeler | Micro Labs Limited |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2024-01-01 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 42571-408 |
NDC Item 42571040892
| NDC 9 | 42571-408 |
|---|---|
| NDC 10 | 42571-408-92 |
| NDC Item | 42571040892 |
| Packaging | 14 POUCH in 1 CARTON (42571-408-92) / 4 AMPULE in 1 POUCH (42571-408-19) / 5 mL in 1 AMPULE (42571-408-09) |
| ANDA | ANDA217344 |
| FDA SPL set id | 812408 |
| Labeler | Micro Labs Limited |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2024-01-01 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 42571-408 |
NDC Item 43598060504
| NDC 9 | 43598-605 |
|---|---|
| NDC 10 | 43598-605-04 |
| NDC Item | 43598060504 |
| ANDA | ANDA207080 |
| FDA SPL set id | 706735 |
| Labeler | Dr. Reddy's Laboratories Inc. |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2019-05-14 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 43598-605 |
NDC Item 43598060511
| NDC 9 | 43598-605 |
|---|---|
| NDC 10 | 43598-605-11 |
| NDC Item | 43598060511 |
| ANDA | ANDA207080 |
| FDA SPL set id | 706735 |
| Labeler | Dr. Reddy's Laboratories Inc. |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2019-05-14 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 43598-605 |
NDC Item 43598060556
| NDC 9 | 43598-605 |
|---|---|
| NDC 10 | 43598-605-56 |
| NDC Item | 43598060556 |
| Packaging | 14 POUCH in 1 CARTON (43598-605-56) / 4 AMPULE in 1 POUCH (43598-605-04) / 5 mL in 1 AMPULE |
| ANDA | ANDA207080 |
| FDA SPL set id | 706735 |
| Labeler | Dr. Reddy's Laboratories Inc. |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2019-05-14 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 43598-605 |
NDC Item 43598060558
| NDC 9 | 43598-605 |
|---|---|
| NDC 10 | 43598-605-58 |
| NDC Item | 43598060558 |
| Packaging | 56 POUCH in 1 CARTON (43598-605-58) / 1 AMPULE in 1 POUCH (43598-605-11) / 5 mL in 1 AMPULE |
| ANDA | ANDA207080 |
| FDA SPL set id | 706735 |
| Labeler | Dr. Reddy's Laboratories Inc. |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2019-05-14 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 43598-605 |
NDC Item 47335017148
| NDC 9 | 47335-171 |
|---|---|
| NDC 10 | 47335-171-48 |
| NDC Item | 47335017148 |
| Packaging | 4 in 1 POUCH |
| Packaging | 5 mL in 1 AMPULE |
| ANDA | ANDA207136 |
| COLORTEXT | YELLOW(Colourless to light yellow) |
| Color | C48330 __ |
| FDA SPL set id | 707885 |
| Labeler | Sun Pharmaceutical Industries, Inc. |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2020-02-28 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 47335-171 |
NDC Item 47335017149
| NDC 9 | 47335-171 |
|---|---|
| NDC 10 | 47335-171-49 |
| NDC Item | 47335017149 |
| Packaging | 14 POUCH in 1 CARTON (47335-171-49) / 4 AMPULE in 1 POUCH (47335-171-48) / 5 mL in 1 AMPULE |
| ANDA | ANDA207136 |
| COLORTEXT | YELLOW(Colourless to light yellow) |
| Color | C48330 __ |
| FDA SPL set id | 707885 |
| Labeler | Sun Pharmaceutical Industries, Inc. |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2020-02-28 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 47335-171 |
NDC Item 59651012904
| NDC 9 | 59651-129 |
|---|---|
| NDC 10 | 59651-129-04 |
| NDC Item | 59651012904 |
| Packaging | 4 in 1 POUCH |
| Packaging | 5 mL in 1 AMPULE |
| ANDA | ANDA210871 |
| FDA SPL set id | 710977 |
| Labeler | Aurobindo Pharma Limited |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2021-01-22 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 59651-129 |
NDC Item 59651012956
| NDC 9 | 59651-129 |
|---|---|
| NDC 10 | 59651-129-56 |
| NDC Item | 59651012956 |
| Packaging | 14 POUCH in 1 CARTON (59651-129-56) / 4 AMPULE in 1 POUCH (59651-129-04) / 5 mL in 1 AMPULE |
| ANDA | ANDA210871 |
| FDA SPL set id | 710977 |
| Labeler | Aurobindo Pharma Limited |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2021-01-22 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 59651-129 |
NDC Item 60687073179
| NDC 9 | 60687-731 |
|---|---|
| NDC 10 | 60687-731-79 |
| NDC Item | 60687073179 |
| Packaging | 1 in 1 POUCH |
| Packaging | 5 mL in 1 AMPULE |
| ANDA | ANDA207136 |
| COLORTEXT | yellow(Colourless to light yellow) |
| Color | C48330 __ |
| FDA SPL set id | 786945 |
| Labeler | American Health Packaging |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2024-05-19 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 60687-731 |
NDC Item 60687073183
| NDC 9 | 60687-731 |
|---|---|
| NDC 10 | 60687-731-83 |
| NDC Item | 60687073183 |
| Packaging | 30 POUCH in 1 CARTON (60687-731-83) / 1 AMPULE in 1 POUCH (60687-731-79) / 5 mL in 1 AMPULE |
| ANDA | ANDA207136 |
| COLORTEXT | yellow(Colourless to light yellow) |
| Color | C48330 __ |
| FDA SPL set id | 786945 |
| Labeler | American Health Packaging |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2024-05-19 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 60687-731 |
NDC Item 65162091446
| NDC 9 | 65162-914 |
|---|---|
| NDC 10 | 65162-914-46 |
| NDC Item | 65162091446 |
| Packaging | 56 AMPULE in 1 CARTON (65162-914-46) / 5 mL in 1 AMPULE |
| ANDA | ANDA205501 |
| COLORTEXT | yellow(clear, slightly yellow) |
| Color | C48330 __ |
| FDA SPL set id | 824547 |
| Labeler | Amneal Pharmaceuticals LLC |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2014-07-13 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 65162-914 |
NDC Item 67877067869
| NDC 9 | 67877-678 |
|---|---|
| NDC 10 | 67877-678-69 |
| NDC Item | 67877067869 |
| Packaging | 5 mL in 1 AMPULE |
| Packaging | 7 in 1 POUCH |
| ANDA | ANDA212848 |
| FDA SPL set id | 762146 |
| Labeler | Ascend Laboratories, LLC |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2021-04-02 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 67877-678 |
NDC Item 67877067870
| NDC 9 | 67877-678 |
|---|---|
| NDC 10 | 67877-678-70 |
| NDC Item | 67877067870 |
| Packaging | 56 POUCH in 1 CARTON (67877-678-70) / 7 AMPULE in 1 POUCH (67877-678-69) / 5 mL in 1 AMPULE |
| ANDA | ANDA212848 |
| FDA SPL set id | 762146 |
| Labeler | Ascend Laboratories, LLC |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2021-04-02 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 67877-678 |
NDC Item 68180096204
| NDC 9 | 68180-962 |
|---|---|
| NDC 10 | 68180-962-04 |
| NDC Item | 68180096204 |
| Packaging | 4 in 1 POUCH |
| Packaging | 5 mL in 1 AMPULE |
| ANDA | ANDA208964 |
| FDA SPL set id | 779846 |
| Labeler | Lupin Pharmaceuticals, Inc. |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2018-06-12 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 68180-962 |
NDC Item 68180096256
| NDC 9 | 68180-962 |
|---|---|
| NDC 10 | 68180-962-56 |
| NDC Item | 68180096256 |
| Packaging | 56 POUCH in 1 CARTON (68180-962-56) / 4 AMPULE in 1 POUCH / 5 mL in 1 AMPULE |
| ANDA | ANDA208964 |
| FDA SPL set id | 779846 |
| Labeler | Lupin Pharmaceuticals, Inc. |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2018-06-12 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 68180-962 |
NDC Item 70644089999
| NDC 9 | 70644-899 |
|---|---|
| NDC 10 | 70644-899-99 |
| NDC Item | 70644089999 |
| Packaging | 14 POUCH in 1 CARTON (70644-899-99) / 4 AMPULE in 1 POUCH / 5 mL in 1 AMPULE |
| FDA SPL set id | 849478 |
| Labeler | Genericus, Inc. |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | NDA AUTHORIZED GENERIC |
| Marketing effective time low | 2016-07-11 |
| Marketing status | ACTIVE |
| NDA_AUTHORIZED_GENERIC | NDA205433 |
| Related queries | Properties for NDC 9 70644-899 |
NDC Item 70756060444
| NDC 9 | 70756-604 |
|---|---|
| NDC 10 | 70756-604-44 |
| NDC Item | 70756060444 |
| Packaging | 4 in 1 POUCH |
| Packaging | 5 mL in 1 AMPULE |
| ANDA | ANDA214478 |
| FDA SPL set id | 805293 |
| Labeler | Lifestar Pharma LLC |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2023-06-30 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 70756-604 |
NDC Item 70756060456
| NDC 9 | 70756-604 |
|---|---|
| NDC 10 | 70756-604-56 |
| NDC Item | 70756060456 |
| Packaging | 14 POUCH in 1 CARTON (70756-604-56) / 4 AMPULE in 1 POUCH (70756-604-44) / 5 mL in 1 AMPULE |
| ANDA | ANDA214478 |
| FDA SPL set id | 805293 |
| Labeler | Lifestar Pharma LLC |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2023-06-30 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 70756-604 |
NDC Item 72603043004
| NDC 9 | 72603-430 |
|---|---|
| NDC 10 | 72603-430-04 |
| NDC Item | 72603043004 |
| Packaging | 4 in 1 POUCH |
| Packaging | 5 mL in 1 AMPULE |
| ANDA | ANDA214478 |
| FDA SPL set id | 801097 |
| Labeler | NorthStar RxLLC |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2024-08-01 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 72603-430 |
NDC Item 72603043056
| NDC 9 | 72603-430 |
|---|---|
| NDC 10 | 72603-430-56 |
| NDC Item | 72603043056 |
| Packaging | 14 POUCH in 1 CARTON (72603-430-56) / 4 AMPULE in 1 POUCH (72603-430-04) / 5 mL in 1 AMPULE |
| ANDA | ANDA214478 |
| FDA SPL set id | 801097 |
| Labeler | NorthStar RxLLC |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2024-08-01 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 72603-430 |
NDC Item 76204002956
| NDC 9 | 76204-029 |
|---|---|
| NDC 10 | 76204-029-56 |
| NDC Item | 76204002956 |
| Packaging | 14 POUCH in 1 CARTON (76204-029-56) / 4 AMPULE in 1 POUCH / 5 mL in 1 AMPULE |
| ANDA | ANDA201422 |
| FDA SPL set id | 866956 |
| Labeler | Ritedose Pharmaceuticals, LLC |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2025-03-25 |
| Marketing status | active |
| Related queries | Properties for NDC 9 76204-029 |
NDC Item 00093408563
| NDC 9 | 0093-4085 |
|---|---|
| NDC 10 | 0093-4085-63 |
| NDC Item | 00093408563 |
| Packaging | 56 AMPULE in 1 CARTON (0093-4085-63) / 5 mL in 1 AMPULE |
| ANDA | ANDA091589 |
| FDA SPL set id | 861925 |
| Labeler | Teva Pharmaceuticals USA, Inc. |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2013-11-19 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 0093-4085 |
NDC Item 00781717156
| NDC 9 | 0781-7171 |
|---|---|
| NDC 10 | 0781-7171-56 |
| NDC Item | 00781717156 |
| Packaging | 56 AMPULE in 1 CARTON (0781-7171-56) / 5 mL in 1 AMPULE (0781-7171-75) |
| FDA SPL set id | 132419 |
| Labeler | Sandoz Inc |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | NDA AUTHORIZED GENERIC |
| Marketing effective time low | 2014-07-09 |
| Marketing status | COMPLETED |
| NDA_AUTHORIZED_GENERIC | NDA050753 |
| Related queries | Properties for NDC 9 0781-7171 |
NDC Item 00781717175
| NDC 9 | 0781-7171 |
|---|---|
| NDC 10 | 0781-7171-75 |
| NDC Item | 00781717175 |
| Packaging | 5 mL in 1 AMPULE |
| FDA SPL set id | 132419 |
| Labeler | Sandoz Inc |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | NDA AUTHORIZED GENERIC |
| Marketing effective time low | 2014-07-09 |
| Marketing status | COMPLETED |
| NDA_AUTHORIZED_GENERIC | NDA050753 |
| Related queries | Properties for NDC 9 0781-7171 |
NDC Item 16714011902
| NDC 9 | 16714-119 |
|---|---|
| NDC 10 | 16714-119-02 |
| NDC Item | 16714011902 |
| Packaging | 5 mL in 1 AMPULE |
| ANDA | ANDA207080 |
| FDA SPL set id | 842222 |
| Labeler | NorthStar RxLLC |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2020-05-21 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 16714-119 |
NDC Item 16714011903
| NDC 9 | 16714-119 |
|---|---|
| NDC 10 | 16714-119-03 |
| NDC Item | 16714011903 |
| Packaging | 14 POUCH in 1 CARTON (16714-119-03) / 4 AMPULE in 1 POUCH / 5 mL in 1 AMPULE (16714-119-02) |
| ANDA | ANDA207080 |
| FDA SPL set id | 842222 |
| Labeler | NorthStar RxLLC |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2020-05-21 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 16714-119 |
NDC Item 17478034038
| NDC 9 | 17478-340 |
|---|---|
| NDC 10 | 17478-340-38 |
| NDC Item | 17478034038 |
| Packaging | 14 POUCH in 1 CARTON (17478-340-38) / 4 AMPULE in 1 POUCH / 5 mL in 1 AMPULE |
| ANDA | ANDA201422 |
| FDA SPL set id | 656792 |
| Labeler | Akorn Operating Company LLC (dba Akorn) |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 17478-340 |
NDC Item 42571040809
| NDC 9 | 42571-408 |
|---|---|
| NDC 10 | 42571-408-09 |
| NDC Item | 42571040809 |
| Packaging | 5 mL in 1 AMPULE |
| ANDA | ANDA217344 |
| FDA SPL set id | 812408 |
| Labeler | Micro Labs Limited |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2024-01-01 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 42571-408 |
NDC Item 42571040819
| NDC 9 | 42571-408 |
|---|---|
| NDC 10 | 42571-408-19 |
| NDC Item | 42571040819 |
| Packaging | 4 in 1 POUCH |
| ANDA | ANDA217344 |
| FDA SPL set id | 812408 |
| Labeler | Micro Labs Limited |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2024-01-01 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 42571-408 |
NDC Item 42571040892
| NDC 9 | 42571-408 |
|---|---|
| NDC 10 | 42571-408-92 |
| NDC Item | 42571040892 |
| Packaging | 14 POUCH in 1 CARTON (42571-408-92) / 4 AMPULE in 1 POUCH (42571-408-19) / 5 mL in 1 AMPULE (42571-408-09) |
| ANDA | ANDA217344 |
| FDA SPL set id | 812408 |
| Labeler | Micro Labs Limited |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2024-01-01 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 42571-408 |
NDC Item 43598060504
| NDC 9 | 43598-605 |
|---|---|
| NDC 10 | 43598-605-04 |
| NDC Item | 43598060504 |
| ANDA | ANDA207080 |
| FDA SPL set id | 706735 |
| Labeler | Dr. Reddy's Laboratories Inc. |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2019-05-14 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 43598-605 |
NDC Item 43598060511
| NDC 9 | 43598-605 |
|---|---|
| NDC 10 | 43598-605-11 |
| NDC Item | 43598060511 |
| ANDA | ANDA207080 |
| FDA SPL set id | 706735 |
| Labeler | Dr. Reddy's Laboratories Inc. |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2019-05-14 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 43598-605 |
NDC Item 43598060556
| NDC 9 | 43598-605 |
|---|---|
| NDC 10 | 43598-605-56 |
| NDC Item | 43598060556 |
| Packaging | 14 POUCH in 1 CARTON (43598-605-56) / 4 AMPULE in 1 POUCH (43598-605-04) / 5 mL in 1 AMPULE |
| ANDA | ANDA207080 |
| FDA SPL set id | 706735 |
| Labeler | Dr. Reddy's Laboratories Inc. |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2019-05-14 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 43598-605 |
NDC Item 43598060558
| NDC 9 | 43598-605 |
|---|---|
| NDC 10 | 43598-605-58 |
| NDC Item | 43598060558 |
| Packaging | 56 POUCH in 1 CARTON (43598-605-58) / 1 AMPULE in 1 POUCH (43598-605-11) / 5 mL in 1 AMPULE |
| ANDA | ANDA207080 |
| FDA SPL set id | 706735 |
| Labeler | Dr. Reddy's Laboratories Inc. |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2019-05-14 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 43598-605 |
NDC Item 47335017148
| NDC 9 | 47335-171 |
|---|---|
| NDC 10 | 47335-171-48 |
| NDC Item | 47335017148 |
| Packaging | 4 in 1 POUCH |
| Packaging | 5 mL in 1 AMPULE |
| ANDA | ANDA207136 |
| COLORTEXT | YELLOW(Colourless to light yellow) |
| Color | C48330 __ |
| FDA SPL set id | 707885 |
| Labeler | Sun Pharmaceutical Industries, Inc. |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2020-02-28 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 47335-171 |
NDC Item 47335017149
| NDC 9 | 47335-171 |
|---|---|
| NDC 10 | 47335-171-49 |
| NDC Item | 47335017149 |
| Packaging | 14 POUCH in 1 CARTON (47335-171-49) / 4 AMPULE in 1 POUCH (47335-171-48) / 5 mL in 1 AMPULE |
| ANDA | ANDA207136 |
| COLORTEXT | YELLOW(Colourless to light yellow) |
| Color | C48330 __ |
| FDA SPL set id | 707885 |
| Labeler | Sun Pharmaceutical Industries, Inc. |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2020-02-28 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 47335-171 |
NDC Item 59651012904
| NDC 9 | 59651-129 |
|---|---|
| NDC 10 | 59651-129-04 |
| NDC Item | 59651012904 |
| Packaging | 4 in 1 POUCH |
| Packaging | 5 mL in 1 AMPULE |
| ANDA | ANDA210871 |
| FDA SPL set id | 710977 |
| Labeler | Aurobindo Pharma Limited |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2021-01-22 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 59651-129 |
NDC Item 59651012956
| NDC 9 | 59651-129 |
|---|---|
| NDC 10 | 59651-129-56 |
| NDC Item | 59651012956 |
| Packaging | 14 POUCH in 1 CARTON (59651-129-56) / 4 AMPULE in 1 POUCH (59651-129-04) / 5 mL in 1 AMPULE |
| ANDA | ANDA210871 |
| FDA SPL set id | 710977 |
| Labeler | Aurobindo Pharma Limited |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2021-01-22 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 59651-129 |
NDC Item 60687073179
| NDC 9 | 60687-731 |
|---|---|
| NDC 10 | 60687-731-79 |
| NDC Item | 60687073179 |
| Packaging | 1 in 1 POUCH |
| Packaging | 5 mL in 1 AMPULE |
| ANDA | ANDA207136 |
| COLORTEXT | yellow(Colourless to light yellow) |
| Color | C48330 __ |
| FDA SPL set id | 786945 |
| Labeler | American Health Packaging |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2024-05-19 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 60687-731 |
NDC Item 60687073183
| NDC 9 | 60687-731 |
|---|---|
| NDC 10 | 60687-731-83 |
| NDC Item | 60687073183 |
| Packaging | 30 POUCH in 1 CARTON (60687-731-83) / 1 AMPULE in 1 POUCH (60687-731-79) / 5 mL in 1 AMPULE |
| ANDA | ANDA207136 |
| COLORTEXT | yellow(Colourless to light yellow) |
| Color | C48330 __ |
| FDA SPL set id | 786945 |
| Labeler | American Health Packaging |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2024-05-19 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 60687-731 |
NDC Item 65162091446
| NDC 9 | 65162-914 |
|---|---|
| NDC 10 | 65162-914-46 |
| NDC Item | 65162091446 |
| Packaging | 56 AMPULE in 1 CARTON (65162-914-46) / 5 mL in 1 AMPULE |
| ANDA | ANDA205501 |
| COLORTEXT | yellow(clear, slightly yellow) |
| Color | C48330 __ |
| FDA SPL set id | 824547 |
| Labeler | Amneal Pharmaceuticals LLC |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2014-07-13 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 65162-914 |
NDC Item 67877067869
| NDC 9 | 67877-678 |
|---|---|
| NDC 10 | 67877-678-69 |
| NDC Item | 67877067869 |
| Packaging | 5 mL in 1 AMPULE |
| Packaging | 7 in 1 POUCH |
| ANDA | ANDA212848 |
| FDA SPL set id | 762146 |
| Labeler | Ascend Laboratories, LLC |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2021-04-02 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 67877-678 |
NDC Item 67877067870
| NDC 9 | 67877-678 |
|---|---|
| NDC 10 | 67877-678-70 |
| NDC Item | 67877067870 |
| Packaging | 56 POUCH in 1 CARTON (67877-678-70) / 7 AMPULE in 1 POUCH (67877-678-69) / 5 mL in 1 AMPULE |
| ANDA | ANDA212848 |
| FDA SPL set id | 762146 |
| Labeler | Ascend Laboratories, LLC |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2021-04-02 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 67877-678 |
NDC Item 68180096204
| NDC 9 | 68180-962 |
|---|---|
| NDC 10 | 68180-962-04 |
| NDC Item | 68180096204 |
| Packaging | 4 in 1 POUCH |
| Packaging | 5 mL in 1 AMPULE |
| ANDA | ANDA208964 |
| FDA SPL set id | 779846 |
| Labeler | Lupin Pharmaceuticals, Inc. |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2018-06-12 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 68180-962 |
NDC Item 68180096256
| NDC 9 | 68180-962 |
|---|---|
| NDC 10 | 68180-962-56 |
| NDC Item | 68180096256 |
| Packaging | 56 POUCH in 1 CARTON (68180-962-56) / 4 AMPULE in 1 POUCH / 5 mL in 1 AMPULE |
| ANDA | ANDA208964 |
| FDA SPL set id | 779846 |
| Labeler | Lupin Pharmaceuticals, Inc. |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2018-06-12 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 68180-962 |
NDC Item 70644089999
| NDC 9 | 70644-899 |
|---|---|
| NDC 10 | 70644-899-99 |
| NDC Item | 70644089999 |
| Packaging | 14 POUCH in 1 CARTON (70644-899-99) / 4 AMPULE in 1 POUCH / 5 mL in 1 AMPULE |
| FDA SPL set id | 849478 |
| Labeler | Genericus, Inc. |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | NDA AUTHORIZED GENERIC |
| Marketing effective time low | 2016-07-11 |
| Marketing status | ACTIVE |
| NDA_AUTHORIZED_GENERIC | NDA205433 |
| Related queries | Properties for NDC 9 70644-899 |
NDC Item 70756060444
| NDC 9 | 70756-604 |
|---|---|
| NDC 10 | 70756-604-44 |
| NDC Item | 70756060444 |
| Packaging | 4 in 1 POUCH |
| Packaging | 5 mL in 1 AMPULE |
| ANDA | ANDA214478 |
| FDA SPL set id | 805293 |
| Labeler | Lifestar Pharma LLC |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2023-06-30 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 70756-604 |
NDC Item 70756060456
| NDC 9 | 70756-604 |
|---|---|
| NDC 10 | 70756-604-56 |
| NDC Item | 70756060456 |
| Packaging | 14 POUCH in 1 CARTON (70756-604-56) / 4 AMPULE in 1 POUCH (70756-604-44) / 5 mL in 1 AMPULE |
| ANDA | ANDA214478 |
| FDA SPL set id | 805293 |
| Labeler | Lifestar Pharma LLC |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2023-06-30 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 70756-604 |
NDC Item 72603043004
| NDC 9 | 72603-430 |
|---|---|
| NDC 10 | 72603-430-04 |
| NDC Item | 72603043004 |
| Packaging | 4 in 1 POUCH |
| Packaging | 5 mL in 1 AMPULE |
| ANDA | ANDA214478 |
| FDA SPL set id | 801097 |
| Labeler | NorthStar RxLLC |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2024-08-01 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 72603-430 |
NDC Item 72603043056
| NDC 9 | 72603-430 |
|---|---|
| NDC 10 | 72603-430-56 |
| NDC Item | 72603043056 |
| Packaging | 14 POUCH in 1 CARTON (72603-430-56) / 4 AMPULE in 1 POUCH (72603-430-04) / 5 mL in 1 AMPULE |
| ANDA | ANDA214478 |
| FDA SPL set id | 801097 |
| Labeler | NorthStar RxLLC |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2024-08-01 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 72603-430 |
NDC Item 76204002956
| NDC 9 | 76204-029 |
|---|---|
| NDC 10 | 76204-029-56 |
| NDC Item | 76204002956 |
| Packaging | 14 POUCH in 1 CARTON (76204-029-56) / 4 AMPULE in 1 POUCH / 5 mL in 1 AMPULE |
| ANDA | ANDA201422 |
| FDA SPL set id | 866956 |
| Labeler | Ritedose Pharmaceuticals, LLC |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2025-03-25 |
| Marketing status | active |
| Related queries | Properties for NDC 9 76204-029 |
NDC Item 00093408563
| NDC 9 | 0093-4085 |
|---|---|
| NDC 10 | 0093-4085-63 |
| NDC Item | 00093408563 |
| Packaging | 56 AMPULE in 1 CARTON (0093-4085-63) / 5 mL in 1 AMPULE |
| ANDA | ANDA091589 |
| FDA SPL set id | 861925 |
| Labeler | Teva Pharmaceuticals USA, Inc. |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2013-11-19 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 0093-4085 |
NDC Item 00781717156
| NDC 9 | 0781-7171 |
|---|---|
| NDC 10 | 0781-7171-56 |
| NDC Item | 00781717156 |
| Packaging | 56 AMPULE in 1 CARTON (0781-7171-56) / 5 mL in 1 AMPULE (0781-7171-75) |
| FDA SPL set id | 132419 |
| Labeler | Sandoz Inc |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | NDA AUTHORIZED GENERIC |
| Marketing effective time low | 2014-07-09 |
| Marketing status | COMPLETED |
| NDA_AUTHORIZED_GENERIC | NDA050753 |
| Related queries | Properties for NDC 9 0781-7171 |
NDC Item 00781717175
| NDC 9 | 0781-7171 |
|---|---|
| NDC 10 | 0781-7171-75 |
| NDC Item | 00781717175 |
| Packaging | 5 mL in 1 AMPULE |
| FDA SPL set id | 132419 |
| Labeler | Sandoz Inc |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | NDA AUTHORIZED GENERIC |
| Marketing effective time low | 2014-07-09 |
| Marketing status | COMPLETED |
| NDA_AUTHORIZED_GENERIC | NDA050753 |
| Related queries | Properties for NDC 9 0781-7171 |
NDC Item 16714011902
| NDC 9 | 16714-119 |
|---|---|
| NDC 10 | 16714-119-02 |
| NDC Item | 16714011902 |
| Packaging | 5 mL in 1 AMPULE |
| ANDA | ANDA207080 |
| FDA SPL set id | 842222 |
| Labeler | NorthStar RxLLC |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2020-05-21 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 16714-119 |
NDC Item 16714011903
| NDC 9 | 16714-119 |
|---|---|
| NDC 10 | 16714-119-03 |
| NDC Item | 16714011903 |
| Packaging | 14 POUCH in 1 CARTON (16714-119-03) / 4 AMPULE in 1 POUCH / 5 mL in 1 AMPULE (16714-119-02) |
| ANDA | ANDA207080 |
| FDA SPL set id | 842222 |
| Labeler | NorthStar RxLLC |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2020-05-21 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 16714-119 |
NDC Item 17478034038
| NDC 9 | 17478-340 |
|---|---|
| NDC 10 | 17478-340-38 |
| NDC Item | 17478034038 |
| Packaging | 14 POUCH in 1 CARTON (17478-340-38) / 4 AMPULE in 1 POUCH / 5 mL in 1 AMPULE |
| ANDA | ANDA201422 |
| FDA SPL set id | 656792 |
| Labeler | Akorn Operating Company LLC (dba Akorn) |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 17478-340 |
NDC Item 42571040809
| NDC 9 | 42571-408 |
|---|---|
| NDC 10 | 42571-408-09 |
| NDC Item | 42571040809 |
| Packaging | 5 mL in 1 AMPULE |
| ANDA | ANDA217344 |
| FDA SPL set id | 812408 |
| Labeler | Micro Labs Limited |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2024-01-01 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 42571-408 |
NDC Item 42571040819
| NDC 9 | 42571-408 |
|---|---|
| NDC 10 | 42571-408-19 |
| NDC Item | 42571040819 |
| Packaging | 4 in 1 POUCH |
| ANDA | ANDA217344 |
| FDA SPL set id | 812408 |
| Labeler | Micro Labs Limited |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2024-01-01 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 42571-408 |
NDC Item 42571040892
| NDC 9 | 42571-408 |
|---|---|
| NDC 10 | 42571-408-92 |
| NDC Item | 42571040892 |
| Packaging | 14 POUCH in 1 CARTON (42571-408-92) / 4 AMPULE in 1 POUCH (42571-408-19) / 5 mL in 1 AMPULE (42571-408-09) |
| ANDA | ANDA217344 |
| FDA SPL set id | 812408 |
| Labeler | Micro Labs Limited |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2024-01-01 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 42571-408 |
NDC Item 43598060504
| NDC 9 | 43598-605 |
|---|---|
| NDC 10 | 43598-605-04 |
| NDC Item | 43598060504 |
| ANDA | ANDA207080 |
| FDA SPL set id | 706735 |
| Labeler | Dr. Reddy's Laboratories Inc. |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2019-05-14 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 43598-605 |
NDC Item 43598060511
| NDC 9 | 43598-605 |
|---|---|
| NDC 10 | 43598-605-11 |
| NDC Item | 43598060511 |
| ANDA | ANDA207080 |
| FDA SPL set id | 706735 |
| Labeler | Dr. Reddy's Laboratories Inc. |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2019-05-14 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 43598-605 |
NDC Item 43598060556
| NDC 9 | 43598-605 |
|---|---|
| NDC 10 | 43598-605-56 |
| NDC Item | 43598060556 |
| Packaging | 14 POUCH in 1 CARTON (43598-605-56) / 4 AMPULE in 1 POUCH (43598-605-04) / 5 mL in 1 AMPULE |
| ANDA | ANDA207080 |
| FDA SPL set id | 706735 |
| Labeler | Dr. Reddy's Laboratories Inc. |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2019-05-14 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 43598-605 |
NDC Item 43598060558
| NDC 9 | 43598-605 |
|---|---|
| NDC 10 | 43598-605-58 |
| NDC Item | 43598060558 |
| Packaging | 56 POUCH in 1 CARTON (43598-605-58) / 1 AMPULE in 1 POUCH (43598-605-11) / 5 mL in 1 AMPULE |
| ANDA | ANDA207080 |
| FDA SPL set id | 706735 |
| Labeler | Dr. Reddy's Laboratories Inc. |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2019-05-14 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 43598-605 |
NDC Item 47335017148
| NDC 9 | 47335-171 |
|---|---|
| NDC 10 | 47335-171-48 |
| NDC Item | 47335017148 |
| Packaging | 4 in 1 POUCH |
| Packaging | 5 mL in 1 AMPULE |
| ANDA | ANDA207136 |
| COLORTEXT | YELLOW(Colourless to light yellow) |
| Color | C48330 __ |
| FDA SPL set id | 707885 |
| Labeler | Sun Pharmaceutical Industries, Inc. |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2020-02-28 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 47335-171 |
NDC Item 47335017149
| NDC 9 | 47335-171 |
|---|---|
| NDC 10 | 47335-171-49 |
| NDC Item | 47335017149 |
| Packaging | 14 POUCH in 1 CARTON (47335-171-49) / 4 AMPULE in 1 POUCH (47335-171-48) / 5 mL in 1 AMPULE |
| ANDA | ANDA207136 |
| COLORTEXT | YELLOW(Colourless to light yellow) |
| Color | C48330 __ |
| FDA SPL set id | 707885 |
| Labeler | Sun Pharmaceutical Industries, Inc. |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2020-02-28 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 47335-171 |
NDC Item 59651012904
| NDC 9 | 59651-129 |
|---|---|
| NDC 10 | 59651-129-04 |
| NDC Item | 59651012904 |
| Packaging | 4 in 1 POUCH |
| Packaging | 5 mL in 1 AMPULE |
| ANDA | ANDA210871 |
| FDA SPL set id | 710977 |
| Labeler | Aurobindo Pharma Limited |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2021-01-22 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 59651-129 |
NDC Item 59651012956
| NDC 9 | 59651-129 |
|---|---|
| NDC 10 | 59651-129-56 |
| NDC Item | 59651012956 |
| Packaging | 14 POUCH in 1 CARTON (59651-129-56) / 4 AMPULE in 1 POUCH (59651-129-04) / 5 mL in 1 AMPULE |
| ANDA | ANDA210871 |
| FDA SPL set id | 710977 |
| Labeler | Aurobindo Pharma Limited |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2021-01-22 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 59651-129 |
NDC Item 60687073179
| NDC 9 | 60687-731 |
|---|---|
| NDC 10 | 60687-731-79 |
| NDC Item | 60687073179 |
| Packaging | 1 in 1 POUCH |
| Packaging | 5 mL in 1 AMPULE |
| ANDA | ANDA207136 |
| COLORTEXT | yellow(Colourless to light yellow) |
| Color | C48330 __ |
| FDA SPL set id | 786945 |
| Labeler | American Health Packaging |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2024-05-19 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 60687-731 |
NDC Item 60687073183
| NDC 9 | 60687-731 |
|---|---|
| NDC 10 | 60687-731-83 |
| NDC Item | 60687073183 |
| Packaging | 30 POUCH in 1 CARTON (60687-731-83) / 1 AMPULE in 1 POUCH (60687-731-79) / 5 mL in 1 AMPULE |
| ANDA | ANDA207136 |
| COLORTEXT | yellow(Colourless to light yellow) |
| Color | C48330 __ |
| FDA SPL set id | 786945 |
| Labeler | American Health Packaging |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2024-05-19 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 60687-731 |
NDC Item 65162091446
| NDC 9 | 65162-914 |
|---|---|
| NDC 10 | 65162-914-46 |
| NDC Item | 65162091446 |
| Packaging | 56 AMPULE in 1 CARTON (65162-914-46) / 5 mL in 1 AMPULE |
| ANDA | ANDA205501 |
| COLORTEXT | yellow(clear, slightly yellow) |
| Color | C48330 __ |
| FDA SPL set id | 824547 |
| Labeler | Amneal Pharmaceuticals LLC |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2014-07-13 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 65162-914 |
NDC Item 67877067869
| NDC 9 | 67877-678 |
|---|---|
| NDC 10 | 67877-678-69 |
| NDC Item | 67877067869 |
| Packaging | 5 mL in 1 AMPULE |
| Packaging | 7 in 1 POUCH |
| ANDA | ANDA212848 |
| FDA SPL set id | 762146 |
| Labeler | Ascend Laboratories, LLC |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2021-04-02 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 67877-678 |
NDC Item 67877067870
| NDC 9 | 67877-678 |
|---|---|
| NDC 10 | 67877-678-70 |
| NDC Item | 67877067870 |
| Packaging | 56 POUCH in 1 CARTON (67877-678-70) / 7 AMPULE in 1 POUCH (67877-678-69) / 5 mL in 1 AMPULE |
| ANDA | ANDA212848 |
| FDA SPL set id | 762146 |
| Labeler | Ascend Laboratories, LLC |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2021-04-02 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 67877-678 |
NDC Item 68180096204
| NDC 9 | 68180-962 |
|---|---|
| NDC 10 | 68180-962-04 |
| NDC Item | 68180096204 |
| Packaging | 4 in 1 POUCH |
| Packaging | 5 mL in 1 AMPULE |
| ANDA | ANDA208964 |
| FDA SPL set id | 779846 |
| Labeler | Lupin Pharmaceuticals, Inc. |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2018-06-12 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 68180-962 |
NDC Item 68180096256
| NDC 9 | 68180-962 |
|---|---|
| NDC 10 | 68180-962-56 |
| NDC Item | 68180096256 |
| Packaging | 56 POUCH in 1 CARTON (68180-962-56) / 4 AMPULE in 1 POUCH / 5 mL in 1 AMPULE |
| ANDA | ANDA208964 |
| FDA SPL set id | 779846 |
| Labeler | Lupin Pharmaceuticals, Inc. |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2018-06-12 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 68180-962 |
NDC Item 70644089999
| NDC 9 | 70644-899 |
|---|---|
| NDC 10 | 70644-899-99 |
| NDC Item | 70644089999 |
| Packaging | 14 POUCH in 1 CARTON (70644-899-99) / 4 AMPULE in 1 POUCH / 5 mL in 1 AMPULE |
| FDA SPL set id | 849478 |
| Labeler | Genericus, Inc. |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | NDA AUTHORIZED GENERIC |
| Marketing effective time low | 2016-07-11 |
| Marketing status | ACTIVE |
| NDA_AUTHORIZED_GENERIC | NDA205433 |
| Related queries | Properties for NDC 9 70644-899 |
NDC Item 70756060444
| NDC 9 | 70756-604 |
|---|---|
| NDC 10 | 70756-604-44 |
| NDC Item | 70756060444 |
| Packaging | 4 in 1 POUCH |
| Packaging | 5 mL in 1 AMPULE |
| ANDA | ANDA214478 |
| FDA SPL set id | 805293 |
| Labeler | Lifestar Pharma LLC |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2023-06-30 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 70756-604 |
NDC Item 70756060456
| NDC 9 | 70756-604 |
|---|---|
| NDC 10 | 70756-604-56 |
| NDC Item | 70756060456 |
| Packaging | 14 POUCH in 1 CARTON (70756-604-56) / 4 AMPULE in 1 POUCH (70756-604-44) / 5 mL in 1 AMPULE |
| ANDA | ANDA214478 |
| FDA SPL set id | 805293 |
| Labeler | Lifestar Pharma LLC |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2023-06-30 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 70756-604 |
NDC Item 72603043004
| NDC 9 | 72603-430 |
|---|---|
| NDC 10 | 72603-430-04 |
| NDC Item | 72603043004 |
| Packaging | 4 in 1 POUCH |
| Packaging | 5 mL in 1 AMPULE |
| ANDA | ANDA214478 |
| FDA SPL set id | 801097 |
| Labeler | NorthStar RxLLC |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2024-08-01 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 72603-430 |
NDC Item 72603043056
| NDC 9 | 72603-430 |
|---|---|
| NDC 10 | 72603-430-56 |
| NDC Item | 72603043056 |
| Packaging | 14 POUCH in 1 CARTON (72603-430-56) / 4 AMPULE in 1 POUCH (72603-430-04) / 5 mL in 1 AMPULE |
| ANDA | ANDA214478 |
| FDA SPL set id | 801097 |
| Labeler | NorthStar RxLLC |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2024-08-01 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 72603-430 |
NDC Item 76204002956
| NDC 9 | 76204-029 |
|---|---|
| NDC 10 | 76204-029-56 |
| NDC Item | 76204002956 |
| Packaging | 14 POUCH in 1 CARTON (76204-029-56) / 4 AMPULE in 1 POUCH / 5 mL in 1 AMPULE |
| ANDA | ANDA201422 |
| FDA SPL set id | 866956 |
| Labeler | Ritedose Pharmaceuticals, LLC |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2025-03-25 |
| Marketing status | active |
| Related queries | Properties for NDC 9 76204-029 |
NDC Item 00093408563
| NDC 9 | 0093-4085 |
|---|---|
| NDC 10 | 0093-4085-63 |
| NDC Item | 00093408563 |
| Packaging | 56 AMPULE in 1 CARTON (0093-4085-63) / 5 mL in 1 AMPULE |
| ANDA | ANDA091589 |
| FDA SPL set id | 861925 |
| Labeler | Teva Pharmaceuticals USA, Inc. |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2013-11-19 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 0093-4085 |
NDC Item 00781717156
| NDC 9 | 0781-7171 |
|---|---|
| NDC 10 | 0781-7171-56 |
| NDC Item | 00781717156 |
| Packaging | 56 AMPULE in 1 CARTON (0781-7171-56) / 5 mL in 1 AMPULE (0781-7171-75) |
| FDA SPL set id | 132419 |
| Labeler | Sandoz Inc |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | NDA AUTHORIZED GENERIC |
| Marketing effective time low | 2014-07-09 |
| Marketing status | COMPLETED |
| NDA_AUTHORIZED_GENERIC | NDA050753 |
| Related queries | Properties for NDC 9 0781-7171 |
NDC Item 00781717175
| NDC 9 | 0781-7171 |
|---|---|
| NDC 10 | 0781-7171-75 |
| NDC Item | 00781717175 |
| Packaging | 5 mL in 1 AMPULE |
| FDA SPL set id | 132419 |
| Labeler | Sandoz Inc |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | NDA AUTHORIZED GENERIC |
| Marketing effective time low | 2014-07-09 |
| Marketing status | COMPLETED |
| NDA_AUTHORIZED_GENERIC | NDA050753 |
| Related queries | Properties for NDC 9 0781-7171 |
NDC Item 16714011902
| NDC 9 | 16714-119 |
|---|---|
| NDC 10 | 16714-119-02 |
| NDC Item | 16714011902 |
| Packaging | 5 mL in 1 AMPULE |
| ANDA | ANDA207080 |
| FDA SPL set id | 842222 |
| Labeler | NorthStar RxLLC |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2020-05-21 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 16714-119 |
NDC Item 16714011903
| NDC 9 | 16714-119 |
|---|---|
| NDC 10 | 16714-119-03 |
| NDC Item | 16714011903 |
| Packaging | 14 POUCH in 1 CARTON (16714-119-03) / 4 AMPULE in 1 POUCH / 5 mL in 1 AMPULE (16714-119-02) |
| ANDA | ANDA207080 |
| FDA SPL set id | 842222 |
| Labeler | NorthStar RxLLC |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2020-05-21 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 16714-119 |
NDC Item 17478034038
| NDC 9 | 17478-340 |
|---|---|
| NDC 10 | 17478-340-38 |
| NDC Item | 17478034038 |
| Packaging | 14 POUCH in 1 CARTON (17478-340-38) / 4 AMPULE in 1 POUCH / 5 mL in 1 AMPULE |
| ANDA | ANDA201422 |
| FDA SPL set id | 656792 |
| Labeler | Akorn Operating Company LLC (dba Akorn) |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 17478-340 |
NDC Item 42571040809
| NDC 9 | 42571-408 |
|---|---|
| NDC 10 | 42571-408-09 |
| NDC Item | 42571040809 |
| Packaging | 5 mL in 1 AMPULE |
| ANDA | ANDA217344 |
| FDA SPL set id | 812408 |
| Labeler | Micro Labs Limited |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2024-01-01 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 42571-408 |
NDC Item 42571040819
| NDC 9 | 42571-408 |
|---|---|
| NDC 10 | 42571-408-19 |
| NDC Item | 42571040819 |
| Packaging | 4 in 1 POUCH |
| ANDA | ANDA217344 |
| FDA SPL set id | 812408 |
| Labeler | Micro Labs Limited |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2024-01-01 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 42571-408 |
NDC Item 42571040892
| NDC 9 | 42571-408 |
|---|---|
| NDC 10 | 42571-408-92 |
| NDC Item | 42571040892 |
| Packaging | 14 POUCH in 1 CARTON (42571-408-92) / 4 AMPULE in 1 POUCH (42571-408-19) / 5 mL in 1 AMPULE (42571-408-09) |
| ANDA | ANDA217344 |
| FDA SPL set id | 812408 |
| Labeler | Micro Labs Limited |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2024-01-01 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 42571-408 |
NDC Item 43598060504
| NDC 9 | 43598-605 |
|---|---|
| NDC 10 | 43598-605-04 |
| NDC Item | 43598060504 |
| ANDA | ANDA207080 |
| FDA SPL set id | 706735 |
| Labeler | Dr. Reddy's Laboratories Inc. |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2019-05-14 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 43598-605 |
NDC Item 43598060511
| NDC 9 | 43598-605 |
|---|---|
| NDC 10 | 43598-605-11 |
| NDC Item | 43598060511 |
| ANDA | ANDA207080 |
| FDA SPL set id | 706735 |
| Labeler | Dr. Reddy's Laboratories Inc. |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2019-05-14 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 43598-605 |
NDC Item 43598060556
| NDC 9 | 43598-605 |
|---|---|
| NDC 10 | 43598-605-56 |
| NDC Item | 43598060556 |
| Packaging | 14 POUCH in 1 CARTON (43598-605-56) / 4 AMPULE in 1 POUCH (43598-605-04) / 5 mL in 1 AMPULE |
| ANDA | ANDA207080 |
| FDA SPL set id | 706735 |
| Labeler | Dr. Reddy's Laboratories Inc. |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2019-05-14 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 43598-605 |
NDC Item 43598060558
| NDC 9 | 43598-605 |
|---|---|
| NDC 10 | 43598-605-58 |
| NDC Item | 43598060558 |
| Packaging | 56 POUCH in 1 CARTON (43598-605-58) / 1 AMPULE in 1 POUCH (43598-605-11) / 5 mL in 1 AMPULE |
| ANDA | ANDA207080 |
| FDA SPL set id | 706735 |
| Labeler | Dr. Reddy's Laboratories Inc. |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2019-05-14 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 43598-605 |
NDC Item 47335017148
| NDC 9 | 47335-171 |
|---|---|
| NDC 10 | 47335-171-48 |
| NDC Item | 47335017148 |
| Packaging | 4 in 1 POUCH |
| Packaging | 5 mL in 1 AMPULE |
| ANDA | ANDA207136 |
| COLORTEXT | YELLOW(Colourless to light yellow) |
| Color | C48330 __ |
| FDA SPL set id | 707885 |
| Labeler | Sun Pharmaceutical Industries, Inc. |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2020-02-28 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 47335-171 |
NDC Item 47335017149
| NDC 9 | 47335-171 |
|---|---|
| NDC 10 | 47335-171-49 |
| NDC Item | 47335017149 |
| Packaging | 14 POUCH in 1 CARTON (47335-171-49) / 4 AMPULE in 1 POUCH (47335-171-48) / 5 mL in 1 AMPULE |
| ANDA | ANDA207136 |
| COLORTEXT | YELLOW(Colourless to light yellow) |
| Color | C48330 __ |
| FDA SPL set id | 707885 |
| Labeler | Sun Pharmaceutical Industries, Inc. |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2020-02-28 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 47335-171 |
NDC Item 59651012904
| NDC 9 | 59651-129 |
|---|---|
| NDC 10 | 59651-129-04 |
| NDC Item | 59651012904 |
| Packaging | 4 in 1 POUCH |
| Packaging | 5 mL in 1 AMPULE |
| ANDA | ANDA210871 |
| FDA SPL set id | 710977 |
| Labeler | Aurobindo Pharma Limited |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2021-01-22 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 59651-129 |
NDC Item 59651012956
| NDC 9 | 59651-129 |
|---|---|
| NDC 10 | 59651-129-56 |
| NDC Item | 59651012956 |
| Packaging | 14 POUCH in 1 CARTON (59651-129-56) / 4 AMPULE in 1 POUCH (59651-129-04) / 5 mL in 1 AMPULE |
| ANDA | ANDA210871 |
| FDA SPL set id | 710977 |
| Labeler | Aurobindo Pharma Limited |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2021-01-22 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 59651-129 |
NDC Item 60687073179
| NDC 9 | 60687-731 |
|---|---|
| NDC 10 | 60687-731-79 |
| NDC Item | 60687073179 |
| Packaging | 1 in 1 POUCH |
| Packaging | 5 mL in 1 AMPULE |
| ANDA | ANDA207136 |
| COLORTEXT | yellow(Colourless to light yellow) |
| Color | C48330 __ |
| FDA SPL set id | 786945 |
| Labeler | American Health Packaging |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2024-05-19 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 60687-731 |
NDC Item 60687073183
| NDC 9 | 60687-731 |
|---|---|
| NDC 10 | 60687-731-83 |
| NDC Item | 60687073183 |
| Packaging | 30 POUCH in 1 CARTON (60687-731-83) / 1 AMPULE in 1 POUCH (60687-731-79) / 5 mL in 1 AMPULE |
| ANDA | ANDA207136 |
| COLORTEXT | yellow(Colourless to light yellow) |
| Color | C48330 __ |
| FDA SPL set id | 786945 |
| Labeler | American Health Packaging |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2024-05-19 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 60687-731 |
NDC Item 65162091446
| NDC 9 | 65162-914 |
|---|---|
| NDC 10 | 65162-914-46 |
| NDC Item | 65162091446 |
| Packaging | 56 AMPULE in 1 CARTON (65162-914-46) / 5 mL in 1 AMPULE |
| ANDA | ANDA205501 |
| COLORTEXT | yellow(clear, slightly yellow) |
| Color | C48330 __ |
| FDA SPL set id | 824547 |
| Labeler | Amneal Pharmaceuticals LLC |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2014-07-13 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 65162-914 |
NDC Item 67877067869
| NDC 9 | 67877-678 |
|---|---|
| NDC 10 | 67877-678-69 |
| NDC Item | 67877067869 |
| Packaging | 5 mL in 1 AMPULE |
| Packaging | 7 in 1 POUCH |
| ANDA | ANDA212848 |
| FDA SPL set id | 762146 |
| Labeler | Ascend Laboratories, LLC |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2021-04-02 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 67877-678 |
NDC Item 67877067870
| NDC 9 | 67877-678 |
|---|---|
| NDC 10 | 67877-678-70 |
| NDC Item | 67877067870 |
| Packaging | 56 POUCH in 1 CARTON (67877-678-70) / 7 AMPULE in 1 POUCH (67877-678-69) / 5 mL in 1 AMPULE |
| ANDA | ANDA212848 |
| FDA SPL set id | 762146 |
| Labeler | Ascend Laboratories, LLC |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2021-04-02 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 67877-678 |
NDC Item 68180096204
| NDC 9 | 68180-962 |
|---|---|
| NDC 10 | 68180-962-04 |
| NDC Item | 68180096204 |
| Packaging | 4 in 1 POUCH |
| Packaging | 5 mL in 1 AMPULE |
| ANDA | ANDA208964 |
| FDA SPL set id | 779846 |
| Labeler | Lupin Pharmaceuticals, Inc. |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2018-06-12 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 68180-962 |
NDC Item 68180096256
| NDC 9 | 68180-962 |
|---|---|
| NDC 10 | 68180-962-56 |
| NDC Item | 68180096256 |
| Packaging | 56 POUCH in 1 CARTON (68180-962-56) / 4 AMPULE in 1 POUCH / 5 mL in 1 AMPULE |
| ANDA | ANDA208964 |
| FDA SPL set id | 779846 |
| Labeler | Lupin Pharmaceuticals, Inc. |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2018-06-12 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 68180-962 |
NDC Item 70644089999
| NDC 9 | 70644-899 |
|---|---|
| NDC 10 | 70644-899-99 |
| NDC Item | 70644089999 |
| Packaging | 14 POUCH in 1 CARTON (70644-899-99) / 4 AMPULE in 1 POUCH / 5 mL in 1 AMPULE |
| FDA SPL set id | 849478 |
| Labeler | Genericus, Inc. |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | NDA AUTHORIZED GENERIC |
| Marketing effective time low | 2016-07-11 |
| Marketing status | ACTIVE |
| NDA_AUTHORIZED_GENERIC | NDA205433 |
| Related queries | Properties for NDC 9 70644-899 |
NDC Item 70756060444
| NDC 9 | 70756-604 |
|---|---|
| NDC 10 | 70756-604-44 |
| NDC Item | 70756060444 |
| Packaging | 4 in 1 POUCH |
| Packaging | 5 mL in 1 AMPULE |
| ANDA | ANDA214478 |
| FDA SPL set id | 805293 |
| Labeler | Lifestar Pharma LLC |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2023-06-30 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 70756-604 |
NDC Item 70756060456
| NDC 9 | 70756-604 |
|---|---|
| NDC 10 | 70756-604-56 |
| NDC Item | 70756060456 |
| Packaging | 14 POUCH in 1 CARTON (70756-604-56) / 4 AMPULE in 1 POUCH (70756-604-44) / 5 mL in 1 AMPULE |
| ANDA | ANDA214478 |
| FDA SPL set id | 805293 |
| Labeler | Lifestar Pharma LLC |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2023-06-30 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 70756-604 |
NDC Item 72603043004
| NDC 9 | 72603-430 |
|---|---|
| NDC 10 | 72603-430-04 |
| NDC Item | 72603043004 |
| Packaging | 4 in 1 POUCH |
| Packaging | 5 mL in 1 AMPULE |
| ANDA | ANDA214478 |
| FDA SPL set id | 801097 |
| Labeler | NorthStar RxLLC |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2024-08-01 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 72603-430 |
NDC Item 72603043056
| NDC 9 | 72603-430 |
|---|---|
| NDC 10 | 72603-430-56 |
| NDC Item | 72603043056 |
| Packaging | 14 POUCH in 1 CARTON (72603-430-56) / 4 AMPULE in 1 POUCH (72603-430-04) / 5 mL in 1 AMPULE |
| ANDA | ANDA214478 |
| FDA SPL set id | 801097 |
| Labeler | NorthStar RxLLC |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2024-08-01 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 72603-430 |
NDC Item 76204002956
| NDC 9 | 76204-029 |
|---|---|
| NDC 10 | 76204-029-56 |
| NDC Item | 76204002956 |
| Packaging | 14 POUCH in 1 CARTON (76204-029-56) / 4 AMPULE in 1 POUCH / 5 mL in 1 AMPULE |
| ANDA | ANDA201422 |
| FDA SPL set id | 866956 |
| Labeler | Ritedose Pharmaceuticals, LLC |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2025-03-25 |
| Marketing status | active |
| Related queries | Properties for NDC 9 76204-029 |
NDC Item 00093408563
| NDC 9 | 0093-4085 |
|---|---|
| NDC 10 | 0093-4085-63 |
| NDC Item | 00093408563 |
| Packaging | 56 AMPULE in 1 CARTON (0093-4085-63) / 5 mL in 1 AMPULE |
| ANDA | ANDA091589 |
| FDA SPL set id | 861925 |
| Labeler | Teva Pharmaceuticals USA, Inc. |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2013-11-19 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 0093-4085 |
NDC Item 00781717156
| NDC 9 | 0781-7171 |
|---|---|
| NDC 10 | 0781-7171-56 |
| NDC Item | 00781717156 |
| Packaging | 56 AMPULE in 1 CARTON (0781-7171-56) / 5 mL in 1 AMPULE (0781-7171-75) |
| FDA SPL set id | 132419 |
| Labeler | Sandoz Inc |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | NDA AUTHORIZED GENERIC |
| Marketing effective time low | 2014-07-09 |
| Marketing status | COMPLETED |
| NDA_AUTHORIZED_GENERIC | NDA050753 |
| Related queries | Properties for NDC 9 0781-7171 |
NDC Item 00781717175
| NDC 9 | 0781-7171 |
|---|---|
| NDC 10 | 0781-7171-75 |
| NDC Item | 00781717175 |
| Packaging | 5 mL in 1 AMPULE |
| FDA SPL set id | 132419 |
| Labeler | Sandoz Inc |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | NDA AUTHORIZED GENERIC |
| Marketing effective time low | 2014-07-09 |
| Marketing status | COMPLETED |
| NDA_AUTHORIZED_GENERIC | NDA050753 |
| Related queries | Properties for NDC 9 0781-7171 |
NDC Item 16714011902
| NDC 9 | 16714-119 |
|---|---|
| NDC 10 | 16714-119-02 |
| NDC Item | 16714011902 |
| Packaging | 5 mL in 1 AMPULE |
| ANDA | ANDA207080 |
| FDA SPL set id | 842222 |
| Labeler | NorthStar RxLLC |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2020-05-21 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 16714-119 |
NDC Item 16714011903
| NDC 9 | 16714-119 |
|---|---|
| NDC 10 | 16714-119-03 |
| NDC Item | 16714011903 |
| Packaging | 14 POUCH in 1 CARTON (16714-119-03) / 4 AMPULE in 1 POUCH / 5 mL in 1 AMPULE (16714-119-02) |
| ANDA | ANDA207080 |
| FDA SPL set id | 842222 |
| Labeler | NorthStar RxLLC |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2020-05-21 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 16714-119 |
NDC Item 17478034038
| NDC 9 | 17478-340 |
|---|---|
| NDC 10 | 17478-340-38 |
| NDC Item | 17478034038 |
| Packaging | 14 POUCH in 1 CARTON (17478-340-38) / 4 AMPULE in 1 POUCH / 5 mL in 1 AMPULE |
| ANDA | ANDA201422 |
| FDA SPL set id | 656792 |
| Labeler | Akorn Operating Company LLC (dba Akorn) |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 17478-340 |
NDC Item 42571040809
| NDC 9 | 42571-408 |
|---|---|
| NDC 10 | 42571-408-09 |
| NDC Item | 42571040809 |
| Packaging | 5 mL in 1 AMPULE |
| ANDA | ANDA217344 |
| FDA SPL set id | 812408 |
| Labeler | Micro Labs Limited |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2024-01-01 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 42571-408 |
NDC Item 42571040819
| NDC 9 | 42571-408 |
|---|---|
| NDC 10 | 42571-408-19 |
| NDC Item | 42571040819 |
| Packaging | 4 in 1 POUCH |
| ANDA | ANDA217344 |
| FDA SPL set id | 812408 |
| Labeler | Micro Labs Limited |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2024-01-01 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 42571-408 |
NDC Item 42571040892
| NDC 9 | 42571-408 |
|---|---|
| NDC 10 | 42571-408-92 |
| NDC Item | 42571040892 |
| Packaging | 14 POUCH in 1 CARTON (42571-408-92) / 4 AMPULE in 1 POUCH (42571-408-19) / 5 mL in 1 AMPULE (42571-408-09) |
| ANDA | ANDA217344 |
| FDA SPL set id | 812408 |
| Labeler | Micro Labs Limited |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2024-01-01 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 42571-408 |
NDC Item 43598060504
| NDC 9 | 43598-605 |
|---|---|
| NDC 10 | 43598-605-04 |
| NDC Item | 43598060504 |
| ANDA | ANDA207080 |
| FDA SPL set id | 706735 |
| Labeler | Dr. Reddy's Laboratories Inc. |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2019-05-14 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 43598-605 |
NDC Item 43598060511
| NDC 9 | 43598-605 |
|---|---|
| NDC 10 | 43598-605-11 |
| NDC Item | 43598060511 |
| ANDA | ANDA207080 |
| FDA SPL set id | 706735 |
| Labeler | Dr. Reddy's Laboratories Inc. |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2019-05-14 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 43598-605 |
NDC Item 43598060556
| NDC 9 | 43598-605 |
|---|---|
| NDC 10 | 43598-605-56 |
| NDC Item | 43598060556 |
| Packaging | 14 POUCH in 1 CARTON (43598-605-56) / 4 AMPULE in 1 POUCH (43598-605-04) / 5 mL in 1 AMPULE |
| ANDA | ANDA207080 |
| FDA SPL set id | 706735 |
| Labeler | Dr. Reddy's Laboratories Inc. |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2019-05-14 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 43598-605 |
NDC Item 43598060558
| NDC 9 | 43598-605 |
|---|---|
| NDC 10 | 43598-605-58 |
| NDC Item | 43598060558 |
| Packaging | 56 POUCH in 1 CARTON (43598-605-58) / 1 AMPULE in 1 POUCH (43598-605-11) / 5 mL in 1 AMPULE |
| ANDA | ANDA207080 |
| FDA SPL set id | 706735 |
| Labeler | Dr. Reddy's Laboratories Inc. |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2019-05-14 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 43598-605 |
NDC Item 47335017148
| NDC 9 | 47335-171 |
|---|---|
| NDC 10 | 47335-171-48 |
| NDC Item | 47335017148 |
| Packaging | 4 in 1 POUCH |
| Packaging | 5 mL in 1 AMPULE |
| ANDA | ANDA207136 |
| COLORTEXT | YELLOW(Colourless to light yellow) |
| Color | C48330 __ |
| FDA SPL set id | 707885 |
| Labeler | Sun Pharmaceutical Industries, Inc. |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2020-02-28 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 47335-171 |
NDC Item 47335017149
| NDC 9 | 47335-171 |
|---|---|
| NDC 10 | 47335-171-49 |
| NDC Item | 47335017149 |
| Packaging | 14 POUCH in 1 CARTON (47335-171-49) / 4 AMPULE in 1 POUCH (47335-171-48) / 5 mL in 1 AMPULE |
| ANDA | ANDA207136 |
| COLORTEXT | YELLOW(Colourless to light yellow) |
| Color | C48330 __ |
| FDA SPL set id | 707885 |
| Labeler | Sun Pharmaceutical Industries, Inc. |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2020-02-28 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 47335-171 |
NDC Item 59651012904
| NDC 9 | 59651-129 |
|---|---|
| NDC 10 | 59651-129-04 |
| NDC Item | 59651012904 |
| Packaging | 4 in 1 POUCH |
| Packaging | 5 mL in 1 AMPULE |
| ANDA | ANDA210871 |
| FDA SPL set id | 710977 |
| Labeler | Aurobindo Pharma Limited |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2021-01-22 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 59651-129 |
NDC Item 59651012956
| NDC 9 | 59651-129 |
|---|---|
| NDC 10 | 59651-129-56 |
| NDC Item | 59651012956 |
| Packaging | 14 POUCH in 1 CARTON (59651-129-56) / 4 AMPULE in 1 POUCH (59651-129-04) / 5 mL in 1 AMPULE |
| ANDA | ANDA210871 |
| FDA SPL set id | 710977 |
| Labeler | Aurobindo Pharma Limited |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2021-01-22 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 59651-129 |
NDC Item 60687073179
| NDC 9 | 60687-731 |
|---|---|
| NDC 10 | 60687-731-79 |
| NDC Item | 60687073179 |
| Packaging | 1 in 1 POUCH |
| Packaging | 5 mL in 1 AMPULE |
| ANDA | ANDA207136 |
| COLORTEXT | yellow(Colourless to light yellow) |
| Color | C48330 __ |
| FDA SPL set id | 786945 |
| Labeler | American Health Packaging |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2024-05-19 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 60687-731 |
NDC Item 60687073183
| NDC 9 | 60687-731 |
|---|---|
| NDC 10 | 60687-731-83 |
| NDC Item | 60687073183 |
| Packaging | 30 POUCH in 1 CARTON (60687-731-83) / 1 AMPULE in 1 POUCH (60687-731-79) / 5 mL in 1 AMPULE |
| ANDA | ANDA207136 |
| COLORTEXT | yellow(Colourless to light yellow) |
| Color | C48330 __ |
| FDA SPL set id | 786945 |
| Labeler | American Health Packaging |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2024-05-19 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 60687-731 |
NDC Item 65162091446
| NDC 9 | 65162-914 |
|---|---|
| NDC 10 | 65162-914-46 |
| NDC Item | 65162091446 |
| Packaging | 56 AMPULE in 1 CARTON (65162-914-46) / 5 mL in 1 AMPULE |
| ANDA | ANDA205501 |
| COLORTEXT | yellow(clear, slightly yellow) |
| Color | C48330 __ |
| FDA SPL set id | 824547 |
| Labeler | Amneal Pharmaceuticals LLC |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2014-07-13 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 65162-914 |
NDC Item 67877067869
| NDC 9 | 67877-678 |
|---|---|
| NDC 10 | 67877-678-69 |
| NDC Item | 67877067869 |
| Packaging | 5 mL in 1 AMPULE |
| Packaging | 7 in 1 POUCH |
| ANDA | ANDA212848 |
| FDA SPL set id | 762146 |
| Labeler | Ascend Laboratories, LLC |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2021-04-02 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 67877-678 |
NDC Item 67877067870
| NDC 9 | 67877-678 |
|---|---|
| NDC 10 | 67877-678-70 |
| NDC Item | 67877067870 |
| Packaging | 56 POUCH in 1 CARTON (67877-678-70) / 7 AMPULE in 1 POUCH (67877-678-69) / 5 mL in 1 AMPULE |
| ANDA | ANDA212848 |
| FDA SPL set id | 762146 |
| Labeler | Ascend Laboratories, LLC |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2021-04-02 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 67877-678 |
NDC Item 68180096204
| NDC 9 | 68180-962 |
|---|---|
| NDC 10 | 68180-962-04 |
| NDC Item | 68180096204 |
| Packaging | 4 in 1 POUCH |
| Packaging | 5 mL in 1 AMPULE |
| ANDA | ANDA208964 |
| FDA SPL set id | 779846 |
| Labeler | Lupin Pharmaceuticals, Inc. |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2018-06-12 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 68180-962 |
NDC Item 68180096256
| NDC 9 | 68180-962 |
|---|---|
| NDC 10 | 68180-962-56 |
| NDC Item | 68180096256 |
| Packaging | 56 POUCH in 1 CARTON (68180-962-56) / 4 AMPULE in 1 POUCH / 5 mL in 1 AMPULE |
| ANDA | ANDA208964 |
| FDA SPL set id | 779846 |
| Labeler | Lupin Pharmaceuticals, Inc. |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2018-06-12 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 68180-962 |
NDC Item 70644089999
| NDC 9 | 70644-899 |
|---|---|
| NDC 10 | 70644-899-99 |
| NDC Item | 70644089999 |
| Packaging | 14 POUCH in 1 CARTON (70644-899-99) / 4 AMPULE in 1 POUCH / 5 mL in 1 AMPULE |
| FDA SPL set id | 849478 |
| Labeler | Genericus, Inc. |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | NDA AUTHORIZED GENERIC |
| Marketing effective time low | 2016-07-11 |
| Marketing status | ACTIVE |
| NDA_AUTHORIZED_GENERIC | NDA205433 |
| Related queries | Properties for NDC 9 70644-899 |
NDC Item 70756060444
| NDC 9 | 70756-604 |
|---|---|
| NDC 10 | 70756-604-44 |
| NDC Item | 70756060444 |
| Packaging | 4 in 1 POUCH |
| Packaging | 5 mL in 1 AMPULE |
| ANDA | ANDA214478 |
| FDA SPL set id | 805293 |
| Labeler | Lifestar Pharma LLC |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2023-06-30 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 70756-604 |
NDC Item 70756060456
| NDC 9 | 70756-604 |
|---|---|
| NDC 10 | 70756-604-56 |
| NDC Item | 70756060456 |
| Packaging | 14 POUCH in 1 CARTON (70756-604-56) / 4 AMPULE in 1 POUCH (70756-604-44) / 5 mL in 1 AMPULE |
| ANDA | ANDA214478 |
| FDA SPL set id | 805293 |
| Labeler | Lifestar Pharma LLC |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2023-06-30 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 70756-604 |
NDC Item 72603043004
| NDC 9 | 72603-430 |
|---|---|
| NDC 10 | 72603-430-04 |
| NDC Item | 72603043004 |
| Packaging | 4 in 1 POUCH |
| Packaging | 5 mL in 1 AMPULE |
| ANDA | ANDA214478 |
| FDA SPL set id | 801097 |
| Labeler | NorthStar RxLLC |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2024-08-01 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 72603-430 |
NDC Item 72603043056
| NDC 9 | 72603-430 |
|---|---|
| NDC 10 | 72603-430-56 |
| NDC Item | 72603043056 |
| Packaging | 14 POUCH in 1 CARTON (72603-430-56) / 4 AMPULE in 1 POUCH (72603-430-04) / 5 mL in 1 AMPULE |
| ANDA | ANDA214478 |
| FDA SPL set id | 801097 |
| Labeler | NorthStar RxLLC |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2024-08-01 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 72603-430 |
NDC Item 76204002956
| NDC 9 | 76204-029 |
|---|---|
| NDC 10 | 76204-029-56 |
| NDC Item | 76204002956 |
| Packaging | 14 POUCH in 1 CARTON (76204-029-56) / 4 AMPULE in 1 POUCH / 5 mL in 1 AMPULE |
| ANDA | ANDA201422 |
| FDA SPL set id | 866956 |
| Labeler | Ritedose Pharmaceuticals, LLC |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2025-03-25 |
| Marketing status | active |
| Related queries | Properties for NDC 9 76204-029 |
NDC Item 00093408563
| NDC 9 | 0093-4085 |
|---|---|
| NDC 10 | 0093-4085-63 |
| NDC Item | 00093408563 |
| Packaging | 56 AMPULE in 1 CARTON (0093-4085-63) / 5 mL in 1 AMPULE |
| ANDA | ANDA091589 |
| FDA SPL set id | 861925 |
| Labeler | Teva Pharmaceuticals USA, Inc. |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2013-11-19 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 0093-4085 |
NDC Item 00781717156
| NDC 9 | 0781-7171 |
|---|---|
| NDC 10 | 0781-7171-56 |
| NDC Item | 00781717156 |
| Packaging | 56 AMPULE in 1 CARTON (0781-7171-56) / 5 mL in 1 AMPULE (0781-7171-75) |
| FDA SPL set id | 132419 |
| Labeler | Sandoz Inc |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | NDA AUTHORIZED GENERIC |
| Marketing effective time low | 2014-07-09 |
| Marketing status | COMPLETED |
| NDA_AUTHORIZED_GENERIC | NDA050753 |
| Related queries | Properties for NDC 9 0781-7171 |
NDC Item 00781717175
| NDC 9 | 0781-7171 |
|---|---|
| NDC 10 | 0781-7171-75 |
| NDC Item | 00781717175 |
| Packaging | 5 mL in 1 AMPULE |
| FDA SPL set id | 132419 |
| Labeler | Sandoz Inc |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | NDA AUTHORIZED GENERIC |
| Marketing effective time low | 2014-07-09 |
| Marketing status | COMPLETED |
| NDA_AUTHORIZED_GENERIC | NDA050753 |
| Related queries | Properties for NDC 9 0781-7171 |
NDC Item 16714011902
| NDC 9 | 16714-119 |
|---|---|
| NDC 10 | 16714-119-02 |
| NDC Item | 16714011902 |
| Packaging | 5 mL in 1 AMPULE |
| ANDA | ANDA207080 |
| FDA SPL set id | 842222 |
| Labeler | NorthStar RxLLC |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2020-05-21 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 16714-119 |
NDC Item 16714011903
| NDC 9 | 16714-119 |
|---|---|
| NDC 10 | 16714-119-03 |
| NDC Item | 16714011903 |
| Packaging | 14 POUCH in 1 CARTON (16714-119-03) / 4 AMPULE in 1 POUCH / 5 mL in 1 AMPULE (16714-119-02) |
| ANDA | ANDA207080 |
| FDA SPL set id | 842222 |
| Labeler | NorthStar RxLLC |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2020-05-21 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 16714-119 |
NDC Item 17478034038
| NDC 9 | 17478-340 |
|---|---|
| NDC 10 | 17478-340-38 |
| NDC Item | 17478034038 |
| Packaging | 14 POUCH in 1 CARTON (17478-340-38) / 4 AMPULE in 1 POUCH / 5 mL in 1 AMPULE |
| ANDA | ANDA201422 |
| FDA SPL set id | 656792 |
| Labeler | Akorn Operating Company LLC (dba Akorn) |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 17478-340 |
NDC Item 42571040809
| NDC 9 | 42571-408 |
|---|---|
| NDC 10 | 42571-408-09 |
| NDC Item | 42571040809 |
| Packaging | 5 mL in 1 AMPULE |
| ANDA | ANDA217344 |
| FDA SPL set id | 812408 |
| Labeler | Micro Labs Limited |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2024-01-01 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 42571-408 |
NDC Item 42571040819
| NDC 9 | 42571-408 |
|---|---|
| NDC 10 | 42571-408-19 |
| NDC Item | 42571040819 |
| Packaging | 4 in 1 POUCH |
| ANDA | ANDA217344 |
| FDA SPL set id | 812408 |
| Labeler | Micro Labs Limited |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2024-01-01 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 42571-408 |
NDC Item 42571040892
| NDC 9 | 42571-408 |
|---|---|
| NDC 10 | 42571-408-92 |
| NDC Item | 42571040892 |
| Packaging | 14 POUCH in 1 CARTON (42571-408-92) / 4 AMPULE in 1 POUCH (42571-408-19) / 5 mL in 1 AMPULE (42571-408-09) |
| ANDA | ANDA217344 |
| FDA SPL set id | 812408 |
| Labeler | Micro Labs Limited |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2024-01-01 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 42571-408 |
NDC Item 43598060504
| NDC 9 | 43598-605 |
|---|---|
| NDC 10 | 43598-605-04 |
| NDC Item | 43598060504 |
| ANDA | ANDA207080 |
| FDA SPL set id | 706735 |
| Labeler | Dr. Reddy's Laboratories Inc. |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2019-05-14 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 43598-605 |
NDC Item 43598060511
| NDC 9 | 43598-605 |
|---|---|
| NDC 10 | 43598-605-11 |
| NDC Item | 43598060511 |
| ANDA | ANDA207080 |
| FDA SPL set id | 706735 |
| Labeler | Dr. Reddy's Laboratories Inc. |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2019-05-14 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 43598-605 |
NDC Item 43598060556
| NDC 9 | 43598-605 |
|---|---|
| NDC 10 | 43598-605-56 |
| NDC Item | 43598060556 |
| Packaging | 14 POUCH in 1 CARTON (43598-605-56) / 4 AMPULE in 1 POUCH (43598-605-04) / 5 mL in 1 AMPULE |
| ANDA | ANDA207080 |
| FDA SPL set id | 706735 |
| Labeler | Dr. Reddy's Laboratories Inc. |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2019-05-14 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 43598-605 |
NDC Item 43598060558
| NDC 9 | 43598-605 |
|---|---|
| NDC 10 | 43598-605-58 |
| NDC Item | 43598060558 |
| Packaging | 56 POUCH in 1 CARTON (43598-605-58) / 1 AMPULE in 1 POUCH (43598-605-11) / 5 mL in 1 AMPULE |
| ANDA | ANDA207080 |
| FDA SPL set id | 706735 |
| Labeler | Dr. Reddy's Laboratories Inc. |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2019-05-14 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 43598-605 |
NDC Item 47335017148
| NDC 9 | 47335-171 |
|---|---|
| NDC 10 | 47335-171-48 |
| NDC Item | 47335017148 |
| Packaging | 4 in 1 POUCH |
| Packaging | 5 mL in 1 AMPULE |
| ANDA | ANDA207136 |
| COLORTEXT | YELLOW(Colourless to light yellow) |
| Color | C48330 __ |
| FDA SPL set id | 707885 |
| Labeler | Sun Pharmaceutical Industries, Inc. |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2020-02-28 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 47335-171 |
NDC Item 47335017149
| NDC 9 | 47335-171 |
|---|---|
| NDC 10 | 47335-171-49 |
| NDC Item | 47335017149 |
| Packaging | 14 POUCH in 1 CARTON (47335-171-49) / 4 AMPULE in 1 POUCH (47335-171-48) / 5 mL in 1 AMPULE |
| ANDA | ANDA207136 |
| COLORTEXT | YELLOW(Colourless to light yellow) |
| Color | C48330 __ |
| FDA SPL set id | 707885 |
| Labeler | Sun Pharmaceutical Industries, Inc. |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2020-02-28 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 47335-171 |
NDC Item 59651012904
| NDC 9 | 59651-129 |
|---|---|
| NDC 10 | 59651-129-04 |
| NDC Item | 59651012904 |
| Packaging | 4 in 1 POUCH |
| Packaging | 5 mL in 1 AMPULE |
| ANDA | ANDA210871 |
| FDA SPL set id | 710977 |
| Labeler | Aurobindo Pharma Limited |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2021-01-22 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 59651-129 |
NDC Item 59651012956
| NDC 9 | 59651-129 |
|---|---|
| NDC 10 | 59651-129-56 |
| NDC Item | 59651012956 |
| Packaging | 14 POUCH in 1 CARTON (59651-129-56) / 4 AMPULE in 1 POUCH (59651-129-04) / 5 mL in 1 AMPULE |
| ANDA | ANDA210871 |
| FDA SPL set id | 710977 |
| Labeler | Aurobindo Pharma Limited |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2021-01-22 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 59651-129 |
NDC Item 60687073179
| NDC 9 | 60687-731 |
|---|---|
| NDC 10 | 60687-731-79 |
| NDC Item | 60687073179 |
| Packaging | 1 in 1 POUCH |
| Packaging | 5 mL in 1 AMPULE |
| ANDA | ANDA207136 |
| COLORTEXT | yellow(Colourless to light yellow) |
| Color | C48330 __ |
| FDA SPL set id | 786945 |
| Labeler | American Health Packaging |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2024-05-19 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 60687-731 |
NDC Item 60687073183
| NDC 9 | 60687-731 |
|---|---|
| NDC 10 | 60687-731-83 |
| NDC Item | 60687073183 |
| Packaging | 30 POUCH in 1 CARTON (60687-731-83) / 1 AMPULE in 1 POUCH (60687-731-79) / 5 mL in 1 AMPULE |
| ANDA | ANDA207136 |
| COLORTEXT | yellow(Colourless to light yellow) |
| Color | C48330 __ |
| FDA SPL set id | 786945 |
| Labeler | American Health Packaging |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2024-05-19 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 60687-731 |
NDC Item 65162091446
| NDC 9 | 65162-914 |
|---|---|
| NDC 10 | 65162-914-46 |
| NDC Item | 65162091446 |
| Packaging | 56 AMPULE in 1 CARTON (65162-914-46) / 5 mL in 1 AMPULE |
| ANDA | ANDA205501 |
| COLORTEXT | yellow(clear, slightly yellow) |
| Color | C48330 __ |
| FDA SPL set id | 824547 |
| Labeler | Amneal Pharmaceuticals LLC |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2014-07-13 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 65162-914 |
NDC Item 67877067869
| NDC 9 | 67877-678 |
|---|---|
| NDC 10 | 67877-678-69 |
| NDC Item | 67877067869 |
| Packaging | 5 mL in 1 AMPULE |
| Packaging | 7 in 1 POUCH |
| ANDA | ANDA212848 |
| FDA SPL set id | 762146 |
| Labeler | Ascend Laboratories, LLC |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2021-04-02 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 67877-678 |
NDC Item 67877067870
| NDC 9 | 67877-678 |
|---|---|
| NDC 10 | 67877-678-70 |
| NDC Item | 67877067870 |
| Packaging | 56 POUCH in 1 CARTON (67877-678-70) / 7 AMPULE in 1 POUCH (67877-678-69) / 5 mL in 1 AMPULE |
| ANDA | ANDA212848 |
| FDA SPL set id | 762146 |
| Labeler | Ascend Laboratories, LLC |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2021-04-02 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 67877-678 |
NDC Item 68180096204
| NDC 9 | 68180-962 |
|---|---|
| NDC 10 | 68180-962-04 |
| NDC Item | 68180096204 |
| Packaging | 4 in 1 POUCH |
| Packaging | 5 mL in 1 AMPULE |
| ANDA | ANDA208964 |
| FDA SPL set id | 779846 |
| Labeler | Lupin Pharmaceuticals, Inc. |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2018-06-12 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 68180-962 |
NDC Item 68180096256
| NDC 9 | 68180-962 |
|---|---|
| NDC 10 | 68180-962-56 |
| NDC Item | 68180096256 |
| Packaging | 56 POUCH in 1 CARTON (68180-962-56) / 4 AMPULE in 1 POUCH / 5 mL in 1 AMPULE |
| ANDA | ANDA208964 |
| FDA SPL set id | 779846 |
| Labeler | Lupin Pharmaceuticals, Inc. |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2018-06-12 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 68180-962 |
NDC Item 70644089999
| NDC 9 | 70644-899 |
|---|---|
| NDC 10 | 70644-899-99 |
| NDC Item | 70644089999 |
| Packaging | 14 POUCH in 1 CARTON (70644-899-99) / 4 AMPULE in 1 POUCH / 5 mL in 1 AMPULE |
| FDA SPL set id | 849478 |
| Labeler | Genericus, Inc. |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | NDA AUTHORIZED GENERIC |
| Marketing effective time low | 2016-07-11 |
| Marketing status | ACTIVE |
| NDA_AUTHORIZED_GENERIC | NDA205433 |
| Related queries | Properties for NDC 9 70644-899 |
NDC Item 70756060444
| NDC 9 | 70756-604 |
|---|---|
| NDC 10 | 70756-604-44 |
| NDC Item | 70756060444 |
| Packaging | 4 in 1 POUCH |
| Packaging | 5 mL in 1 AMPULE |
| ANDA | ANDA214478 |
| FDA SPL set id | 805293 |
| Labeler | Lifestar Pharma LLC |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2023-06-30 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 70756-604 |
NDC Item 70756060456
| NDC 9 | 70756-604 |
|---|---|
| NDC 10 | 70756-604-56 |
| NDC Item | 70756060456 |
| Packaging | 14 POUCH in 1 CARTON (70756-604-56) / 4 AMPULE in 1 POUCH (70756-604-44) / 5 mL in 1 AMPULE |
| ANDA | ANDA214478 |
| FDA SPL set id | 805293 |
| Labeler | Lifestar Pharma LLC |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2023-06-30 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 70756-604 |
NDC Item 72603043004
| NDC 9 | 72603-430 |
|---|---|
| NDC 10 | 72603-430-04 |
| NDC Item | 72603043004 |
| Packaging | 4 in 1 POUCH |
| Packaging | 5 mL in 1 AMPULE |
| ANDA | ANDA214478 |
| FDA SPL set id | 801097 |
| Labeler | NorthStar RxLLC |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2024-08-01 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 72603-430 |
NDC Item 72603043056
| NDC 9 | 72603-430 |
|---|---|
| NDC 10 | 72603-430-56 |
| NDC Item | 72603043056 |
| Packaging | 14 POUCH in 1 CARTON (72603-430-56) / 4 AMPULE in 1 POUCH (72603-430-04) / 5 mL in 1 AMPULE |
| ANDA | ANDA214478 |
| FDA SPL set id | 801097 |
| Labeler | NorthStar RxLLC |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2024-08-01 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 72603-430 |
NDC Item 76204002956
| NDC 9 | 76204-029 |
|---|---|
| NDC 10 | 76204-029-56 |
| NDC Item | 76204002956 |
| Packaging | 14 POUCH in 1 CARTON (76204-029-56) / 4 AMPULE in 1 POUCH / 5 mL in 1 AMPULE |
| ANDA | ANDA201422 |
| FDA SPL set id | 866956 |
| Labeler | Ritedose Pharmaceuticals, LLC |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2025-03-25 |
| Marketing status | active |
| Related queries | Properties for NDC 9 76204-029 |
NDC Item 00093408563
| NDC 9 | 0093-4085 |
|---|---|
| NDC 10 | 0093-4085-63 |
| NDC Item | 00093408563 |
| Packaging | 56 AMPULE in 1 CARTON (0093-4085-63) / 5 mL in 1 AMPULE |
| ANDA | ANDA091589 |
| FDA SPL set id | 861925 |
| Labeler | Teva Pharmaceuticals USA, Inc. |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2013-11-19 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 0093-4085 |
NDC Item 00781717156
| NDC 9 | 0781-7171 |
|---|---|
| NDC 10 | 0781-7171-56 |
| NDC Item | 00781717156 |
| Packaging | 56 AMPULE in 1 CARTON (0781-7171-56) / 5 mL in 1 AMPULE (0781-7171-75) |
| FDA SPL set id | 132419 |
| Labeler | Sandoz Inc |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | NDA AUTHORIZED GENERIC |
| Marketing effective time low | 2014-07-09 |
| Marketing status | COMPLETED |
| NDA_AUTHORIZED_GENERIC | NDA050753 |
| Related queries | Properties for NDC 9 0781-7171 |
NDC Item 00781717175
| NDC 9 | 0781-7171 |
|---|---|
| NDC 10 | 0781-7171-75 |
| NDC Item | 00781717175 |
| Packaging | 5 mL in 1 AMPULE |
| FDA SPL set id | 132419 |
| Labeler | Sandoz Inc |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | NDA AUTHORIZED GENERIC |
| Marketing effective time low | 2014-07-09 |
| Marketing status | COMPLETED |
| NDA_AUTHORIZED_GENERIC | NDA050753 |
| Related queries | Properties for NDC 9 0781-7171 |
NDC Item 16714011902
| NDC 9 | 16714-119 |
|---|---|
| NDC 10 | 16714-119-02 |
| NDC Item | 16714011902 |
| Packaging | 5 mL in 1 AMPULE |
| ANDA | ANDA207080 |
| FDA SPL set id | 842222 |
| Labeler | NorthStar RxLLC |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2020-05-21 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 16714-119 |
NDC Item 16714011903
| NDC 9 | 16714-119 |
|---|---|
| NDC 10 | 16714-119-03 |
| NDC Item | 16714011903 |
| Packaging | 14 POUCH in 1 CARTON (16714-119-03) / 4 AMPULE in 1 POUCH / 5 mL in 1 AMPULE (16714-119-02) |
| ANDA | ANDA207080 |
| FDA SPL set id | 842222 |
| Labeler | NorthStar RxLLC |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2020-05-21 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 16714-119 |
NDC Item 17478034038
| NDC 9 | 17478-340 |
|---|---|
| NDC 10 | 17478-340-38 |
| NDC Item | 17478034038 |
| Packaging | 14 POUCH in 1 CARTON (17478-340-38) / 4 AMPULE in 1 POUCH / 5 mL in 1 AMPULE |
| ANDA | ANDA201422 |
| FDA SPL set id | 656792 |
| Labeler | Akorn Operating Company LLC (dba Akorn) |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 17478-340 |
NDC Item 42571040809
| NDC 9 | 42571-408 |
|---|---|
| NDC 10 | 42571-408-09 |
| NDC Item | 42571040809 |
| Packaging | 5 mL in 1 AMPULE |
| ANDA | ANDA217344 |
| FDA SPL set id | 812408 |
| Labeler | Micro Labs Limited |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2024-01-01 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 42571-408 |
NDC Item 42571040819
| NDC 9 | 42571-408 |
|---|---|
| NDC 10 | 42571-408-19 |
| NDC Item | 42571040819 |
| Packaging | 4 in 1 POUCH |
| ANDA | ANDA217344 |
| FDA SPL set id | 812408 |
| Labeler | Micro Labs Limited |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2024-01-01 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 42571-408 |
NDC Item 42571040892
| NDC 9 | 42571-408 |
|---|---|
| NDC 10 | 42571-408-92 |
| NDC Item | 42571040892 |
| Packaging | 14 POUCH in 1 CARTON (42571-408-92) / 4 AMPULE in 1 POUCH (42571-408-19) / 5 mL in 1 AMPULE (42571-408-09) |
| ANDA | ANDA217344 |
| FDA SPL set id | 812408 |
| Labeler | Micro Labs Limited |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2024-01-01 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 42571-408 |
NDC Item 43598060504
| NDC 9 | 43598-605 |
|---|---|
| NDC 10 | 43598-605-04 |
| NDC Item | 43598060504 |
| ANDA | ANDA207080 |
| FDA SPL set id | 706735 |
| Labeler | Dr. Reddy's Laboratories Inc. |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2019-05-14 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 43598-605 |
NDC Item 43598060511
| NDC 9 | 43598-605 |
|---|---|
| NDC 10 | 43598-605-11 |
| NDC Item | 43598060511 |
| ANDA | ANDA207080 |
| FDA SPL set id | 706735 |
| Labeler | Dr. Reddy's Laboratories Inc. |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2019-05-14 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 43598-605 |
NDC Item 43598060556
| NDC 9 | 43598-605 |
|---|---|
| NDC 10 | 43598-605-56 |
| NDC Item | 43598060556 |
| Packaging | 14 POUCH in 1 CARTON (43598-605-56) / 4 AMPULE in 1 POUCH (43598-605-04) / 5 mL in 1 AMPULE |
| ANDA | ANDA207080 |
| FDA SPL set id | 706735 |
| Labeler | Dr. Reddy's Laboratories Inc. |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2019-05-14 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 43598-605 |
NDC Item 43598060558
| NDC 9 | 43598-605 |
|---|---|
| NDC 10 | 43598-605-58 |
| NDC Item | 43598060558 |
| Packaging | 56 POUCH in 1 CARTON (43598-605-58) / 1 AMPULE in 1 POUCH (43598-605-11) / 5 mL in 1 AMPULE |
| ANDA | ANDA207080 |
| FDA SPL set id | 706735 |
| Labeler | Dr. Reddy's Laboratories Inc. |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2019-05-14 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 43598-605 |
NDC Item 47335017148
| NDC 9 | 47335-171 |
|---|---|
| NDC 10 | 47335-171-48 |
| NDC Item | 47335017148 |
| Packaging | 4 in 1 POUCH |
| Packaging | 5 mL in 1 AMPULE |
| ANDA | ANDA207136 |
| COLORTEXT | YELLOW(Colourless to light yellow) |
| Color | C48330 __ |
| FDA SPL set id | 707885 |
| Labeler | Sun Pharmaceutical Industries, Inc. |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2020-02-28 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 47335-171 |
NDC Item 47335017149
| NDC 9 | 47335-171 |
|---|---|
| NDC 10 | 47335-171-49 |
| NDC Item | 47335017149 |
| Packaging | 14 POUCH in 1 CARTON (47335-171-49) / 4 AMPULE in 1 POUCH (47335-171-48) / 5 mL in 1 AMPULE |
| ANDA | ANDA207136 |
| COLORTEXT | YELLOW(Colourless to light yellow) |
| Color | C48330 __ |
| FDA SPL set id | 707885 |
| Labeler | Sun Pharmaceutical Industries, Inc. |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2020-02-28 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 47335-171 |
NDC Item 59651012904
| NDC 9 | 59651-129 |
|---|---|
| NDC 10 | 59651-129-04 |
| NDC Item | 59651012904 |
| Packaging | 4 in 1 POUCH |
| Packaging | 5 mL in 1 AMPULE |
| ANDA | ANDA210871 |
| FDA SPL set id | 710977 |
| Labeler | Aurobindo Pharma Limited |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2021-01-22 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 59651-129 |
NDC Item 59651012956
| NDC 9 | 59651-129 |
|---|---|
| NDC 10 | 59651-129-56 |
| NDC Item | 59651012956 |
| Packaging | 14 POUCH in 1 CARTON (59651-129-56) / 4 AMPULE in 1 POUCH (59651-129-04) / 5 mL in 1 AMPULE |
| ANDA | ANDA210871 |
| FDA SPL set id | 710977 |
| Labeler | Aurobindo Pharma Limited |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2021-01-22 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 59651-129 |
NDC Item 60687073179
| NDC 9 | 60687-731 |
|---|---|
| NDC 10 | 60687-731-79 |
| NDC Item | 60687073179 |
| Packaging | 1 in 1 POUCH |
| Packaging | 5 mL in 1 AMPULE |
| ANDA | ANDA207136 |
| COLORTEXT | yellow(Colourless to light yellow) |
| Color | C48330 __ |
| FDA SPL set id | 786945 |
| Labeler | American Health Packaging |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2024-05-19 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 60687-731 |
NDC Item 60687073183
| NDC 9 | 60687-731 |
|---|---|
| NDC 10 | 60687-731-83 |
| NDC Item | 60687073183 |
| Packaging | 30 POUCH in 1 CARTON (60687-731-83) / 1 AMPULE in 1 POUCH (60687-731-79) / 5 mL in 1 AMPULE |
| ANDA | ANDA207136 |
| COLORTEXT | yellow(Colourless to light yellow) |
| Color | C48330 __ |
| FDA SPL set id | 786945 |
| Labeler | American Health Packaging |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2024-05-19 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 60687-731 |
NDC Item 65162091446
| NDC 9 | 65162-914 |
|---|---|
| NDC 10 | 65162-914-46 |
| NDC Item | 65162091446 |
| Packaging | 56 AMPULE in 1 CARTON (65162-914-46) / 5 mL in 1 AMPULE |
| ANDA | ANDA205501 |
| COLORTEXT | yellow(clear, slightly yellow) |
| Color | C48330 __ |
| FDA SPL set id | 824547 |
| Labeler | Amneal Pharmaceuticals LLC |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2014-07-13 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 65162-914 |
NDC Item 67877067869
| NDC 9 | 67877-678 |
|---|---|
| NDC 10 | 67877-678-69 |
| NDC Item | 67877067869 |
| Packaging | 5 mL in 1 AMPULE |
| Packaging | 7 in 1 POUCH |
| ANDA | ANDA212848 |
| FDA SPL set id | 762146 |
| Labeler | Ascend Laboratories, LLC |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2021-04-02 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 67877-678 |
NDC Item 67877067870
| NDC 9 | 67877-678 |
|---|---|
| NDC 10 | 67877-678-70 |
| NDC Item | 67877067870 |
| Packaging | 56 POUCH in 1 CARTON (67877-678-70) / 7 AMPULE in 1 POUCH (67877-678-69) / 5 mL in 1 AMPULE |
| ANDA | ANDA212848 |
| FDA SPL set id | 762146 |
| Labeler | Ascend Laboratories, LLC |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2021-04-02 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 67877-678 |
NDC Item 68180096204
| NDC 9 | 68180-962 |
|---|---|
| NDC 10 | 68180-962-04 |
| NDC Item | 68180096204 |
| Packaging | 4 in 1 POUCH |
| Packaging | 5 mL in 1 AMPULE |
| ANDA | ANDA208964 |
| FDA SPL set id | 779846 |
| Labeler | Lupin Pharmaceuticals, Inc. |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2018-06-12 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 68180-962 |
NDC Item 68180096256
| NDC 9 | 68180-962 |
|---|---|
| NDC 10 | 68180-962-56 |
| NDC Item | 68180096256 |
| Packaging | 56 POUCH in 1 CARTON (68180-962-56) / 4 AMPULE in 1 POUCH / 5 mL in 1 AMPULE |
| ANDA | ANDA208964 |
| FDA SPL set id | 779846 |
| Labeler | Lupin Pharmaceuticals, Inc. |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2018-06-12 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 68180-962 |
NDC Item 70644089999
| NDC 9 | 70644-899 |
|---|---|
| NDC 10 | 70644-899-99 |
| NDC Item | 70644089999 |
| Packaging | 14 POUCH in 1 CARTON (70644-899-99) / 4 AMPULE in 1 POUCH / 5 mL in 1 AMPULE |
| FDA SPL set id | 849478 |
| Labeler | Genericus, Inc. |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | NDA AUTHORIZED GENERIC |
| Marketing effective time low | 2016-07-11 |
| Marketing status | ACTIVE |
| NDA_AUTHORIZED_GENERIC | NDA205433 |
| Related queries | Properties for NDC 9 70644-899 |
NDC Item 70756060444
| NDC 9 | 70756-604 |
|---|---|
| NDC 10 | 70756-604-44 |
| NDC Item | 70756060444 |
| Packaging | 4 in 1 POUCH |
| Packaging | 5 mL in 1 AMPULE |
| ANDA | ANDA214478 |
| FDA SPL set id | 805293 |
| Labeler | Lifestar Pharma LLC |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2023-06-30 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 70756-604 |
NDC Item 70756060456
| NDC 9 | 70756-604 |
|---|---|
| NDC 10 | 70756-604-56 |
| NDC Item | 70756060456 |
| Packaging | 14 POUCH in 1 CARTON (70756-604-56) / 4 AMPULE in 1 POUCH (70756-604-44) / 5 mL in 1 AMPULE |
| ANDA | ANDA214478 |
| FDA SPL set id | 805293 |
| Labeler | Lifestar Pharma LLC |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2023-06-30 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 70756-604 |
NDC Item 72603043004
| NDC 9 | 72603-430 |
|---|---|
| NDC 10 | 72603-430-04 |
| NDC Item | 72603043004 |
| Packaging | 4 in 1 POUCH |
| Packaging | 5 mL in 1 AMPULE |
| ANDA | ANDA214478 |
| FDA SPL set id | 801097 |
| Labeler | NorthStar RxLLC |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2024-08-01 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 72603-430 |
NDC Item 72603043056
| NDC 9 | 72603-430 |
|---|---|
| NDC 10 | 72603-430-56 |
| NDC Item | 72603043056 |
| Packaging | 14 POUCH in 1 CARTON (72603-430-56) / 4 AMPULE in 1 POUCH (72603-430-04) / 5 mL in 1 AMPULE |
| ANDA | ANDA214478 |
| FDA SPL set id | 801097 |
| Labeler | NorthStar RxLLC |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2024-08-01 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 72603-430 |
NDC Item 76204002956
| NDC 9 | 76204-029 |
|---|---|
| NDC 10 | 76204-029-56 |
| NDC Item | 76204002956 |
| Packaging | 14 POUCH in 1 CARTON (76204-029-56) / 4 AMPULE in 1 POUCH / 5 mL in 1 AMPULE |
| ANDA | ANDA201422 |
| FDA SPL set id | 866956 |
| Labeler | Ritedose Pharmaceuticals, LLC |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2025-03-25 |
| Marketing status | active |
| Related queries | Properties for NDC 9 76204-029 |
NDC Item 00093408563
| NDC 9 | 0093-4085 |
|---|---|
| NDC 10 | 0093-4085-63 |
| NDC Item | 00093408563 |
| Packaging | 56 AMPULE in 1 CARTON (0093-4085-63) / 5 mL in 1 AMPULE |
| ANDA | ANDA091589 |
| FDA SPL set id | 861925 |
| Labeler | Teva Pharmaceuticals USA, Inc. |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2013-11-19 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 0093-4085 |
NDC Item 00781717156
| NDC 9 | 0781-7171 |
|---|---|
| NDC 10 | 0781-7171-56 |
| NDC Item | 00781717156 |
| Packaging | 56 AMPULE in 1 CARTON (0781-7171-56) / 5 mL in 1 AMPULE (0781-7171-75) |
| FDA SPL set id | 132419 |
| Labeler | Sandoz Inc |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | NDA AUTHORIZED GENERIC |
| Marketing effective time low | 2014-07-09 |
| Marketing status | COMPLETED |
| NDA_AUTHORIZED_GENERIC | NDA050753 |
| Related queries | Properties for NDC 9 0781-7171 |
NDC Item 00781717175
| NDC 9 | 0781-7171 |
|---|---|
| NDC 10 | 0781-7171-75 |
| NDC Item | 00781717175 |
| Packaging | 5 mL in 1 AMPULE |
| FDA SPL set id | 132419 |
| Labeler | Sandoz Inc |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | NDA AUTHORIZED GENERIC |
| Marketing effective time low | 2014-07-09 |
| Marketing status | COMPLETED |
| NDA_AUTHORIZED_GENERIC | NDA050753 |
| Related queries | Properties for NDC 9 0781-7171 |
NDC Item 16714011902
| NDC 9 | 16714-119 |
|---|---|
| NDC 10 | 16714-119-02 |
| NDC Item | 16714011902 |
| Packaging | 5 mL in 1 AMPULE |
| ANDA | ANDA207080 |
| FDA SPL set id | 842222 |
| Labeler | NorthStar RxLLC |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2020-05-21 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 16714-119 |
NDC Item 16714011903
| NDC 9 | 16714-119 |
|---|---|
| NDC 10 | 16714-119-03 |
| NDC Item | 16714011903 |
| Packaging | 14 POUCH in 1 CARTON (16714-119-03) / 4 AMPULE in 1 POUCH / 5 mL in 1 AMPULE (16714-119-02) |
| ANDA | ANDA207080 |
| FDA SPL set id | 842222 |
| Labeler | NorthStar RxLLC |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2020-05-21 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 16714-119 |
NDC Item 17478034038
| NDC 9 | 17478-340 |
|---|---|
| NDC 10 | 17478-340-38 |
| NDC Item | 17478034038 |
| Packaging | 14 POUCH in 1 CARTON (17478-340-38) / 4 AMPULE in 1 POUCH / 5 mL in 1 AMPULE |
| ANDA | ANDA201422 |
| FDA SPL set id | 656792 |
| Labeler | Akorn Operating Company LLC (dba Akorn) |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 17478-340 |
NDC Item 42571040809
| NDC 9 | 42571-408 |
|---|---|
| NDC 10 | 42571-408-09 |
| NDC Item | 42571040809 |
| Packaging | 5 mL in 1 AMPULE |
| ANDA | ANDA217344 |
| FDA SPL set id | 812408 |
| Labeler | Micro Labs Limited |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2024-01-01 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 42571-408 |
NDC Item 42571040819
| NDC 9 | 42571-408 |
|---|---|
| NDC 10 | 42571-408-19 |
| NDC Item | 42571040819 |
| Packaging | 4 in 1 POUCH |
| ANDA | ANDA217344 |
| FDA SPL set id | 812408 |
| Labeler | Micro Labs Limited |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2024-01-01 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 42571-408 |
NDC Item 42571040892
| NDC 9 | 42571-408 |
|---|---|
| NDC 10 | 42571-408-92 |
| NDC Item | 42571040892 |
| Packaging | 14 POUCH in 1 CARTON (42571-408-92) / 4 AMPULE in 1 POUCH (42571-408-19) / 5 mL in 1 AMPULE (42571-408-09) |
| ANDA | ANDA217344 |
| FDA SPL set id | 812408 |
| Labeler | Micro Labs Limited |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2024-01-01 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 42571-408 |
NDC Item 43598060504
| NDC 9 | 43598-605 |
|---|---|
| NDC 10 | 43598-605-04 |
| NDC Item | 43598060504 |
| ANDA | ANDA207080 |
| FDA SPL set id | 706735 |
| Labeler | Dr. Reddy's Laboratories Inc. |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2019-05-14 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 43598-605 |
NDC Item 43598060511
| NDC 9 | 43598-605 |
|---|---|
| NDC 10 | 43598-605-11 |
| NDC Item | 43598060511 |
| ANDA | ANDA207080 |
| FDA SPL set id | 706735 |
| Labeler | Dr. Reddy's Laboratories Inc. |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2019-05-14 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 43598-605 |
NDC Item 43598060556
| NDC 9 | 43598-605 |
|---|---|
| NDC 10 | 43598-605-56 |
| NDC Item | 43598060556 |
| Packaging | 14 POUCH in 1 CARTON (43598-605-56) / 4 AMPULE in 1 POUCH (43598-605-04) / 5 mL in 1 AMPULE |
| ANDA | ANDA207080 |
| FDA SPL set id | 706735 |
| Labeler | Dr. Reddy's Laboratories Inc. |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2019-05-14 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 43598-605 |
NDC Item 43598060558
| NDC 9 | 43598-605 |
|---|---|
| NDC 10 | 43598-605-58 |
| NDC Item | 43598060558 |
| Packaging | 56 POUCH in 1 CARTON (43598-605-58) / 1 AMPULE in 1 POUCH (43598-605-11) / 5 mL in 1 AMPULE |
| ANDA | ANDA207080 |
| FDA SPL set id | 706735 |
| Labeler | Dr. Reddy's Laboratories Inc. |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2019-05-14 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 43598-605 |
NDC Item 47335017148
| NDC 9 | 47335-171 |
|---|---|
| NDC 10 | 47335-171-48 |
| NDC Item | 47335017148 |
| Packaging | 4 in 1 POUCH |
| Packaging | 5 mL in 1 AMPULE |
| ANDA | ANDA207136 |
| COLORTEXT | YELLOW(Colourless to light yellow) |
| Color | C48330 __ |
| FDA SPL set id | 707885 |
| Labeler | Sun Pharmaceutical Industries, Inc. |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2020-02-28 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 47335-171 |
NDC Item 47335017149
| NDC 9 | 47335-171 |
|---|---|
| NDC 10 | 47335-171-49 |
| NDC Item | 47335017149 |
| Packaging | 14 POUCH in 1 CARTON (47335-171-49) / 4 AMPULE in 1 POUCH (47335-171-48) / 5 mL in 1 AMPULE |
| ANDA | ANDA207136 |
| COLORTEXT | YELLOW(Colourless to light yellow) |
| Color | C48330 __ |
| FDA SPL set id | 707885 |
| Labeler | Sun Pharmaceutical Industries, Inc. |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2020-02-28 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 47335-171 |
NDC Item 59651012904
| NDC 9 | 59651-129 |
|---|---|
| NDC 10 | 59651-129-04 |
| NDC Item | 59651012904 |
| Packaging | 4 in 1 POUCH |
| Packaging | 5 mL in 1 AMPULE |
| ANDA | ANDA210871 |
| FDA SPL set id | 710977 |
| Labeler | Aurobindo Pharma Limited |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2021-01-22 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 59651-129 |
NDC Item 59651012956
| NDC 9 | 59651-129 |
|---|---|
| NDC 10 | 59651-129-56 |
| NDC Item | 59651012956 |
| Packaging | 14 POUCH in 1 CARTON (59651-129-56) / 4 AMPULE in 1 POUCH (59651-129-04) / 5 mL in 1 AMPULE |
| ANDA | ANDA210871 |
| FDA SPL set id | 710977 |
| Labeler | Aurobindo Pharma Limited |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2021-01-22 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 59651-129 |
NDC Item 60687073179
| NDC 9 | 60687-731 |
|---|---|
| NDC 10 | 60687-731-79 |
| NDC Item | 60687073179 |
| Packaging | 1 in 1 POUCH |
| Packaging | 5 mL in 1 AMPULE |
| ANDA | ANDA207136 |
| COLORTEXT | yellow(Colourless to light yellow) |
| Color | C48330 __ |
| FDA SPL set id | 786945 |
| Labeler | American Health Packaging |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2024-05-19 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 60687-731 |
NDC Item 60687073183
| NDC 9 | 60687-731 |
|---|---|
| NDC 10 | 60687-731-83 |
| NDC Item | 60687073183 |
| Packaging | 30 POUCH in 1 CARTON (60687-731-83) / 1 AMPULE in 1 POUCH (60687-731-79) / 5 mL in 1 AMPULE |
| ANDA | ANDA207136 |
| COLORTEXT | yellow(Colourless to light yellow) |
| Color | C48330 __ |
| FDA SPL set id | 786945 |
| Labeler | American Health Packaging |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2024-05-19 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 60687-731 |
NDC Item 65162091446
| NDC 9 | 65162-914 |
|---|---|
| NDC 10 | 65162-914-46 |
| NDC Item | 65162091446 |
| Packaging | 56 AMPULE in 1 CARTON (65162-914-46) / 5 mL in 1 AMPULE |
| ANDA | ANDA205501 |
| COLORTEXT | yellow(clear, slightly yellow) |
| Color | C48330 __ |
| FDA SPL set id | 824547 |
| Labeler | Amneal Pharmaceuticals LLC |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2014-07-13 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 65162-914 |
NDC Item 67877067869
| NDC 9 | 67877-678 |
|---|---|
| NDC 10 | 67877-678-69 |
| NDC Item | 67877067869 |
| Packaging | 5 mL in 1 AMPULE |
| Packaging | 7 in 1 POUCH |
| ANDA | ANDA212848 |
| FDA SPL set id | 762146 |
| Labeler | Ascend Laboratories, LLC |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2021-04-02 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 67877-678 |
NDC Item 67877067870
| NDC 9 | 67877-678 |
|---|---|
| NDC 10 | 67877-678-70 |
| NDC Item | 67877067870 |
| Packaging | 56 POUCH in 1 CARTON (67877-678-70) / 7 AMPULE in 1 POUCH (67877-678-69) / 5 mL in 1 AMPULE |
| ANDA | ANDA212848 |
| FDA SPL set id | 762146 |
| Labeler | Ascend Laboratories, LLC |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2021-04-02 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 67877-678 |
NDC Item 68180096204
| NDC 9 | 68180-962 |
|---|---|
| NDC 10 | 68180-962-04 |
| NDC Item | 68180096204 |
| Packaging | 4 in 1 POUCH |
| Packaging | 5 mL in 1 AMPULE |
| ANDA | ANDA208964 |
| FDA SPL set id | 779846 |
| Labeler | Lupin Pharmaceuticals, Inc. |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2018-06-12 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 68180-962 |
NDC Item 68180096256
| NDC 9 | 68180-962 |
|---|---|
| NDC 10 | 68180-962-56 |
| NDC Item | 68180096256 |
| Packaging | 56 POUCH in 1 CARTON (68180-962-56) / 4 AMPULE in 1 POUCH / 5 mL in 1 AMPULE |
| ANDA | ANDA208964 |
| FDA SPL set id | 779846 |
| Labeler | Lupin Pharmaceuticals, Inc. |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2018-06-12 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 68180-962 |
NDC Item 70644089999
| NDC 9 | 70644-899 |
|---|---|
| NDC 10 | 70644-899-99 |
| NDC Item | 70644089999 |
| Packaging | 14 POUCH in 1 CARTON (70644-899-99) / 4 AMPULE in 1 POUCH / 5 mL in 1 AMPULE |
| FDA SPL set id | 849478 |
| Labeler | Genericus, Inc. |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | NDA AUTHORIZED GENERIC |
| Marketing effective time low | 2016-07-11 |
| Marketing status | ACTIVE |
| NDA_AUTHORIZED_GENERIC | NDA205433 |
| Related queries | Properties for NDC 9 70644-899 |
NDC Item 70756060444
| NDC 9 | 70756-604 |
|---|---|
| NDC 10 | 70756-604-44 |
| NDC Item | 70756060444 |
| Packaging | 4 in 1 POUCH |
| Packaging | 5 mL in 1 AMPULE |
| ANDA | ANDA214478 |
| FDA SPL set id | 805293 |
| Labeler | Lifestar Pharma LLC |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2023-06-30 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 70756-604 |
NDC Item 70756060456
| NDC 9 | 70756-604 |
|---|---|
| NDC 10 | 70756-604-56 |
| NDC Item | 70756060456 |
| Packaging | 14 POUCH in 1 CARTON (70756-604-56) / 4 AMPULE in 1 POUCH (70756-604-44) / 5 mL in 1 AMPULE |
| ANDA | ANDA214478 |
| FDA SPL set id | 805293 |
| Labeler | Lifestar Pharma LLC |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2023-06-30 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 70756-604 |
NDC Item 72603043004
| NDC 9 | 72603-430 |
|---|---|
| NDC 10 | 72603-430-04 |
| NDC Item | 72603043004 |
| Packaging | 4 in 1 POUCH |
| Packaging | 5 mL in 1 AMPULE |
| ANDA | ANDA214478 |
| FDA SPL set id | 801097 |
| Labeler | NorthStar RxLLC |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2024-08-01 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 72603-430 |
NDC Item 72603043056
| NDC 9 | 72603-430 |
|---|---|
| NDC 10 | 72603-430-56 |
| NDC Item | 72603043056 |
| Packaging | 14 POUCH in 1 CARTON (72603-430-56) / 4 AMPULE in 1 POUCH (72603-430-04) / 5 mL in 1 AMPULE |
| ANDA | ANDA214478 |
| FDA SPL set id | 801097 |
| Labeler | NorthStar RxLLC |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2024-08-01 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 72603-430 |
NDC Item 76204002956
| NDC 9 | 76204-029 |
|---|---|
| NDC 10 | 76204-029-56 |
| NDC Item | 76204002956 |
| Packaging | 14 POUCH in 1 CARTON (76204-029-56) / 4 AMPULE in 1 POUCH / 5 mL in 1 AMPULE |
| ANDA | ANDA201422 |
| FDA SPL set id | 866956 |
| Labeler | Ritedose Pharmaceuticals, LLC |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2025-03-25 |
| Marketing status | active |
| Related queries | Properties for NDC 9 76204-029 |
NDC Item 00093408563
| NDC 9 | 0093-4085 |
|---|---|
| NDC 10 | 0093-4085-63 |
| NDC Item | 00093408563 |
| Packaging | 56 AMPULE in 1 CARTON (0093-4085-63) / 5 mL in 1 AMPULE |
| ANDA | ANDA091589 |
| FDA SPL set id | 861925 |
| Labeler | Teva Pharmaceuticals USA, Inc. |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2013-11-19 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 0093-4085 |
NDC Item 00781717156
| NDC 9 | 0781-7171 |
|---|---|
| NDC 10 | 0781-7171-56 |
| NDC Item | 00781717156 |
| Packaging | 56 AMPULE in 1 CARTON (0781-7171-56) / 5 mL in 1 AMPULE (0781-7171-75) |
| FDA SPL set id | 132419 |
| Labeler | Sandoz Inc |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | NDA AUTHORIZED GENERIC |
| Marketing effective time low | 2014-07-09 |
| Marketing status | COMPLETED |
| NDA_AUTHORIZED_GENERIC | NDA050753 |
| Related queries | Properties for NDC 9 0781-7171 |
NDC Item 00781717175
| NDC 9 | 0781-7171 |
|---|---|
| NDC 10 | 0781-7171-75 |
| NDC Item | 00781717175 |
| Packaging | 5 mL in 1 AMPULE |
| FDA SPL set id | 132419 |
| Labeler | Sandoz Inc |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | NDA AUTHORIZED GENERIC |
| Marketing effective time low | 2014-07-09 |
| Marketing status | COMPLETED |
| NDA_AUTHORIZED_GENERIC | NDA050753 |
| Related queries | Properties for NDC 9 0781-7171 |
NDC Item 16714011902
| NDC 9 | 16714-119 |
|---|---|
| NDC 10 | 16714-119-02 |
| NDC Item | 16714011902 |
| Packaging | 5 mL in 1 AMPULE |
| ANDA | ANDA207080 |
| FDA SPL set id | 842222 |
| Labeler | NorthStar RxLLC |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2020-05-21 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 16714-119 |
NDC Item 16714011903
| NDC 9 | 16714-119 |
|---|---|
| NDC 10 | 16714-119-03 |
| NDC Item | 16714011903 |
| Packaging | 14 POUCH in 1 CARTON (16714-119-03) / 4 AMPULE in 1 POUCH / 5 mL in 1 AMPULE (16714-119-02) |
| ANDA | ANDA207080 |
| FDA SPL set id | 842222 |
| Labeler | NorthStar RxLLC |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2020-05-21 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 16714-119 |
NDC Item 17478034038
| NDC 9 | 17478-340 |
|---|---|
| NDC 10 | 17478-340-38 |
| NDC Item | 17478034038 |
| Packaging | 14 POUCH in 1 CARTON (17478-340-38) / 4 AMPULE in 1 POUCH / 5 mL in 1 AMPULE |
| ANDA | ANDA201422 |
| FDA SPL set id | 656792 |
| Labeler | Akorn Operating Company LLC (dba Akorn) |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 17478-340 |
NDC Item 42571040809
| NDC 9 | 42571-408 |
|---|---|
| NDC 10 | 42571-408-09 |
| NDC Item | 42571040809 |
| Packaging | 5 mL in 1 AMPULE |
| ANDA | ANDA217344 |
| FDA SPL set id | 812408 |
| Labeler | Micro Labs Limited |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2024-01-01 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 42571-408 |
NDC Item 42571040819
| NDC 9 | 42571-408 |
|---|---|
| NDC 10 | 42571-408-19 |
| NDC Item | 42571040819 |
| Packaging | 4 in 1 POUCH |
| ANDA | ANDA217344 |
| FDA SPL set id | 812408 |
| Labeler | Micro Labs Limited |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2024-01-01 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 42571-408 |
NDC Item 42571040892
| NDC 9 | 42571-408 |
|---|---|
| NDC 10 | 42571-408-92 |
| NDC Item | 42571040892 |
| Packaging | 14 POUCH in 1 CARTON (42571-408-92) / 4 AMPULE in 1 POUCH (42571-408-19) / 5 mL in 1 AMPULE (42571-408-09) |
| ANDA | ANDA217344 |
| FDA SPL set id | 812408 |
| Labeler | Micro Labs Limited |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2024-01-01 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 42571-408 |
NDC Item 43598060504
| NDC 9 | 43598-605 |
|---|---|
| NDC 10 | 43598-605-04 |
| NDC Item | 43598060504 |
| ANDA | ANDA207080 |
| FDA SPL set id | 706735 |
| Labeler | Dr. Reddy's Laboratories Inc. |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2019-05-14 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 43598-605 |
NDC Item 43598060511
| NDC 9 | 43598-605 |
|---|---|
| NDC 10 | 43598-605-11 |
| NDC Item | 43598060511 |
| ANDA | ANDA207080 |
| FDA SPL set id | 706735 |
| Labeler | Dr. Reddy's Laboratories Inc. |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2019-05-14 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 43598-605 |
NDC Item 43598060556
| NDC 9 | 43598-605 |
|---|---|
| NDC 10 | 43598-605-56 |
| NDC Item | 43598060556 |
| Packaging | 14 POUCH in 1 CARTON (43598-605-56) / 4 AMPULE in 1 POUCH (43598-605-04) / 5 mL in 1 AMPULE |
| ANDA | ANDA207080 |
| FDA SPL set id | 706735 |
| Labeler | Dr. Reddy's Laboratories Inc. |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2019-05-14 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 43598-605 |
NDC Item 43598060558
| NDC 9 | 43598-605 |
|---|---|
| NDC 10 | 43598-605-58 |
| NDC Item | 43598060558 |
| Packaging | 56 POUCH in 1 CARTON (43598-605-58) / 1 AMPULE in 1 POUCH (43598-605-11) / 5 mL in 1 AMPULE |
| ANDA | ANDA207080 |
| FDA SPL set id | 706735 |
| Labeler | Dr. Reddy's Laboratories Inc. |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2019-05-14 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 43598-605 |
NDC Item 47335017148
| NDC 9 | 47335-171 |
|---|---|
| NDC 10 | 47335-171-48 |
| NDC Item | 47335017148 |
| Packaging | 4 in 1 POUCH |
| Packaging | 5 mL in 1 AMPULE |
| ANDA | ANDA207136 |
| COLORTEXT | YELLOW(Colourless to light yellow) |
| Color | C48330 __ |
| FDA SPL set id | 707885 |
| Labeler | Sun Pharmaceutical Industries, Inc. |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2020-02-28 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 47335-171 |
NDC Item 47335017149
| NDC 9 | 47335-171 |
|---|---|
| NDC 10 | 47335-171-49 |
| NDC Item | 47335017149 |
| Packaging | 14 POUCH in 1 CARTON (47335-171-49) / 4 AMPULE in 1 POUCH (47335-171-48) / 5 mL in 1 AMPULE |
| ANDA | ANDA207136 |
| COLORTEXT | YELLOW(Colourless to light yellow) |
| Color | C48330 __ |
| FDA SPL set id | 707885 |
| Labeler | Sun Pharmaceutical Industries, Inc. |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2020-02-28 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 47335-171 |
NDC Item 59651012904
| NDC 9 | 59651-129 |
|---|---|
| NDC 10 | 59651-129-04 |
| NDC Item | 59651012904 |
| Packaging | 4 in 1 POUCH |
| Packaging | 5 mL in 1 AMPULE |
| ANDA | ANDA210871 |
| FDA SPL set id | 710977 |
| Labeler | Aurobindo Pharma Limited |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2021-01-22 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 59651-129 |
NDC Item 59651012956
| NDC 9 | 59651-129 |
|---|---|
| NDC 10 | 59651-129-56 |
| NDC Item | 59651012956 |
| Packaging | 14 POUCH in 1 CARTON (59651-129-56) / 4 AMPULE in 1 POUCH (59651-129-04) / 5 mL in 1 AMPULE |
| ANDA | ANDA210871 |
| FDA SPL set id | 710977 |
| Labeler | Aurobindo Pharma Limited |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2021-01-22 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 59651-129 |
NDC Item 60687073179
| NDC 9 | 60687-731 |
|---|---|
| NDC 10 | 60687-731-79 |
| NDC Item | 60687073179 |
| Packaging | 1 in 1 POUCH |
| Packaging | 5 mL in 1 AMPULE |
| ANDA | ANDA207136 |
| COLORTEXT | yellow(Colourless to light yellow) |
| Color | C48330 __ |
| FDA SPL set id | 786945 |
| Labeler | American Health Packaging |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2024-05-19 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 60687-731 |
NDC Item 60687073183
| NDC 9 | 60687-731 |
|---|---|
| NDC 10 | 60687-731-83 |
| NDC Item | 60687073183 |
| Packaging | 30 POUCH in 1 CARTON (60687-731-83) / 1 AMPULE in 1 POUCH (60687-731-79) / 5 mL in 1 AMPULE |
| ANDA | ANDA207136 |
| COLORTEXT | yellow(Colourless to light yellow) |
| Color | C48330 __ |
| FDA SPL set id | 786945 |
| Labeler | American Health Packaging |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2024-05-19 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 60687-731 |
NDC Item 65162091446
| NDC 9 | 65162-914 |
|---|---|
| NDC 10 | 65162-914-46 |
| NDC Item | 65162091446 |
| Packaging | 56 AMPULE in 1 CARTON (65162-914-46) / 5 mL in 1 AMPULE |
| ANDA | ANDA205501 |
| COLORTEXT | yellow(clear, slightly yellow) |
| Color | C48330 __ |
| FDA SPL set id | 824547 |
| Labeler | Amneal Pharmaceuticals LLC |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2014-07-13 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 65162-914 |
NDC Item 67877067869
| NDC 9 | 67877-678 |
|---|---|
| NDC 10 | 67877-678-69 |
| NDC Item | 67877067869 |
| Packaging | 5 mL in 1 AMPULE |
| Packaging | 7 in 1 POUCH |
| ANDA | ANDA212848 |
| FDA SPL set id | 762146 |
| Labeler | Ascend Laboratories, LLC |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2021-04-02 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 67877-678 |
NDC Item 67877067870
| NDC 9 | 67877-678 |
|---|---|
| NDC 10 | 67877-678-70 |
| NDC Item | 67877067870 |
| Packaging | 56 POUCH in 1 CARTON (67877-678-70) / 7 AMPULE in 1 POUCH (67877-678-69) / 5 mL in 1 AMPULE |
| ANDA | ANDA212848 |
| FDA SPL set id | 762146 |
| Labeler | Ascend Laboratories, LLC |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2021-04-02 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 67877-678 |
NDC Item 68180096204
| NDC 9 | 68180-962 |
|---|---|
| NDC 10 | 68180-962-04 |
| NDC Item | 68180096204 |
| Packaging | 4 in 1 POUCH |
| Packaging | 5 mL in 1 AMPULE |
| ANDA | ANDA208964 |
| FDA SPL set id | 779846 |
| Labeler | Lupin Pharmaceuticals, Inc. |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2018-06-12 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 68180-962 |
NDC Item 68180096256
| NDC 9 | 68180-962 |
|---|---|
| NDC 10 | 68180-962-56 |
| NDC Item | 68180096256 |
| Packaging | 56 POUCH in 1 CARTON (68180-962-56) / 4 AMPULE in 1 POUCH / 5 mL in 1 AMPULE |
| ANDA | ANDA208964 |
| FDA SPL set id | 779846 |
| Labeler | Lupin Pharmaceuticals, Inc. |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2018-06-12 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 68180-962 |
NDC Item 70644089999
| NDC 9 | 70644-899 |
|---|---|
| NDC 10 | 70644-899-99 |
| NDC Item | 70644089999 |
| Packaging | 14 POUCH in 1 CARTON (70644-899-99) / 4 AMPULE in 1 POUCH / 5 mL in 1 AMPULE |
| FDA SPL set id | 849478 |
| Labeler | Genericus, Inc. |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | NDA AUTHORIZED GENERIC |
| Marketing effective time low | 2016-07-11 |
| Marketing status | ACTIVE |
| NDA_AUTHORIZED_GENERIC | NDA205433 |
| Related queries | Properties for NDC 9 70644-899 |
NDC Item 70756060444
| NDC 9 | 70756-604 |
|---|---|
| NDC 10 | 70756-604-44 |
| NDC Item | 70756060444 |
| Packaging | 4 in 1 POUCH |
| Packaging | 5 mL in 1 AMPULE |
| ANDA | ANDA214478 |
| FDA SPL set id | 805293 |
| Labeler | Lifestar Pharma LLC |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2023-06-30 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 70756-604 |
NDC Item 70756060456
| NDC 9 | 70756-604 |
|---|---|
| NDC 10 | 70756-604-56 |
| NDC Item | 70756060456 |
| Packaging | 14 POUCH in 1 CARTON (70756-604-56) / 4 AMPULE in 1 POUCH (70756-604-44) / 5 mL in 1 AMPULE |
| ANDA | ANDA214478 |
| FDA SPL set id | 805293 |
| Labeler | Lifestar Pharma LLC |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2023-06-30 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 70756-604 |
NDC Item 72603043004
| NDC 9 | 72603-430 |
|---|---|
| NDC 10 | 72603-430-04 |
| NDC Item | 72603043004 |
| Packaging | 4 in 1 POUCH |
| Packaging | 5 mL in 1 AMPULE |
| ANDA | ANDA214478 |
| FDA SPL set id | 801097 |
| Labeler | NorthStar RxLLC |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2024-08-01 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 72603-430 |
NDC Item 72603043056
| NDC 9 | 72603-430 |
|---|---|
| NDC 10 | 72603-430-56 |
| NDC Item | 72603043056 |
| Packaging | 14 POUCH in 1 CARTON (72603-430-56) / 4 AMPULE in 1 POUCH (72603-430-04) / 5 mL in 1 AMPULE |
| ANDA | ANDA214478 |
| FDA SPL set id | 801097 |
| Labeler | NorthStar RxLLC |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2024-08-01 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 72603-430 |
NDC Item 76204002956
| NDC 9 | 76204-029 |
|---|---|
| NDC 10 | 76204-029-56 |
| NDC Item | 76204002956 |
| Packaging | 14 POUCH in 1 CARTON (76204-029-56) / 4 AMPULE in 1 POUCH / 5 mL in 1 AMPULE |
| ANDA | ANDA201422 |
| FDA SPL set id | 866956 |
| Labeler | Ritedose Pharmaceuticals, LLC |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2025-03-25 |
| Marketing status | active |
| Related queries | Properties for NDC 9 76204-029 |
NDC Item 00093408563
| NDC 9 | 0093-4085 |
|---|---|
| NDC 10 | 0093-4085-63 |
| NDC Item | 00093408563 |
| Packaging | 56 AMPULE in 1 CARTON (0093-4085-63) / 5 mL in 1 AMPULE |
| ANDA | ANDA091589 |
| FDA SPL set id | 861925 |
| Labeler | Teva Pharmaceuticals USA, Inc. |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2013-11-19 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 0093-4085 |
NDC Item 00781717156
| NDC 9 | 0781-7171 |
|---|---|
| NDC 10 | 0781-7171-56 |
| NDC Item | 00781717156 |
| Packaging | 56 AMPULE in 1 CARTON (0781-7171-56) / 5 mL in 1 AMPULE (0781-7171-75) |
| FDA SPL set id | 132419 |
| Labeler | Sandoz Inc |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | NDA AUTHORIZED GENERIC |
| Marketing effective time low | 2014-07-09 |
| Marketing status | COMPLETED |
| NDA_AUTHORIZED_GENERIC | NDA050753 |
| Related queries | Properties for NDC 9 0781-7171 |
NDC Item 00781717175
| NDC 9 | 0781-7171 |
|---|---|
| NDC 10 | 0781-7171-75 |
| NDC Item | 00781717175 |
| Packaging | 5 mL in 1 AMPULE |
| FDA SPL set id | 132419 |
| Labeler | Sandoz Inc |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | NDA AUTHORIZED GENERIC |
| Marketing effective time low | 2014-07-09 |
| Marketing status | COMPLETED |
| NDA_AUTHORIZED_GENERIC | NDA050753 |
| Related queries | Properties for NDC 9 0781-7171 |
NDC Item 16714011902
| NDC 9 | 16714-119 |
|---|---|
| NDC 10 | 16714-119-02 |
| NDC Item | 16714011902 |
| Packaging | 5 mL in 1 AMPULE |
| ANDA | ANDA207080 |
| FDA SPL set id | 842222 |
| Labeler | NorthStar RxLLC |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2020-05-21 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 16714-119 |
NDC Item 16714011903
| NDC 9 | 16714-119 |
|---|---|
| NDC 10 | 16714-119-03 |
| NDC Item | 16714011903 |
| Packaging | 14 POUCH in 1 CARTON (16714-119-03) / 4 AMPULE in 1 POUCH / 5 mL in 1 AMPULE (16714-119-02) |
| ANDA | ANDA207080 |
| FDA SPL set id | 842222 |
| Labeler | NorthStar RxLLC |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2020-05-21 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 16714-119 |
NDC Item 17478034038
| NDC 9 | 17478-340 |
|---|---|
| NDC 10 | 17478-340-38 |
| NDC Item | 17478034038 |
| Packaging | 14 POUCH in 1 CARTON (17478-340-38) / 4 AMPULE in 1 POUCH / 5 mL in 1 AMPULE |
| ANDA | ANDA201422 |
| FDA SPL set id | 656792 |
| Labeler | Akorn Operating Company LLC (dba Akorn) |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 17478-340 |
NDC Item 42571040809
| NDC 9 | 42571-408 |
|---|---|
| NDC 10 | 42571-408-09 |
| NDC Item | 42571040809 |
| Packaging | 5 mL in 1 AMPULE |
| ANDA | ANDA217344 |
| FDA SPL set id | 812408 |
| Labeler | Micro Labs Limited |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2024-01-01 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 42571-408 |
NDC Item 42571040819
| NDC 9 | 42571-408 |
|---|---|
| NDC 10 | 42571-408-19 |
| NDC Item | 42571040819 |
| Packaging | 4 in 1 POUCH |
| ANDA | ANDA217344 |
| FDA SPL set id | 812408 |
| Labeler | Micro Labs Limited |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2024-01-01 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 42571-408 |
NDC Item 42571040892
| NDC 9 | 42571-408 |
|---|---|
| NDC 10 | 42571-408-92 |
| NDC Item | 42571040892 |
| Packaging | 14 POUCH in 1 CARTON (42571-408-92) / 4 AMPULE in 1 POUCH (42571-408-19) / 5 mL in 1 AMPULE (42571-408-09) |
| ANDA | ANDA217344 |
| FDA SPL set id | 812408 |
| Labeler | Micro Labs Limited |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2024-01-01 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 42571-408 |
NDC Item 43598060504
| NDC 9 | 43598-605 |
|---|---|
| NDC 10 | 43598-605-04 |
| NDC Item | 43598060504 |
| ANDA | ANDA207080 |
| FDA SPL set id | 706735 |
| Labeler | Dr. Reddy's Laboratories Inc. |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2019-05-14 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 43598-605 |
NDC Item 43598060511
| NDC 9 | 43598-605 |
|---|---|
| NDC 10 | 43598-605-11 |
| NDC Item | 43598060511 |
| ANDA | ANDA207080 |
| FDA SPL set id | 706735 |
| Labeler | Dr. Reddy's Laboratories Inc. |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2019-05-14 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 43598-605 |
NDC Item 43598060556
| NDC 9 | 43598-605 |
|---|---|
| NDC 10 | 43598-605-56 |
| NDC Item | 43598060556 |
| Packaging | 14 POUCH in 1 CARTON (43598-605-56) / 4 AMPULE in 1 POUCH (43598-605-04) / 5 mL in 1 AMPULE |
| ANDA | ANDA207080 |
| FDA SPL set id | 706735 |
| Labeler | Dr. Reddy's Laboratories Inc. |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2019-05-14 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 43598-605 |
NDC Item 43598060558
| NDC 9 | 43598-605 |
|---|---|
| NDC 10 | 43598-605-58 |
| NDC Item | 43598060558 |
| Packaging | 56 POUCH in 1 CARTON (43598-605-58) / 1 AMPULE in 1 POUCH (43598-605-11) / 5 mL in 1 AMPULE |
| ANDA | ANDA207080 |
| FDA SPL set id | 706735 |
| Labeler | Dr. Reddy's Laboratories Inc. |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2019-05-14 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 43598-605 |
NDC Item 47335017148
| NDC 9 | 47335-171 |
|---|---|
| NDC 10 | 47335-171-48 |
| NDC Item | 47335017148 |
| Packaging | 4 in 1 POUCH |
| Packaging | 5 mL in 1 AMPULE |
| ANDA | ANDA207136 |
| COLORTEXT | YELLOW(Colourless to light yellow) |
| Color | C48330 __ |
| FDA SPL set id | 707885 |
| Labeler | Sun Pharmaceutical Industries, Inc. |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2020-02-28 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 47335-171 |
NDC Item 47335017149
| NDC 9 | 47335-171 |
|---|---|
| NDC 10 | 47335-171-49 |
| NDC Item | 47335017149 |
| Packaging | 14 POUCH in 1 CARTON (47335-171-49) / 4 AMPULE in 1 POUCH (47335-171-48) / 5 mL in 1 AMPULE |
| ANDA | ANDA207136 |
| COLORTEXT | YELLOW(Colourless to light yellow) |
| Color | C48330 __ |
| FDA SPL set id | 707885 |
| Labeler | Sun Pharmaceutical Industries, Inc. |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2020-02-28 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 47335-171 |
NDC Item 59651012904
| NDC 9 | 59651-129 |
|---|---|
| NDC 10 | 59651-129-04 |
| NDC Item | 59651012904 |
| Packaging | 4 in 1 POUCH |
| Packaging | 5 mL in 1 AMPULE |
| ANDA | ANDA210871 |
| FDA SPL set id | 710977 |
| Labeler | Aurobindo Pharma Limited |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2021-01-22 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 59651-129 |
NDC Item 59651012956
| NDC 9 | 59651-129 |
|---|---|
| NDC 10 | 59651-129-56 |
| NDC Item | 59651012956 |
| Packaging | 14 POUCH in 1 CARTON (59651-129-56) / 4 AMPULE in 1 POUCH (59651-129-04) / 5 mL in 1 AMPULE |
| ANDA | ANDA210871 |
| FDA SPL set id | 710977 |
| Labeler | Aurobindo Pharma Limited |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2021-01-22 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 59651-129 |
NDC Item 60687073179
| NDC 9 | 60687-731 |
|---|---|
| NDC 10 | 60687-731-79 |
| NDC Item | 60687073179 |
| Packaging | 1 in 1 POUCH |
| Packaging | 5 mL in 1 AMPULE |
| ANDA | ANDA207136 |
| COLORTEXT | yellow(Colourless to light yellow) |
| Color | C48330 __ |
| FDA SPL set id | 786945 |
| Labeler | American Health Packaging |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2024-05-19 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 60687-731 |
NDC Item 60687073183
| NDC 9 | 60687-731 |
|---|---|
| NDC 10 | 60687-731-83 |
| NDC Item | 60687073183 |
| Packaging | 30 POUCH in 1 CARTON (60687-731-83) / 1 AMPULE in 1 POUCH (60687-731-79) / 5 mL in 1 AMPULE |
| ANDA | ANDA207136 |
| COLORTEXT | yellow(Colourless to light yellow) |
| Color | C48330 __ |
| FDA SPL set id | 786945 |
| Labeler | American Health Packaging |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2024-05-19 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 60687-731 |
NDC Item 65162091446
| NDC 9 | 65162-914 |
|---|---|
| NDC 10 | 65162-914-46 |
| NDC Item | 65162091446 |
| Packaging | 56 AMPULE in 1 CARTON (65162-914-46) / 5 mL in 1 AMPULE |
| ANDA | ANDA205501 |
| COLORTEXT | yellow(clear, slightly yellow) |
| Color | C48330 __ |
| FDA SPL set id | 824547 |
| Labeler | Amneal Pharmaceuticals LLC |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2014-07-13 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 65162-914 |
NDC Item 67877067869
| NDC 9 | 67877-678 |
|---|---|
| NDC 10 | 67877-678-69 |
| NDC Item | 67877067869 |
| Packaging | 5 mL in 1 AMPULE |
| Packaging | 7 in 1 POUCH |
| ANDA | ANDA212848 |
| FDA SPL set id | 762146 |
| Labeler | Ascend Laboratories, LLC |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2021-04-02 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 67877-678 |
NDC Item 67877067870
| NDC 9 | 67877-678 |
|---|---|
| NDC 10 | 67877-678-70 |
| NDC Item | 67877067870 |
| Packaging | 56 POUCH in 1 CARTON (67877-678-70) / 7 AMPULE in 1 POUCH (67877-678-69) / 5 mL in 1 AMPULE |
| ANDA | ANDA212848 |
| FDA SPL set id | 762146 |
| Labeler | Ascend Laboratories, LLC |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2021-04-02 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 67877-678 |
NDC Item 68180096204
| NDC 9 | 68180-962 |
|---|---|
| NDC 10 | 68180-962-04 |
| NDC Item | 68180096204 |
| Packaging | 4 in 1 POUCH |
| Packaging | 5 mL in 1 AMPULE |
| ANDA | ANDA208964 |
| FDA SPL set id | 779846 |
| Labeler | Lupin Pharmaceuticals, Inc. |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2018-06-12 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 68180-962 |
NDC Item 68180096256
| NDC 9 | 68180-962 |
|---|---|
| NDC 10 | 68180-962-56 |
| NDC Item | 68180096256 |
| Packaging | 56 POUCH in 1 CARTON (68180-962-56) / 4 AMPULE in 1 POUCH / 5 mL in 1 AMPULE |
| ANDA | ANDA208964 |
| FDA SPL set id | 779846 |
| Labeler | Lupin Pharmaceuticals, Inc. |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2018-06-12 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 68180-962 |
NDC Item 70644089999
| NDC 9 | 70644-899 |
|---|---|
| NDC 10 | 70644-899-99 |
| NDC Item | 70644089999 |
| Packaging | 14 POUCH in 1 CARTON (70644-899-99) / 4 AMPULE in 1 POUCH / 5 mL in 1 AMPULE |
| FDA SPL set id | 849478 |
| Labeler | Genericus, Inc. |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | NDA AUTHORIZED GENERIC |
| Marketing effective time low | 2016-07-11 |
| Marketing status | ACTIVE |
| NDA_AUTHORIZED_GENERIC | NDA205433 |
| Related queries | Properties for NDC 9 70644-899 |
NDC Item 70756060444
| NDC 9 | 70756-604 |
|---|---|
| NDC 10 | 70756-604-44 |
| NDC Item | 70756060444 |
| Packaging | 4 in 1 POUCH |
| Packaging | 5 mL in 1 AMPULE |
| ANDA | ANDA214478 |
| FDA SPL set id | 805293 |
| Labeler | Lifestar Pharma LLC |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2023-06-30 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 70756-604 |
NDC Item 70756060456
| NDC 9 | 70756-604 |
|---|---|
| NDC 10 | 70756-604-56 |
| NDC Item | 70756060456 |
| Packaging | 14 POUCH in 1 CARTON (70756-604-56) / 4 AMPULE in 1 POUCH (70756-604-44) / 5 mL in 1 AMPULE |
| ANDA | ANDA214478 |
| FDA SPL set id | 805293 |
| Labeler | Lifestar Pharma LLC |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2023-06-30 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 70756-604 |
NDC Item 72603043004
| NDC 9 | 72603-430 |
|---|---|
| NDC 10 | 72603-430-04 |
| NDC Item | 72603043004 |
| Packaging | 4 in 1 POUCH |
| Packaging | 5 mL in 1 AMPULE |
| ANDA | ANDA214478 |
| FDA SPL set id | 801097 |
| Labeler | NorthStar RxLLC |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2024-08-01 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 72603-430 |
NDC Item 72603043056
| NDC 9 | 72603-430 |
|---|---|
| NDC 10 | 72603-430-56 |
| NDC Item | 72603043056 |
| Packaging | 14 POUCH in 1 CARTON (72603-430-56) / 4 AMPULE in 1 POUCH (72603-430-04) / 5 mL in 1 AMPULE |
| ANDA | ANDA214478 |
| FDA SPL set id | 801097 |
| Labeler | NorthStar RxLLC |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2024-08-01 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 72603-430 |
NDC Item 76204002956
| NDC 9 | 76204-029 |
|---|---|
| NDC 10 | 76204-029-56 |
| NDC Item | 76204002956 |
| Packaging | 14 POUCH in 1 CARTON (76204-029-56) / 4 AMPULE in 1 POUCH / 5 mL in 1 AMPULE |
| ANDA | ANDA201422 |
| FDA SPL set id | 866956 |
| Labeler | Ritedose Pharmaceuticals, LLC |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2025-03-25 |
| Marketing status | active |
| Related queries | Properties for NDC 9 76204-029 |
NDC Item 00093408563
| NDC 9 | 0093-4085 |
|---|---|
| NDC 10 | 0093-4085-63 |
| NDC Item | 00093408563 |
| Packaging | 56 AMPULE in 1 CARTON (0093-4085-63) / 5 mL in 1 AMPULE |
| ANDA | ANDA091589 |
| FDA SPL set id | 861925 |
| Labeler | Teva Pharmaceuticals USA, Inc. |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2013-11-19 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 0093-4085 |
NDC Item 00781717156
| NDC 9 | 0781-7171 |
|---|---|
| NDC 10 | 0781-7171-56 |
| NDC Item | 00781717156 |
| Packaging | 56 AMPULE in 1 CARTON (0781-7171-56) / 5 mL in 1 AMPULE (0781-7171-75) |
| FDA SPL set id | 132419 |
| Labeler | Sandoz Inc |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | NDA AUTHORIZED GENERIC |
| Marketing effective time low | 2014-07-09 |
| Marketing status | COMPLETED |
| NDA_AUTHORIZED_GENERIC | NDA050753 |
| Related queries | Properties for NDC 9 0781-7171 |
NDC Item 00781717175
| NDC 9 | 0781-7171 |
|---|---|
| NDC 10 | 0781-7171-75 |
| NDC Item | 00781717175 |
| Packaging | 5 mL in 1 AMPULE |
| FDA SPL set id | 132419 |
| Labeler | Sandoz Inc |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | NDA AUTHORIZED GENERIC |
| Marketing effective time low | 2014-07-09 |
| Marketing status | COMPLETED |
| NDA_AUTHORIZED_GENERIC | NDA050753 |
| Related queries | Properties for NDC 9 0781-7171 |
NDC Item 16714011902
| NDC 9 | 16714-119 |
|---|---|
| NDC 10 | 16714-119-02 |
| NDC Item | 16714011902 |
| Packaging | 5 mL in 1 AMPULE |
| ANDA | ANDA207080 |
| FDA SPL set id | 842222 |
| Labeler | NorthStar RxLLC |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2020-05-21 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 16714-119 |
NDC Item 16714011903
| NDC 9 | 16714-119 |
|---|---|
| NDC 10 | 16714-119-03 |
| NDC Item | 16714011903 |
| Packaging | 14 POUCH in 1 CARTON (16714-119-03) / 4 AMPULE in 1 POUCH / 5 mL in 1 AMPULE (16714-119-02) |
| ANDA | ANDA207080 |
| FDA SPL set id | 842222 |
| Labeler | NorthStar RxLLC |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2020-05-21 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 16714-119 |
NDC Item 17478034038
| NDC 9 | 17478-340 |
|---|---|
| NDC 10 | 17478-340-38 |
| NDC Item | 17478034038 |
| Packaging | 14 POUCH in 1 CARTON (17478-340-38) / 4 AMPULE in 1 POUCH / 5 mL in 1 AMPULE |
| ANDA | ANDA201422 |
| FDA SPL set id | 656792 |
| Labeler | Akorn Operating Company LLC (dba Akorn) |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 17478-340 |
NDC Item 42571040809
| NDC 9 | 42571-408 |
|---|---|
| NDC 10 | 42571-408-09 |
| NDC Item | 42571040809 |
| Packaging | 5 mL in 1 AMPULE |
| ANDA | ANDA217344 |
| FDA SPL set id | 812408 |
| Labeler | Micro Labs Limited |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2024-01-01 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 42571-408 |
NDC Item 42571040819
| NDC 9 | 42571-408 |
|---|---|
| NDC 10 | 42571-408-19 |
| NDC Item | 42571040819 |
| Packaging | 4 in 1 POUCH |
| ANDA | ANDA217344 |
| FDA SPL set id | 812408 |
| Labeler | Micro Labs Limited |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2024-01-01 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 42571-408 |
NDC Item 42571040892
| NDC 9 | 42571-408 |
|---|---|
| NDC 10 | 42571-408-92 |
| NDC Item | 42571040892 |
| Packaging | 14 POUCH in 1 CARTON (42571-408-92) / 4 AMPULE in 1 POUCH (42571-408-19) / 5 mL in 1 AMPULE (42571-408-09) |
| ANDA | ANDA217344 |
| FDA SPL set id | 812408 |
| Labeler | Micro Labs Limited |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2024-01-01 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 42571-408 |
NDC Item 43598060504
| NDC 9 | 43598-605 |
|---|---|
| NDC 10 | 43598-605-04 |
| NDC Item | 43598060504 |
| ANDA | ANDA207080 |
| FDA SPL set id | 706735 |
| Labeler | Dr. Reddy's Laboratories Inc. |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2019-05-14 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 43598-605 |
NDC Item 43598060511
| NDC 9 | 43598-605 |
|---|---|
| NDC 10 | 43598-605-11 |
| NDC Item | 43598060511 |
| ANDA | ANDA207080 |
| FDA SPL set id | 706735 |
| Labeler | Dr. Reddy's Laboratories Inc. |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2019-05-14 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 43598-605 |
NDC Item 43598060556
| NDC 9 | 43598-605 |
|---|---|
| NDC 10 | 43598-605-56 |
| NDC Item | 43598060556 |
| Packaging | 14 POUCH in 1 CARTON (43598-605-56) / 4 AMPULE in 1 POUCH (43598-605-04) / 5 mL in 1 AMPULE |
| ANDA | ANDA207080 |
| FDA SPL set id | 706735 |
| Labeler | Dr. Reddy's Laboratories Inc. |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2019-05-14 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 43598-605 |
NDC Item 43598060558
| NDC 9 | 43598-605 |
|---|---|
| NDC 10 | 43598-605-58 |
| NDC Item | 43598060558 |
| Packaging | 56 POUCH in 1 CARTON (43598-605-58) / 1 AMPULE in 1 POUCH (43598-605-11) / 5 mL in 1 AMPULE |
| ANDA | ANDA207080 |
| FDA SPL set id | 706735 |
| Labeler | Dr. Reddy's Laboratories Inc. |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2019-05-14 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 43598-605 |
NDC Item 47335017148
| NDC 9 | 47335-171 |
|---|---|
| NDC 10 | 47335-171-48 |
| NDC Item | 47335017148 |
| Packaging | 4 in 1 POUCH |
| Packaging | 5 mL in 1 AMPULE |
| ANDA | ANDA207136 |
| COLORTEXT | YELLOW(Colourless to light yellow) |
| Color | C48330 __ |
| FDA SPL set id | 707885 |
| Labeler | Sun Pharmaceutical Industries, Inc. |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2020-02-28 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 47335-171 |
NDC Item 47335017149
| NDC 9 | 47335-171 |
|---|---|
| NDC 10 | 47335-171-49 |
| NDC Item | 47335017149 |
| Packaging | 14 POUCH in 1 CARTON (47335-171-49) / 4 AMPULE in 1 POUCH (47335-171-48) / 5 mL in 1 AMPULE |
| ANDA | ANDA207136 |
| COLORTEXT | YELLOW(Colourless to light yellow) |
| Color | C48330 __ |
| FDA SPL set id | 707885 |
| Labeler | Sun Pharmaceutical Industries, Inc. |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2020-02-28 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 47335-171 |
NDC Item 59651012904
| NDC 9 | 59651-129 |
|---|---|
| NDC 10 | 59651-129-04 |
| NDC Item | 59651012904 |
| Packaging | 4 in 1 POUCH |
| Packaging | 5 mL in 1 AMPULE |
| ANDA | ANDA210871 |
| FDA SPL set id | 710977 |
| Labeler | Aurobindo Pharma Limited |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2021-01-22 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 59651-129 |
NDC Item 59651012956
| NDC 9 | 59651-129 |
|---|---|
| NDC 10 | 59651-129-56 |
| NDC Item | 59651012956 |
| Packaging | 14 POUCH in 1 CARTON (59651-129-56) / 4 AMPULE in 1 POUCH (59651-129-04) / 5 mL in 1 AMPULE |
| ANDA | ANDA210871 |
| FDA SPL set id | 710977 |
| Labeler | Aurobindo Pharma Limited |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2021-01-22 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 59651-129 |
NDC Item 60687073179
| NDC 9 | 60687-731 |
|---|---|
| NDC 10 | 60687-731-79 |
| NDC Item | 60687073179 |
| Packaging | 1 in 1 POUCH |
| Packaging | 5 mL in 1 AMPULE |
| ANDA | ANDA207136 |
| COLORTEXT | yellow(Colourless to light yellow) |
| Color | C48330 __ |
| FDA SPL set id | 786945 |
| Labeler | American Health Packaging |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2024-05-19 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 60687-731 |
NDC Item 60687073183
| NDC 9 | 60687-731 |
|---|---|
| NDC 10 | 60687-731-83 |
| NDC Item | 60687073183 |
| Packaging | 30 POUCH in 1 CARTON (60687-731-83) / 1 AMPULE in 1 POUCH (60687-731-79) / 5 mL in 1 AMPULE |
| ANDA | ANDA207136 |
| COLORTEXT | yellow(Colourless to light yellow) |
| Color | C48330 __ |
| FDA SPL set id | 786945 |
| Labeler | American Health Packaging |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2024-05-19 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 60687-731 |
NDC Item 65162091446
| NDC 9 | 65162-914 |
|---|---|
| NDC 10 | 65162-914-46 |
| NDC Item | 65162091446 |
| Packaging | 56 AMPULE in 1 CARTON (65162-914-46) / 5 mL in 1 AMPULE |
| ANDA | ANDA205501 |
| COLORTEXT | yellow(clear, slightly yellow) |
| Color | C48330 __ |
| FDA SPL set id | 824547 |
| Labeler | Amneal Pharmaceuticals LLC |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2014-07-13 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 65162-914 |
NDC Item 67877067869
| NDC 9 | 67877-678 |
|---|---|
| NDC 10 | 67877-678-69 |
| NDC Item | 67877067869 |
| Packaging | 5 mL in 1 AMPULE |
| Packaging | 7 in 1 POUCH |
| ANDA | ANDA212848 |
| FDA SPL set id | 762146 |
| Labeler | Ascend Laboratories, LLC |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2021-04-02 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 67877-678 |
NDC Item 67877067870
| NDC 9 | 67877-678 |
|---|---|
| NDC 10 | 67877-678-70 |
| NDC Item | 67877067870 |
| Packaging | 56 POUCH in 1 CARTON (67877-678-70) / 7 AMPULE in 1 POUCH (67877-678-69) / 5 mL in 1 AMPULE |
| ANDA | ANDA212848 |
| FDA SPL set id | 762146 |
| Labeler | Ascend Laboratories, LLC |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2021-04-02 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 67877-678 |
NDC Item 68180096204
| NDC 9 | 68180-962 |
|---|---|
| NDC 10 | 68180-962-04 |
| NDC Item | 68180096204 |
| Packaging | 4 in 1 POUCH |
| Packaging | 5 mL in 1 AMPULE |
| ANDA | ANDA208964 |
| FDA SPL set id | 779846 |
| Labeler | Lupin Pharmaceuticals, Inc. |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2018-06-12 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 68180-962 |
NDC Item 68180096256
| NDC 9 | 68180-962 |
|---|---|
| NDC 10 | 68180-962-56 |
| NDC Item | 68180096256 |
| Packaging | 56 POUCH in 1 CARTON (68180-962-56) / 4 AMPULE in 1 POUCH / 5 mL in 1 AMPULE |
| ANDA | ANDA208964 |
| FDA SPL set id | 779846 |
| Labeler | Lupin Pharmaceuticals, Inc. |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2018-06-12 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 68180-962 |
NDC Item 70644089999
| NDC 9 | 70644-899 |
|---|---|
| NDC 10 | 70644-899-99 |
| NDC Item | 70644089999 |
| Packaging | 14 POUCH in 1 CARTON (70644-899-99) / 4 AMPULE in 1 POUCH / 5 mL in 1 AMPULE |
| FDA SPL set id | 849478 |
| Labeler | Genericus, Inc. |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | NDA AUTHORIZED GENERIC |
| Marketing effective time low | 2016-07-11 |
| Marketing status | ACTIVE |
| NDA_AUTHORIZED_GENERIC | NDA205433 |
| Related queries | Properties for NDC 9 70644-899 |
NDC Item 70756060444
| NDC 9 | 70756-604 |
|---|---|
| NDC 10 | 70756-604-44 |
| NDC Item | 70756060444 |
| Packaging | 4 in 1 POUCH |
| Packaging | 5 mL in 1 AMPULE |
| ANDA | ANDA214478 |
| FDA SPL set id | 805293 |
| Labeler | Lifestar Pharma LLC |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2023-06-30 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 70756-604 |
NDC Item 70756060456
| NDC 9 | 70756-604 |
|---|---|
| NDC 10 | 70756-604-56 |
| NDC Item | 70756060456 |
| Packaging | 14 POUCH in 1 CARTON (70756-604-56) / 4 AMPULE in 1 POUCH (70756-604-44) / 5 mL in 1 AMPULE |
| ANDA | ANDA214478 |
| FDA SPL set id | 805293 |
| Labeler | Lifestar Pharma LLC |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2023-06-30 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 70756-604 |
NDC Item 72603043004
| NDC 9 | 72603-430 |
|---|---|
| NDC 10 | 72603-430-04 |
| NDC Item | 72603043004 |
| Packaging | 4 in 1 POUCH |
| Packaging | 5 mL in 1 AMPULE |
| ANDA | ANDA214478 |
| FDA SPL set id | 801097 |
| Labeler | NorthStar RxLLC |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2024-08-01 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 72603-430 |
NDC Item 72603043056
| NDC 9 | 72603-430 |
|---|---|
| NDC 10 | 72603-430-56 |
| NDC Item | 72603043056 |
| Packaging | 14 POUCH in 1 CARTON (72603-430-56) / 4 AMPULE in 1 POUCH (72603-430-04) / 5 mL in 1 AMPULE |
| ANDA | ANDA214478 |
| FDA SPL set id | 801097 |
| Labeler | NorthStar RxLLC |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2024-08-01 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 72603-430 |
NDC Item 76204002956
| NDC 9 | 76204-029 |
|---|---|
| NDC 10 | 76204-029-56 |
| NDC Item | 76204002956 |
| Packaging | 14 POUCH in 1 CARTON (76204-029-56) / 4 AMPULE in 1 POUCH / 5 mL in 1 AMPULE |
| ANDA | ANDA201422 |
| FDA SPL set id | 866956 |
| Labeler | Ritedose Pharmaceuticals, LLC |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2025-03-25 |
| Marketing status | active |
| Related queries | Properties for NDC 9 76204-029 |
NDC Item 00093408563
| NDC 9 | 0093-4085 |
|---|---|
| NDC 10 | 0093-4085-63 |
| NDC Item | 00093408563 |
| Packaging | 56 AMPULE in 1 CARTON (0093-4085-63) / 5 mL in 1 AMPULE |
| ANDA | ANDA091589 |
| FDA SPL set id | 861925 |
| Labeler | Teva Pharmaceuticals USA, Inc. |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2013-11-19 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 0093-4085 |
NDC Item 00781717156
| NDC 9 | 0781-7171 |
|---|---|
| NDC 10 | 0781-7171-56 |
| NDC Item | 00781717156 |
| Packaging | 56 AMPULE in 1 CARTON (0781-7171-56) / 5 mL in 1 AMPULE (0781-7171-75) |
| FDA SPL set id | 132419 |
| Labeler | Sandoz Inc |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | NDA AUTHORIZED GENERIC |
| Marketing effective time low | 2014-07-09 |
| Marketing status | COMPLETED |
| NDA_AUTHORIZED_GENERIC | NDA050753 |
| Related queries | Properties for NDC 9 0781-7171 |
NDC Item 00781717175
| NDC 9 | 0781-7171 |
|---|---|
| NDC 10 | 0781-7171-75 |
| NDC Item | 00781717175 |
| Packaging | 5 mL in 1 AMPULE |
| FDA SPL set id | 132419 |
| Labeler | Sandoz Inc |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | NDA AUTHORIZED GENERIC |
| Marketing effective time low | 2014-07-09 |
| Marketing status | COMPLETED |
| NDA_AUTHORIZED_GENERIC | NDA050753 |
| Related queries | Properties for NDC 9 0781-7171 |
NDC Item 16714011902
| NDC 9 | 16714-119 |
|---|---|
| NDC 10 | 16714-119-02 |
| NDC Item | 16714011902 |
| Packaging | 5 mL in 1 AMPULE |
| ANDA | ANDA207080 |
| FDA SPL set id | 842222 |
| Labeler | NorthStar RxLLC |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2020-05-21 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 16714-119 |
NDC Item 16714011903
| NDC 9 | 16714-119 |
|---|---|
| NDC 10 | 16714-119-03 |
| NDC Item | 16714011903 |
| Packaging | 14 POUCH in 1 CARTON (16714-119-03) / 4 AMPULE in 1 POUCH / 5 mL in 1 AMPULE (16714-119-02) |
| ANDA | ANDA207080 |
| FDA SPL set id | 842222 |
| Labeler | NorthStar RxLLC |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2020-05-21 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 16714-119 |
NDC Item 17478034038
| NDC 9 | 17478-340 |
|---|---|
| NDC 10 | 17478-340-38 |
| NDC Item | 17478034038 |
| Packaging | 14 POUCH in 1 CARTON (17478-340-38) / 4 AMPULE in 1 POUCH / 5 mL in 1 AMPULE |
| ANDA | ANDA201422 |
| FDA SPL set id | 656792 |
| Labeler | Akorn Operating Company LLC (dba Akorn) |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 17478-340 |
NDC Item 42571040809
| NDC 9 | 42571-408 |
|---|---|
| NDC 10 | 42571-408-09 |
| NDC Item | 42571040809 |
| Packaging | 5 mL in 1 AMPULE |
| ANDA | ANDA217344 |
| FDA SPL set id | 812408 |
| Labeler | Micro Labs Limited |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2024-01-01 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 42571-408 |
NDC Item 42571040819
| NDC 9 | 42571-408 |
|---|---|
| NDC 10 | 42571-408-19 |
| NDC Item | 42571040819 |
| Packaging | 4 in 1 POUCH |
| ANDA | ANDA217344 |
| FDA SPL set id | 812408 |
| Labeler | Micro Labs Limited |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2024-01-01 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 42571-408 |
NDC Item 42571040892
| NDC 9 | 42571-408 |
|---|---|
| NDC 10 | 42571-408-92 |
| NDC Item | 42571040892 |
| Packaging | 14 POUCH in 1 CARTON (42571-408-92) / 4 AMPULE in 1 POUCH (42571-408-19) / 5 mL in 1 AMPULE (42571-408-09) |
| ANDA | ANDA217344 |
| FDA SPL set id | 812408 |
| Labeler | Micro Labs Limited |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2024-01-01 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 42571-408 |
NDC Item 43598060504
| NDC 9 | 43598-605 |
|---|---|
| NDC 10 | 43598-605-04 |
| NDC Item | 43598060504 |
| ANDA | ANDA207080 |
| FDA SPL set id | 706735 |
| Labeler | Dr. Reddy's Laboratories Inc. |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2019-05-14 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 43598-605 |
NDC Item 43598060511
| NDC 9 | 43598-605 |
|---|---|
| NDC 10 | 43598-605-11 |
| NDC Item | 43598060511 |
| ANDA | ANDA207080 |
| FDA SPL set id | 706735 |
| Labeler | Dr. Reddy's Laboratories Inc. |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2019-05-14 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 43598-605 |
NDC Item 43598060556
| NDC 9 | 43598-605 |
|---|---|
| NDC 10 | 43598-605-56 |
| NDC Item | 43598060556 |
| Packaging | 14 POUCH in 1 CARTON (43598-605-56) / 4 AMPULE in 1 POUCH (43598-605-04) / 5 mL in 1 AMPULE |
| ANDA | ANDA207080 |
| FDA SPL set id | 706735 |
| Labeler | Dr. Reddy's Laboratories Inc. |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2019-05-14 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 43598-605 |
NDC Item 43598060558
| NDC 9 | 43598-605 |
|---|---|
| NDC 10 | 43598-605-58 |
| NDC Item | 43598060558 |
| Packaging | 56 POUCH in 1 CARTON (43598-605-58) / 1 AMPULE in 1 POUCH (43598-605-11) / 5 mL in 1 AMPULE |
| ANDA | ANDA207080 |
| FDA SPL set id | 706735 |
| Labeler | Dr. Reddy's Laboratories Inc. |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2019-05-14 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 43598-605 |
NDC Item 47335017148
| NDC 9 | 47335-171 |
|---|---|
| NDC 10 | 47335-171-48 |
| NDC Item | 47335017148 |
| Packaging | 4 in 1 POUCH |
| Packaging | 5 mL in 1 AMPULE |
| ANDA | ANDA207136 |
| COLORTEXT | YELLOW(Colourless to light yellow) |
| Color | C48330 __ |
| FDA SPL set id | 707885 |
| Labeler | Sun Pharmaceutical Industries, Inc. |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2020-02-28 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 47335-171 |
NDC Item 47335017149
| NDC 9 | 47335-171 |
|---|---|
| NDC 10 | 47335-171-49 |
| NDC Item | 47335017149 |
| Packaging | 14 POUCH in 1 CARTON (47335-171-49) / 4 AMPULE in 1 POUCH (47335-171-48) / 5 mL in 1 AMPULE |
| ANDA | ANDA207136 |
| COLORTEXT | YELLOW(Colourless to light yellow) |
| Color | C48330 __ |
| FDA SPL set id | 707885 |
| Labeler | Sun Pharmaceutical Industries, Inc. |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2020-02-28 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 47335-171 |
NDC Item 59651012904
| NDC 9 | 59651-129 |
|---|---|
| NDC 10 | 59651-129-04 |
| NDC Item | 59651012904 |
| Packaging | 4 in 1 POUCH |
| Packaging | 5 mL in 1 AMPULE |
| ANDA | ANDA210871 |
| FDA SPL set id | 710977 |
| Labeler | Aurobindo Pharma Limited |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2021-01-22 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 59651-129 |
NDC Item 59651012956
| NDC 9 | 59651-129 |
|---|---|
| NDC 10 | 59651-129-56 |
| NDC Item | 59651012956 |
| Packaging | 14 POUCH in 1 CARTON (59651-129-56) / 4 AMPULE in 1 POUCH (59651-129-04) / 5 mL in 1 AMPULE |
| ANDA | ANDA210871 |
| FDA SPL set id | 710977 |
| Labeler | Aurobindo Pharma Limited |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2021-01-22 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 59651-129 |
NDC Item 60687073179
| NDC 9 | 60687-731 |
|---|---|
| NDC 10 | 60687-731-79 |
| NDC Item | 60687073179 |
| Packaging | 1 in 1 POUCH |
| Packaging | 5 mL in 1 AMPULE |
| ANDA | ANDA207136 |
| COLORTEXT | yellow(Colourless to light yellow) |
| Color | C48330 __ |
| FDA SPL set id | 786945 |
| Labeler | American Health Packaging |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2024-05-19 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 60687-731 |
NDC Item 60687073183
| NDC 9 | 60687-731 |
|---|---|
| NDC 10 | 60687-731-83 |
| NDC Item | 60687073183 |
| Packaging | 30 POUCH in 1 CARTON (60687-731-83) / 1 AMPULE in 1 POUCH (60687-731-79) / 5 mL in 1 AMPULE |
| ANDA | ANDA207136 |
| COLORTEXT | yellow(Colourless to light yellow) |
| Color | C48330 __ |
| FDA SPL set id | 786945 |
| Labeler | American Health Packaging |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2024-05-19 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 60687-731 |
NDC Item 65162091446
| NDC 9 | 65162-914 |
|---|---|
| NDC 10 | 65162-914-46 |
| NDC Item | 65162091446 |
| Packaging | 56 AMPULE in 1 CARTON (65162-914-46) / 5 mL in 1 AMPULE |
| ANDA | ANDA205501 |
| COLORTEXT | yellow(clear, slightly yellow) |
| Color | C48330 __ |
| FDA SPL set id | 824547 |
| Labeler | Amneal Pharmaceuticals LLC |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2014-07-13 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 65162-914 |
NDC Item 67877067869
| NDC 9 | 67877-678 |
|---|---|
| NDC 10 | 67877-678-69 |
| NDC Item | 67877067869 |
| Packaging | 5 mL in 1 AMPULE |
| Packaging | 7 in 1 POUCH |
| ANDA | ANDA212848 |
| FDA SPL set id | 762146 |
| Labeler | Ascend Laboratories, LLC |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2021-04-02 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 67877-678 |
NDC Item 67877067870
| NDC 9 | 67877-678 |
|---|---|
| NDC 10 | 67877-678-70 |
| NDC Item | 67877067870 |
| Packaging | 56 POUCH in 1 CARTON (67877-678-70) / 7 AMPULE in 1 POUCH (67877-678-69) / 5 mL in 1 AMPULE |
| ANDA | ANDA212848 |
| FDA SPL set id | 762146 |
| Labeler | Ascend Laboratories, LLC |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2021-04-02 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 67877-678 |
NDC Item 68180096204
| NDC 9 | 68180-962 |
|---|---|
| NDC 10 | 68180-962-04 |
| NDC Item | 68180096204 |
| Packaging | 4 in 1 POUCH |
| Packaging | 5 mL in 1 AMPULE |
| ANDA | ANDA208964 |
| FDA SPL set id | 779846 |
| Labeler | Lupin Pharmaceuticals, Inc. |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2018-06-12 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 68180-962 |
NDC Item 68180096256
| NDC 9 | 68180-962 |
|---|---|
| NDC 10 | 68180-962-56 |
| NDC Item | 68180096256 |
| Packaging | 56 POUCH in 1 CARTON (68180-962-56) / 4 AMPULE in 1 POUCH / 5 mL in 1 AMPULE |
| ANDA | ANDA208964 |
| FDA SPL set id | 779846 |
| Labeler | Lupin Pharmaceuticals, Inc. |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2018-06-12 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 68180-962 |
NDC Item 70644089999
| NDC 9 | 70644-899 |
|---|---|
| NDC 10 | 70644-899-99 |
| NDC Item | 70644089999 |
| Packaging | 14 POUCH in 1 CARTON (70644-899-99) / 4 AMPULE in 1 POUCH / 5 mL in 1 AMPULE |
| FDA SPL set id | 849478 |
| Labeler | Genericus, Inc. |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | NDA AUTHORIZED GENERIC |
| Marketing effective time low | 2016-07-11 |
| Marketing status | ACTIVE |
| NDA_AUTHORIZED_GENERIC | NDA205433 |
| Related queries | Properties for NDC 9 70644-899 |
NDC Item 70756060444
| NDC 9 | 70756-604 |
|---|---|
| NDC 10 | 70756-604-44 |
| NDC Item | 70756060444 |
| Packaging | 4 in 1 POUCH |
| Packaging | 5 mL in 1 AMPULE |
| ANDA | ANDA214478 |
| FDA SPL set id | 805293 |
| Labeler | Lifestar Pharma LLC |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2023-06-30 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 70756-604 |
NDC Item 70756060456
| NDC 9 | 70756-604 |
|---|---|
| NDC 10 | 70756-604-56 |
| NDC Item | 70756060456 |
| Packaging | 14 POUCH in 1 CARTON (70756-604-56) / 4 AMPULE in 1 POUCH (70756-604-44) / 5 mL in 1 AMPULE |
| ANDA | ANDA214478 |
| FDA SPL set id | 805293 |
| Labeler | Lifestar Pharma LLC |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2023-06-30 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 70756-604 |
NDC Item 72603043004
| NDC 9 | 72603-430 |
|---|---|
| NDC 10 | 72603-430-04 |
| NDC Item | 72603043004 |
| Packaging | 4 in 1 POUCH |
| Packaging | 5 mL in 1 AMPULE |
| ANDA | ANDA214478 |
| FDA SPL set id | 801097 |
| Labeler | NorthStar RxLLC |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2024-08-01 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 72603-430 |
NDC Item 72603043056
| NDC 9 | 72603-430 |
|---|---|
| NDC 10 | 72603-430-56 |
| NDC Item | 72603043056 |
| Packaging | 14 POUCH in 1 CARTON (72603-430-56) / 4 AMPULE in 1 POUCH (72603-430-04) / 5 mL in 1 AMPULE |
| ANDA | ANDA214478 |
| FDA SPL set id | 801097 |
| Labeler | NorthStar RxLLC |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2024-08-01 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 72603-430 |
NDC Item 76204002956
| NDC 9 | 76204-029 |
|---|---|
| NDC 10 | 76204-029-56 |
| NDC Item | 76204002956 |
| Packaging | 14 POUCH in 1 CARTON (76204-029-56) / 4 AMPULE in 1 POUCH / 5 mL in 1 AMPULE |
| ANDA | ANDA201422 |
| FDA SPL set id | 866956 |
| Labeler | Ritedose Pharmaceuticals, LLC |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2025-03-25 |
| Marketing status | active |
| Related queries | Properties for NDC 9 76204-029 |
NDC Item 00093408563
| NDC 9 | 0093-4085 |
|---|---|
| NDC 10 | 0093-4085-63 |
| NDC Item | 00093408563 |
| Packaging | 56 AMPULE in 1 CARTON (0093-4085-63) / 5 mL in 1 AMPULE |
| ANDA | ANDA091589 |
| FDA SPL set id | 861925 |
| Labeler | Teva Pharmaceuticals USA, Inc. |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2013-11-19 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 0093-4085 |
NDC Item 00781717156
| NDC 9 | 0781-7171 |
|---|---|
| NDC 10 | 0781-7171-56 |
| NDC Item | 00781717156 |
| Packaging | 56 AMPULE in 1 CARTON (0781-7171-56) / 5 mL in 1 AMPULE (0781-7171-75) |
| FDA SPL set id | 132419 |
| Labeler | Sandoz Inc |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | NDA AUTHORIZED GENERIC |
| Marketing effective time low | 2014-07-09 |
| Marketing status | COMPLETED |
| NDA_AUTHORIZED_GENERIC | NDA050753 |
| Related queries | Properties for NDC 9 0781-7171 |
NDC Item 00781717175
| NDC 9 | 0781-7171 |
|---|---|
| NDC 10 | 0781-7171-75 |
| NDC Item | 00781717175 |
| Packaging | 5 mL in 1 AMPULE |
| FDA SPL set id | 132419 |
| Labeler | Sandoz Inc |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | NDA AUTHORIZED GENERIC |
| Marketing effective time low | 2014-07-09 |
| Marketing status | COMPLETED |
| NDA_AUTHORIZED_GENERIC | NDA050753 |
| Related queries | Properties for NDC 9 0781-7171 |
NDC Item 16714011902
| NDC 9 | 16714-119 |
|---|---|
| NDC 10 | 16714-119-02 |
| NDC Item | 16714011902 |
| Packaging | 5 mL in 1 AMPULE |
| ANDA | ANDA207080 |
| FDA SPL set id | 842222 |
| Labeler | NorthStar RxLLC |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2020-05-21 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 16714-119 |
NDC Item 16714011903
| NDC 9 | 16714-119 |
|---|---|
| NDC 10 | 16714-119-03 |
| NDC Item | 16714011903 |
| Packaging | 14 POUCH in 1 CARTON (16714-119-03) / 4 AMPULE in 1 POUCH / 5 mL in 1 AMPULE (16714-119-02) |
| ANDA | ANDA207080 |
| FDA SPL set id | 842222 |
| Labeler | NorthStar RxLLC |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2020-05-21 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 16714-119 |
NDC Item 17478034038
| NDC 9 | 17478-340 |
|---|---|
| NDC 10 | 17478-340-38 |
| NDC Item | 17478034038 |
| Packaging | 14 POUCH in 1 CARTON (17478-340-38) / 4 AMPULE in 1 POUCH / 5 mL in 1 AMPULE |
| ANDA | ANDA201422 |
| FDA SPL set id | 656792 |
| Labeler | Akorn Operating Company LLC (dba Akorn) |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 17478-340 |
NDC Item 42571040809
| NDC 9 | 42571-408 |
|---|---|
| NDC 10 | 42571-408-09 |
| NDC Item | 42571040809 |
| Packaging | 5 mL in 1 AMPULE |
| ANDA | ANDA217344 |
| FDA SPL set id | 812408 |
| Labeler | Micro Labs Limited |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2024-01-01 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 42571-408 |
NDC Item 42571040819
| NDC 9 | 42571-408 |
|---|---|
| NDC 10 | 42571-408-19 |
| NDC Item | 42571040819 |
| Packaging | 4 in 1 POUCH |
| ANDA | ANDA217344 |
| FDA SPL set id | 812408 |
| Labeler | Micro Labs Limited |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2024-01-01 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 42571-408 |
NDC Item 42571040892
| NDC 9 | 42571-408 |
|---|---|
| NDC 10 | 42571-408-92 |
| NDC Item | 42571040892 |
| Packaging | 14 POUCH in 1 CARTON (42571-408-92) / 4 AMPULE in 1 POUCH (42571-408-19) / 5 mL in 1 AMPULE (42571-408-09) |
| ANDA | ANDA217344 |
| FDA SPL set id | 812408 |
| Labeler | Micro Labs Limited |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2024-01-01 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 42571-408 |
NDC Item 43598060504
| NDC 9 | 43598-605 |
|---|---|
| NDC 10 | 43598-605-04 |
| NDC Item | 43598060504 |
| ANDA | ANDA207080 |
| FDA SPL set id | 706735 |
| Labeler | Dr. Reddy's Laboratories Inc. |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2019-05-14 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 43598-605 |
NDC Item 43598060511
| NDC 9 | 43598-605 |
|---|---|
| NDC 10 | 43598-605-11 |
| NDC Item | 43598060511 |
| ANDA | ANDA207080 |
| FDA SPL set id | 706735 |
| Labeler | Dr. Reddy's Laboratories Inc. |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2019-05-14 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 43598-605 |
NDC Item 43598060556
| NDC 9 | 43598-605 |
|---|---|
| NDC 10 | 43598-605-56 |
| NDC Item | 43598060556 |
| Packaging | 14 POUCH in 1 CARTON (43598-605-56) / 4 AMPULE in 1 POUCH (43598-605-04) / 5 mL in 1 AMPULE |
| ANDA | ANDA207080 |
| FDA SPL set id | 706735 |
| Labeler | Dr. Reddy's Laboratories Inc. |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2019-05-14 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 43598-605 |
NDC Item 43598060558
| NDC 9 | 43598-605 |
|---|---|
| NDC 10 | 43598-605-58 |
| NDC Item | 43598060558 |
| Packaging | 56 POUCH in 1 CARTON (43598-605-58) / 1 AMPULE in 1 POUCH (43598-605-11) / 5 mL in 1 AMPULE |
| ANDA | ANDA207080 |
| FDA SPL set id | 706735 |
| Labeler | Dr. Reddy's Laboratories Inc. |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2019-05-14 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 43598-605 |
NDC Item 47335017148
| NDC 9 | 47335-171 |
|---|---|
| NDC 10 | 47335-171-48 |
| NDC Item | 47335017148 |
| Packaging | 4 in 1 POUCH |
| Packaging | 5 mL in 1 AMPULE |
| ANDA | ANDA207136 |
| COLORTEXT | YELLOW(Colourless to light yellow) |
| Color | C48330 __ |
| FDA SPL set id | 707885 |
| Labeler | Sun Pharmaceutical Industries, Inc. |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2020-02-28 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 47335-171 |
NDC Item 47335017149
| NDC 9 | 47335-171 |
|---|---|
| NDC 10 | 47335-171-49 |
| NDC Item | 47335017149 |
| Packaging | 14 POUCH in 1 CARTON (47335-171-49) / 4 AMPULE in 1 POUCH (47335-171-48) / 5 mL in 1 AMPULE |
| ANDA | ANDA207136 |
| COLORTEXT | YELLOW(Colourless to light yellow) |
| Color | C48330 __ |
| FDA SPL set id | 707885 |
| Labeler | Sun Pharmaceutical Industries, Inc. |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2020-02-28 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 47335-171 |
NDC Item 59651012904
| NDC 9 | 59651-129 |
|---|---|
| NDC 10 | 59651-129-04 |
| NDC Item | 59651012904 |
| Packaging | 4 in 1 POUCH |
| Packaging | 5 mL in 1 AMPULE |
| ANDA | ANDA210871 |
| FDA SPL set id | 710977 |
| Labeler | Aurobindo Pharma Limited |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2021-01-22 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 59651-129 |
NDC Item 59651012956
| NDC 9 | 59651-129 |
|---|---|
| NDC 10 | 59651-129-56 |
| NDC Item | 59651012956 |
| Packaging | 14 POUCH in 1 CARTON (59651-129-56) / 4 AMPULE in 1 POUCH (59651-129-04) / 5 mL in 1 AMPULE |
| ANDA | ANDA210871 |
| FDA SPL set id | 710977 |
| Labeler | Aurobindo Pharma Limited |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2021-01-22 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 59651-129 |
NDC Item 60687073179
| NDC 9 | 60687-731 |
|---|---|
| NDC 10 | 60687-731-79 |
| NDC Item | 60687073179 |
| Packaging | 1 in 1 POUCH |
| Packaging | 5 mL in 1 AMPULE |
| ANDA | ANDA207136 |
| COLORTEXT | yellow(Colourless to light yellow) |
| Color | C48330 __ |
| FDA SPL set id | 786945 |
| Labeler | American Health Packaging |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2024-05-19 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 60687-731 |
NDC Item 60687073183
| NDC 9 | 60687-731 |
|---|---|
| NDC 10 | 60687-731-83 |
| NDC Item | 60687073183 |
| Packaging | 30 POUCH in 1 CARTON (60687-731-83) / 1 AMPULE in 1 POUCH (60687-731-79) / 5 mL in 1 AMPULE |
| ANDA | ANDA207136 |
| COLORTEXT | yellow(Colourless to light yellow) |
| Color | C48330 __ |
| FDA SPL set id | 786945 |
| Labeler | American Health Packaging |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2024-05-19 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 60687-731 |
NDC Item 65162091446
| NDC 9 | 65162-914 |
|---|---|
| NDC 10 | 65162-914-46 |
| NDC Item | 65162091446 |
| Packaging | 56 AMPULE in 1 CARTON (65162-914-46) / 5 mL in 1 AMPULE |
| ANDA | ANDA205501 |
| COLORTEXT | yellow(clear, slightly yellow) |
| Color | C48330 __ |
| FDA SPL set id | 824547 |
| Labeler | Amneal Pharmaceuticals LLC |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2014-07-13 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 65162-914 |
NDC Item 67877067869
| NDC 9 | 67877-678 |
|---|---|
| NDC 10 | 67877-678-69 |
| NDC Item | 67877067869 |
| Packaging | 5 mL in 1 AMPULE |
| Packaging | 7 in 1 POUCH |
| ANDA | ANDA212848 |
| FDA SPL set id | 762146 |
| Labeler | Ascend Laboratories, LLC |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2021-04-02 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 67877-678 |
NDC Item 67877067870
| NDC 9 | 67877-678 |
|---|---|
| NDC 10 | 67877-678-70 |
| NDC Item | 67877067870 |
| Packaging | 56 POUCH in 1 CARTON (67877-678-70) / 7 AMPULE in 1 POUCH (67877-678-69) / 5 mL in 1 AMPULE |
| ANDA | ANDA212848 |
| FDA SPL set id | 762146 |
| Labeler | Ascend Laboratories, LLC |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2021-04-02 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 67877-678 |
NDC Item 68180096204
| NDC 9 | 68180-962 |
|---|---|
| NDC 10 | 68180-962-04 |
| NDC Item | 68180096204 |
| Packaging | 4 in 1 POUCH |
| Packaging | 5 mL in 1 AMPULE |
| ANDA | ANDA208964 |
| FDA SPL set id | 779846 |
| Labeler | Lupin Pharmaceuticals, Inc. |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2018-06-12 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 68180-962 |
NDC Item 68180096256
| NDC 9 | 68180-962 |
|---|---|
| NDC 10 | 68180-962-56 |
| NDC Item | 68180096256 |
| Packaging | 56 POUCH in 1 CARTON (68180-962-56) / 4 AMPULE in 1 POUCH / 5 mL in 1 AMPULE |
| ANDA | ANDA208964 |
| FDA SPL set id | 779846 |
| Labeler | Lupin Pharmaceuticals, Inc. |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2018-06-12 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 68180-962 |
NDC Item 70644089999
| NDC 9 | 70644-899 |
|---|---|
| NDC 10 | 70644-899-99 |
| NDC Item | 70644089999 |
| Packaging | 14 POUCH in 1 CARTON (70644-899-99) / 4 AMPULE in 1 POUCH / 5 mL in 1 AMPULE |
| FDA SPL set id | 849478 |
| Labeler | Genericus, Inc. |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | NDA AUTHORIZED GENERIC |
| Marketing effective time low | 2016-07-11 |
| Marketing status | ACTIVE |
| NDA_AUTHORIZED_GENERIC | NDA205433 |
| Related queries | Properties for NDC 9 70644-899 |
NDC Item 70756060444
| NDC 9 | 70756-604 |
|---|---|
| NDC 10 | 70756-604-44 |
| NDC Item | 70756060444 |
| Packaging | 4 in 1 POUCH |
| Packaging | 5 mL in 1 AMPULE |
| ANDA | ANDA214478 |
| FDA SPL set id | 805293 |
| Labeler | Lifestar Pharma LLC |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2023-06-30 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 70756-604 |
NDC Item 70756060456
| NDC 9 | 70756-604 |
|---|---|
| NDC 10 | 70756-604-56 |
| NDC Item | 70756060456 |
| Packaging | 14 POUCH in 1 CARTON (70756-604-56) / 4 AMPULE in 1 POUCH (70756-604-44) / 5 mL in 1 AMPULE |
| ANDA | ANDA214478 |
| FDA SPL set id | 805293 |
| Labeler | Lifestar Pharma LLC |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2023-06-30 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 70756-604 |
NDC Item 72603043004
| NDC 9 | 72603-430 |
|---|---|
| NDC 10 | 72603-430-04 |
| NDC Item | 72603043004 |
| Packaging | 4 in 1 POUCH |
| Packaging | 5 mL in 1 AMPULE |
| ANDA | ANDA214478 |
| FDA SPL set id | 801097 |
| Labeler | NorthStar RxLLC |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2024-08-01 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 72603-430 |
NDC Item 72603043056
| NDC 9 | 72603-430 |
|---|---|
| NDC 10 | 72603-430-56 |
| NDC Item | 72603043056 |
| Packaging | 14 POUCH in 1 CARTON (72603-430-56) / 4 AMPULE in 1 POUCH (72603-430-04) / 5 mL in 1 AMPULE |
| ANDA | ANDA214478 |
| FDA SPL set id | 801097 |
| Labeler | NorthStar RxLLC |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2024-08-01 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 72603-430 |
NDC Item 76204002956
| NDC 9 | 76204-029 |
|---|---|
| NDC 10 | 76204-029-56 |
| NDC Item | 76204002956 |
| Packaging | 14 POUCH in 1 CARTON (76204-029-56) / 4 AMPULE in 1 POUCH / 5 mL in 1 AMPULE |
| ANDA | ANDA201422 |
| FDA SPL set id | 866956 |
| Labeler | Ritedose Pharmaceuticals, LLC |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2025-03-25 |
| Marketing status | active |
| Related queries | Properties for NDC 9 76204-029 |
NDC Item 00093408563
| NDC 9 | 0093-4085 |
|---|---|
| NDC 10 | 0093-4085-63 |
| NDC Item | 00093408563 |
| Packaging | 56 AMPULE in 1 CARTON (0093-4085-63) / 5 mL in 1 AMPULE |
| ANDA | ANDA091589 |
| FDA SPL set id | 861925 |
| Labeler | Teva Pharmaceuticals USA, Inc. |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2013-11-19 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 0093-4085 |
NDC Item 00781717156
| NDC 9 | 0781-7171 |
|---|---|
| NDC 10 | 0781-7171-56 |
| NDC Item | 00781717156 |
| Packaging | 56 AMPULE in 1 CARTON (0781-7171-56) / 5 mL in 1 AMPULE (0781-7171-75) |
| FDA SPL set id | 132419 |
| Labeler | Sandoz Inc |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | NDA AUTHORIZED GENERIC |
| Marketing effective time low | 2014-07-09 |
| Marketing status | COMPLETED |
| NDA_AUTHORIZED_GENERIC | NDA050753 |
| Related queries | Properties for NDC 9 0781-7171 |
NDC Item 00781717175
| NDC 9 | 0781-7171 |
|---|---|
| NDC 10 | 0781-7171-75 |
| NDC Item | 00781717175 |
| Packaging | 5 mL in 1 AMPULE |
| FDA SPL set id | 132419 |
| Labeler | Sandoz Inc |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | NDA AUTHORIZED GENERIC |
| Marketing effective time low | 2014-07-09 |
| Marketing status | COMPLETED |
| NDA_AUTHORIZED_GENERIC | NDA050753 |
| Related queries | Properties for NDC 9 0781-7171 |
NDC Item 16714011902
| NDC 9 | 16714-119 |
|---|---|
| NDC 10 | 16714-119-02 |
| NDC Item | 16714011902 |
| Packaging | 5 mL in 1 AMPULE |
| ANDA | ANDA207080 |
| FDA SPL set id | 842222 |
| Labeler | NorthStar RxLLC |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2020-05-21 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 16714-119 |
NDC Item 16714011903
| NDC 9 | 16714-119 |
|---|---|
| NDC 10 | 16714-119-03 |
| NDC Item | 16714011903 |
| Packaging | 14 POUCH in 1 CARTON (16714-119-03) / 4 AMPULE in 1 POUCH / 5 mL in 1 AMPULE (16714-119-02) |
| ANDA | ANDA207080 |
| FDA SPL set id | 842222 |
| Labeler | NorthStar RxLLC |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2020-05-21 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 16714-119 |
NDC Item 17478034038
| NDC 9 | 17478-340 |
|---|---|
| NDC 10 | 17478-340-38 |
| NDC Item | 17478034038 |
| Packaging | 14 POUCH in 1 CARTON (17478-340-38) / 4 AMPULE in 1 POUCH / 5 mL in 1 AMPULE |
| ANDA | ANDA201422 |
| FDA SPL set id | 656792 |
| Labeler | Akorn Operating Company LLC (dba Akorn) |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 17478-340 |
NDC Item 42571040809
| NDC 9 | 42571-408 |
|---|---|
| NDC 10 | 42571-408-09 |
| NDC Item | 42571040809 |
| Packaging | 5 mL in 1 AMPULE |
| ANDA | ANDA217344 |
| FDA SPL set id | 812408 |
| Labeler | Micro Labs Limited |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2024-01-01 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 42571-408 |
NDC Item 42571040819
| NDC 9 | 42571-408 |
|---|---|
| NDC 10 | 42571-408-19 |
| NDC Item | 42571040819 |
| Packaging | 4 in 1 POUCH |
| ANDA | ANDA217344 |
| FDA SPL set id | 812408 |
| Labeler | Micro Labs Limited |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2024-01-01 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 42571-408 |
NDC Item 42571040892
| NDC 9 | 42571-408 |
|---|---|
| NDC 10 | 42571-408-92 |
| NDC Item | 42571040892 |
| Packaging | 14 POUCH in 1 CARTON (42571-408-92) / 4 AMPULE in 1 POUCH (42571-408-19) / 5 mL in 1 AMPULE (42571-408-09) |
| ANDA | ANDA217344 |
| FDA SPL set id | 812408 |
| Labeler | Micro Labs Limited |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2024-01-01 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 42571-408 |
NDC Item 43598060504
| NDC 9 | 43598-605 |
|---|---|
| NDC 10 | 43598-605-04 |
| NDC Item | 43598060504 |
| ANDA | ANDA207080 |
| FDA SPL set id | 706735 |
| Labeler | Dr. Reddy's Laboratories Inc. |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2019-05-14 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 43598-605 |
NDC Item 43598060511
| NDC 9 | 43598-605 |
|---|---|
| NDC 10 | 43598-605-11 |
| NDC Item | 43598060511 |
| ANDA | ANDA207080 |
| FDA SPL set id | 706735 |
| Labeler | Dr. Reddy's Laboratories Inc. |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2019-05-14 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 43598-605 |
NDC Item 43598060556
| NDC 9 | 43598-605 |
|---|---|
| NDC 10 | 43598-605-56 |
| NDC Item | 43598060556 |
| Packaging | 14 POUCH in 1 CARTON (43598-605-56) / 4 AMPULE in 1 POUCH (43598-605-04) / 5 mL in 1 AMPULE |
| ANDA | ANDA207080 |
| FDA SPL set id | 706735 |
| Labeler | Dr. Reddy's Laboratories Inc. |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2019-05-14 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 43598-605 |
NDC Item 43598060558
| NDC 9 | 43598-605 |
|---|---|
| NDC 10 | 43598-605-58 |
| NDC Item | 43598060558 |
| Packaging | 56 POUCH in 1 CARTON (43598-605-58) / 1 AMPULE in 1 POUCH (43598-605-11) / 5 mL in 1 AMPULE |
| ANDA | ANDA207080 |
| FDA SPL set id | 706735 |
| Labeler | Dr. Reddy's Laboratories Inc. |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2019-05-14 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 43598-605 |
NDC Item 47335017148
| NDC 9 | 47335-171 |
|---|---|
| NDC 10 | 47335-171-48 |
| NDC Item | 47335017148 |
| Packaging | 4 in 1 POUCH |
| Packaging | 5 mL in 1 AMPULE |
| ANDA | ANDA207136 |
| COLORTEXT | YELLOW(Colourless to light yellow) |
| Color | C48330 __ |
| FDA SPL set id | 707885 |
| Labeler | Sun Pharmaceutical Industries, Inc. |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2020-02-28 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 47335-171 |
NDC Item 47335017149
| NDC 9 | 47335-171 |
|---|---|
| NDC 10 | 47335-171-49 |
| NDC Item | 47335017149 |
| Packaging | 14 POUCH in 1 CARTON (47335-171-49) / 4 AMPULE in 1 POUCH (47335-171-48) / 5 mL in 1 AMPULE |
| ANDA | ANDA207136 |
| COLORTEXT | YELLOW(Colourless to light yellow) |
| Color | C48330 __ |
| FDA SPL set id | 707885 |
| Labeler | Sun Pharmaceutical Industries, Inc. |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2020-02-28 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 47335-171 |
NDC Item 59651012904
| NDC 9 | 59651-129 |
|---|---|
| NDC 10 | 59651-129-04 |
| NDC Item | 59651012904 |
| Packaging | 4 in 1 POUCH |
| Packaging | 5 mL in 1 AMPULE |
| ANDA | ANDA210871 |
| FDA SPL set id | 710977 |
| Labeler | Aurobindo Pharma Limited |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2021-01-22 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 59651-129 |
NDC Item 59651012956
| NDC 9 | 59651-129 |
|---|---|
| NDC 10 | 59651-129-56 |
| NDC Item | 59651012956 |
| Packaging | 14 POUCH in 1 CARTON (59651-129-56) / 4 AMPULE in 1 POUCH (59651-129-04) / 5 mL in 1 AMPULE |
| ANDA | ANDA210871 |
| FDA SPL set id | 710977 |
| Labeler | Aurobindo Pharma Limited |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2021-01-22 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 59651-129 |
NDC Item 60687073179
| NDC 9 | 60687-731 |
|---|---|
| NDC 10 | 60687-731-79 |
| NDC Item | 60687073179 |
| Packaging | 1 in 1 POUCH |
| Packaging | 5 mL in 1 AMPULE |
| ANDA | ANDA207136 |
| COLORTEXT | yellow(Colourless to light yellow) |
| Color | C48330 __ |
| FDA SPL set id | 786945 |
| Labeler | American Health Packaging |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2024-05-19 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 60687-731 |
NDC Item 60687073183
| NDC 9 | 60687-731 |
|---|---|
| NDC 10 | 60687-731-83 |
| NDC Item | 60687073183 |
| Packaging | 30 POUCH in 1 CARTON (60687-731-83) / 1 AMPULE in 1 POUCH (60687-731-79) / 5 mL in 1 AMPULE |
| ANDA | ANDA207136 |
| COLORTEXT | yellow(Colourless to light yellow) |
| Color | C48330 __ |
| FDA SPL set id | 786945 |
| Labeler | American Health Packaging |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2024-05-19 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 60687-731 |
NDC Item 65162091446
| NDC 9 | 65162-914 |
|---|---|
| NDC 10 | 65162-914-46 |
| NDC Item | 65162091446 |
| Packaging | 56 AMPULE in 1 CARTON (65162-914-46) / 5 mL in 1 AMPULE |
| ANDA | ANDA205501 |
| COLORTEXT | yellow(clear, slightly yellow) |
| Color | C48330 __ |
| FDA SPL set id | 824547 |
| Labeler | Amneal Pharmaceuticals LLC |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2014-07-13 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 65162-914 |
NDC Item 67877067869
| NDC 9 | 67877-678 |
|---|---|
| NDC 10 | 67877-678-69 |
| NDC Item | 67877067869 |
| Packaging | 5 mL in 1 AMPULE |
| Packaging | 7 in 1 POUCH |
| ANDA | ANDA212848 |
| FDA SPL set id | 762146 |
| Labeler | Ascend Laboratories, LLC |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2021-04-02 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 67877-678 |
NDC Item 67877067870
| NDC 9 | 67877-678 |
|---|---|
| NDC 10 | 67877-678-70 |
| NDC Item | 67877067870 |
| Packaging | 56 POUCH in 1 CARTON (67877-678-70) / 7 AMPULE in 1 POUCH (67877-678-69) / 5 mL in 1 AMPULE |
| ANDA | ANDA212848 |
| FDA SPL set id | 762146 |
| Labeler | Ascend Laboratories, LLC |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2021-04-02 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 67877-678 |
NDC Item 68180096204
| NDC 9 | 68180-962 |
|---|---|
| NDC 10 | 68180-962-04 |
| NDC Item | 68180096204 |
| Packaging | 4 in 1 POUCH |
| Packaging | 5 mL in 1 AMPULE |
| ANDA | ANDA208964 |
| FDA SPL set id | 779846 |
| Labeler | Lupin Pharmaceuticals, Inc. |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2018-06-12 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 68180-962 |
NDC Item 68180096256
| NDC 9 | 68180-962 |
|---|---|
| NDC 10 | 68180-962-56 |
| NDC Item | 68180096256 |
| Packaging | 56 POUCH in 1 CARTON (68180-962-56) / 4 AMPULE in 1 POUCH / 5 mL in 1 AMPULE |
| ANDA | ANDA208964 |
| FDA SPL set id | 779846 |
| Labeler | Lupin Pharmaceuticals, Inc. |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2018-06-12 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 68180-962 |
NDC Item 70644089999
| NDC 9 | 70644-899 |
|---|---|
| NDC 10 | 70644-899-99 |
| NDC Item | 70644089999 |
| Packaging | 14 POUCH in 1 CARTON (70644-899-99) / 4 AMPULE in 1 POUCH / 5 mL in 1 AMPULE |
| FDA SPL set id | 849478 |
| Labeler | Genericus, Inc. |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | NDA AUTHORIZED GENERIC |
| Marketing effective time low | 2016-07-11 |
| Marketing status | ACTIVE |
| NDA_AUTHORIZED_GENERIC | NDA205433 |
| Related queries | Properties for NDC 9 70644-899 |
NDC Item 70756060444
| NDC 9 | 70756-604 |
|---|---|
| NDC 10 | 70756-604-44 |
| NDC Item | 70756060444 |
| Packaging | 4 in 1 POUCH |
| Packaging | 5 mL in 1 AMPULE |
| ANDA | ANDA214478 |
| FDA SPL set id | 805293 |
| Labeler | Lifestar Pharma LLC |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2023-06-30 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 70756-604 |
NDC Item 70756060456
| NDC 9 | 70756-604 |
|---|---|
| NDC 10 | 70756-604-56 |
| NDC Item | 70756060456 |
| Packaging | 14 POUCH in 1 CARTON (70756-604-56) / 4 AMPULE in 1 POUCH (70756-604-44) / 5 mL in 1 AMPULE |
| ANDA | ANDA214478 |
| FDA SPL set id | 805293 |
| Labeler | Lifestar Pharma LLC |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2023-06-30 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 70756-604 |
NDC Item 72603043004
| NDC 9 | 72603-430 |
|---|---|
| NDC 10 | 72603-430-04 |
| NDC Item | 72603043004 |
| Packaging | 4 in 1 POUCH |
| Packaging | 5 mL in 1 AMPULE |
| ANDA | ANDA214478 |
| FDA SPL set id | 801097 |
| Labeler | NorthStar RxLLC |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2024-08-01 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 72603-430 |
NDC Item 72603043056
| NDC 9 | 72603-430 |
|---|---|
| NDC 10 | 72603-430-56 |
| NDC Item | 72603043056 |
| Packaging | 14 POUCH in 1 CARTON (72603-430-56) / 4 AMPULE in 1 POUCH (72603-430-04) / 5 mL in 1 AMPULE |
| ANDA | ANDA214478 |
| FDA SPL set id | 801097 |
| Labeler | NorthStar RxLLC |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2024-08-01 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 72603-430 |
NDC Item 76204002956
| NDC 9 | 76204-029 |
|---|---|
| NDC 10 | 76204-029-56 |
| NDC Item | 76204002956 |
| Packaging | 14 POUCH in 1 CARTON (76204-029-56) / 4 AMPULE in 1 POUCH / 5 mL in 1 AMPULE |
| ANDA | ANDA201422 |
| FDA SPL set id | 866956 |
| Labeler | Ritedose Pharmaceuticals, LLC |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2025-03-25 |
| Marketing status | active |
| Related queries | Properties for NDC 9 76204-029 |
NDC Item 00093408563
| NDC 9 | 0093-4085 |
|---|---|
| NDC 10 | 0093-4085-63 |
| NDC Item | 00093408563 |
| Packaging | 56 AMPULE in 1 CARTON (0093-4085-63) / 5 mL in 1 AMPULE |
| ANDA | ANDA091589 |
| FDA SPL set id | 861925 |
| Labeler | Teva Pharmaceuticals USA, Inc. |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2013-11-19 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 0093-4085 |
NDC Item 00781717156
| NDC 9 | 0781-7171 |
|---|---|
| NDC 10 | 0781-7171-56 |
| NDC Item | 00781717156 |
| Packaging | 56 AMPULE in 1 CARTON (0781-7171-56) / 5 mL in 1 AMPULE (0781-7171-75) |
| FDA SPL set id | 132419 |
| Labeler | Sandoz Inc |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | NDA AUTHORIZED GENERIC |
| Marketing effective time low | 2014-07-09 |
| Marketing status | COMPLETED |
| NDA_AUTHORIZED_GENERIC | NDA050753 |
| Related queries | Properties for NDC 9 0781-7171 |
NDC Item 00781717175
| NDC 9 | 0781-7171 |
|---|---|
| NDC 10 | 0781-7171-75 |
| NDC Item | 00781717175 |
| Packaging | 5 mL in 1 AMPULE |
| FDA SPL set id | 132419 |
| Labeler | Sandoz Inc |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | NDA AUTHORIZED GENERIC |
| Marketing effective time low | 2014-07-09 |
| Marketing status | COMPLETED |
| NDA_AUTHORIZED_GENERIC | NDA050753 |
| Related queries | Properties for NDC 9 0781-7171 |
NDC Item 16714011902
| NDC 9 | 16714-119 |
|---|---|
| NDC 10 | 16714-119-02 |
| NDC Item | 16714011902 |
| Packaging | 5 mL in 1 AMPULE |
| ANDA | ANDA207080 |
| FDA SPL set id | 842222 |
| Labeler | NorthStar RxLLC |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2020-05-21 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 16714-119 |
NDC Item 16714011903
| NDC 9 | 16714-119 |
|---|---|
| NDC 10 | 16714-119-03 |
| NDC Item | 16714011903 |
| Packaging | 14 POUCH in 1 CARTON (16714-119-03) / 4 AMPULE in 1 POUCH / 5 mL in 1 AMPULE (16714-119-02) |
| ANDA | ANDA207080 |
| FDA SPL set id | 842222 |
| Labeler | NorthStar RxLLC |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2020-05-21 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 16714-119 |
NDC Item 17478034038
| NDC 9 | 17478-340 |
|---|---|
| NDC 10 | 17478-340-38 |
| NDC Item | 17478034038 |
| Packaging | 14 POUCH in 1 CARTON (17478-340-38) / 4 AMPULE in 1 POUCH / 5 mL in 1 AMPULE |
| ANDA | ANDA201422 |
| FDA SPL set id | 656792 |
| Labeler | Akorn Operating Company LLC (dba Akorn) |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 17478-340 |
NDC Item 42571040809
| NDC 9 | 42571-408 |
|---|---|
| NDC 10 | 42571-408-09 |
| NDC Item | 42571040809 |
| Packaging | 5 mL in 1 AMPULE |
| ANDA | ANDA217344 |
| FDA SPL set id | 812408 |
| Labeler | Micro Labs Limited |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2024-01-01 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 42571-408 |
NDC Item 42571040819
| NDC 9 | 42571-408 |
|---|---|
| NDC 10 | 42571-408-19 |
| NDC Item | 42571040819 |
| Packaging | 4 in 1 POUCH |
| ANDA | ANDA217344 |
| FDA SPL set id | 812408 |
| Labeler | Micro Labs Limited |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2024-01-01 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 42571-408 |
NDC Item 42571040892
| NDC 9 | 42571-408 |
|---|---|
| NDC 10 | 42571-408-92 |
| NDC Item | 42571040892 |
| Packaging | 14 POUCH in 1 CARTON (42571-408-92) / 4 AMPULE in 1 POUCH (42571-408-19) / 5 mL in 1 AMPULE (42571-408-09) |
| ANDA | ANDA217344 |
| FDA SPL set id | 812408 |
| Labeler | Micro Labs Limited |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2024-01-01 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 42571-408 |
NDC Item 43598060504
| NDC 9 | 43598-605 |
|---|---|
| NDC 10 | 43598-605-04 |
| NDC Item | 43598060504 |
| ANDA | ANDA207080 |
| FDA SPL set id | 706735 |
| Labeler | Dr. Reddy's Laboratories Inc. |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2019-05-14 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 43598-605 |
NDC Item 43598060511
| NDC 9 | 43598-605 |
|---|---|
| NDC 10 | 43598-605-11 |
| NDC Item | 43598060511 |
| ANDA | ANDA207080 |
| FDA SPL set id | 706735 |
| Labeler | Dr. Reddy's Laboratories Inc. |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2019-05-14 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 43598-605 |
NDC Item 43598060556
| NDC 9 | 43598-605 |
|---|---|
| NDC 10 | 43598-605-56 |
| NDC Item | 43598060556 |
| Packaging | 14 POUCH in 1 CARTON (43598-605-56) / 4 AMPULE in 1 POUCH (43598-605-04) / 5 mL in 1 AMPULE |
| ANDA | ANDA207080 |
| FDA SPL set id | 706735 |
| Labeler | Dr. Reddy's Laboratories Inc. |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2019-05-14 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 43598-605 |
NDC Item 43598060558
| NDC 9 | 43598-605 |
|---|---|
| NDC 10 | 43598-605-58 |
| NDC Item | 43598060558 |
| Packaging | 56 POUCH in 1 CARTON (43598-605-58) / 1 AMPULE in 1 POUCH (43598-605-11) / 5 mL in 1 AMPULE |
| ANDA | ANDA207080 |
| FDA SPL set id | 706735 |
| Labeler | Dr. Reddy's Laboratories Inc. |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2019-05-14 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 43598-605 |
NDC Item 47335017148
| NDC 9 | 47335-171 |
|---|---|
| NDC 10 | 47335-171-48 |
| NDC Item | 47335017148 |
| Packaging | 4 in 1 POUCH |
| Packaging | 5 mL in 1 AMPULE |
| ANDA | ANDA207136 |
| COLORTEXT | YELLOW(Colourless to light yellow) |
| Color | C48330 __ |
| FDA SPL set id | 707885 |
| Labeler | Sun Pharmaceutical Industries, Inc. |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2020-02-28 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 47335-171 |
NDC Item 47335017149
| NDC 9 | 47335-171 |
|---|---|
| NDC 10 | 47335-171-49 |
| NDC Item | 47335017149 |
| Packaging | 14 POUCH in 1 CARTON (47335-171-49) / 4 AMPULE in 1 POUCH (47335-171-48) / 5 mL in 1 AMPULE |
| ANDA | ANDA207136 |
| COLORTEXT | YELLOW(Colourless to light yellow) |
| Color | C48330 __ |
| FDA SPL set id | 707885 |
| Labeler | Sun Pharmaceutical Industries, Inc. |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2020-02-28 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 47335-171 |
NDC Item 59651012904
| NDC 9 | 59651-129 |
|---|---|
| NDC 10 | 59651-129-04 |
| NDC Item | 59651012904 |
| Packaging | 4 in 1 POUCH |
| Packaging | 5 mL in 1 AMPULE |
| ANDA | ANDA210871 |
| FDA SPL set id | 710977 |
| Labeler | Aurobindo Pharma Limited |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2021-01-22 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 59651-129 |
NDC Item 59651012956
| NDC 9 | 59651-129 |
|---|---|
| NDC 10 | 59651-129-56 |
| NDC Item | 59651012956 |
| Packaging | 14 POUCH in 1 CARTON (59651-129-56) / 4 AMPULE in 1 POUCH (59651-129-04) / 5 mL in 1 AMPULE |
| ANDA | ANDA210871 |
| FDA SPL set id | 710977 |
| Labeler | Aurobindo Pharma Limited |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2021-01-22 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 59651-129 |
NDC Item 60687073179
| NDC 9 | 60687-731 |
|---|---|
| NDC 10 | 60687-731-79 |
| NDC Item | 60687073179 |
| Packaging | 1 in 1 POUCH |
| Packaging | 5 mL in 1 AMPULE |
| ANDA | ANDA207136 |
| COLORTEXT | yellow(Colourless to light yellow) |
| Color | C48330 __ |
| FDA SPL set id | 786945 |
| Labeler | American Health Packaging |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2024-05-19 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 60687-731 |
NDC Item 60687073183
| NDC 9 | 60687-731 |
|---|---|
| NDC 10 | 60687-731-83 |
| NDC Item | 60687073183 |
| Packaging | 30 POUCH in 1 CARTON (60687-731-83) / 1 AMPULE in 1 POUCH (60687-731-79) / 5 mL in 1 AMPULE |
| ANDA | ANDA207136 |
| COLORTEXT | yellow(Colourless to light yellow) |
| Color | C48330 __ |
| FDA SPL set id | 786945 |
| Labeler | American Health Packaging |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2024-05-19 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 60687-731 |
NDC Item 65162091446
| NDC 9 | 65162-914 |
|---|---|
| NDC 10 | 65162-914-46 |
| NDC Item | 65162091446 |
| Packaging | 56 AMPULE in 1 CARTON (65162-914-46) / 5 mL in 1 AMPULE |
| ANDA | ANDA205501 |
| COLORTEXT | yellow(clear, slightly yellow) |
| Color | C48330 __ |
| FDA SPL set id | 824547 |
| Labeler | Amneal Pharmaceuticals LLC |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2014-07-13 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 65162-914 |
NDC Item 67877067869
| NDC 9 | 67877-678 |
|---|---|
| NDC 10 | 67877-678-69 |
| NDC Item | 67877067869 |
| Packaging | 5 mL in 1 AMPULE |
| Packaging | 7 in 1 POUCH |
| ANDA | ANDA212848 |
| FDA SPL set id | 762146 |
| Labeler | Ascend Laboratories, LLC |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2021-04-02 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 67877-678 |
NDC Item 67877067870
| NDC 9 | 67877-678 |
|---|---|
| NDC 10 | 67877-678-70 |
| NDC Item | 67877067870 |
| Packaging | 56 POUCH in 1 CARTON (67877-678-70) / 7 AMPULE in 1 POUCH (67877-678-69) / 5 mL in 1 AMPULE |
| ANDA | ANDA212848 |
| FDA SPL set id | 762146 |
| Labeler | Ascend Laboratories, LLC |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2021-04-02 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 67877-678 |
NDC Item 68180096204
| NDC 9 | 68180-962 |
|---|---|
| NDC 10 | 68180-962-04 |
| NDC Item | 68180096204 |
| Packaging | 4 in 1 POUCH |
| Packaging | 5 mL in 1 AMPULE |
| ANDA | ANDA208964 |
| FDA SPL set id | 779846 |
| Labeler | Lupin Pharmaceuticals, Inc. |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2018-06-12 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 68180-962 |
NDC Item 68180096256
| NDC 9 | 68180-962 |
|---|---|
| NDC 10 | 68180-962-56 |
| NDC Item | 68180096256 |
| Packaging | 56 POUCH in 1 CARTON (68180-962-56) / 4 AMPULE in 1 POUCH / 5 mL in 1 AMPULE |
| ANDA | ANDA208964 |
| FDA SPL set id | 779846 |
| Labeler | Lupin Pharmaceuticals, Inc. |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2018-06-12 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 68180-962 |
NDC Item 70644089999
| NDC 9 | 70644-899 |
|---|---|
| NDC 10 | 70644-899-99 |
| NDC Item | 70644089999 |
| Packaging | 14 POUCH in 1 CARTON (70644-899-99) / 4 AMPULE in 1 POUCH / 5 mL in 1 AMPULE |
| FDA SPL set id | 849478 |
| Labeler | Genericus, Inc. |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | NDA AUTHORIZED GENERIC |
| Marketing effective time low | 2016-07-11 |
| Marketing status | ACTIVE |
| NDA_AUTHORIZED_GENERIC | NDA205433 |
| Related queries | Properties for NDC 9 70644-899 |
NDC Item 70756060444
| NDC 9 | 70756-604 |
|---|---|
| NDC 10 | 70756-604-44 |
| NDC Item | 70756060444 |
| Packaging | 4 in 1 POUCH |
| Packaging | 5 mL in 1 AMPULE |
| ANDA | ANDA214478 |
| FDA SPL set id | 805293 |
| Labeler | Lifestar Pharma LLC |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2023-06-30 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 70756-604 |
NDC Item 70756060456
| NDC 9 | 70756-604 |
|---|---|
| NDC 10 | 70756-604-56 |
| NDC Item | 70756060456 |
| Packaging | 14 POUCH in 1 CARTON (70756-604-56) / 4 AMPULE in 1 POUCH (70756-604-44) / 5 mL in 1 AMPULE |
| ANDA | ANDA214478 |
| FDA SPL set id | 805293 |
| Labeler | Lifestar Pharma LLC |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2023-06-30 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 70756-604 |
NDC Item 72603043004
| NDC 9 | 72603-430 |
|---|---|
| NDC 10 | 72603-430-04 |
| NDC Item | 72603043004 |
| Packaging | 4 in 1 POUCH |
| Packaging | 5 mL in 1 AMPULE |
| ANDA | ANDA214478 |
| FDA SPL set id | 801097 |
| Labeler | NorthStar RxLLC |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2024-08-01 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 72603-430 |
NDC Item 72603043056
| NDC 9 | 72603-430 |
|---|---|
| NDC 10 | 72603-430-56 |
| NDC Item | 72603043056 |
| Packaging | 14 POUCH in 1 CARTON (72603-430-56) / 4 AMPULE in 1 POUCH (72603-430-04) / 5 mL in 1 AMPULE |
| ANDA | ANDA214478 |
| FDA SPL set id | 801097 |
| Labeler | NorthStar RxLLC |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2024-08-01 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 72603-430 |
NDC Item 76204002956
| NDC 9 | 76204-029 |
|---|---|
| NDC 10 | 76204-029-56 |
| NDC Item | 76204002956 |
| Packaging | 14 POUCH in 1 CARTON (76204-029-56) / 4 AMPULE in 1 POUCH / 5 mL in 1 AMPULE |
| ANDA | ANDA201422 |
| FDA SPL set id | 866956 |
| Labeler | Ritedose Pharmaceuticals, LLC |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2025-03-25 |
| Marketing status | active |
| Related queries | Properties for NDC 9 76204-029 |
NDC Item 00093408563
| NDC 9 | 0093-4085 |
|---|---|
| NDC 10 | 0093-4085-63 |
| NDC Item | 00093408563 |
| Packaging | 56 AMPULE in 1 CARTON (0093-4085-63) / 5 mL in 1 AMPULE |
| ANDA | ANDA091589 |
| FDA SPL set id | 861925 |
| Labeler | Teva Pharmaceuticals USA, Inc. |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2013-11-19 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 0093-4085 |
NDC Item 00781717156
| NDC 9 | 0781-7171 |
|---|---|
| NDC 10 | 0781-7171-56 |
| NDC Item | 00781717156 |
| Packaging | 56 AMPULE in 1 CARTON (0781-7171-56) / 5 mL in 1 AMPULE (0781-7171-75) |
| FDA SPL set id | 132419 |
| Labeler | Sandoz Inc |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | NDA AUTHORIZED GENERIC |
| Marketing effective time low | 2014-07-09 |
| Marketing status | COMPLETED |
| NDA_AUTHORIZED_GENERIC | NDA050753 |
| Related queries | Properties for NDC 9 0781-7171 |
NDC Item 00781717175
| NDC 9 | 0781-7171 |
|---|---|
| NDC 10 | 0781-7171-75 |
| NDC Item | 00781717175 |
| Packaging | 5 mL in 1 AMPULE |
| FDA SPL set id | 132419 |
| Labeler | Sandoz Inc |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | NDA AUTHORIZED GENERIC |
| Marketing effective time low | 2014-07-09 |
| Marketing status | COMPLETED |
| NDA_AUTHORIZED_GENERIC | NDA050753 |
| Related queries | Properties for NDC 9 0781-7171 |
NDC Item 16714011902
| NDC 9 | 16714-119 |
|---|---|
| NDC 10 | 16714-119-02 |
| NDC Item | 16714011902 |
| Packaging | 5 mL in 1 AMPULE |
| ANDA | ANDA207080 |
| FDA SPL set id | 842222 |
| Labeler | NorthStar RxLLC |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2020-05-21 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 16714-119 |
NDC Item 16714011903
| NDC 9 | 16714-119 |
|---|---|
| NDC 10 | 16714-119-03 |
| NDC Item | 16714011903 |
| Packaging | 14 POUCH in 1 CARTON (16714-119-03) / 4 AMPULE in 1 POUCH / 5 mL in 1 AMPULE (16714-119-02) |
| ANDA | ANDA207080 |
| FDA SPL set id | 842222 |
| Labeler | NorthStar RxLLC |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2020-05-21 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 16714-119 |
NDC Item 17478034038
| NDC 9 | 17478-340 |
|---|---|
| NDC 10 | 17478-340-38 |
| NDC Item | 17478034038 |
| Packaging | 14 POUCH in 1 CARTON (17478-340-38) / 4 AMPULE in 1 POUCH / 5 mL in 1 AMPULE |
| ANDA | ANDA201422 |
| FDA SPL set id | 656792 |
| Labeler | Akorn Operating Company LLC (dba Akorn) |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 17478-340 |
NDC Item 42571040809
| NDC 9 | 42571-408 |
|---|---|
| NDC 10 | 42571-408-09 |
| NDC Item | 42571040809 |
| Packaging | 5 mL in 1 AMPULE |
| ANDA | ANDA217344 |
| FDA SPL set id | 812408 |
| Labeler | Micro Labs Limited |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2024-01-01 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 42571-408 |
NDC Item 42571040819
| NDC 9 | 42571-408 |
|---|---|
| NDC 10 | 42571-408-19 |
| NDC Item | 42571040819 |
| Packaging | 4 in 1 POUCH |
| ANDA | ANDA217344 |
| FDA SPL set id | 812408 |
| Labeler | Micro Labs Limited |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2024-01-01 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 42571-408 |
NDC Item 42571040892
| NDC 9 | 42571-408 |
|---|---|
| NDC 10 | 42571-408-92 |
| NDC Item | 42571040892 |
| Packaging | 14 POUCH in 1 CARTON (42571-408-92) / 4 AMPULE in 1 POUCH (42571-408-19) / 5 mL in 1 AMPULE (42571-408-09) |
| ANDA | ANDA217344 |
| FDA SPL set id | 812408 |
| Labeler | Micro Labs Limited |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2024-01-01 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 42571-408 |
NDC Item 43598060504
| NDC 9 | 43598-605 |
|---|---|
| NDC 10 | 43598-605-04 |
| NDC Item | 43598060504 |
| ANDA | ANDA207080 |
| FDA SPL set id | 706735 |
| Labeler | Dr. Reddy's Laboratories Inc. |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2019-05-14 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 43598-605 |
NDC Item 43598060511
| NDC 9 | 43598-605 |
|---|---|
| NDC 10 | 43598-605-11 |
| NDC Item | 43598060511 |
| ANDA | ANDA207080 |
| FDA SPL set id | 706735 |
| Labeler | Dr. Reddy's Laboratories Inc. |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2019-05-14 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 43598-605 |
NDC Item 43598060556
| NDC 9 | 43598-605 |
|---|---|
| NDC 10 | 43598-605-56 |
| NDC Item | 43598060556 |
| Packaging | 14 POUCH in 1 CARTON (43598-605-56) / 4 AMPULE in 1 POUCH (43598-605-04) / 5 mL in 1 AMPULE |
| ANDA | ANDA207080 |
| FDA SPL set id | 706735 |
| Labeler | Dr. Reddy's Laboratories Inc. |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2019-05-14 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 43598-605 |
NDC Item 43598060558
| NDC 9 | 43598-605 |
|---|---|
| NDC 10 | 43598-605-58 |
| NDC Item | 43598060558 |
| Packaging | 56 POUCH in 1 CARTON (43598-605-58) / 1 AMPULE in 1 POUCH (43598-605-11) / 5 mL in 1 AMPULE |
| ANDA | ANDA207080 |
| FDA SPL set id | 706735 |
| Labeler | Dr. Reddy's Laboratories Inc. |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2019-05-14 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 43598-605 |
NDC Item 47335017148
| NDC 9 | 47335-171 |
|---|---|
| NDC 10 | 47335-171-48 |
| NDC Item | 47335017148 |
| Packaging | 4 in 1 POUCH |
| Packaging | 5 mL in 1 AMPULE |
| ANDA | ANDA207136 |
| COLORTEXT | YELLOW(Colourless to light yellow) |
| Color | C48330 __ |
| FDA SPL set id | 707885 |
| Labeler | Sun Pharmaceutical Industries, Inc. |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2020-02-28 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 47335-171 |
NDC Item 47335017149
| NDC 9 | 47335-171 |
|---|---|
| NDC 10 | 47335-171-49 |
| NDC Item | 47335017149 |
| Packaging | 14 POUCH in 1 CARTON (47335-171-49) / 4 AMPULE in 1 POUCH (47335-171-48) / 5 mL in 1 AMPULE |
| ANDA | ANDA207136 |
| COLORTEXT | YELLOW(Colourless to light yellow) |
| Color | C48330 __ |
| FDA SPL set id | 707885 |
| Labeler | Sun Pharmaceutical Industries, Inc. |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2020-02-28 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 47335-171 |
NDC Item 59651012904
| NDC 9 | 59651-129 |
|---|---|
| NDC 10 | 59651-129-04 |
| NDC Item | 59651012904 |
| Packaging | 4 in 1 POUCH |
| Packaging | 5 mL in 1 AMPULE |
| ANDA | ANDA210871 |
| FDA SPL set id | 710977 |
| Labeler | Aurobindo Pharma Limited |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2021-01-22 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 59651-129 |
NDC Item 59651012956
| NDC 9 | 59651-129 |
|---|---|
| NDC 10 | 59651-129-56 |
| NDC Item | 59651012956 |
| Packaging | 14 POUCH in 1 CARTON (59651-129-56) / 4 AMPULE in 1 POUCH (59651-129-04) / 5 mL in 1 AMPULE |
| ANDA | ANDA210871 |
| FDA SPL set id | 710977 |
| Labeler | Aurobindo Pharma Limited |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2021-01-22 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 59651-129 |
NDC Item 60687073179
| NDC 9 | 60687-731 |
|---|---|
| NDC 10 | 60687-731-79 |
| NDC Item | 60687073179 |
| Packaging | 1 in 1 POUCH |
| Packaging | 5 mL in 1 AMPULE |
| ANDA | ANDA207136 |
| COLORTEXT | yellow(Colourless to light yellow) |
| Color | C48330 __ |
| FDA SPL set id | 786945 |
| Labeler | American Health Packaging |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2024-05-19 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 60687-731 |
NDC Item 60687073183
| NDC 9 | 60687-731 |
|---|---|
| NDC 10 | 60687-731-83 |
| NDC Item | 60687073183 |
| Packaging | 30 POUCH in 1 CARTON (60687-731-83) / 1 AMPULE in 1 POUCH (60687-731-79) / 5 mL in 1 AMPULE |
| ANDA | ANDA207136 |
| COLORTEXT | yellow(Colourless to light yellow) |
| Color | C48330 __ |
| FDA SPL set id | 786945 |
| Labeler | American Health Packaging |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2024-05-19 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 60687-731 |
NDC Item 65162091446
| NDC 9 | 65162-914 |
|---|---|
| NDC 10 | 65162-914-46 |
| NDC Item | 65162091446 |
| Packaging | 56 AMPULE in 1 CARTON (65162-914-46) / 5 mL in 1 AMPULE |
| ANDA | ANDA205501 |
| COLORTEXT | yellow(clear, slightly yellow) |
| Color | C48330 __ |
| FDA SPL set id | 824547 |
| Labeler | Amneal Pharmaceuticals LLC |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2014-07-13 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 65162-914 |
NDC Item 67877067869
| NDC 9 | 67877-678 |
|---|---|
| NDC 10 | 67877-678-69 |
| NDC Item | 67877067869 |
| Packaging | 5 mL in 1 AMPULE |
| Packaging | 7 in 1 POUCH |
| ANDA | ANDA212848 |
| FDA SPL set id | 762146 |
| Labeler | Ascend Laboratories, LLC |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2021-04-02 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 67877-678 |
NDC Item 67877067870
| NDC 9 | 67877-678 |
|---|---|
| NDC 10 | 67877-678-70 |
| NDC Item | 67877067870 |
| Packaging | 56 POUCH in 1 CARTON (67877-678-70) / 7 AMPULE in 1 POUCH (67877-678-69) / 5 mL in 1 AMPULE |
| ANDA | ANDA212848 |
| FDA SPL set id | 762146 |
| Labeler | Ascend Laboratories, LLC |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2021-04-02 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 67877-678 |
NDC Item 68180096204
| NDC 9 | 68180-962 |
|---|---|
| NDC 10 | 68180-962-04 |
| NDC Item | 68180096204 |
| Packaging | 4 in 1 POUCH |
| Packaging | 5 mL in 1 AMPULE |
| ANDA | ANDA208964 |
| FDA SPL set id | 779846 |
| Labeler | Lupin Pharmaceuticals, Inc. |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2018-06-12 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 68180-962 |
NDC Item 68180096256
| NDC 9 | 68180-962 |
|---|---|
| NDC 10 | 68180-962-56 |
| NDC Item | 68180096256 |
| Packaging | 56 POUCH in 1 CARTON (68180-962-56) / 4 AMPULE in 1 POUCH / 5 mL in 1 AMPULE |
| ANDA | ANDA208964 |
| FDA SPL set id | 779846 |
| Labeler | Lupin Pharmaceuticals, Inc. |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2018-06-12 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 68180-962 |
NDC Item 70644089999
| NDC 9 | 70644-899 |
|---|---|
| NDC 10 | 70644-899-99 |
| NDC Item | 70644089999 |
| Packaging | 14 POUCH in 1 CARTON (70644-899-99) / 4 AMPULE in 1 POUCH / 5 mL in 1 AMPULE |
| FDA SPL set id | 849478 |
| Labeler | Genericus, Inc. |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | NDA AUTHORIZED GENERIC |
| Marketing effective time low | 2016-07-11 |
| Marketing status | ACTIVE |
| NDA_AUTHORIZED_GENERIC | NDA205433 |
| Related queries | Properties for NDC 9 70644-899 |
NDC Item 70756060444
| NDC 9 | 70756-604 |
|---|---|
| NDC 10 | 70756-604-44 |
| NDC Item | 70756060444 |
| Packaging | 4 in 1 POUCH |
| Packaging | 5 mL in 1 AMPULE |
| ANDA | ANDA214478 |
| FDA SPL set id | 805293 |
| Labeler | Lifestar Pharma LLC |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2023-06-30 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 70756-604 |
NDC Item 70756060456
| NDC 9 | 70756-604 |
|---|---|
| NDC 10 | 70756-604-56 |
| NDC Item | 70756060456 |
| Packaging | 14 POUCH in 1 CARTON (70756-604-56) / 4 AMPULE in 1 POUCH (70756-604-44) / 5 mL in 1 AMPULE |
| ANDA | ANDA214478 |
| FDA SPL set id | 805293 |
| Labeler | Lifestar Pharma LLC |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2023-06-30 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 70756-604 |
NDC Item 72603043004
| NDC 9 | 72603-430 |
|---|---|
| NDC 10 | 72603-430-04 |
| NDC Item | 72603043004 |
| Packaging | 4 in 1 POUCH |
| Packaging | 5 mL in 1 AMPULE |
| ANDA | ANDA214478 |
| FDA SPL set id | 801097 |
| Labeler | NorthStar RxLLC |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2024-08-01 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 72603-430 |
NDC Item 72603043056
| NDC 9 | 72603-430 |
|---|---|
| NDC 10 | 72603-430-56 |
| NDC Item | 72603043056 |
| Packaging | 14 POUCH in 1 CARTON (72603-430-56) / 4 AMPULE in 1 POUCH (72603-430-04) / 5 mL in 1 AMPULE |
| ANDA | ANDA214478 |
| FDA SPL set id | 801097 |
| Labeler | NorthStar RxLLC |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2024-08-01 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 72603-430 |
NDC Item 76204002956
| NDC 9 | 76204-029 |
|---|---|
| NDC 10 | 76204-029-56 |
| NDC Item | 76204002956 |
| Packaging | 14 POUCH in 1 CARTON (76204-029-56) / 4 AMPULE in 1 POUCH / 5 mL in 1 AMPULE |
| ANDA | ANDA201422 |
| FDA SPL set id | 866956 |
| Labeler | Ritedose Pharmaceuticals, LLC |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2025-03-25 |
| Marketing status | active |
| Related queries | Properties for NDC 9 76204-029 |
NDC Item 00093408563
| NDC 9 | 0093-4085 |
|---|---|
| NDC 10 | 0093-4085-63 |
| NDC Item | 00093408563 |
| Packaging | 56 AMPULE in 1 CARTON (0093-4085-63) / 5 mL in 1 AMPULE |
| ANDA | ANDA091589 |
| FDA SPL set id | 861925 |
| Labeler | Teva Pharmaceuticals USA, Inc. |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2013-11-19 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 0093-4085 |
NDC Item 00781717156
| NDC 9 | 0781-7171 |
|---|---|
| NDC 10 | 0781-7171-56 |
| NDC Item | 00781717156 |
| Packaging | 56 AMPULE in 1 CARTON (0781-7171-56) / 5 mL in 1 AMPULE (0781-7171-75) |
| FDA SPL set id | 132419 |
| Labeler | Sandoz Inc |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | NDA AUTHORIZED GENERIC |
| Marketing effective time low | 2014-07-09 |
| Marketing status | COMPLETED |
| NDA_AUTHORIZED_GENERIC | NDA050753 |
| Related queries | Properties for NDC 9 0781-7171 |
NDC Item 00781717175
| NDC 9 | 0781-7171 |
|---|---|
| NDC 10 | 0781-7171-75 |
| NDC Item | 00781717175 |
| Packaging | 5 mL in 1 AMPULE |
| FDA SPL set id | 132419 |
| Labeler | Sandoz Inc |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | NDA AUTHORIZED GENERIC |
| Marketing effective time low | 2014-07-09 |
| Marketing status | COMPLETED |
| NDA_AUTHORIZED_GENERIC | NDA050753 |
| Related queries | Properties for NDC 9 0781-7171 |
NDC Item 16714011902
| NDC 9 | 16714-119 |
|---|---|
| NDC 10 | 16714-119-02 |
| NDC Item | 16714011902 |
| Packaging | 5 mL in 1 AMPULE |
| ANDA | ANDA207080 |
| FDA SPL set id | 842222 |
| Labeler | NorthStar RxLLC |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2020-05-21 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 16714-119 |
NDC Item 16714011903
| NDC 9 | 16714-119 |
|---|---|
| NDC 10 | 16714-119-03 |
| NDC Item | 16714011903 |
| Packaging | 14 POUCH in 1 CARTON (16714-119-03) / 4 AMPULE in 1 POUCH / 5 mL in 1 AMPULE (16714-119-02) |
| ANDA | ANDA207080 |
| FDA SPL set id | 842222 |
| Labeler | NorthStar RxLLC |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2020-05-21 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 16714-119 |
NDC Item 17478034038
| NDC 9 | 17478-340 |
|---|---|
| NDC 10 | 17478-340-38 |
| NDC Item | 17478034038 |
| Packaging | 14 POUCH in 1 CARTON (17478-340-38) / 4 AMPULE in 1 POUCH / 5 mL in 1 AMPULE |
| ANDA | ANDA201422 |
| FDA SPL set id | 656792 |
| Labeler | Akorn Operating Company LLC (dba Akorn) |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 17478-340 |
NDC Item 42571040809
| NDC 9 | 42571-408 |
|---|---|
| NDC 10 | 42571-408-09 |
| NDC Item | 42571040809 |
| Packaging | 5 mL in 1 AMPULE |
| ANDA | ANDA217344 |
| FDA SPL set id | 812408 |
| Labeler | Micro Labs Limited |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2024-01-01 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 42571-408 |
NDC Item 42571040819
| NDC 9 | 42571-408 |
|---|---|
| NDC 10 | 42571-408-19 |
| NDC Item | 42571040819 |
| Packaging | 4 in 1 POUCH |
| ANDA | ANDA217344 |
| FDA SPL set id | 812408 |
| Labeler | Micro Labs Limited |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2024-01-01 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 42571-408 |
NDC Item 42571040892
| NDC 9 | 42571-408 |
|---|---|
| NDC 10 | 42571-408-92 |
| NDC Item | 42571040892 |
| Packaging | 14 POUCH in 1 CARTON (42571-408-92) / 4 AMPULE in 1 POUCH (42571-408-19) / 5 mL in 1 AMPULE (42571-408-09) |
| ANDA | ANDA217344 |
| FDA SPL set id | 812408 |
| Labeler | Micro Labs Limited |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2024-01-01 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 42571-408 |
NDC Item 43598060504
| NDC 9 | 43598-605 |
|---|---|
| NDC 10 | 43598-605-04 |
| NDC Item | 43598060504 |
| ANDA | ANDA207080 |
| FDA SPL set id | 706735 |
| Labeler | Dr. Reddy's Laboratories Inc. |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2019-05-14 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 43598-605 |
NDC Item 43598060511
| NDC 9 | 43598-605 |
|---|---|
| NDC 10 | 43598-605-11 |
| NDC Item | 43598060511 |
| ANDA | ANDA207080 |
| FDA SPL set id | 706735 |
| Labeler | Dr. Reddy's Laboratories Inc. |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2019-05-14 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 43598-605 |
NDC Item 43598060556
| NDC 9 | 43598-605 |
|---|---|
| NDC 10 | 43598-605-56 |
| NDC Item | 43598060556 |
| Packaging | 14 POUCH in 1 CARTON (43598-605-56) / 4 AMPULE in 1 POUCH (43598-605-04) / 5 mL in 1 AMPULE |
| ANDA | ANDA207080 |
| FDA SPL set id | 706735 |
| Labeler | Dr. Reddy's Laboratories Inc. |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2019-05-14 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 43598-605 |
NDC Item 43598060558
| NDC 9 | 43598-605 |
|---|---|
| NDC 10 | 43598-605-58 |
| NDC Item | 43598060558 |
| Packaging | 56 POUCH in 1 CARTON (43598-605-58) / 1 AMPULE in 1 POUCH (43598-605-11) / 5 mL in 1 AMPULE |
| ANDA | ANDA207080 |
| FDA SPL set id | 706735 |
| Labeler | Dr. Reddy's Laboratories Inc. |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2019-05-14 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 43598-605 |
NDC Item 47335017148
| NDC 9 | 47335-171 |
|---|---|
| NDC 10 | 47335-171-48 |
| NDC Item | 47335017148 |
| Packaging | 4 in 1 POUCH |
| Packaging | 5 mL in 1 AMPULE |
| ANDA | ANDA207136 |
| COLORTEXT | YELLOW(Colourless to light yellow) |
| Color | C48330 __ |
| FDA SPL set id | 707885 |
| Labeler | Sun Pharmaceutical Industries, Inc. |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2020-02-28 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 47335-171 |
NDC Item 47335017149
| NDC 9 | 47335-171 |
|---|---|
| NDC 10 | 47335-171-49 |
| NDC Item | 47335017149 |
| Packaging | 14 POUCH in 1 CARTON (47335-171-49) / 4 AMPULE in 1 POUCH (47335-171-48) / 5 mL in 1 AMPULE |
| ANDA | ANDA207136 |
| COLORTEXT | YELLOW(Colourless to light yellow) |
| Color | C48330 __ |
| FDA SPL set id | 707885 |
| Labeler | Sun Pharmaceutical Industries, Inc. |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2020-02-28 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 47335-171 |
NDC Item 59651012904
| NDC 9 | 59651-129 |
|---|---|
| NDC 10 | 59651-129-04 |
| NDC Item | 59651012904 |
| Packaging | 4 in 1 POUCH |
| Packaging | 5 mL in 1 AMPULE |
| ANDA | ANDA210871 |
| FDA SPL set id | 710977 |
| Labeler | Aurobindo Pharma Limited |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2021-01-22 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 59651-129 |
NDC Item 59651012956
| NDC 9 | 59651-129 |
|---|---|
| NDC 10 | 59651-129-56 |
| NDC Item | 59651012956 |
| Packaging | 14 POUCH in 1 CARTON (59651-129-56) / 4 AMPULE in 1 POUCH (59651-129-04) / 5 mL in 1 AMPULE |
| ANDA | ANDA210871 |
| FDA SPL set id | 710977 |
| Labeler | Aurobindo Pharma Limited |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2021-01-22 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 59651-129 |
NDC Item 60687073179
| NDC 9 | 60687-731 |
|---|---|
| NDC 10 | 60687-731-79 |
| NDC Item | 60687073179 |
| Packaging | 1 in 1 POUCH |
| Packaging | 5 mL in 1 AMPULE |
| ANDA | ANDA207136 |
| COLORTEXT | yellow(Colourless to light yellow) |
| Color | C48330 __ |
| FDA SPL set id | 786945 |
| Labeler | American Health Packaging |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2024-05-19 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 60687-731 |
NDC Item 60687073183
| NDC 9 | 60687-731 |
|---|---|
| NDC 10 | 60687-731-83 |
| NDC Item | 60687073183 |
| Packaging | 30 POUCH in 1 CARTON (60687-731-83) / 1 AMPULE in 1 POUCH (60687-731-79) / 5 mL in 1 AMPULE |
| ANDA | ANDA207136 |
| COLORTEXT | yellow(Colourless to light yellow) |
| Color | C48330 __ |
| FDA SPL set id | 786945 |
| Labeler | American Health Packaging |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2024-05-19 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 60687-731 |
NDC Item 65162091446
| NDC 9 | 65162-914 |
|---|---|
| NDC 10 | 65162-914-46 |
| NDC Item | 65162091446 |
| Packaging | 56 AMPULE in 1 CARTON (65162-914-46) / 5 mL in 1 AMPULE |
| ANDA | ANDA205501 |
| COLORTEXT | yellow(clear, slightly yellow) |
| Color | C48330 __ |
| FDA SPL set id | 824547 |
| Labeler | Amneal Pharmaceuticals LLC |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2014-07-13 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 65162-914 |
NDC Item 67877067869
| NDC 9 | 67877-678 |
|---|---|
| NDC 10 | 67877-678-69 |
| NDC Item | 67877067869 |
| Packaging | 5 mL in 1 AMPULE |
| Packaging | 7 in 1 POUCH |
| ANDA | ANDA212848 |
| FDA SPL set id | 762146 |
| Labeler | Ascend Laboratories, LLC |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2021-04-02 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 67877-678 |
NDC Item 67877067870
| NDC 9 | 67877-678 |
|---|---|
| NDC 10 | 67877-678-70 |
| NDC Item | 67877067870 |
| Packaging | 56 POUCH in 1 CARTON (67877-678-70) / 7 AMPULE in 1 POUCH (67877-678-69) / 5 mL in 1 AMPULE |
| ANDA | ANDA212848 |
| FDA SPL set id | 762146 |
| Labeler | Ascend Laboratories, LLC |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2021-04-02 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 67877-678 |
NDC Item 68180096204
| NDC 9 | 68180-962 |
|---|---|
| NDC 10 | 68180-962-04 |
| NDC Item | 68180096204 |
| Packaging | 4 in 1 POUCH |
| Packaging | 5 mL in 1 AMPULE |
| ANDA | ANDA208964 |
| FDA SPL set id | 779846 |
| Labeler | Lupin Pharmaceuticals, Inc. |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2018-06-12 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 68180-962 |
NDC Item 68180096256
| NDC 9 | 68180-962 |
|---|---|
| NDC 10 | 68180-962-56 |
| NDC Item | 68180096256 |
| Packaging | 56 POUCH in 1 CARTON (68180-962-56) / 4 AMPULE in 1 POUCH / 5 mL in 1 AMPULE |
| ANDA | ANDA208964 |
| FDA SPL set id | 779846 |
| Labeler | Lupin Pharmaceuticals, Inc. |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2018-06-12 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 68180-962 |
NDC Item 70644089999
| NDC 9 | 70644-899 |
|---|---|
| NDC 10 | 70644-899-99 |
| NDC Item | 70644089999 |
| Packaging | 14 POUCH in 1 CARTON (70644-899-99) / 4 AMPULE in 1 POUCH / 5 mL in 1 AMPULE |
| FDA SPL set id | 849478 |
| Labeler | Genericus, Inc. |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | NDA AUTHORIZED GENERIC |
| Marketing effective time low | 2016-07-11 |
| Marketing status | ACTIVE |
| NDA_AUTHORIZED_GENERIC | NDA205433 |
| Related queries | Properties for NDC 9 70644-899 |
NDC Item 70756060444
| NDC 9 | 70756-604 |
|---|---|
| NDC 10 | 70756-604-44 |
| NDC Item | 70756060444 |
| Packaging | 4 in 1 POUCH |
| Packaging | 5 mL in 1 AMPULE |
| ANDA | ANDA214478 |
| FDA SPL set id | 805293 |
| Labeler | Lifestar Pharma LLC |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2023-06-30 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 70756-604 |
NDC Item 70756060456
| NDC 9 | 70756-604 |
|---|---|
| NDC 10 | 70756-604-56 |
| NDC Item | 70756060456 |
| Packaging | 14 POUCH in 1 CARTON (70756-604-56) / 4 AMPULE in 1 POUCH (70756-604-44) / 5 mL in 1 AMPULE |
| ANDA | ANDA214478 |
| FDA SPL set id | 805293 |
| Labeler | Lifestar Pharma LLC |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2023-06-30 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 70756-604 |
NDC Item 72603043004
| NDC 9 | 72603-430 |
|---|---|
| NDC 10 | 72603-430-04 |
| NDC Item | 72603043004 |
| Packaging | 4 in 1 POUCH |
| Packaging | 5 mL in 1 AMPULE |
| ANDA | ANDA214478 |
| FDA SPL set id | 801097 |
| Labeler | NorthStar RxLLC |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2024-08-01 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 72603-430 |
NDC Item 72603043056
| NDC 9 | 72603-430 |
|---|---|
| NDC 10 | 72603-430-56 |
| NDC Item | 72603043056 |
| Packaging | 14 POUCH in 1 CARTON (72603-430-56) / 4 AMPULE in 1 POUCH (72603-430-04) / 5 mL in 1 AMPULE |
| ANDA | ANDA214478 |
| FDA SPL set id | 801097 |
| Labeler | NorthStar RxLLC |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2024-08-01 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 72603-430 |
NDC Item 76204002956
| NDC 9 | 76204-029 |
|---|---|
| NDC 10 | 76204-029-56 |
| NDC Item | 76204002956 |
| Packaging | 14 POUCH in 1 CARTON (76204-029-56) / 4 AMPULE in 1 POUCH / 5 mL in 1 AMPULE |
| ANDA | ANDA201422 |
| FDA SPL set id | 866956 |
| Labeler | Ritedose Pharmaceuticals, LLC |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2025-03-25 |
| Marketing status | active |
| Related queries | Properties for NDC 9 76204-029 |
NDC Item 00093408563
| NDC 9 | 0093-4085 |
|---|---|
| NDC 10 | 0093-4085-63 |
| NDC Item | 00093408563 |
| Packaging | 56 AMPULE in 1 CARTON (0093-4085-63) / 5 mL in 1 AMPULE |
| ANDA | ANDA091589 |
| FDA SPL set id | 861925 |
| Labeler | Teva Pharmaceuticals USA, Inc. |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2013-11-19 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 0093-4085 |
NDC Item 00781717156
| NDC 9 | 0781-7171 |
|---|---|
| NDC 10 | 0781-7171-56 |
| NDC Item | 00781717156 |
| Packaging | 56 AMPULE in 1 CARTON (0781-7171-56) / 5 mL in 1 AMPULE (0781-7171-75) |
| FDA SPL set id | 132419 |
| Labeler | Sandoz Inc |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | NDA AUTHORIZED GENERIC |
| Marketing effective time low | 2014-07-09 |
| Marketing status | COMPLETED |
| NDA_AUTHORIZED_GENERIC | NDA050753 |
| Related queries | Properties for NDC 9 0781-7171 |
NDC Item 00781717175
| NDC 9 | 0781-7171 |
|---|---|
| NDC 10 | 0781-7171-75 |
| NDC Item | 00781717175 |
| Packaging | 5 mL in 1 AMPULE |
| FDA SPL set id | 132419 |
| Labeler | Sandoz Inc |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | NDA AUTHORIZED GENERIC |
| Marketing effective time low | 2014-07-09 |
| Marketing status | COMPLETED |
| NDA_AUTHORIZED_GENERIC | NDA050753 |
| Related queries | Properties for NDC 9 0781-7171 |
NDC Item 16714011902
| NDC 9 | 16714-119 |
|---|---|
| NDC 10 | 16714-119-02 |
| NDC Item | 16714011902 |
| Packaging | 5 mL in 1 AMPULE |
| ANDA | ANDA207080 |
| FDA SPL set id | 842222 |
| Labeler | NorthStar RxLLC |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2020-05-21 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 16714-119 |
NDC Item 16714011903
| NDC 9 | 16714-119 |
|---|---|
| NDC 10 | 16714-119-03 |
| NDC Item | 16714011903 |
| Packaging | 14 POUCH in 1 CARTON (16714-119-03) / 4 AMPULE in 1 POUCH / 5 mL in 1 AMPULE (16714-119-02) |
| ANDA | ANDA207080 |
| FDA SPL set id | 842222 |
| Labeler | NorthStar RxLLC |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2020-05-21 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 16714-119 |
NDC Item 17478034038
| NDC 9 | 17478-340 |
|---|---|
| NDC 10 | 17478-340-38 |
| NDC Item | 17478034038 |
| Packaging | 14 POUCH in 1 CARTON (17478-340-38) / 4 AMPULE in 1 POUCH / 5 mL in 1 AMPULE |
| ANDA | ANDA201422 |
| FDA SPL set id | 656792 |
| Labeler | Akorn Operating Company LLC (dba Akorn) |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 17478-340 |
NDC Item 42571040809
| NDC 9 | 42571-408 |
|---|---|
| NDC 10 | 42571-408-09 |
| NDC Item | 42571040809 |
| Packaging | 5 mL in 1 AMPULE |
| ANDA | ANDA217344 |
| FDA SPL set id | 812408 |
| Labeler | Micro Labs Limited |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2024-01-01 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 42571-408 |
NDC Item 42571040819
| NDC 9 | 42571-408 |
|---|---|
| NDC 10 | 42571-408-19 |
| NDC Item | 42571040819 |
| Packaging | 4 in 1 POUCH |
| ANDA | ANDA217344 |
| FDA SPL set id | 812408 |
| Labeler | Micro Labs Limited |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2024-01-01 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 42571-408 |
NDC Item 42571040892
| NDC 9 | 42571-408 |
|---|---|
| NDC 10 | 42571-408-92 |
| NDC Item | 42571040892 |
| Packaging | 14 POUCH in 1 CARTON (42571-408-92) / 4 AMPULE in 1 POUCH (42571-408-19) / 5 mL in 1 AMPULE (42571-408-09) |
| ANDA | ANDA217344 |
| FDA SPL set id | 812408 |
| Labeler | Micro Labs Limited |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2024-01-01 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 42571-408 |
NDC Item 43598060504
| NDC 9 | 43598-605 |
|---|---|
| NDC 10 | 43598-605-04 |
| NDC Item | 43598060504 |
| ANDA | ANDA207080 |
| FDA SPL set id | 706735 |
| Labeler | Dr. Reddy's Laboratories Inc. |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2019-05-14 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 43598-605 |
NDC Item 43598060511
| NDC 9 | 43598-605 |
|---|---|
| NDC 10 | 43598-605-11 |
| NDC Item | 43598060511 |
| ANDA | ANDA207080 |
| FDA SPL set id | 706735 |
| Labeler | Dr. Reddy's Laboratories Inc. |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2019-05-14 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 43598-605 |
NDC Item 43598060556
| NDC 9 | 43598-605 |
|---|---|
| NDC 10 | 43598-605-56 |
| NDC Item | 43598060556 |
| Packaging | 14 POUCH in 1 CARTON (43598-605-56) / 4 AMPULE in 1 POUCH (43598-605-04) / 5 mL in 1 AMPULE |
| ANDA | ANDA207080 |
| FDA SPL set id | 706735 |
| Labeler | Dr. Reddy's Laboratories Inc. |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2019-05-14 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 43598-605 |
NDC Item 43598060558
| NDC 9 | 43598-605 |
|---|---|
| NDC 10 | 43598-605-58 |
| NDC Item | 43598060558 |
| Packaging | 56 POUCH in 1 CARTON (43598-605-58) / 1 AMPULE in 1 POUCH (43598-605-11) / 5 mL in 1 AMPULE |
| ANDA | ANDA207080 |
| FDA SPL set id | 706735 |
| Labeler | Dr. Reddy's Laboratories Inc. |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2019-05-14 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 43598-605 |
NDC Item 47335017148
| NDC 9 | 47335-171 |
|---|---|
| NDC 10 | 47335-171-48 |
| NDC Item | 47335017148 |
| Packaging | 4 in 1 POUCH |
| Packaging | 5 mL in 1 AMPULE |
| ANDA | ANDA207136 |
| COLORTEXT | YELLOW(Colourless to light yellow) |
| Color | C48330 __ |
| FDA SPL set id | 707885 |
| Labeler | Sun Pharmaceutical Industries, Inc. |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2020-02-28 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 47335-171 |
NDC Item 47335017149
| NDC 9 | 47335-171 |
|---|---|
| NDC 10 | 47335-171-49 |
| NDC Item | 47335017149 |
| Packaging | 14 POUCH in 1 CARTON (47335-171-49) / 4 AMPULE in 1 POUCH (47335-171-48) / 5 mL in 1 AMPULE |
| ANDA | ANDA207136 |
| COLORTEXT | YELLOW(Colourless to light yellow) |
| Color | C48330 __ |
| FDA SPL set id | 707885 |
| Labeler | Sun Pharmaceutical Industries, Inc. |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2020-02-28 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 47335-171 |
NDC Item 59651012904
| NDC 9 | 59651-129 |
|---|---|
| NDC 10 | 59651-129-04 |
| NDC Item | 59651012904 |
| Packaging | 4 in 1 POUCH |
| Packaging | 5 mL in 1 AMPULE |
| ANDA | ANDA210871 |
| FDA SPL set id | 710977 |
| Labeler | Aurobindo Pharma Limited |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2021-01-22 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 59651-129 |
NDC Item 59651012956
| NDC 9 | 59651-129 |
|---|---|
| NDC 10 | 59651-129-56 |
| NDC Item | 59651012956 |
| Packaging | 14 POUCH in 1 CARTON (59651-129-56) / 4 AMPULE in 1 POUCH (59651-129-04) / 5 mL in 1 AMPULE |
| ANDA | ANDA210871 |
| FDA SPL set id | 710977 |
| Labeler | Aurobindo Pharma Limited |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2021-01-22 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 59651-129 |
NDC Item 60687073179
| NDC 9 | 60687-731 |
|---|---|
| NDC 10 | 60687-731-79 |
| NDC Item | 60687073179 |
| Packaging | 1 in 1 POUCH |
| Packaging | 5 mL in 1 AMPULE |
| ANDA | ANDA207136 |
| COLORTEXT | yellow(Colourless to light yellow) |
| Color | C48330 __ |
| FDA SPL set id | 786945 |
| Labeler | American Health Packaging |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2024-05-19 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 60687-731 |
NDC Item 60687073183
| NDC 9 | 60687-731 |
|---|---|
| NDC 10 | 60687-731-83 |
| NDC Item | 60687073183 |
| Packaging | 30 POUCH in 1 CARTON (60687-731-83) / 1 AMPULE in 1 POUCH (60687-731-79) / 5 mL in 1 AMPULE |
| ANDA | ANDA207136 |
| COLORTEXT | yellow(Colourless to light yellow) |
| Color | C48330 __ |
| FDA SPL set id | 786945 |
| Labeler | American Health Packaging |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2024-05-19 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 60687-731 |
NDC Item 65162091446
| NDC 9 | 65162-914 |
|---|---|
| NDC 10 | 65162-914-46 |
| NDC Item | 65162091446 |
| Packaging | 56 AMPULE in 1 CARTON (65162-914-46) / 5 mL in 1 AMPULE |
| ANDA | ANDA205501 |
| COLORTEXT | yellow(clear, slightly yellow) |
| Color | C48330 __ |
| FDA SPL set id | 824547 |
| Labeler | Amneal Pharmaceuticals LLC |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2014-07-13 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 65162-914 |
NDC Item 67877067869
| NDC 9 | 67877-678 |
|---|---|
| NDC 10 | 67877-678-69 |
| NDC Item | 67877067869 |
| Packaging | 5 mL in 1 AMPULE |
| Packaging | 7 in 1 POUCH |
| ANDA | ANDA212848 |
| FDA SPL set id | 762146 |
| Labeler | Ascend Laboratories, LLC |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2021-04-02 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 67877-678 |
NDC Item 67877067870
| NDC 9 | 67877-678 |
|---|---|
| NDC 10 | 67877-678-70 |
| NDC Item | 67877067870 |
| Packaging | 56 POUCH in 1 CARTON (67877-678-70) / 7 AMPULE in 1 POUCH (67877-678-69) / 5 mL in 1 AMPULE |
| ANDA | ANDA212848 |
| FDA SPL set id | 762146 |
| Labeler | Ascend Laboratories, LLC |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2021-04-02 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 67877-678 |
NDC Item 68180096204
| NDC 9 | 68180-962 |
|---|---|
| NDC 10 | 68180-962-04 |
| NDC Item | 68180096204 |
| Packaging | 4 in 1 POUCH |
| Packaging | 5 mL in 1 AMPULE |
| ANDA | ANDA208964 |
| FDA SPL set id | 779846 |
| Labeler | Lupin Pharmaceuticals, Inc. |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2018-06-12 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 68180-962 |
NDC Item 68180096256
| NDC 9 | 68180-962 |
|---|---|
| NDC 10 | 68180-962-56 |
| NDC Item | 68180096256 |
| Packaging | 56 POUCH in 1 CARTON (68180-962-56) / 4 AMPULE in 1 POUCH / 5 mL in 1 AMPULE |
| ANDA | ANDA208964 |
| FDA SPL set id | 779846 |
| Labeler | Lupin Pharmaceuticals, Inc. |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2018-06-12 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 68180-962 |
NDC Item 70644089999
| NDC 9 | 70644-899 |
|---|---|
| NDC 10 | 70644-899-99 |
| NDC Item | 70644089999 |
| Packaging | 14 POUCH in 1 CARTON (70644-899-99) / 4 AMPULE in 1 POUCH / 5 mL in 1 AMPULE |
| FDA SPL set id | 849478 |
| Labeler | Genericus, Inc. |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | NDA AUTHORIZED GENERIC |
| Marketing effective time low | 2016-07-11 |
| Marketing status | ACTIVE |
| NDA_AUTHORIZED_GENERIC | NDA205433 |
| Related queries | Properties for NDC 9 70644-899 |
NDC Item 70756060444
| NDC 9 | 70756-604 |
|---|---|
| NDC 10 | 70756-604-44 |
| NDC Item | 70756060444 |
| Packaging | 4 in 1 POUCH |
| Packaging | 5 mL in 1 AMPULE |
| ANDA | ANDA214478 |
| FDA SPL set id | 805293 |
| Labeler | Lifestar Pharma LLC |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2023-06-30 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 70756-604 |
NDC Item 70756060456
| NDC 9 | 70756-604 |
|---|---|
| NDC 10 | 70756-604-56 |
| NDC Item | 70756060456 |
| Packaging | 14 POUCH in 1 CARTON (70756-604-56) / 4 AMPULE in 1 POUCH (70756-604-44) / 5 mL in 1 AMPULE |
| ANDA | ANDA214478 |
| FDA SPL set id | 805293 |
| Labeler | Lifestar Pharma LLC |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2023-06-30 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 70756-604 |
NDC Item 72603043004
| NDC 9 | 72603-430 |
|---|---|
| NDC 10 | 72603-430-04 |
| NDC Item | 72603043004 |
| Packaging | 4 in 1 POUCH |
| Packaging | 5 mL in 1 AMPULE |
| ANDA | ANDA214478 |
| FDA SPL set id | 801097 |
| Labeler | NorthStar RxLLC |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2024-08-01 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 72603-430 |
NDC Item 72603043056
| NDC 9 | 72603-430 |
|---|---|
| NDC 10 | 72603-430-56 |
| NDC Item | 72603043056 |
| Packaging | 14 POUCH in 1 CARTON (72603-430-56) / 4 AMPULE in 1 POUCH (72603-430-04) / 5 mL in 1 AMPULE |
| ANDA | ANDA214478 |
| FDA SPL set id | 801097 |
| Labeler | NorthStar RxLLC |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2024-08-01 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 72603-430 |
NDC Item 76204002956
| NDC 9 | 76204-029 |
|---|---|
| NDC 10 | 76204-029-56 |
| NDC Item | 76204002956 |
| Packaging | 14 POUCH in 1 CARTON (76204-029-56) / 4 AMPULE in 1 POUCH / 5 mL in 1 AMPULE |
| ANDA | ANDA201422 |
| FDA SPL set id | 866956 |
| Labeler | Ritedose Pharmaceuticals, LLC |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2025-03-25 |
| Marketing status | active |
| Related queries | Properties for NDC 9 76204-029 |
NDC Item 00093408563
| NDC 9 | 0093-4085 |
|---|---|
| NDC 10 | 0093-4085-63 |
| NDC Item | 00093408563 |
| Packaging | 56 AMPULE in 1 CARTON (0093-4085-63) / 5 mL in 1 AMPULE |
| ANDA | ANDA091589 |
| FDA SPL set id | 861925 |
| Labeler | Teva Pharmaceuticals USA, Inc. |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2013-11-19 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 0093-4085 |
NDC Item 00781717156
| NDC 9 | 0781-7171 |
|---|---|
| NDC 10 | 0781-7171-56 |
| NDC Item | 00781717156 |
| Packaging | 56 AMPULE in 1 CARTON (0781-7171-56) / 5 mL in 1 AMPULE (0781-7171-75) |
| FDA SPL set id | 132419 |
| Labeler | Sandoz Inc |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | NDA AUTHORIZED GENERIC |
| Marketing effective time low | 2014-07-09 |
| Marketing status | COMPLETED |
| NDA_AUTHORIZED_GENERIC | NDA050753 |
| Related queries | Properties for NDC 9 0781-7171 |
NDC Item 00781717175
| NDC 9 | 0781-7171 |
|---|---|
| NDC 10 | 0781-7171-75 |
| NDC Item | 00781717175 |
| Packaging | 5 mL in 1 AMPULE |
| FDA SPL set id | 132419 |
| Labeler | Sandoz Inc |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | NDA AUTHORIZED GENERIC |
| Marketing effective time low | 2014-07-09 |
| Marketing status | COMPLETED |
| NDA_AUTHORIZED_GENERIC | NDA050753 |
| Related queries | Properties for NDC 9 0781-7171 |
NDC Item 16714011902
| NDC 9 | 16714-119 |
|---|---|
| NDC 10 | 16714-119-02 |
| NDC Item | 16714011902 |
| Packaging | 5 mL in 1 AMPULE |
| ANDA | ANDA207080 |
| FDA SPL set id | 842222 |
| Labeler | NorthStar RxLLC |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2020-05-21 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 16714-119 |
NDC Item 16714011903
| NDC 9 | 16714-119 |
|---|---|
| NDC 10 | 16714-119-03 |
| NDC Item | 16714011903 |
| Packaging | 14 POUCH in 1 CARTON (16714-119-03) / 4 AMPULE in 1 POUCH / 5 mL in 1 AMPULE (16714-119-02) |
| ANDA | ANDA207080 |
| FDA SPL set id | 842222 |
| Labeler | NorthStar RxLLC |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2020-05-21 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 16714-119 |
NDC Item 17478034038
| NDC 9 | 17478-340 |
|---|---|
| NDC 10 | 17478-340-38 |
| NDC Item | 17478034038 |
| Packaging | 14 POUCH in 1 CARTON (17478-340-38) / 4 AMPULE in 1 POUCH / 5 mL in 1 AMPULE |
| ANDA | ANDA201422 |
| FDA SPL set id | 656792 |
| Labeler | Akorn Operating Company LLC (dba Akorn) |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 17478-340 |
NDC Item 42571040809
| NDC 9 | 42571-408 |
|---|---|
| NDC 10 | 42571-408-09 |
| NDC Item | 42571040809 |
| Packaging | 5 mL in 1 AMPULE |
| ANDA | ANDA217344 |
| FDA SPL set id | 812408 |
| Labeler | Micro Labs Limited |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2024-01-01 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 42571-408 |
NDC Item 42571040819
| NDC 9 | 42571-408 |
|---|---|
| NDC 10 | 42571-408-19 |
| NDC Item | 42571040819 |
| Packaging | 4 in 1 POUCH |
| ANDA | ANDA217344 |
| FDA SPL set id | 812408 |
| Labeler | Micro Labs Limited |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2024-01-01 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 42571-408 |
NDC Item 42571040892
| NDC 9 | 42571-408 |
|---|---|
| NDC 10 | 42571-408-92 |
| NDC Item | 42571040892 |
| Packaging | 14 POUCH in 1 CARTON (42571-408-92) / 4 AMPULE in 1 POUCH (42571-408-19) / 5 mL in 1 AMPULE (42571-408-09) |
| ANDA | ANDA217344 |
| FDA SPL set id | 812408 |
| Labeler | Micro Labs Limited |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2024-01-01 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 42571-408 |
NDC Item 43598060504
| NDC 9 | 43598-605 |
|---|---|
| NDC 10 | 43598-605-04 |
| NDC Item | 43598060504 |
| ANDA | ANDA207080 |
| FDA SPL set id | 706735 |
| Labeler | Dr. Reddy's Laboratories Inc. |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2019-05-14 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 43598-605 |
NDC Item 43598060511
| NDC 9 | 43598-605 |
|---|---|
| NDC 10 | 43598-605-11 |
| NDC Item | 43598060511 |
| ANDA | ANDA207080 |
| FDA SPL set id | 706735 |
| Labeler | Dr. Reddy's Laboratories Inc. |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2019-05-14 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 43598-605 |
NDC Item 43598060556
| NDC 9 | 43598-605 |
|---|---|
| NDC 10 | 43598-605-56 |
| NDC Item | 43598060556 |
| Packaging | 14 POUCH in 1 CARTON (43598-605-56) / 4 AMPULE in 1 POUCH (43598-605-04) / 5 mL in 1 AMPULE |
| ANDA | ANDA207080 |
| FDA SPL set id | 706735 |
| Labeler | Dr. Reddy's Laboratories Inc. |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2019-05-14 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 43598-605 |
NDC Item 43598060558
| NDC 9 | 43598-605 |
|---|---|
| NDC 10 | 43598-605-58 |
| NDC Item | 43598060558 |
| Packaging | 56 POUCH in 1 CARTON (43598-605-58) / 1 AMPULE in 1 POUCH (43598-605-11) / 5 mL in 1 AMPULE |
| ANDA | ANDA207080 |
| FDA SPL set id | 706735 |
| Labeler | Dr. Reddy's Laboratories Inc. |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2019-05-14 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 43598-605 |
NDC Item 47335017148
| NDC 9 | 47335-171 |
|---|---|
| NDC 10 | 47335-171-48 |
| NDC Item | 47335017148 |
| Packaging | 4 in 1 POUCH |
| Packaging | 5 mL in 1 AMPULE |
| ANDA | ANDA207136 |
| COLORTEXT | YELLOW(Colourless to light yellow) |
| Color | C48330 __ |
| FDA SPL set id | 707885 |
| Labeler | Sun Pharmaceutical Industries, Inc. |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2020-02-28 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 47335-171 |
NDC Item 47335017149
| NDC 9 | 47335-171 |
|---|---|
| NDC 10 | 47335-171-49 |
| NDC Item | 47335017149 |
| Packaging | 14 POUCH in 1 CARTON (47335-171-49) / 4 AMPULE in 1 POUCH (47335-171-48) / 5 mL in 1 AMPULE |
| ANDA | ANDA207136 |
| COLORTEXT | YELLOW(Colourless to light yellow) |
| Color | C48330 __ |
| FDA SPL set id | 707885 |
| Labeler | Sun Pharmaceutical Industries, Inc. |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2020-02-28 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 47335-171 |
NDC Item 59651012904
| NDC 9 | 59651-129 |
|---|---|
| NDC 10 | 59651-129-04 |
| NDC Item | 59651012904 |
| Packaging | 4 in 1 POUCH |
| Packaging | 5 mL in 1 AMPULE |
| ANDA | ANDA210871 |
| FDA SPL set id | 710977 |
| Labeler | Aurobindo Pharma Limited |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2021-01-22 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 59651-129 |
NDC Item 59651012956
| NDC 9 | 59651-129 |
|---|---|
| NDC 10 | 59651-129-56 |
| NDC Item | 59651012956 |
| Packaging | 14 POUCH in 1 CARTON (59651-129-56) / 4 AMPULE in 1 POUCH (59651-129-04) / 5 mL in 1 AMPULE |
| ANDA | ANDA210871 |
| FDA SPL set id | 710977 |
| Labeler | Aurobindo Pharma Limited |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2021-01-22 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 59651-129 |
NDC Item 60687073179
| NDC 9 | 60687-731 |
|---|---|
| NDC 10 | 60687-731-79 |
| NDC Item | 60687073179 |
| Packaging | 1 in 1 POUCH |
| Packaging | 5 mL in 1 AMPULE |
| ANDA | ANDA207136 |
| COLORTEXT | yellow(Colourless to light yellow) |
| Color | C48330 __ |
| FDA SPL set id | 786945 |
| Labeler | American Health Packaging |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2024-05-19 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 60687-731 |
NDC Item 60687073183
| NDC 9 | 60687-731 |
|---|---|
| NDC 10 | 60687-731-83 |
| NDC Item | 60687073183 |
| Packaging | 30 POUCH in 1 CARTON (60687-731-83) / 1 AMPULE in 1 POUCH (60687-731-79) / 5 mL in 1 AMPULE |
| ANDA | ANDA207136 |
| COLORTEXT | yellow(Colourless to light yellow) |
| Color | C48330 __ |
| FDA SPL set id | 786945 |
| Labeler | American Health Packaging |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2024-05-19 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 60687-731 |
NDC Item 65162091446
| NDC 9 | 65162-914 |
|---|---|
| NDC 10 | 65162-914-46 |
| NDC Item | 65162091446 |
| Packaging | 56 AMPULE in 1 CARTON (65162-914-46) / 5 mL in 1 AMPULE |
| ANDA | ANDA205501 |
| COLORTEXT | yellow(clear, slightly yellow) |
| Color | C48330 __ |
| FDA SPL set id | 824547 |
| Labeler | Amneal Pharmaceuticals LLC |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2014-07-13 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 65162-914 |
NDC Item 67877067869
| NDC 9 | 67877-678 |
|---|---|
| NDC 10 | 67877-678-69 |
| NDC Item | 67877067869 |
| Packaging | 5 mL in 1 AMPULE |
| Packaging | 7 in 1 POUCH |
| ANDA | ANDA212848 |
| FDA SPL set id | 762146 |
| Labeler | Ascend Laboratories, LLC |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2021-04-02 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 67877-678 |
NDC Item 67877067870
| NDC 9 | 67877-678 |
|---|---|
| NDC 10 | 67877-678-70 |
| NDC Item | 67877067870 |
| Packaging | 56 POUCH in 1 CARTON (67877-678-70) / 7 AMPULE in 1 POUCH (67877-678-69) / 5 mL in 1 AMPULE |
| ANDA | ANDA212848 |
| FDA SPL set id | 762146 |
| Labeler | Ascend Laboratories, LLC |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2021-04-02 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 67877-678 |
NDC Item 68180096204
| NDC 9 | 68180-962 |
|---|---|
| NDC 10 | 68180-962-04 |
| NDC Item | 68180096204 |
| Packaging | 4 in 1 POUCH |
| Packaging | 5 mL in 1 AMPULE |
| ANDA | ANDA208964 |
| FDA SPL set id | 779846 |
| Labeler | Lupin Pharmaceuticals, Inc. |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2018-06-12 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 68180-962 |
NDC Item 68180096256
| NDC 9 | 68180-962 |
|---|---|
| NDC 10 | 68180-962-56 |
| NDC Item | 68180096256 |
| Packaging | 56 POUCH in 1 CARTON (68180-962-56) / 4 AMPULE in 1 POUCH / 5 mL in 1 AMPULE |
| ANDA | ANDA208964 |
| FDA SPL set id | 779846 |
| Labeler | Lupin Pharmaceuticals, Inc. |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2018-06-12 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 68180-962 |
NDC Item 70644089999
| NDC 9 | 70644-899 |
|---|---|
| NDC 10 | 70644-899-99 |
| NDC Item | 70644089999 |
| Packaging | 14 POUCH in 1 CARTON (70644-899-99) / 4 AMPULE in 1 POUCH / 5 mL in 1 AMPULE |
| FDA SPL set id | 849478 |
| Labeler | Genericus, Inc. |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | NDA AUTHORIZED GENERIC |
| Marketing effective time low | 2016-07-11 |
| Marketing status | ACTIVE |
| NDA_AUTHORIZED_GENERIC | NDA205433 |
| Related queries | Properties for NDC 9 70644-899 |
NDC Item 70756060444
| NDC 9 | 70756-604 |
|---|---|
| NDC 10 | 70756-604-44 |
| NDC Item | 70756060444 |
| Packaging | 4 in 1 POUCH |
| Packaging | 5 mL in 1 AMPULE |
| ANDA | ANDA214478 |
| FDA SPL set id | 805293 |
| Labeler | Lifestar Pharma LLC |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2023-06-30 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 70756-604 |
NDC Item 70756060456
| NDC 9 | 70756-604 |
|---|---|
| NDC 10 | 70756-604-56 |
| NDC Item | 70756060456 |
| Packaging | 14 POUCH in 1 CARTON (70756-604-56) / 4 AMPULE in 1 POUCH (70756-604-44) / 5 mL in 1 AMPULE |
| ANDA | ANDA214478 |
| FDA SPL set id | 805293 |
| Labeler | Lifestar Pharma LLC |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2023-06-30 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 70756-604 |
NDC Item 72603043004
| NDC 9 | 72603-430 |
|---|---|
| NDC 10 | 72603-430-04 |
| NDC Item | 72603043004 |
| Packaging | 4 in 1 POUCH |
| Packaging | 5 mL in 1 AMPULE |
| ANDA | ANDA214478 |
| FDA SPL set id | 801097 |
| Labeler | NorthStar RxLLC |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2024-08-01 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 72603-430 |
NDC Item 72603043056
| NDC 9 | 72603-430 |
|---|---|
| NDC 10 | 72603-430-56 |
| NDC Item | 72603043056 |
| Packaging | 14 POUCH in 1 CARTON (72603-430-56) / 4 AMPULE in 1 POUCH (72603-430-04) / 5 mL in 1 AMPULE |
| ANDA | ANDA214478 |
| FDA SPL set id | 801097 |
| Labeler | NorthStar RxLLC |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2024-08-01 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 72603-430 |
NDC Item 76204002956
| NDC 9 | 76204-029 |
|---|---|
| NDC 10 | 76204-029-56 |
| NDC Item | 76204002956 |
| Packaging | 14 POUCH in 1 CARTON (76204-029-56) / 4 AMPULE in 1 POUCH / 5 mL in 1 AMPULE |
| ANDA | ANDA201422 |
| FDA SPL set id | 866956 |
| Labeler | Ritedose Pharmaceuticals, LLC |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2025-03-25 |
| Marketing status | active |
| Related queries | Properties for NDC 9 76204-029 |
NDC Item 00093408563
| NDC 9 | 0093-4085 |
|---|---|
| NDC 10 | 0093-4085-63 |
| NDC Item | 00093408563 |
| Packaging | 56 AMPULE in 1 CARTON (0093-4085-63) / 5 mL in 1 AMPULE |
| ANDA | ANDA091589 |
| FDA SPL set id | 861925 |
| Labeler | Teva Pharmaceuticals USA, Inc. |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2013-11-19 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 0093-4085 |
NDC Item 00781717156
| NDC 9 | 0781-7171 |
|---|---|
| NDC 10 | 0781-7171-56 |
| NDC Item | 00781717156 |
| Packaging | 56 AMPULE in 1 CARTON (0781-7171-56) / 5 mL in 1 AMPULE (0781-7171-75) |
| FDA SPL set id | 132419 |
| Labeler | Sandoz Inc |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | NDA AUTHORIZED GENERIC |
| Marketing effective time low | 2014-07-09 |
| Marketing status | COMPLETED |
| NDA_AUTHORIZED_GENERIC | NDA050753 |
| Related queries | Properties for NDC 9 0781-7171 |
NDC Item 00781717175
| NDC 9 | 0781-7171 |
|---|---|
| NDC 10 | 0781-7171-75 |
| NDC Item | 00781717175 |
| Packaging | 5 mL in 1 AMPULE |
| FDA SPL set id | 132419 |
| Labeler | Sandoz Inc |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | NDA AUTHORIZED GENERIC |
| Marketing effective time low | 2014-07-09 |
| Marketing status | COMPLETED |
| NDA_AUTHORIZED_GENERIC | NDA050753 |
| Related queries | Properties for NDC 9 0781-7171 |
NDC Item 16714011902
| NDC 9 | 16714-119 |
|---|---|
| NDC 10 | 16714-119-02 |
| NDC Item | 16714011902 |
| Packaging | 5 mL in 1 AMPULE |
| ANDA | ANDA207080 |
| FDA SPL set id | 842222 |
| Labeler | NorthStar RxLLC |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2020-05-21 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 16714-119 |
NDC Item 16714011903
| NDC 9 | 16714-119 |
|---|---|
| NDC 10 | 16714-119-03 |
| NDC Item | 16714011903 |
| Packaging | 14 POUCH in 1 CARTON (16714-119-03) / 4 AMPULE in 1 POUCH / 5 mL in 1 AMPULE (16714-119-02) |
| ANDA | ANDA207080 |
| FDA SPL set id | 842222 |
| Labeler | NorthStar RxLLC |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2020-05-21 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 16714-119 |
NDC Item 17478034038
| NDC 9 | 17478-340 |
|---|---|
| NDC 10 | 17478-340-38 |
| NDC Item | 17478034038 |
| Packaging | 14 POUCH in 1 CARTON (17478-340-38) / 4 AMPULE in 1 POUCH / 5 mL in 1 AMPULE |
| ANDA | ANDA201422 |
| FDA SPL set id | 656792 |
| Labeler | Akorn Operating Company LLC (dba Akorn) |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 17478-340 |
NDC Item 42571040809
| NDC 9 | 42571-408 |
|---|---|
| NDC 10 | 42571-408-09 |
| NDC Item | 42571040809 |
| Packaging | 5 mL in 1 AMPULE |
| ANDA | ANDA217344 |
| FDA SPL set id | 812408 |
| Labeler | Micro Labs Limited |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2024-01-01 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 42571-408 |
NDC Item 42571040819
| NDC 9 | 42571-408 |
|---|---|
| NDC 10 | 42571-408-19 |
| NDC Item | 42571040819 |
| Packaging | 4 in 1 POUCH |
| ANDA | ANDA217344 |
| FDA SPL set id | 812408 |
| Labeler | Micro Labs Limited |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2024-01-01 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 42571-408 |
NDC Item 42571040892
| NDC 9 | 42571-408 |
|---|---|
| NDC 10 | 42571-408-92 |
| NDC Item | 42571040892 |
| Packaging | 14 POUCH in 1 CARTON (42571-408-92) / 4 AMPULE in 1 POUCH (42571-408-19) / 5 mL in 1 AMPULE (42571-408-09) |
| ANDA | ANDA217344 |
| FDA SPL set id | 812408 |
| Labeler | Micro Labs Limited |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2024-01-01 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 42571-408 |
NDC Item 43598060504
| NDC 9 | 43598-605 |
|---|---|
| NDC 10 | 43598-605-04 |
| NDC Item | 43598060504 |
| ANDA | ANDA207080 |
| FDA SPL set id | 706735 |
| Labeler | Dr. Reddy's Laboratories Inc. |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2019-05-14 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 43598-605 |
NDC Item 43598060511
| NDC 9 | 43598-605 |
|---|---|
| NDC 10 | 43598-605-11 |
| NDC Item | 43598060511 |
| ANDA | ANDA207080 |
| FDA SPL set id | 706735 |
| Labeler | Dr. Reddy's Laboratories Inc. |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2019-05-14 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 43598-605 |
NDC Item 43598060556
| NDC 9 | 43598-605 |
|---|---|
| NDC 10 | 43598-605-56 |
| NDC Item | 43598060556 |
| Packaging | 14 POUCH in 1 CARTON (43598-605-56) / 4 AMPULE in 1 POUCH (43598-605-04) / 5 mL in 1 AMPULE |
| ANDA | ANDA207080 |
| FDA SPL set id | 706735 |
| Labeler | Dr. Reddy's Laboratories Inc. |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2019-05-14 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 43598-605 |
NDC Item 43598060558
| NDC 9 | 43598-605 |
|---|---|
| NDC 10 | 43598-605-58 |
| NDC Item | 43598060558 |
| Packaging | 56 POUCH in 1 CARTON (43598-605-58) / 1 AMPULE in 1 POUCH (43598-605-11) / 5 mL in 1 AMPULE |
| ANDA | ANDA207080 |
| FDA SPL set id | 706735 |
| Labeler | Dr. Reddy's Laboratories Inc. |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2019-05-14 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 43598-605 |
NDC Item 47335017148
| NDC 9 | 47335-171 |
|---|---|
| NDC 10 | 47335-171-48 |
| NDC Item | 47335017148 |
| Packaging | 4 in 1 POUCH |
| Packaging | 5 mL in 1 AMPULE |
| ANDA | ANDA207136 |
| COLORTEXT | YELLOW(Colourless to light yellow) |
| Color | C48330 __ |
| FDA SPL set id | 707885 |
| Labeler | Sun Pharmaceutical Industries, Inc. |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2020-02-28 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 47335-171 |
NDC Item 47335017149
| NDC 9 | 47335-171 |
|---|---|
| NDC 10 | 47335-171-49 |
| NDC Item | 47335017149 |
| Packaging | 14 POUCH in 1 CARTON (47335-171-49) / 4 AMPULE in 1 POUCH (47335-171-48) / 5 mL in 1 AMPULE |
| ANDA | ANDA207136 |
| COLORTEXT | YELLOW(Colourless to light yellow) |
| Color | C48330 __ |
| FDA SPL set id | 707885 |
| Labeler | Sun Pharmaceutical Industries, Inc. |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2020-02-28 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 47335-171 |
NDC Item 59651012904
| NDC 9 | 59651-129 |
|---|---|
| NDC 10 | 59651-129-04 |
| NDC Item | 59651012904 |
| Packaging | 4 in 1 POUCH |
| Packaging | 5 mL in 1 AMPULE |
| ANDA | ANDA210871 |
| FDA SPL set id | 710977 |
| Labeler | Aurobindo Pharma Limited |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2021-01-22 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 59651-129 |
NDC Item 59651012956
| NDC 9 | 59651-129 |
|---|---|
| NDC 10 | 59651-129-56 |
| NDC Item | 59651012956 |
| Packaging | 14 POUCH in 1 CARTON (59651-129-56) / 4 AMPULE in 1 POUCH (59651-129-04) / 5 mL in 1 AMPULE |
| ANDA | ANDA210871 |
| FDA SPL set id | 710977 |
| Labeler | Aurobindo Pharma Limited |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2021-01-22 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 59651-129 |
NDC Item 60687073179
| NDC 9 | 60687-731 |
|---|---|
| NDC 10 | 60687-731-79 |
| NDC Item | 60687073179 |
| Packaging | 1 in 1 POUCH |
| Packaging | 5 mL in 1 AMPULE |
| ANDA | ANDA207136 |
| COLORTEXT | yellow(Colourless to light yellow) |
| Color | C48330 __ |
| FDA SPL set id | 786945 |
| Labeler | American Health Packaging |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2024-05-19 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 60687-731 |
NDC Item 60687073183
| NDC 9 | 60687-731 |
|---|---|
| NDC 10 | 60687-731-83 |
| NDC Item | 60687073183 |
| Packaging | 30 POUCH in 1 CARTON (60687-731-83) / 1 AMPULE in 1 POUCH (60687-731-79) / 5 mL in 1 AMPULE |
| ANDA | ANDA207136 |
| COLORTEXT | yellow(Colourless to light yellow) |
| Color | C48330 __ |
| FDA SPL set id | 786945 |
| Labeler | American Health Packaging |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2024-05-19 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 60687-731 |
NDC Item 65162091446
| NDC 9 | 65162-914 |
|---|---|
| NDC 10 | 65162-914-46 |
| NDC Item | 65162091446 |
| Packaging | 56 AMPULE in 1 CARTON (65162-914-46) / 5 mL in 1 AMPULE |
| ANDA | ANDA205501 |
| COLORTEXT | yellow(clear, slightly yellow) |
| Color | C48330 __ |
| FDA SPL set id | 824547 |
| Labeler | Amneal Pharmaceuticals LLC |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2014-07-13 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 65162-914 |
NDC Item 67877067869
| NDC 9 | 67877-678 |
|---|---|
| NDC 10 | 67877-678-69 |
| NDC Item | 67877067869 |
| Packaging | 5 mL in 1 AMPULE |
| Packaging | 7 in 1 POUCH |
| ANDA | ANDA212848 |
| FDA SPL set id | 762146 |
| Labeler | Ascend Laboratories, LLC |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2021-04-02 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 67877-678 |
NDC Item 67877067870
| NDC 9 | 67877-678 |
|---|---|
| NDC 10 | 67877-678-70 |
| NDC Item | 67877067870 |
| Packaging | 56 POUCH in 1 CARTON (67877-678-70) / 7 AMPULE in 1 POUCH (67877-678-69) / 5 mL in 1 AMPULE |
| ANDA | ANDA212848 |
| FDA SPL set id | 762146 |
| Labeler | Ascend Laboratories, LLC |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2021-04-02 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 67877-678 |
NDC Item 68180096204
| NDC 9 | 68180-962 |
|---|---|
| NDC 10 | 68180-962-04 |
| NDC Item | 68180096204 |
| Packaging | 4 in 1 POUCH |
| Packaging | 5 mL in 1 AMPULE |
| ANDA | ANDA208964 |
| FDA SPL set id | 779846 |
| Labeler | Lupin Pharmaceuticals, Inc. |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2018-06-12 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 68180-962 |
NDC Item 68180096256
| NDC 9 | 68180-962 |
|---|---|
| NDC 10 | 68180-962-56 |
| NDC Item | 68180096256 |
| Packaging | 56 POUCH in 1 CARTON (68180-962-56) / 4 AMPULE in 1 POUCH / 5 mL in 1 AMPULE |
| ANDA | ANDA208964 |
| FDA SPL set id | 779846 |
| Labeler | Lupin Pharmaceuticals, Inc. |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2018-06-12 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 68180-962 |
NDC Item 70644089999
| NDC 9 | 70644-899 |
|---|---|
| NDC 10 | 70644-899-99 |
| NDC Item | 70644089999 |
| Packaging | 14 POUCH in 1 CARTON (70644-899-99) / 4 AMPULE in 1 POUCH / 5 mL in 1 AMPULE |
| FDA SPL set id | 849478 |
| Labeler | Genericus, Inc. |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | NDA AUTHORIZED GENERIC |
| Marketing effective time low | 2016-07-11 |
| Marketing status | ACTIVE |
| NDA_AUTHORIZED_GENERIC | NDA205433 |
| Related queries | Properties for NDC 9 70644-899 |
NDC Item 70756060444
| NDC 9 | 70756-604 |
|---|---|
| NDC 10 | 70756-604-44 |
| NDC Item | 70756060444 |
| Packaging | 4 in 1 POUCH |
| Packaging | 5 mL in 1 AMPULE |
| ANDA | ANDA214478 |
| FDA SPL set id | 805293 |
| Labeler | Lifestar Pharma LLC |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2023-06-30 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 70756-604 |
NDC Item 70756060456
| NDC 9 | 70756-604 |
|---|---|
| NDC 10 | 70756-604-56 |
| NDC Item | 70756060456 |
| Packaging | 14 POUCH in 1 CARTON (70756-604-56) / 4 AMPULE in 1 POUCH (70756-604-44) / 5 mL in 1 AMPULE |
| ANDA | ANDA214478 |
| FDA SPL set id | 805293 |
| Labeler | Lifestar Pharma LLC |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2023-06-30 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 70756-604 |
NDC Item 72603043004
| NDC 9 | 72603-430 |
|---|---|
| NDC 10 | 72603-430-04 |
| NDC Item | 72603043004 |
| Packaging | 4 in 1 POUCH |
| Packaging | 5 mL in 1 AMPULE |
| ANDA | ANDA214478 |
| FDA SPL set id | 801097 |
| Labeler | NorthStar RxLLC |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2024-08-01 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 72603-430 |
NDC Item 72603043056
| NDC 9 | 72603-430 |
|---|---|
| NDC 10 | 72603-430-56 |
| NDC Item | 72603043056 |
| Packaging | 14 POUCH in 1 CARTON (72603-430-56) / 4 AMPULE in 1 POUCH (72603-430-04) / 5 mL in 1 AMPULE |
| ANDA | ANDA214478 |
| FDA SPL set id | 801097 |
| Labeler | NorthStar RxLLC |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2024-08-01 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 72603-430 |
NDC Item 76204002956
| NDC 9 | 76204-029 |
|---|---|
| NDC 10 | 76204-029-56 |
| NDC Item | 76204002956 |
| Packaging | 14 POUCH in 1 CARTON (76204-029-56) / 4 AMPULE in 1 POUCH / 5 mL in 1 AMPULE |
| ANDA | ANDA201422 |
| FDA SPL set id | 866956 |
| Labeler | Ritedose Pharmaceuticals, LLC |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2025-03-25 |
| Marketing status | active |
| Related queries | Properties for NDC 9 76204-029 |
NDC Item 00093408563
| NDC 9 | 0093-4085 |
|---|---|
| NDC 10 | 0093-4085-63 |
| NDC Item | 00093408563 |
| Packaging | 56 AMPULE in 1 CARTON (0093-4085-63) / 5 mL in 1 AMPULE |
| ANDA | ANDA091589 |
| FDA SPL set id | 861925 |
| Labeler | Teva Pharmaceuticals USA, Inc. |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2013-11-19 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 0093-4085 |
NDC Item 00781717156
| NDC 9 | 0781-7171 |
|---|---|
| NDC 10 | 0781-7171-56 |
| NDC Item | 00781717156 |
| Packaging | 56 AMPULE in 1 CARTON (0781-7171-56) / 5 mL in 1 AMPULE (0781-7171-75) |
| FDA SPL set id | 132419 |
| Labeler | Sandoz Inc |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | NDA AUTHORIZED GENERIC |
| Marketing effective time low | 2014-07-09 |
| Marketing status | COMPLETED |
| NDA_AUTHORIZED_GENERIC | NDA050753 |
| Related queries | Properties for NDC 9 0781-7171 |
NDC Item 00781717175
| NDC 9 | 0781-7171 |
|---|---|
| NDC 10 | 0781-7171-75 |
| NDC Item | 00781717175 |
| Packaging | 5 mL in 1 AMPULE |
| FDA SPL set id | 132419 |
| Labeler | Sandoz Inc |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | NDA AUTHORIZED GENERIC |
| Marketing effective time low | 2014-07-09 |
| Marketing status | COMPLETED |
| NDA_AUTHORIZED_GENERIC | NDA050753 |
| Related queries | Properties for NDC 9 0781-7171 |
NDC Item 16714011902
| NDC 9 | 16714-119 |
|---|---|
| NDC 10 | 16714-119-02 |
| NDC Item | 16714011902 |
| Packaging | 5 mL in 1 AMPULE |
| ANDA | ANDA207080 |
| FDA SPL set id | 842222 |
| Labeler | NorthStar RxLLC |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2020-05-21 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 16714-119 |
NDC Item 16714011903
| NDC 9 | 16714-119 |
|---|---|
| NDC 10 | 16714-119-03 |
| NDC Item | 16714011903 |
| Packaging | 14 POUCH in 1 CARTON (16714-119-03) / 4 AMPULE in 1 POUCH / 5 mL in 1 AMPULE (16714-119-02) |
| ANDA | ANDA207080 |
| FDA SPL set id | 842222 |
| Labeler | NorthStar RxLLC |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2020-05-21 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 16714-119 |
NDC Item 17478034038
| NDC 9 | 17478-340 |
|---|---|
| NDC 10 | 17478-340-38 |
| NDC Item | 17478034038 |
| Packaging | 14 POUCH in 1 CARTON (17478-340-38) / 4 AMPULE in 1 POUCH / 5 mL in 1 AMPULE |
| ANDA | ANDA201422 |
| FDA SPL set id | 656792 |
| Labeler | Akorn Operating Company LLC (dba Akorn) |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 17478-340 |
NDC Item 42571040809
| NDC 9 | 42571-408 |
|---|---|
| NDC 10 | 42571-408-09 |
| NDC Item | 42571040809 |
| Packaging | 5 mL in 1 AMPULE |
| ANDA | ANDA217344 |
| FDA SPL set id | 812408 |
| Labeler | Micro Labs Limited |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2024-01-01 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 42571-408 |
NDC Item 42571040819
| NDC 9 | 42571-408 |
|---|---|
| NDC 10 | 42571-408-19 |
| NDC Item | 42571040819 |
| Packaging | 4 in 1 POUCH |
| ANDA | ANDA217344 |
| FDA SPL set id | 812408 |
| Labeler | Micro Labs Limited |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2024-01-01 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 42571-408 |
NDC Item 42571040892
| NDC 9 | 42571-408 |
|---|---|
| NDC 10 | 42571-408-92 |
| NDC Item | 42571040892 |
| Packaging | 14 POUCH in 1 CARTON (42571-408-92) / 4 AMPULE in 1 POUCH (42571-408-19) / 5 mL in 1 AMPULE (42571-408-09) |
| ANDA | ANDA217344 |
| FDA SPL set id | 812408 |
| Labeler | Micro Labs Limited |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2024-01-01 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 42571-408 |
NDC Item 43598060504
| NDC 9 | 43598-605 |
|---|---|
| NDC 10 | 43598-605-04 |
| NDC Item | 43598060504 |
| ANDA | ANDA207080 |
| FDA SPL set id | 706735 |
| Labeler | Dr. Reddy's Laboratories Inc. |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2019-05-14 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 43598-605 |
NDC Item 43598060511
| NDC 9 | 43598-605 |
|---|---|
| NDC 10 | 43598-605-11 |
| NDC Item | 43598060511 |
| ANDA | ANDA207080 |
| FDA SPL set id | 706735 |
| Labeler | Dr. Reddy's Laboratories Inc. |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2019-05-14 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 43598-605 |
NDC Item 43598060556
| NDC 9 | 43598-605 |
|---|---|
| NDC 10 | 43598-605-56 |
| NDC Item | 43598060556 |
| Packaging | 14 POUCH in 1 CARTON (43598-605-56) / 4 AMPULE in 1 POUCH (43598-605-04) / 5 mL in 1 AMPULE |
| ANDA | ANDA207080 |
| FDA SPL set id | 706735 |
| Labeler | Dr. Reddy's Laboratories Inc. |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2019-05-14 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 43598-605 |
NDC Item 43598060558
| NDC 9 | 43598-605 |
|---|---|
| NDC 10 | 43598-605-58 |
| NDC Item | 43598060558 |
| Packaging | 56 POUCH in 1 CARTON (43598-605-58) / 1 AMPULE in 1 POUCH (43598-605-11) / 5 mL in 1 AMPULE |
| ANDA | ANDA207080 |
| FDA SPL set id | 706735 |
| Labeler | Dr. Reddy's Laboratories Inc. |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2019-05-14 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 43598-605 |
NDC Item 47335017148
| NDC 9 | 47335-171 |
|---|---|
| NDC 10 | 47335-171-48 |
| NDC Item | 47335017148 |
| Packaging | 4 in 1 POUCH |
| Packaging | 5 mL in 1 AMPULE |
| ANDA | ANDA207136 |
| COLORTEXT | YELLOW(Colourless to light yellow) |
| Color | C48330 __ |
| FDA SPL set id | 707885 |
| Labeler | Sun Pharmaceutical Industries, Inc. |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2020-02-28 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 47335-171 |
NDC Item 47335017149
| NDC 9 | 47335-171 |
|---|---|
| NDC 10 | 47335-171-49 |
| NDC Item | 47335017149 |
| Packaging | 14 POUCH in 1 CARTON (47335-171-49) / 4 AMPULE in 1 POUCH (47335-171-48) / 5 mL in 1 AMPULE |
| ANDA | ANDA207136 |
| COLORTEXT | YELLOW(Colourless to light yellow) |
| Color | C48330 __ |
| FDA SPL set id | 707885 |
| Labeler | Sun Pharmaceutical Industries, Inc. |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2020-02-28 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 47335-171 |
NDC Item 59651012904
| NDC 9 | 59651-129 |
|---|---|
| NDC 10 | 59651-129-04 |
| NDC Item | 59651012904 |
| Packaging | 4 in 1 POUCH |
| Packaging | 5 mL in 1 AMPULE |
| ANDA | ANDA210871 |
| FDA SPL set id | 710977 |
| Labeler | Aurobindo Pharma Limited |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2021-01-22 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 59651-129 |
NDC Item 59651012956
| NDC 9 | 59651-129 |
|---|---|
| NDC 10 | 59651-129-56 |
| NDC Item | 59651012956 |
| Packaging | 14 POUCH in 1 CARTON (59651-129-56) / 4 AMPULE in 1 POUCH (59651-129-04) / 5 mL in 1 AMPULE |
| ANDA | ANDA210871 |
| FDA SPL set id | 710977 |
| Labeler | Aurobindo Pharma Limited |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2021-01-22 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 59651-129 |
NDC Item 60687073179
| NDC 9 | 60687-731 |
|---|---|
| NDC 10 | 60687-731-79 |
| NDC Item | 60687073179 |
| Packaging | 1 in 1 POUCH |
| Packaging | 5 mL in 1 AMPULE |
| ANDA | ANDA207136 |
| COLORTEXT | yellow(Colourless to light yellow) |
| Color | C48330 __ |
| FDA SPL set id | 786945 |
| Labeler | American Health Packaging |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2024-05-19 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 60687-731 |
NDC Item 60687073183
| NDC 9 | 60687-731 |
|---|---|
| NDC 10 | 60687-731-83 |
| NDC Item | 60687073183 |
| Packaging | 30 POUCH in 1 CARTON (60687-731-83) / 1 AMPULE in 1 POUCH (60687-731-79) / 5 mL in 1 AMPULE |
| ANDA | ANDA207136 |
| COLORTEXT | yellow(Colourless to light yellow) |
| Color | C48330 __ |
| FDA SPL set id | 786945 |
| Labeler | American Health Packaging |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2024-05-19 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 60687-731 |
NDC Item 65162091446
| NDC 9 | 65162-914 |
|---|---|
| NDC 10 | 65162-914-46 |
| NDC Item | 65162091446 |
| Packaging | 56 AMPULE in 1 CARTON (65162-914-46) / 5 mL in 1 AMPULE |
| ANDA | ANDA205501 |
| COLORTEXT | yellow(clear, slightly yellow) |
| Color | C48330 __ |
| FDA SPL set id | 824547 |
| Labeler | Amneal Pharmaceuticals LLC |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2014-07-13 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 65162-914 |
NDC Item 67877067869
| NDC 9 | 67877-678 |
|---|---|
| NDC 10 | 67877-678-69 |
| NDC Item | 67877067869 |
| Packaging | 5 mL in 1 AMPULE |
| Packaging | 7 in 1 POUCH |
| ANDA | ANDA212848 |
| FDA SPL set id | 762146 |
| Labeler | Ascend Laboratories, LLC |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2021-04-02 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 67877-678 |
NDC Item 67877067870
| NDC 9 | 67877-678 |
|---|---|
| NDC 10 | 67877-678-70 |
| NDC Item | 67877067870 |
| Packaging | 56 POUCH in 1 CARTON (67877-678-70) / 7 AMPULE in 1 POUCH (67877-678-69) / 5 mL in 1 AMPULE |
| ANDA | ANDA212848 |
| FDA SPL set id | 762146 |
| Labeler | Ascend Laboratories, LLC |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2021-04-02 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 67877-678 |
NDC Item 68180096204
| NDC 9 | 68180-962 |
|---|---|
| NDC 10 | 68180-962-04 |
| NDC Item | 68180096204 |
| Packaging | 4 in 1 POUCH |
| Packaging | 5 mL in 1 AMPULE |
| ANDA | ANDA208964 |
| FDA SPL set id | 779846 |
| Labeler | Lupin Pharmaceuticals, Inc. |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2018-06-12 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 68180-962 |
NDC Item 68180096256
| NDC 9 | 68180-962 |
|---|---|
| NDC 10 | 68180-962-56 |
| NDC Item | 68180096256 |
| Packaging | 56 POUCH in 1 CARTON (68180-962-56) / 4 AMPULE in 1 POUCH / 5 mL in 1 AMPULE |
| ANDA | ANDA208964 |
| FDA SPL set id | 779846 |
| Labeler | Lupin Pharmaceuticals, Inc. |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2018-06-12 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 68180-962 |
NDC Item 70644089999
| NDC 9 | 70644-899 |
|---|---|
| NDC 10 | 70644-899-99 |
| NDC Item | 70644089999 |
| Packaging | 14 POUCH in 1 CARTON (70644-899-99) / 4 AMPULE in 1 POUCH / 5 mL in 1 AMPULE |
| FDA SPL set id | 849478 |
| Labeler | Genericus, Inc. |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | NDA AUTHORIZED GENERIC |
| Marketing effective time low | 2016-07-11 |
| Marketing status | ACTIVE |
| NDA_AUTHORIZED_GENERIC | NDA205433 |
| Related queries | Properties for NDC 9 70644-899 |
NDC Item 70756060444
| NDC 9 | 70756-604 |
|---|---|
| NDC 10 | 70756-604-44 |
| NDC Item | 70756060444 |
| Packaging | 4 in 1 POUCH |
| Packaging | 5 mL in 1 AMPULE |
| ANDA | ANDA214478 |
| FDA SPL set id | 805293 |
| Labeler | Lifestar Pharma LLC |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2023-06-30 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 70756-604 |
NDC Item 70756060456
| NDC 9 | 70756-604 |
|---|---|
| NDC 10 | 70756-604-56 |
| NDC Item | 70756060456 |
| Packaging | 14 POUCH in 1 CARTON (70756-604-56) / 4 AMPULE in 1 POUCH (70756-604-44) / 5 mL in 1 AMPULE |
| ANDA | ANDA214478 |
| FDA SPL set id | 805293 |
| Labeler | Lifestar Pharma LLC |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2023-06-30 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 70756-604 |
NDC Item 72603043004
| NDC 9 | 72603-430 |
|---|---|
| NDC 10 | 72603-430-04 |
| NDC Item | 72603043004 |
| Packaging | 4 in 1 POUCH |
| Packaging | 5 mL in 1 AMPULE |
| ANDA | ANDA214478 |
| FDA SPL set id | 801097 |
| Labeler | NorthStar RxLLC |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2024-08-01 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 72603-430 |
NDC Item 72603043056
| NDC 9 | 72603-430 |
|---|---|
| NDC 10 | 72603-430-56 |
| NDC Item | 72603043056 |
| Packaging | 14 POUCH in 1 CARTON (72603-430-56) / 4 AMPULE in 1 POUCH (72603-430-04) / 5 mL in 1 AMPULE |
| ANDA | ANDA214478 |
| FDA SPL set id | 801097 |
| Labeler | NorthStar RxLLC |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2024-08-01 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 72603-430 |
NDC Item 76204002956
| NDC 9 | 76204-029 |
|---|---|
| NDC 10 | 76204-029-56 |
| NDC Item | 76204002956 |
| Packaging | 14 POUCH in 1 CARTON (76204-029-56) / 4 AMPULE in 1 POUCH / 5 mL in 1 AMPULE |
| ANDA | ANDA201422 |
| FDA SPL set id | 866956 |
| Labeler | Ritedose Pharmaceuticals, LLC |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2025-03-25 |
| Marketing status | active |
| Related queries | Properties for NDC 9 76204-029 |
NDC Item 00093408563
| NDC 9 | 0093-4085 |
|---|---|
| NDC 10 | 0093-4085-63 |
| NDC Item | 00093408563 |
| Packaging | 56 AMPULE in 1 CARTON (0093-4085-63) / 5 mL in 1 AMPULE |
| ANDA | ANDA091589 |
| FDA SPL set id | 861925 |
| Labeler | Teva Pharmaceuticals USA, Inc. |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2013-11-19 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 0093-4085 |
NDC Item 00781717156
| NDC 9 | 0781-7171 |
|---|---|
| NDC 10 | 0781-7171-56 |
| NDC Item | 00781717156 |
| Packaging | 56 AMPULE in 1 CARTON (0781-7171-56) / 5 mL in 1 AMPULE (0781-7171-75) |
| FDA SPL set id | 132419 |
| Labeler | Sandoz Inc |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | NDA AUTHORIZED GENERIC |
| Marketing effective time low | 2014-07-09 |
| Marketing status | COMPLETED |
| NDA_AUTHORIZED_GENERIC | NDA050753 |
| Related queries | Properties for NDC 9 0781-7171 |
NDC Item 00781717175
| NDC 9 | 0781-7171 |
|---|---|
| NDC 10 | 0781-7171-75 |
| NDC Item | 00781717175 |
| Packaging | 5 mL in 1 AMPULE |
| FDA SPL set id | 132419 |
| Labeler | Sandoz Inc |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | NDA AUTHORIZED GENERIC |
| Marketing effective time low | 2014-07-09 |
| Marketing status | COMPLETED |
| NDA_AUTHORIZED_GENERIC | NDA050753 |
| Related queries | Properties for NDC 9 0781-7171 |
NDC Item 16714011902
| NDC 9 | 16714-119 |
|---|---|
| NDC 10 | 16714-119-02 |
| NDC Item | 16714011902 |
| Packaging | 5 mL in 1 AMPULE |
| ANDA | ANDA207080 |
| FDA SPL set id | 842222 |
| Labeler | NorthStar RxLLC |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2020-05-21 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 16714-119 |
NDC Item 16714011903
| NDC 9 | 16714-119 |
|---|---|
| NDC 10 | 16714-119-03 |
| NDC Item | 16714011903 |
| Packaging | 14 POUCH in 1 CARTON (16714-119-03) / 4 AMPULE in 1 POUCH / 5 mL in 1 AMPULE (16714-119-02) |
| ANDA | ANDA207080 |
| FDA SPL set id | 842222 |
| Labeler | NorthStar RxLLC |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2020-05-21 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 16714-119 |
NDC Item 17478034038
| NDC 9 | 17478-340 |
|---|---|
| NDC 10 | 17478-340-38 |
| NDC Item | 17478034038 |
| Packaging | 14 POUCH in 1 CARTON (17478-340-38) / 4 AMPULE in 1 POUCH / 5 mL in 1 AMPULE |
| ANDA | ANDA201422 |
| FDA SPL set id | 656792 |
| Labeler | Akorn Operating Company LLC (dba Akorn) |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 17478-340 |
NDC Item 42571040809
| NDC 9 | 42571-408 |
|---|---|
| NDC 10 | 42571-408-09 |
| NDC Item | 42571040809 |
| Packaging | 5 mL in 1 AMPULE |
| ANDA | ANDA217344 |
| FDA SPL set id | 812408 |
| Labeler | Micro Labs Limited |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2024-01-01 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 42571-408 |
NDC Item 42571040819
| NDC 9 | 42571-408 |
|---|---|
| NDC 10 | 42571-408-19 |
| NDC Item | 42571040819 |
| Packaging | 4 in 1 POUCH |
| ANDA | ANDA217344 |
| FDA SPL set id | 812408 |
| Labeler | Micro Labs Limited |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2024-01-01 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 42571-408 |
NDC Item 42571040892
| NDC 9 | 42571-408 |
|---|---|
| NDC 10 | 42571-408-92 |
| NDC Item | 42571040892 |
| Packaging | 14 POUCH in 1 CARTON (42571-408-92) / 4 AMPULE in 1 POUCH (42571-408-19) / 5 mL in 1 AMPULE (42571-408-09) |
| ANDA | ANDA217344 |
| FDA SPL set id | 812408 |
| Labeler | Micro Labs Limited |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2024-01-01 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 42571-408 |
NDC Item 43598060504
| NDC 9 | 43598-605 |
|---|---|
| NDC 10 | 43598-605-04 |
| NDC Item | 43598060504 |
| ANDA | ANDA207080 |
| FDA SPL set id | 706735 |
| Labeler | Dr. Reddy's Laboratories Inc. |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2019-05-14 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 43598-605 |
NDC Item 43598060511
| NDC 9 | 43598-605 |
|---|---|
| NDC 10 | 43598-605-11 |
| NDC Item | 43598060511 |
| ANDA | ANDA207080 |
| FDA SPL set id | 706735 |
| Labeler | Dr. Reddy's Laboratories Inc. |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2019-05-14 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 43598-605 |
NDC Item 43598060556
| NDC 9 | 43598-605 |
|---|---|
| NDC 10 | 43598-605-56 |
| NDC Item | 43598060556 |
| Packaging | 14 POUCH in 1 CARTON (43598-605-56) / 4 AMPULE in 1 POUCH (43598-605-04) / 5 mL in 1 AMPULE |
| ANDA | ANDA207080 |
| FDA SPL set id | 706735 |
| Labeler | Dr. Reddy's Laboratories Inc. |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2019-05-14 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 43598-605 |
NDC Item 43598060558
| NDC 9 | 43598-605 |
|---|---|
| NDC 10 | 43598-605-58 |
| NDC Item | 43598060558 |
| Packaging | 56 POUCH in 1 CARTON (43598-605-58) / 1 AMPULE in 1 POUCH (43598-605-11) / 5 mL in 1 AMPULE |
| ANDA | ANDA207080 |
| FDA SPL set id | 706735 |
| Labeler | Dr. Reddy's Laboratories Inc. |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2019-05-14 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 43598-605 |
NDC Item 47335017148
| NDC 9 | 47335-171 |
|---|---|
| NDC 10 | 47335-171-48 |
| NDC Item | 47335017148 |
| Packaging | 4 in 1 POUCH |
| Packaging | 5 mL in 1 AMPULE |
| ANDA | ANDA207136 |
| COLORTEXT | YELLOW(Colourless to light yellow) |
| Color | C48330 __ |
| FDA SPL set id | 707885 |
| Labeler | Sun Pharmaceutical Industries, Inc. |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2020-02-28 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 47335-171 |
NDC Item 47335017149
| NDC 9 | 47335-171 |
|---|---|
| NDC 10 | 47335-171-49 |
| NDC Item | 47335017149 |
| Packaging | 14 POUCH in 1 CARTON (47335-171-49) / 4 AMPULE in 1 POUCH (47335-171-48) / 5 mL in 1 AMPULE |
| ANDA | ANDA207136 |
| COLORTEXT | YELLOW(Colourless to light yellow) |
| Color | C48330 __ |
| FDA SPL set id | 707885 |
| Labeler | Sun Pharmaceutical Industries, Inc. |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2020-02-28 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 47335-171 |
NDC Item 59651012904
| NDC 9 | 59651-129 |
|---|---|
| NDC 10 | 59651-129-04 |
| NDC Item | 59651012904 |
| Packaging | 4 in 1 POUCH |
| Packaging | 5 mL in 1 AMPULE |
| ANDA | ANDA210871 |
| FDA SPL set id | 710977 |
| Labeler | Aurobindo Pharma Limited |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2021-01-22 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 59651-129 |
NDC Item 59651012956
| NDC 9 | 59651-129 |
|---|---|
| NDC 10 | 59651-129-56 |
| NDC Item | 59651012956 |
| Packaging | 14 POUCH in 1 CARTON (59651-129-56) / 4 AMPULE in 1 POUCH (59651-129-04) / 5 mL in 1 AMPULE |
| ANDA | ANDA210871 |
| FDA SPL set id | 710977 |
| Labeler | Aurobindo Pharma Limited |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2021-01-22 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 59651-129 |
NDC Item 60687073179
| NDC 9 | 60687-731 |
|---|---|
| NDC 10 | 60687-731-79 |
| NDC Item | 60687073179 |
| Packaging | 1 in 1 POUCH |
| Packaging | 5 mL in 1 AMPULE |
| ANDA | ANDA207136 |
| COLORTEXT | yellow(Colourless to light yellow) |
| Color | C48330 __ |
| FDA SPL set id | 786945 |
| Labeler | American Health Packaging |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2024-05-19 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 60687-731 |
NDC Item 60687073183
| NDC 9 | 60687-731 |
|---|---|
| NDC 10 | 60687-731-83 |
| NDC Item | 60687073183 |
| Packaging | 30 POUCH in 1 CARTON (60687-731-83) / 1 AMPULE in 1 POUCH (60687-731-79) / 5 mL in 1 AMPULE |
| ANDA | ANDA207136 |
| COLORTEXT | yellow(Colourless to light yellow) |
| Color | C48330 __ |
| FDA SPL set id | 786945 |
| Labeler | American Health Packaging |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2024-05-19 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 60687-731 |
NDC Item 65162091446
| NDC 9 | 65162-914 |
|---|---|
| NDC 10 | 65162-914-46 |
| NDC Item | 65162091446 |
| Packaging | 56 AMPULE in 1 CARTON (65162-914-46) / 5 mL in 1 AMPULE |
| ANDA | ANDA205501 |
| COLORTEXT | yellow(clear, slightly yellow) |
| Color | C48330 __ |
| FDA SPL set id | 824547 |
| Labeler | Amneal Pharmaceuticals LLC |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2014-07-13 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 65162-914 |
NDC Item 67877067869
| NDC 9 | 67877-678 |
|---|---|
| NDC 10 | 67877-678-69 |
| NDC Item | 67877067869 |
| Packaging | 5 mL in 1 AMPULE |
| Packaging | 7 in 1 POUCH |
| ANDA | ANDA212848 |
| FDA SPL set id | 762146 |
| Labeler | Ascend Laboratories, LLC |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2021-04-02 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 67877-678 |
NDC Item 67877067870
| NDC 9 | 67877-678 |
|---|---|
| NDC 10 | 67877-678-70 |
| NDC Item | 67877067870 |
| Packaging | 56 POUCH in 1 CARTON (67877-678-70) / 7 AMPULE in 1 POUCH (67877-678-69) / 5 mL in 1 AMPULE |
| ANDA | ANDA212848 |
| FDA SPL set id | 762146 |
| Labeler | Ascend Laboratories, LLC |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2021-04-02 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 67877-678 |
NDC Item 68180096204
| NDC 9 | 68180-962 |
|---|---|
| NDC 10 | 68180-962-04 |
| NDC Item | 68180096204 |
| Packaging | 4 in 1 POUCH |
| Packaging | 5 mL in 1 AMPULE |
| ANDA | ANDA208964 |
| FDA SPL set id | 779846 |
| Labeler | Lupin Pharmaceuticals, Inc. |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2018-06-12 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 68180-962 |
NDC Item 68180096256
| NDC 9 | 68180-962 |
|---|---|
| NDC 10 | 68180-962-56 |
| NDC Item | 68180096256 |
| Packaging | 56 POUCH in 1 CARTON (68180-962-56) / 4 AMPULE in 1 POUCH / 5 mL in 1 AMPULE |
| ANDA | ANDA208964 |
| FDA SPL set id | 779846 |
| Labeler | Lupin Pharmaceuticals, Inc. |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2018-06-12 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 68180-962 |
NDC Item 70644089999
| NDC 9 | 70644-899 |
|---|---|
| NDC 10 | 70644-899-99 |
| NDC Item | 70644089999 |
| Packaging | 14 POUCH in 1 CARTON (70644-899-99) / 4 AMPULE in 1 POUCH / 5 mL in 1 AMPULE |
| FDA SPL set id | 849478 |
| Labeler | Genericus, Inc. |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | NDA AUTHORIZED GENERIC |
| Marketing effective time low | 2016-07-11 |
| Marketing status | ACTIVE |
| NDA_AUTHORIZED_GENERIC | NDA205433 |
| Related queries | Properties for NDC 9 70644-899 |
NDC Item 70756060444
| NDC 9 | 70756-604 |
|---|---|
| NDC 10 | 70756-604-44 |
| NDC Item | 70756060444 |
| Packaging | 4 in 1 POUCH |
| Packaging | 5 mL in 1 AMPULE |
| ANDA | ANDA214478 |
| FDA SPL set id | 805293 |
| Labeler | Lifestar Pharma LLC |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2023-06-30 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 70756-604 |
NDC Item 70756060456
| NDC 9 | 70756-604 |
|---|---|
| NDC 10 | 70756-604-56 |
| NDC Item | 70756060456 |
| Packaging | 14 POUCH in 1 CARTON (70756-604-56) / 4 AMPULE in 1 POUCH (70756-604-44) / 5 mL in 1 AMPULE |
| ANDA | ANDA214478 |
| FDA SPL set id | 805293 |
| Labeler | Lifestar Pharma LLC |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2023-06-30 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 70756-604 |
NDC Item 72603043004
| NDC 9 | 72603-430 |
|---|---|
| NDC 10 | 72603-430-04 |
| NDC Item | 72603043004 |
| Packaging | 4 in 1 POUCH |
| Packaging | 5 mL in 1 AMPULE |
| ANDA | ANDA214478 |
| FDA SPL set id | 801097 |
| Labeler | NorthStar RxLLC |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2024-08-01 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 72603-430 |
NDC Item 72603043056
| NDC 9 | 72603-430 |
|---|---|
| NDC 10 | 72603-430-56 |
| NDC Item | 72603043056 |
| Packaging | 14 POUCH in 1 CARTON (72603-430-56) / 4 AMPULE in 1 POUCH (72603-430-04) / 5 mL in 1 AMPULE |
| ANDA | ANDA214478 |
| FDA SPL set id | 801097 |
| Labeler | NorthStar RxLLC |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2024-08-01 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 72603-430 |
NDC Item 76204002956
| NDC 9 | 76204-029 |
|---|---|
| NDC 10 | 76204-029-56 |
| NDC Item | 76204002956 |
| Packaging | 14 POUCH in 1 CARTON (76204-029-56) / 4 AMPULE in 1 POUCH / 5 mL in 1 AMPULE |
| ANDA | ANDA201422 |
| FDA SPL set id | 866956 |
| Labeler | Ritedose Pharmaceuticals, LLC |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2025-03-25 |
| Marketing status | active |
| Related queries | Properties for NDC 9 76204-029 |
NDC Item 00093408563
| NDC 9 | 0093-4085 |
|---|---|
| NDC 10 | 0093-4085-63 |
| NDC Item | 00093408563 |
| Packaging | 56 AMPULE in 1 CARTON (0093-4085-63) / 5 mL in 1 AMPULE |
| ANDA | ANDA091589 |
| FDA SPL set id | 861925 |
| Labeler | Teva Pharmaceuticals USA, Inc. |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2013-11-19 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 0093-4085 |
NDC Item 00781717156
| NDC 9 | 0781-7171 |
|---|---|
| NDC 10 | 0781-7171-56 |
| NDC Item | 00781717156 |
| Packaging | 56 AMPULE in 1 CARTON (0781-7171-56) / 5 mL in 1 AMPULE (0781-7171-75) |
| FDA SPL set id | 132419 |
| Labeler | Sandoz Inc |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | NDA AUTHORIZED GENERIC |
| Marketing effective time low | 2014-07-09 |
| Marketing status | COMPLETED |
| NDA_AUTHORIZED_GENERIC | NDA050753 |
| Related queries | Properties for NDC 9 0781-7171 |
NDC Item 00781717175
| NDC 9 | 0781-7171 |
|---|---|
| NDC 10 | 0781-7171-75 |
| NDC Item | 00781717175 |
| Packaging | 5 mL in 1 AMPULE |
| FDA SPL set id | 132419 |
| Labeler | Sandoz Inc |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | NDA AUTHORIZED GENERIC |
| Marketing effective time low | 2014-07-09 |
| Marketing status | COMPLETED |
| NDA_AUTHORIZED_GENERIC | NDA050753 |
| Related queries | Properties for NDC 9 0781-7171 |
NDC Item 16714011902
| NDC 9 | 16714-119 |
|---|---|
| NDC 10 | 16714-119-02 |
| NDC Item | 16714011902 |
| Packaging | 5 mL in 1 AMPULE |
| ANDA | ANDA207080 |
| FDA SPL set id | 842222 |
| Labeler | NorthStar RxLLC |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2020-05-21 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 16714-119 |
NDC Item 16714011903
| NDC 9 | 16714-119 |
|---|---|
| NDC 10 | 16714-119-03 |
| NDC Item | 16714011903 |
| Packaging | 14 POUCH in 1 CARTON (16714-119-03) / 4 AMPULE in 1 POUCH / 5 mL in 1 AMPULE (16714-119-02) |
| ANDA | ANDA207080 |
| FDA SPL set id | 842222 |
| Labeler | NorthStar RxLLC |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2020-05-21 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 16714-119 |
NDC Item 17478034038
| NDC 9 | 17478-340 |
|---|---|
| NDC 10 | 17478-340-38 |
| NDC Item | 17478034038 |
| Packaging | 14 POUCH in 1 CARTON (17478-340-38) / 4 AMPULE in 1 POUCH / 5 mL in 1 AMPULE |
| ANDA | ANDA201422 |
| FDA SPL set id | 656792 |
| Labeler | Akorn Operating Company LLC (dba Akorn) |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 17478-340 |
NDC Item 42571040809
| NDC 9 | 42571-408 |
|---|---|
| NDC 10 | 42571-408-09 |
| NDC Item | 42571040809 |
| Packaging | 5 mL in 1 AMPULE |
| ANDA | ANDA217344 |
| FDA SPL set id | 812408 |
| Labeler | Micro Labs Limited |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2024-01-01 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 42571-408 |
NDC Item 42571040819
| NDC 9 | 42571-408 |
|---|---|
| NDC 10 | 42571-408-19 |
| NDC Item | 42571040819 |
| Packaging | 4 in 1 POUCH |
| ANDA | ANDA217344 |
| FDA SPL set id | 812408 |
| Labeler | Micro Labs Limited |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2024-01-01 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 42571-408 |
NDC Item 42571040892
| NDC 9 | 42571-408 |
|---|---|
| NDC 10 | 42571-408-92 |
| NDC Item | 42571040892 |
| Packaging | 14 POUCH in 1 CARTON (42571-408-92) / 4 AMPULE in 1 POUCH (42571-408-19) / 5 mL in 1 AMPULE (42571-408-09) |
| ANDA | ANDA217344 |
| FDA SPL set id | 812408 |
| Labeler | Micro Labs Limited |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2024-01-01 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 42571-408 |
NDC Item 43598060504
| NDC 9 | 43598-605 |
|---|---|
| NDC 10 | 43598-605-04 |
| NDC Item | 43598060504 |
| ANDA | ANDA207080 |
| FDA SPL set id | 706735 |
| Labeler | Dr. Reddy's Laboratories Inc. |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2019-05-14 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 43598-605 |
NDC Item 43598060511
| NDC 9 | 43598-605 |
|---|---|
| NDC 10 | 43598-605-11 |
| NDC Item | 43598060511 |
| ANDA | ANDA207080 |
| FDA SPL set id | 706735 |
| Labeler | Dr. Reddy's Laboratories Inc. |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2019-05-14 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 43598-605 |
NDC Item 43598060556
| NDC 9 | 43598-605 |
|---|---|
| NDC 10 | 43598-605-56 |
| NDC Item | 43598060556 |
| Packaging | 14 POUCH in 1 CARTON (43598-605-56) / 4 AMPULE in 1 POUCH (43598-605-04) / 5 mL in 1 AMPULE |
| ANDA | ANDA207080 |
| FDA SPL set id | 706735 |
| Labeler | Dr. Reddy's Laboratories Inc. |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2019-05-14 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 43598-605 |
NDC Item 43598060558
| NDC 9 | 43598-605 |
|---|---|
| NDC 10 | 43598-605-58 |
| NDC Item | 43598060558 |
| Packaging | 56 POUCH in 1 CARTON (43598-605-58) / 1 AMPULE in 1 POUCH (43598-605-11) / 5 mL in 1 AMPULE |
| ANDA | ANDA207080 |
| FDA SPL set id | 706735 |
| Labeler | Dr. Reddy's Laboratories Inc. |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2019-05-14 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 43598-605 |
NDC Item 47335017148
| NDC 9 | 47335-171 |
|---|---|
| NDC 10 | 47335-171-48 |
| NDC Item | 47335017148 |
| Packaging | 4 in 1 POUCH |
| Packaging | 5 mL in 1 AMPULE |
| ANDA | ANDA207136 |
| COLORTEXT | YELLOW(Colourless to light yellow) |
| Color | C48330 __ |
| FDA SPL set id | 707885 |
| Labeler | Sun Pharmaceutical Industries, Inc. |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2020-02-28 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 47335-171 |
NDC Item 47335017149
| NDC 9 | 47335-171 |
|---|---|
| NDC 10 | 47335-171-49 |
| NDC Item | 47335017149 |
| Packaging | 14 POUCH in 1 CARTON (47335-171-49) / 4 AMPULE in 1 POUCH (47335-171-48) / 5 mL in 1 AMPULE |
| ANDA | ANDA207136 |
| COLORTEXT | YELLOW(Colourless to light yellow) |
| Color | C48330 __ |
| FDA SPL set id | 707885 |
| Labeler | Sun Pharmaceutical Industries, Inc. |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2020-02-28 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 47335-171 |
NDC Item 59651012904
| NDC 9 | 59651-129 |
|---|---|
| NDC 10 | 59651-129-04 |
| NDC Item | 59651012904 |
| Packaging | 4 in 1 POUCH |
| Packaging | 5 mL in 1 AMPULE |
| ANDA | ANDA210871 |
| FDA SPL set id | 710977 |
| Labeler | Aurobindo Pharma Limited |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2021-01-22 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 59651-129 |
NDC Item 59651012956
| NDC 9 | 59651-129 |
|---|---|
| NDC 10 | 59651-129-56 |
| NDC Item | 59651012956 |
| Packaging | 14 POUCH in 1 CARTON (59651-129-56) / 4 AMPULE in 1 POUCH (59651-129-04) / 5 mL in 1 AMPULE |
| ANDA | ANDA210871 |
| FDA SPL set id | 710977 |
| Labeler | Aurobindo Pharma Limited |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2021-01-22 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 59651-129 |
NDC Item 60687073179
| NDC 9 | 60687-731 |
|---|---|
| NDC 10 | 60687-731-79 |
| NDC Item | 60687073179 |
| Packaging | 1 in 1 POUCH |
| Packaging | 5 mL in 1 AMPULE |
| ANDA | ANDA207136 |
| COLORTEXT | yellow(Colourless to light yellow) |
| Color | C48330 __ |
| FDA SPL set id | 786945 |
| Labeler | American Health Packaging |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2024-05-19 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 60687-731 |
NDC Item 60687073183
| NDC 9 | 60687-731 |
|---|---|
| NDC 10 | 60687-731-83 |
| NDC Item | 60687073183 |
| Packaging | 30 POUCH in 1 CARTON (60687-731-83) / 1 AMPULE in 1 POUCH (60687-731-79) / 5 mL in 1 AMPULE |
| ANDA | ANDA207136 |
| COLORTEXT | yellow(Colourless to light yellow) |
| Color | C48330 __ |
| FDA SPL set id | 786945 |
| Labeler | American Health Packaging |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2024-05-19 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 60687-731 |
NDC Item 65162091446
| NDC 9 | 65162-914 |
|---|---|
| NDC 10 | 65162-914-46 |
| NDC Item | 65162091446 |
| Packaging | 56 AMPULE in 1 CARTON (65162-914-46) / 5 mL in 1 AMPULE |
| ANDA | ANDA205501 |
| COLORTEXT | yellow(clear, slightly yellow) |
| Color | C48330 __ |
| FDA SPL set id | 824547 |
| Labeler | Amneal Pharmaceuticals LLC |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2014-07-13 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 65162-914 |
NDC Item 67877067869
| NDC 9 | 67877-678 |
|---|---|
| NDC 10 | 67877-678-69 |
| NDC Item | 67877067869 |
| Packaging | 5 mL in 1 AMPULE |
| Packaging | 7 in 1 POUCH |
| ANDA | ANDA212848 |
| FDA SPL set id | 762146 |
| Labeler | Ascend Laboratories, LLC |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2021-04-02 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 67877-678 |
NDC Item 67877067870
| NDC 9 | 67877-678 |
|---|---|
| NDC 10 | 67877-678-70 |
| NDC Item | 67877067870 |
| Packaging | 56 POUCH in 1 CARTON (67877-678-70) / 7 AMPULE in 1 POUCH (67877-678-69) / 5 mL in 1 AMPULE |
| ANDA | ANDA212848 |
| FDA SPL set id | 762146 |
| Labeler | Ascend Laboratories, LLC |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2021-04-02 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 67877-678 |
NDC Item 68180096204
| NDC 9 | 68180-962 |
|---|---|
| NDC 10 | 68180-962-04 |
| NDC Item | 68180096204 |
| Packaging | 4 in 1 POUCH |
| Packaging | 5 mL in 1 AMPULE |
| ANDA | ANDA208964 |
| FDA SPL set id | 779846 |
| Labeler | Lupin Pharmaceuticals, Inc. |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2018-06-12 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 68180-962 |
NDC Item 68180096256
| NDC 9 | 68180-962 |
|---|---|
| NDC 10 | 68180-962-56 |
| NDC Item | 68180096256 |
| Packaging | 56 POUCH in 1 CARTON (68180-962-56) / 4 AMPULE in 1 POUCH / 5 mL in 1 AMPULE |
| ANDA | ANDA208964 |
| FDA SPL set id | 779846 |
| Labeler | Lupin Pharmaceuticals, Inc. |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2018-06-12 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 68180-962 |
NDC Item 70644089999
| NDC 9 | 70644-899 |
|---|---|
| NDC 10 | 70644-899-99 |
| NDC Item | 70644089999 |
| Packaging | 14 POUCH in 1 CARTON (70644-899-99) / 4 AMPULE in 1 POUCH / 5 mL in 1 AMPULE |
| FDA SPL set id | 849478 |
| Labeler | Genericus, Inc. |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | NDA AUTHORIZED GENERIC |
| Marketing effective time low | 2016-07-11 |
| Marketing status | ACTIVE |
| NDA_AUTHORIZED_GENERIC | NDA205433 |
| Related queries | Properties for NDC 9 70644-899 |
NDC Item 70756060444
| NDC 9 | 70756-604 |
|---|---|
| NDC 10 | 70756-604-44 |
| NDC Item | 70756060444 |
| Packaging | 4 in 1 POUCH |
| Packaging | 5 mL in 1 AMPULE |
| ANDA | ANDA214478 |
| FDA SPL set id | 805293 |
| Labeler | Lifestar Pharma LLC |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2023-06-30 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 70756-604 |
NDC Item 70756060456
| NDC 9 | 70756-604 |
|---|---|
| NDC 10 | 70756-604-56 |
| NDC Item | 70756060456 |
| Packaging | 14 POUCH in 1 CARTON (70756-604-56) / 4 AMPULE in 1 POUCH (70756-604-44) / 5 mL in 1 AMPULE |
| ANDA | ANDA214478 |
| FDA SPL set id | 805293 |
| Labeler | Lifestar Pharma LLC |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2023-06-30 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 70756-604 |
NDC Item 72603043004
| NDC 9 | 72603-430 |
|---|---|
| NDC 10 | 72603-430-04 |
| NDC Item | 72603043004 |
| Packaging | 4 in 1 POUCH |
| Packaging | 5 mL in 1 AMPULE |
| ANDA | ANDA214478 |
| FDA SPL set id | 801097 |
| Labeler | NorthStar RxLLC |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2024-08-01 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 72603-430 |
NDC Item 72603043056
| NDC 9 | 72603-430 |
|---|---|
| NDC 10 | 72603-430-56 |
| NDC Item | 72603043056 |
| Packaging | 14 POUCH in 1 CARTON (72603-430-56) / 4 AMPULE in 1 POUCH (72603-430-04) / 5 mL in 1 AMPULE |
| ANDA | ANDA214478 |
| FDA SPL set id | 801097 |
| Labeler | NorthStar RxLLC |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2024-08-01 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 72603-430 |
NDC Item 76204002956
| NDC 9 | 76204-029 |
|---|---|
| NDC 10 | 76204-029-56 |
| NDC Item | 76204002956 |
| Packaging | 14 POUCH in 1 CARTON (76204-029-56) / 4 AMPULE in 1 POUCH / 5 mL in 1 AMPULE |
| ANDA | ANDA201422 |
| FDA SPL set id | 866956 |
| Labeler | Ritedose Pharmaceuticals, LLC |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2025-03-25 |
| Marketing status | active |
| Related queries | Properties for NDC 9 76204-029 |