NDC properties for "dorzolamide 2 % / timolol 0.5 % PF Ophthalmic Solution" (RxCUI 1922783)
About this data
The tables show NDC propoerties for dorzolamide 2 % / timolol 0.5 % PF Ophthalmic Solution with the RxCUI 1922783
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 dorzolamide 2 % / timolol 0.5 % PF Ophthalmic Solution (RxCUI 1922783)
| ANDA | ANDA207630 |
|---|---|
| ANDA | ANDA215936 |
| ANDA | ANDA217260 |
| MMSL_CODE | BD28812 |
| MMSL_CODE | CD28812 |
| NDA | NDA202667 |
| RxCUI | 1922783 |
| SPL_SET_ID | 36c0e765-dfda-4b3b-8a98-a5f8b32607f7 |
| SPL_SET_ID | 4e90c721-21e8-46ea-ab49-19f535bf7202 |
| SPL_SET_ID | 6bb5919c-dd14-10e8-e053-2991aa0a6695 |
| SPL_SET_ID | b0a1d984-efee-4751-9797-c09adc2d307d |
| SPL_SET_ID | cfdc5577-fe7a-4b51-b2f5-95806e1dee2d |
| SPL_SET_ID | f41a9cd5-48c8-42eb-bb1b-d0355d981201 |
| VUID | 4031388 |
| Prescribable Synonym | dorzolamide 2 % / timolol 0.5 % PF Ophthalmic Solution |
| RXNAV_STR | Preservative-Free dorzolamide 20 MG/ML / timolol 5 MG/ML Ophthalmic Solution |
| RxNorm Name | Preservative-Free dorzolamide 20 MG/ML / timolol 5 MG/ML Ophthalmic Solution |
| RxNorm Synonym | dorzolamide 2 % / timolol 0.5 % PF Ophthalmic Solution |
| Related queries | Interactions (for RxCUI 1922783) |
NDC Properties
NDC Item 42571038227
| NDC 9 | 42571-382 |
|---|---|
| NDC 10 | 42571-382-27 |
| NDC Item | 42571038227 |
| Packaging | 12 POUCH in 1 CARTON (42571-382-27) / 15 VIAL, SINGLE-USE in 1 POUCH / .2 mL in 1 VIAL, SINGLE-USE |
| ANDA | ANDA215936 |
| Labeler | Micro Labs Limited |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2022-02-15 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 42571-382 |
NDC Item 42571038271
| NDC 9 | 42571-382 |
|---|---|
| NDC 10 | 42571-382-71 |
| NDC Item | 42571038271 |
| Packaging | 0.2 mL in 1 VIAL, SINGLE-USE |
| Packaging | 15 in 1 POUCH |
| ANDA | ANDA215936 |
| Labeler | Micro Labs Limited |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2022-02-15 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 42571-382 |
NDC Item 42571038273
| NDC 9 | 42571-382 |
|---|---|
| NDC 10 | 42571-382-73 |
| NDC Item | 42571038273 |
| Packaging | 4 POUCH in 1 CARTON (42571-382-73) / 15 VIAL, SINGLE-USE in 1 POUCH (42571-382-71) / .2 mL in 1 VIAL, SINGLE-USE |
| ANDA | ANDA215936 |
| Labeler | Micro Labs Limited |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2022-02-15 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 42571-382 |
NDC Item 50383026161
| NDC 9 | 50383-261 |
|---|---|
| NDC 10 | 50383-261-61 |
| NDC Item | 50383026161 |
| Packaging | 4 POUCH in 1 CARTON (50383-261-61) / 15 VIAL, SINGLE-USE in 1 POUCH / .2 mL in 1 VIAL, SINGLE-USE |
| Labeler | Akorn |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | NDA |
| Marketing effective time low | 2019-02-01 |
| Marketing status | ACTIVE |
| NDA | NDA202667 |
| Related queries | Properties for NDC 9 50383-261 |
NDC Item 50383026191
| NDC 9 | 50383-261 |
|---|---|
| NDC 10 | 50383-261-91 |
| NDC Item | 50383026191 |
| Packaging | 12 POUCH in 1 CARTON (50383-261-91) / 15 VIAL, SINGLE-USE in 1 POUCH / .2 mL in 1 VIAL, SINGLE-USE |
| Labeler | Akorn Operating Company LLC (dba Akorn) |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | NDA |
| Marketing effective time low | 2019-02-01 |
| Marketing status | ACTIVE |
| NDA | NDA202667 |
| Related queries | Properties for NDC 9 50383-261 |
NDC Item 50742032305
| NDC 9 | 50742-323 |
|---|---|
| NDC 10 | 50742-323-05 |
| NDC Item | 50742032305 |
| Packaging | 0.2 mL in 1 VIAL |
| Packaging | 5 in 1 POUCH |
| ANDA | ANDA217260 |
| Labeler | Ingenus Pharmaceuticals, LLC |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2023-05-02 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 50742-323 |
NDC Item 50742032360
| NDC 9 | 50742-323 |
|---|---|
| NDC 10 | 50742-323-60 |
| NDC Item | 50742032360 |
| Packaging | 12 POUCH in 1 CARTON (50742-323-60) / 5 VIAL in 1 POUCH (50742-323-05) / .2 mL in 1 VIAL |
| ANDA | ANDA217260 |
| Labeler | Ingenus Pharmaceuticals, LLC |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2023-05-02 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 50742-323 |
NDC Item 65862094715
| NDC 9 | 65862-947 |
|---|---|
| NDC 10 | 65862-947-15 |
| NDC Item | 65862094715 |
| Packaging | 0.2 mL in 1 VIAL, SINGLE-USE |
| Packaging | 15 in 1 POUCH |
| ANDA | ANDA207630 |
| Labeler | Aurobindo Pharma Limited |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2018-07-24 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 65862-947 |
NDC Item 65862094718
| NDC 9 | 65862-947 |
|---|---|
| NDC 10 | 65862-947-18 |
| NDC Item | 65862094718 |
| Packaging | 12 POUCH in 1 CARTON (65862-947-18) / 15 VIAL, SINGLE-USE in 1 POUCH / .2 mL in 1 VIAL, SINGLE-USE |
| ANDA | ANDA207630 |
| Labeler | Aurobindo Pharma Limited |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2018-07-24 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 65862-947 |
NDC Item 65862094760
| NDC 9 | 65862-947 |
|---|---|
| NDC 10 | 65862-947-60 |
| NDC Item | 65862094760 |
| Packaging | 4 POUCH in 1 CARTON (65862-947-60) / 15 VIAL, SINGLE-USE in 1 POUCH (65862-947-15) / .2 mL in 1 VIAL, SINGLE-USE |
| ANDA | ANDA207630 |
| Labeler | Aurobindo Pharma Limited |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2018-07-24 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 65862-947 |
NDC Item 72162238706
| NDC 9 | 72162-2387 |
|---|---|
| NDC 10 | 72162-2387-6 |
| NDC Item | 72162238706 |
| Packaging | 4 POUCH in 1 CARTON (72162-2387-6) / 15 VIAL, SINGLE-USE in 1 POUCH (72162-2387-7) / .2 mL in 1 VIAL, SINGLE-USE |
| ANDA | ANDA215936 |
| Labeler | Bryant Ranch Prepack |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2022-02-15 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 72162-2387 |
NDC Item 72162238707
| NDC 9 | 72162-2387 |
|---|---|
| NDC 10 | 72162-2387-7 |
| NDC Item | 72162238707 |
| Packaging | 0.2 mL in 1 VIAL, SINGLE-USE |
| Packaging | 15 in 1 POUCH |
| ANDA | ANDA215936 |
| Labeler | Bryant Ranch Prepack |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2022-02-15 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 72162-2387 |
NDC Item 42571038227
| NDC 9 | 42571-382 |
|---|---|
| NDC 10 | 42571-382-27 |
| NDC Item | 42571038227 |
| Packaging | 12 POUCH in 1 CARTON (42571-382-27) / 15 VIAL, SINGLE-USE in 1 POUCH / .2 mL in 1 VIAL, SINGLE-USE |
| ANDA | ANDA215936 |
| Labeler | Micro Labs Limited |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2022-02-15 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 42571-382 |
NDC Item 42571038271
| NDC 9 | 42571-382 |
|---|---|
| NDC 10 | 42571-382-71 |
| NDC Item | 42571038271 |
| Packaging | 0.2 mL in 1 VIAL, SINGLE-USE |
| Packaging | 15 in 1 POUCH |
| ANDA | ANDA215936 |
| Labeler | Micro Labs Limited |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2022-02-15 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 42571-382 |
NDC Item 42571038273
| NDC 9 | 42571-382 |
|---|---|
| NDC 10 | 42571-382-73 |
| NDC Item | 42571038273 |
| Packaging | 4 POUCH in 1 CARTON (42571-382-73) / 15 VIAL, SINGLE-USE in 1 POUCH (42571-382-71) / .2 mL in 1 VIAL, SINGLE-USE |
| ANDA | ANDA215936 |
| Labeler | Micro Labs Limited |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2022-02-15 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 42571-382 |
NDC Item 50383026161
| NDC 9 | 50383-261 |
|---|---|
| NDC 10 | 50383-261-61 |
| NDC Item | 50383026161 |
| Packaging | 4 POUCH in 1 CARTON (50383-261-61) / 15 VIAL, SINGLE-USE in 1 POUCH / .2 mL in 1 VIAL, SINGLE-USE |
| Labeler | Akorn |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | NDA |
| Marketing effective time low | 2019-02-01 |
| Marketing status | ACTIVE |
| NDA | NDA202667 |
| Related queries | Properties for NDC 9 50383-261 |
NDC Item 50383026191
| NDC 9 | 50383-261 |
|---|---|
| NDC 10 | 50383-261-91 |
| NDC Item | 50383026191 |
| Packaging | 12 POUCH in 1 CARTON (50383-261-91) / 15 VIAL, SINGLE-USE in 1 POUCH / .2 mL in 1 VIAL, SINGLE-USE |
| Labeler | Akorn Operating Company LLC (dba Akorn) |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | NDA |
| Marketing effective time low | 2019-02-01 |
| Marketing status | ACTIVE |
| NDA | NDA202667 |
| Related queries | Properties for NDC 9 50383-261 |
NDC Item 50742032305
| NDC 9 | 50742-323 |
|---|---|
| NDC 10 | 50742-323-05 |
| NDC Item | 50742032305 |
| Packaging | 0.2 mL in 1 VIAL |
| Packaging | 5 in 1 POUCH |
| ANDA | ANDA217260 |
| Labeler | Ingenus Pharmaceuticals, LLC |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2023-05-02 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 50742-323 |
NDC Item 50742032360
| NDC 9 | 50742-323 |
|---|---|
| NDC 10 | 50742-323-60 |
| NDC Item | 50742032360 |
| Packaging | 12 POUCH in 1 CARTON (50742-323-60) / 5 VIAL in 1 POUCH (50742-323-05) / .2 mL in 1 VIAL |
| ANDA | ANDA217260 |
| Labeler | Ingenus Pharmaceuticals, LLC |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2023-05-02 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 50742-323 |
NDC Item 65862094715
| NDC 9 | 65862-947 |
|---|---|
| NDC 10 | 65862-947-15 |
| NDC Item | 65862094715 |
| Packaging | 0.2 mL in 1 VIAL, SINGLE-USE |
| Packaging | 15 in 1 POUCH |
| ANDA | ANDA207630 |
| Labeler | Aurobindo Pharma Limited |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2018-07-24 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 65862-947 |
NDC Item 65862094718
| NDC 9 | 65862-947 |
|---|---|
| NDC 10 | 65862-947-18 |
| NDC Item | 65862094718 |
| Packaging | 12 POUCH in 1 CARTON (65862-947-18) / 15 VIAL, SINGLE-USE in 1 POUCH / .2 mL in 1 VIAL, SINGLE-USE |
| ANDA | ANDA207630 |
| Labeler | Aurobindo Pharma Limited |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2018-07-24 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 65862-947 |
NDC Item 65862094760
| NDC 9 | 65862-947 |
|---|---|
| NDC 10 | 65862-947-60 |
| NDC Item | 65862094760 |
| Packaging | 4 POUCH in 1 CARTON (65862-947-60) / 15 VIAL, SINGLE-USE in 1 POUCH (65862-947-15) / .2 mL in 1 VIAL, SINGLE-USE |
| ANDA | ANDA207630 |
| Labeler | Aurobindo Pharma Limited |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2018-07-24 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 65862-947 |
NDC Item 72162238706
| NDC 9 | 72162-2387 |
|---|---|
| NDC 10 | 72162-2387-6 |
| NDC Item | 72162238706 |
| Packaging | 4 POUCH in 1 CARTON (72162-2387-6) / 15 VIAL, SINGLE-USE in 1 POUCH (72162-2387-7) / .2 mL in 1 VIAL, SINGLE-USE |
| ANDA | ANDA215936 |
| Labeler | Bryant Ranch Prepack |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2022-02-15 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 72162-2387 |
NDC Item 72162238707
| NDC 9 | 72162-2387 |
|---|---|
| NDC 10 | 72162-2387-7 |
| NDC Item | 72162238707 |
| Packaging | 0.2 mL in 1 VIAL, SINGLE-USE |
| Packaging | 15 in 1 POUCH |
| ANDA | ANDA215936 |
| Labeler | Bryant Ranch Prepack |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2022-02-15 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 72162-2387 |
NDC Item 42571038227
| NDC 9 | 42571-382 |
|---|---|
| NDC 10 | 42571-382-27 |
| NDC Item | 42571038227 |
| Packaging | 12 POUCH in 1 CARTON (42571-382-27) / 15 VIAL, SINGLE-USE in 1 POUCH / .2 mL in 1 VIAL, SINGLE-USE |
| ANDA | ANDA215936 |
| Labeler | Micro Labs Limited |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2022-02-15 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 42571-382 |
NDC Item 42571038271
| NDC 9 | 42571-382 |
|---|---|
| NDC 10 | 42571-382-71 |
| NDC Item | 42571038271 |
| Packaging | 0.2 mL in 1 VIAL, SINGLE-USE |
| Packaging | 15 in 1 POUCH |
| ANDA | ANDA215936 |
| Labeler | Micro Labs Limited |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2022-02-15 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 42571-382 |
NDC Item 42571038273
| NDC 9 | 42571-382 |
|---|---|
| NDC 10 | 42571-382-73 |
| NDC Item | 42571038273 |
| Packaging | 4 POUCH in 1 CARTON (42571-382-73) / 15 VIAL, SINGLE-USE in 1 POUCH (42571-382-71) / .2 mL in 1 VIAL, SINGLE-USE |
| ANDA | ANDA215936 |
| Labeler | Micro Labs Limited |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2022-02-15 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 42571-382 |
NDC Item 50383026161
| NDC 9 | 50383-261 |
|---|---|
| NDC 10 | 50383-261-61 |
| NDC Item | 50383026161 |
| Packaging | 4 POUCH in 1 CARTON (50383-261-61) / 15 VIAL, SINGLE-USE in 1 POUCH / .2 mL in 1 VIAL, SINGLE-USE |
| Labeler | Akorn |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | NDA |
| Marketing effective time low | 2019-02-01 |
| Marketing status | ACTIVE |
| NDA | NDA202667 |
| Related queries | Properties for NDC 9 50383-261 |
NDC Item 50383026191
| NDC 9 | 50383-261 |
|---|---|
| NDC 10 | 50383-261-91 |
| NDC Item | 50383026191 |
| Packaging | 12 POUCH in 1 CARTON (50383-261-91) / 15 VIAL, SINGLE-USE in 1 POUCH / .2 mL in 1 VIAL, SINGLE-USE |
| Labeler | Akorn Operating Company LLC (dba Akorn) |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | NDA |
| Marketing effective time low | 2019-02-01 |
| Marketing status | ACTIVE |
| NDA | NDA202667 |
| Related queries | Properties for NDC 9 50383-261 |
NDC Item 50742032305
| NDC 9 | 50742-323 |
|---|---|
| NDC 10 | 50742-323-05 |
| NDC Item | 50742032305 |
| Packaging | 0.2 mL in 1 VIAL |
| Packaging | 5 in 1 POUCH |
| ANDA | ANDA217260 |
| Labeler | Ingenus Pharmaceuticals, LLC |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2023-05-02 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 50742-323 |
NDC Item 50742032360
| NDC 9 | 50742-323 |
|---|---|
| NDC 10 | 50742-323-60 |
| NDC Item | 50742032360 |
| Packaging | 12 POUCH in 1 CARTON (50742-323-60) / 5 VIAL in 1 POUCH (50742-323-05) / .2 mL in 1 VIAL |
| ANDA | ANDA217260 |
| Labeler | Ingenus Pharmaceuticals, LLC |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2023-05-02 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 50742-323 |
NDC Item 65862094715
| NDC 9 | 65862-947 |
|---|---|
| NDC 10 | 65862-947-15 |
| NDC Item | 65862094715 |
| Packaging | 0.2 mL in 1 VIAL, SINGLE-USE |
| Packaging | 15 in 1 POUCH |
| ANDA | ANDA207630 |
| Labeler | Aurobindo Pharma Limited |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2018-07-24 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 65862-947 |
NDC Item 65862094718
| NDC 9 | 65862-947 |
|---|---|
| NDC 10 | 65862-947-18 |
| NDC Item | 65862094718 |
| Packaging | 12 POUCH in 1 CARTON (65862-947-18) / 15 VIAL, SINGLE-USE in 1 POUCH / .2 mL in 1 VIAL, SINGLE-USE |
| ANDA | ANDA207630 |
| Labeler | Aurobindo Pharma Limited |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2018-07-24 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 65862-947 |
NDC Item 65862094760
| NDC 9 | 65862-947 |
|---|---|
| NDC 10 | 65862-947-60 |
| NDC Item | 65862094760 |
| Packaging | 4 POUCH in 1 CARTON (65862-947-60) / 15 VIAL, SINGLE-USE in 1 POUCH (65862-947-15) / .2 mL in 1 VIAL, SINGLE-USE |
| ANDA | ANDA207630 |
| Labeler | Aurobindo Pharma Limited |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2018-07-24 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 65862-947 |
NDC Item 72162238706
| NDC 9 | 72162-2387 |
|---|---|
| NDC 10 | 72162-2387-6 |
| NDC Item | 72162238706 |
| Packaging | 4 POUCH in 1 CARTON (72162-2387-6) / 15 VIAL, SINGLE-USE in 1 POUCH (72162-2387-7) / .2 mL in 1 VIAL, SINGLE-USE |
| ANDA | ANDA215936 |
| Labeler | Bryant Ranch Prepack |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2022-02-15 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 72162-2387 |
NDC Item 72162238707
| NDC 9 | 72162-2387 |
|---|---|
| NDC 10 | 72162-2387-7 |
| NDC Item | 72162238707 |
| Packaging | 0.2 mL in 1 VIAL, SINGLE-USE |
| Packaging | 15 in 1 POUCH |
| ANDA | ANDA215936 |
| Labeler | Bryant Ranch Prepack |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2022-02-15 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 72162-2387 |
NDC Item 42571038227
| NDC 9 | 42571-382 |
|---|---|
| NDC 10 | 42571-382-27 |
| NDC Item | 42571038227 |
| Packaging | 12 POUCH in 1 CARTON (42571-382-27) / 15 VIAL, SINGLE-USE in 1 POUCH / .2 mL in 1 VIAL, SINGLE-USE |
| ANDA | ANDA215936 |
| Labeler | Micro Labs Limited |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2022-02-15 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 42571-382 |
NDC Item 42571038271
| NDC 9 | 42571-382 |
|---|---|
| NDC 10 | 42571-382-71 |
| NDC Item | 42571038271 |
| Packaging | 0.2 mL in 1 VIAL, SINGLE-USE |
| Packaging | 15 in 1 POUCH |
| ANDA | ANDA215936 |
| Labeler | Micro Labs Limited |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2022-02-15 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 42571-382 |
NDC Item 42571038273
| NDC 9 | 42571-382 |
|---|---|
| NDC 10 | 42571-382-73 |
| NDC Item | 42571038273 |
| Packaging | 4 POUCH in 1 CARTON (42571-382-73) / 15 VIAL, SINGLE-USE in 1 POUCH (42571-382-71) / .2 mL in 1 VIAL, SINGLE-USE |
| ANDA | ANDA215936 |
| Labeler | Micro Labs Limited |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2022-02-15 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 42571-382 |
NDC Item 50383026161
| NDC 9 | 50383-261 |
|---|---|
| NDC 10 | 50383-261-61 |
| NDC Item | 50383026161 |
| Packaging | 4 POUCH in 1 CARTON (50383-261-61) / 15 VIAL, SINGLE-USE in 1 POUCH / .2 mL in 1 VIAL, SINGLE-USE |
| Labeler | Akorn |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | NDA |
| Marketing effective time low | 2019-02-01 |
| Marketing status | ACTIVE |
| NDA | NDA202667 |
| Related queries | Properties for NDC 9 50383-261 |
NDC Item 50383026191
| NDC 9 | 50383-261 |
|---|---|
| NDC 10 | 50383-261-91 |
| NDC Item | 50383026191 |
| Packaging | 12 POUCH in 1 CARTON (50383-261-91) / 15 VIAL, SINGLE-USE in 1 POUCH / .2 mL in 1 VIAL, SINGLE-USE |
| Labeler | Akorn Operating Company LLC (dba Akorn) |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | NDA |
| Marketing effective time low | 2019-02-01 |
| Marketing status | ACTIVE |
| NDA | NDA202667 |
| Related queries | Properties for NDC 9 50383-261 |
NDC Item 50742032305
| NDC 9 | 50742-323 |
|---|---|
| NDC 10 | 50742-323-05 |
| NDC Item | 50742032305 |
| Packaging | 0.2 mL in 1 VIAL |
| Packaging | 5 in 1 POUCH |
| ANDA | ANDA217260 |
| Labeler | Ingenus Pharmaceuticals, LLC |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2023-05-02 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 50742-323 |
NDC Item 50742032360
| NDC 9 | 50742-323 |
|---|---|
| NDC 10 | 50742-323-60 |
| NDC Item | 50742032360 |
| Packaging | 12 POUCH in 1 CARTON (50742-323-60) / 5 VIAL in 1 POUCH (50742-323-05) / .2 mL in 1 VIAL |
| ANDA | ANDA217260 |
| Labeler | Ingenus Pharmaceuticals, LLC |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2023-05-02 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 50742-323 |
NDC Item 65862094715
| NDC 9 | 65862-947 |
|---|---|
| NDC 10 | 65862-947-15 |
| NDC Item | 65862094715 |
| Packaging | 0.2 mL in 1 VIAL, SINGLE-USE |
| Packaging | 15 in 1 POUCH |
| ANDA | ANDA207630 |
| Labeler | Aurobindo Pharma Limited |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2018-07-24 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 65862-947 |
NDC Item 65862094718
| NDC 9 | 65862-947 |
|---|---|
| NDC 10 | 65862-947-18 |
| NDC Item | 65862094718 |
| Packaging | 12 POUCH in 1 CARTON (65862-947-18) / 15 VIAL, SINGLE-USE in 1 POUCH / .2 mL in 1 VIAL, SINGLE-USE |
| ANDA | ANDA207630 |
| Labeler | Aurobindo Pharma Limited |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2018-07-24 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 65862-947 |
NDC Item 65862094760
| NDC 9 | 65862-947 |
|---|---|
| NDC 10 | 65862-947-60 |
| NDC Item | 65862094760 |
| Packaging | 4 POUCH in 1 CARTON (65862-947-60) / 15 VIAL, SINGLE-USE in 1 POUCH (65862-947-15) / .2 mL in 1 VIAL, SINGLE-USE |
| ANDA | ANDA207630 |
| Labeler | Aurobindo Pharma Limited |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2018-07-24 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 65862-947 |
NDC Item 72162238706
| NDC 9 | 72162-2387 |
|---|---|
| NDC 10 | 72162-2387-6 |
| NDC Item | 72162238706 |
| Packaging | 4 POUCH in 1 CARTON (72162-2387-6) / 15 VIAL, SINGLE-USE in 1 POUCH (72162-2387-7) / .2 mL in 1 VIAL, SINGLE-USE |
| ANDA | ANDA215936 |
| Labeler | Bryant Ranch Prepack |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2022-02-15 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 72162-2387 |
NDC Item 72162238707
| NDC 9 | 72162-2387 |
|---|---|
| NDC 10 | 72162-2387-7 |
| NDC Item | 72162238707 |
| Packaging | 0.2 mL in 1 VIAL, SINGLE-USE |
| Packaging | 15 in 1 POUCH |
| ANDA | ANDA215936 |
| Labeler | Bryant Ranch Prepack |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2022-02-15 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 72162-2387 |
NDC Item 42571038227
| NDC 9 | 42571-382 |
|---|---|
| NDC 10 | 42571-382-27 |
| NDC Item | 42571038227 |
| Packaging | 12 POUCH in 1 CARTON (42571-382-27) / 15 VIAL, SINGLE-USE in 1 POUCH / .2 mL in 1 VIAL, SINGLE-USE |
| ANDA | ANDA215936 |
| Labeler | Micro Labs Limited |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2022-02-15 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 42571-382 |
NDC Item 42571038271
| NDC 9 | 42571-382 |
|---|---|
| NDC 10 | 42571-382-71 |
| NDC Item | 42571038271 |
| Packaging | 0.2 mL in 1 VIAL, SINGLE-USE |
| Packaging | 15 in 1 POUCH |
| ANDA | ANDA215936 |
| Labeler | Micro Labs Limited |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2022-02-15 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 42571-382 |
NDC Item 42571038273
| NDC 9 | 42571-382 |
|---|---|
| NDC 10 | 42571-382-73 |
| NDC Item | 42571038273 |
| Packaging | 4 POUCH in 1 CARTON (42571-382-73) / 15 VIAL, SINGLE-USE in 1 POUCH (42571-382-71) / .2 mL in 1 VIAL, SINGLE-USE |
| ANDA | ANDA215936 |
| Labeler | Micro Labs Limited |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2022-02-15 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 42571-382 |
NDC Item 50383026161
| NDC 9 | 50383-261 |
|---|---|
| NDC 10 | 50383-261-61 |
| NDC Item | 50383026161 |
| Packaging | 4 POUCH in 1 CARTON (50383-261-61) / 15 VIAL, SINGLE-USE in 1 POUCH / .2 mL in 1 VIAL, SINGLE-USE |
| Labeler | Akorn |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | NDA |
| Marketing effective time low | 2019-02-01 |
| Marketing status | ACTIVE |
| NDA | NDA202667 |
| Related queries | Properties for NDC 9 50383-261 |
NDC Item 50383026191
| NDC 9 | 50383-261 |
|---|---|
| NDC 10 | 50383-261-91 |
| NDC Item | 50383026191 |
| Packaging | 12 POUCH in 1 CARTON (50383-261-91) / 15 VIAL, SINGLE-USE in 1 POUCH / .2 mL in 1 VIAL, SINGLE-USE |
| Labeler | Akorn Operating Company LLC (dba Akorn) |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | NDA |
| Marketing effective time low | 2019-02-01 |
| Marketing status | ACTIVE |
| NDA | NDA202667 |
| Related queries | Properties for NDC 9 50383-261 |
NDC Item 50742032305
| NDC 9 | 50742-323 |
|---|---|
| NDC 10 | 50742-323-05 |
| NDC Item | 50742032305 |
| Packaging | 0.2 mL in 1 VIAL |
| Packaging | 5 in 1 POUCH |
| ANDA | ANDA217260 |
| Labeler | Ingenus Pharmaceuticals, LLC |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2023-05-02 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 50742-323 |
NDC Item 50742032360
| NDC 9 | 50742-323 |
|---|---|
| NDC 10 | 50742-323-60 |
| NDC Item | 50742032360 |
| Packaging | 12 POUCH in 1 CARTON (50742-323-60) / 5 VIAL in 1 POUCH (50742-323-05) / .2 mL in 1 VIAL |
| ANDA | ANDA217260 |
| Labeler | Ingenus Pharmaceuticals, LLC |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2023-05-02 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 50742-323 |
NDC Item 65862094715
| NDC 9 | 65862-947 |
|---|---|
| NDC 10 | 65862-947-15 |
| NDC Item | 65862094715 |
| Packaging | 0.2 mL in 1 VIAL, SINGLE-USE |
| Packaging | 15 in 1 POUCH |
| ANDA | ANDA207630 |
| Labeler | Aurobindo Pharma Limited |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2018-07-24 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 65862-947 |
NDC Item 65862094718
| NDC 9 | 65862-947 |
|---|---|
| NDC 10 | 65862-947-18 |
| NDC Item | 65862094718 |
| Packaging | 12 POUCH in 1 CARTON (65862-947-18) / 15 VIAL, SINGLE-USE in 1 POUCH / .2 mL in 1 VIAL, SINGLE-USE |
| ANDA | ANDA207630 |
| Labeler | Aurobindo Pharma Limited |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2018-07-24 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 65862-947 |
NDC Item 65862094760
| NDC 9 | 65862-947 |
|---|---|
| NDC 10 | 65862-947-60 |
| NDC Item | 65862094760 |
| Packaging | 4 POUCH in 1 CARTON (65862-947-60) / 15 VIAL, SINGLE-USE in 1 POUCH (65862-947-15) / .2 mL in 1 VIAL, SINGLE-USE |
| ANDA | ANDA207630 |
| Labeler | Aurobindo Pharma Limited |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2018-07-24 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 65862-947 |
NDC Item 72162238706
| NDC 9 | 72162-2387 |
|---|---|
| NDC 10 | 72162-2387-6 |
| NDC Item | 72162238706 |
| Packaging | 4 POUCH in 1 CARTON (72162-2387-6) / 15 VIAL, SINGLE-USE in 1 POUCH (72162-2387-7) / .2 mL in 1 VIAL, SINGLE-USE |
| ANDA | ANDA215936 |
| Labeler | Bryant Ranch Prepack |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2022-02-15 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 72162-2387 |
NDC Item 72162238707
| NDC 9 | 72162-2387 |
|---|---|
| NDC 10 | 72162-2387-7 |
| NDC Item | 72162238707 |
| Packaging | 0.2 mL in 1 VIAL, SINGLE-USE |
| Packaging | 15 in 1 POUCH |
| ANDA | ANDA215936 |
| Labeler | Bryant Ranch Prepack |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2022-02-15 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 72162-2387 |
NDC Item 42571038227
| NDC 9 | 42571-382 |
|---|---|
| NDC 10 | 42571-382-27 |
| NDC Item | 42571038227 |
| Packaging | 12 POUCH in 1 CARTON (42571-382-27) / 15 VIAL, SINGLE-USE in 1 POUCH / .2 mL in 1 VIAL, SINGLE-USE |
| ANDA | ANDA215936 |
| Labeler | Micro Labs Limited |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2022-02-15 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 42571-382 |
NDC Item 42571038271
| NDC 9 | 42571-382 |
|---|---|
| NDC 10 | 42571-382-71 |
| NDC Item | 42571038271 |
| Packaging | 0.2 mL in 1 VIAL, SINGLE-USE |
| Packaging | 15 in 1 POUCH |
| ANDA | ANDA215936 |
| Labeler | Micro Labs Limited |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2022-02-15 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 42571-382 |
NDC Item 42571038273
| NDC 9 | 42571-382 |
|---|---|
| NDC 10 | 42571-382-73 |
| NDC Item | 42571038273 |
| Packaging | 4 POUCH in 1 CARTON (42571-382-73) / 15 VIAL, SINGLE-USE in 1 POUCH (42571-382-71) / .2 mL in 1 VIAL, SINGLE-USE |
| ANDA | ANDA215936 |
| Labeler | Micro Labs Limited |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2022-02-15 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 42571-382 |
NDC Item 50383026161
| NDC 9 | 50383-261 |
|---|---|
| NDC 10 | 50383-261-61 |
| NDC Item | 50383026161 |
| Packaging | 4 POUCH in 1 CARTON (50383-261-61) / 15 VIAL, SINGLE-USE in 1 POUCH / .2 mL in 1 VIAL, SINGLE-USE |
| Labeler | Akorn |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | NDA |
| Marketing effective time low | 2019-02-01 |
| Marketing status | ACTIVE |
| NDA | NDA202667 |
| Related queries | Properties for NDC 9 50383-261 |
NDC Item 50383026191
| NDC 9 | 50383-261 |
|---|---|
| NDC 10 | 50383-261-91 |
| NDC Item | 50383026191 |
| Packaging | 12 POUCH in 1 CARTON (50383-261-91) / 15 VIAL, SINGLE-USE in 1 POUCH / .2 mL in 1 VIAL, SINGLE-USE |
| Labeler | Akorn Operating Company LLC (dba Akorn) |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | NDA |
| Marketing effective time low | 2019-02-01 |
| Marketing status | ACTIVE |
| NDA | NDA202667 |
| Related queries | Properties for NDC 9 50383-261 |
NDC Item 50742032305
| NDC 9 | 50742-323 |
|---|---|
| NDC 10 | 50742-323-05 |
| NDC Item | 50742032305 |
| Packaging | 0.2 mL in 1 VIAL |
| Packaging | 5 in 1 POUCH |
| ANDA | ANDA217260 |
| Labeler | Ingenus Pharmaceuticals, LLC |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2023-05-02 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 50742-323 |
NDC Item 50742032360
| NDC 9 | 50742-323 |
|---|---|
| NDC 10 | 50742-323-60 |
| NDC Item | 50742032360 |
| Packaging | 12 POUCH in 1 CARTON (50742-323-60) / 5 VIAL in 1 POUCH (50742-323-05) / .2 mL in 1 VIAL |
| ANDA | ANDA217260 |
| Labeler | Ingenus Pharmaceuticals, LLC |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2023-05-02 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 50742-323 |
NDC Item 65862094715
| NDC 9 | 65862-947 |
|---|---|
| NDC 10 | 65862-947-15 |
| NDC Item | 65862094715 |
| Packaging | 0.2 mL in 1 VIAL, SINGLE-USE |
| Packaging | 15 in 1 POUCH |
| ANDA | ANDA207630 |
| Labeler | Aurobindo Pharma Limited |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2018-07-24 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 65862-947 |
NDC Item 65862094718
| NDC 9 | 65862-947 |
|---|---|
| NDC 10 | 65862-947-18 |
| NDC Item | 65862094718 |
| Packaging | 12 POUCH in 1 CARTON (65862-947-18) / 15 VIAL, SINGLE-USE in 1 POUCH / .2 mL in 1 VIAL, SINGLE-USE |
| ANDA | ANDA207630 |
| Labeler | Aurobindo Pharma Limited |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2018-07-24 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 65862-947 |
NDC Item 65862094760
| NDC 9 | 65862-947 |
|---|---|
| NDC 10 | 65862-947-60 |
| NDC Item | 65862094760 |
| Packaging | 4 POUCH in 1 CARTON (65862-947-60) / 15 VIAL, SINGLE-USE in 1 POUCH (65862-947-15) / .2 mL in 1 VIAL, SINGLE-USE |
| ANDA | ANDA207630 |
| Labeler | Aurobindo Pharma Limited |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2018-07-24 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 65862-947 |
NDC Item 72162238706
| NDC 9 | 72162-2387 |
|---|---|
| NDC 10 | 72162-2387-6 |
| NDC Item | 72162238706 |
| Packaging | 4 POUCH in 1 CARTON (72162-2387-6) / 15 VIAL, SINGLE-USE in 1 POUCH (72162-2387-7) / .2 mL in 1 VIAL, SINGLE-USE |
| ANDA | ANDA215936 |
| Labeler | Bryant Ranch Prepack |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2022-02-15 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 72162-2387 |
NDC Item 72162238707
| NDC 9 | 72162-2387 |
|---|---|
| NDC 10 | 72162-2387-7 |
| NDC Item | 72162238707 |
| Packaging | 0.2 mL in 1 VIAL, SINGLE-USE |
| Packaging | 15 in 1 POUCH |
| ANDA | ANDA215936 |
| Labeler | Bryant Ranch Prepack |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2022-02-15 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 72162-2387 |
NDC Item 42571038227
| NDC 9 | 42571-382 |
|---|---|
| NDC 10 | 42571-382-27 |
| NDC Item | 42571038227 |
| Packaging | 12 POUCH in 1 CARTON (42571-382-27) / 15 VIAL, SINGLE-USE in 1 POUCH / .2 mL in 1 VIAL, SINGLE-USE |
| ANDA | ANDA215936 |
| Labeler | Micro Labs Limited |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2022-02-15 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 42571-382 |
NDC Item 42571038271
| NDC 9 | 42571-382 |
|---|---|
| NDC 10 | 42571-382-71 |
| NDC Item | 42571038271 |
| Packaging | 0.2 mL in 1 VIAL, SINGLE-USE |
| Packaging | 15 in 1 POUCH |
| ANDA | ANDA215936 |
| Labeler | Micro Labs Limited |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2022-02-15 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 42571-382 |
NDC Item 42571038273
| NDC 9 | 42571-382 |
|---|---|
| NDC 10 | 42571-382-73 |
| NDC Item | 42571038273 |
| Packaging | 4 POUCH in 1 CARTON (42571-382-73) / 15 VIAL, SINGLE-USE in 1 POUCH (42571-382-71) / .2 mL in 1 VIAL, SINGLE-USE |
| ANDA | ANDA215936 |
| Labeler | Micro Labs Limited |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2022-02-15 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 42571-382 |
NDC Item 50383026161
| NDC 9 | 50383-261 |
|---|---|
| NDC 10 | 50383-261-61 |
| NDC Item | 50383026161 |
| Packaging | 4 POUCH in 1 CARTON (50383-261-61) / 15 VIAL, SINGLE-USE in 1 POUCH / .2 mL in 1 VIAL, SINGLE-USE |
| Labeler | Akorn |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | NDA |
| Marketing effective time low | 2019-02-01 |
| Marketing status | ACTIVE |
| NDA | NDA202667 |
| Related queries | Properties for NDC 9 50383-261 |
NDC Item 50383026191
| NDC 9 | 50383-261 |
|---|---|
| NDC 10 | 50383-261-91 |
| NDC Item | 50383026191 |
| Packaging | 12 POUCH in 1 CARTON (50383-261-91) / 15 VIAL, SINGLE-USE in 1 POUCH / .2 mL in 1 VIAL, SINGLE-USE |
| Labeler | Akorn Operating Company LLC (dba Akorn) |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | NDA |
| Marketing effective time low | 2019-02-01 |
| Marketing status | ACTIVE |
| NDA | NDA202667 |
| Related queries | Properties for NDC 9 50383-261 |
NDC Item 50742032305
| NDC 9 | 50742-323 |
|---|---|
| NDC 10 | 50742-323-05 |
| NDC Item | 50742032305 |
| Packaging | 0.2 mL in 1 VIAL |
| Packaging | 5 in 1 POUCH |
| ANDA | ANDA217260 |
| Labeler | Ingenus Pharmaceuticals, LLC |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2023-05-02 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 50742-323 |
NDC Item 50742032360
| NDC 9 | 50742-323 |
|---|---|
| NDC 10 | 50742-323-60 |
| NDC Item | 50742032360 |
| Packaging | 12 POUCH in 1 CARTON (50742-323-60) / 5 VIAL in 1 POUCH (50742-323-05) / .2 mL in 1 VIAL |
| ANDA | ANDA217260 |
| Labeler | Ingenus Pharmaceuticals, LLC |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2023-05-02 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 50742-323 |
NDC Item 65862094715
| NDC 9 | 65862-947 |
|---|---|
| NDC 10 | 65862-947-15 |
| NDC Item | 65862094715 |
| Packaging | 0.2 mL in 1 VIAL, SINGLE-USE |
| Packaging | 15 in 1 POUCH |
| ANDA | ANDA207630 |
| Labeler | Aurobindo Pharma Limited |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2018-07-24 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 65862-947 |
NDC Item 65862094718
| NDC 9 | 65862-947 |
|---|---|
| NDC 10 | 65862-947-18 |
| NDC Item | 65862094718 |
| Packaging | 12 POUCH in 1 CARTON (65862-947-18) / 15 VIAL, SINGLE-USE in 1 POUCH / .2 mL in 1 VIAL, SINGLE-USE |
| ANDA | ANDA207630 |
| Labeler | Aurobindo Pharma Limited |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2018-07-24 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 65862-947 |
NDC Item 65862094760
| NDC 9 | 65862-947 |
|---|---|
| NDC 10 | 65862-947-60 |
| NDC Item | 65862094760 |
| Packaging | 4 POUCH in 1 CARTON (65862-947-60) / 15 VIAL, SINGLE-USE in 1 POUCH (65862-947-15) / .2 mL in 1 VIAL, SINGLE-USE |
| ANDA | ANDA207630 |
| Labeler | Aurobindo Pharma Limited |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2018-07-24 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 65862-947 |
NDC Item 72162238706
| NDC 9 | 72162-2387 |
|---|---|
| NDC 10 | 72162-2387-6 |
| NDC Item | 72162238706 |
| Packaging | 4 POUCH in 1 CARTON (72162-2387-6) / 15 VIAL, SINGLE-USE in 1 POUCH (72162-2387-7) / .2 mL in 1 VIAL, SINGLE-USE |
| ANDA | ANDA215936 |
| Labeler | Bryant Ranch Prepack |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2022-02-15 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 72162-2387 |
NDC Item 72162238707
| NDC 9 | 72162-2387 |
|---|---|
| NDC 10 | 72162-2387-7 |
| NDC Item | 72162238707 |
| Packaging | 0.2 mL in 1 VIAL, SINGLE-USE |
| Packaging | 15 in 1 POUCH |
| ANDA | ANDA215936 |
| Labeler | Bryant Ranch Prepack |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2022-02-15 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 72162-2387 |
NDC Item 42571038227
| NDC 9 | 42571-382 |
|---|---|
| NDC 10 | 42571-382-27 |
| NDC Item | 42571038227 |
| Packaging | 12 POUCH in 1 CARTON (42571-382-27) / 15 VIAL, SINGLE-USE in 1 POUCH / .2 mL in 1 VIAL, SINGLE-USE |
| ANDA | ANDA215936 |
| Labeler | Micro Labs Limited |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2022-02-15 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 42571-382 |
NDC Item 42571038271
| NDC 9 | 42571-382 |
|---|---|
| NDC 10 | 42571-382-71 |
| NDC Item | 42571038271 |
| Packaging | 0.2 mL in 1 VIAL, SINGLE-USE |
| Packaging | 15 in 1 POUCH |
| ANDA | ANDA215936 |
| Labeler | Micro Labs Limited |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2022-02-15 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 42571-382 |
NDC Item 42571038273
| NDC 9 | 42571-382 |
|---|---|
| NDC 10 | 42571-382-73 |
| NDC Item | 42571038273 |
| Packaging | 4 POUCH in 1 CARTON (42571-382-73) / 15 VIAL, SINGLE-USE in 1 POUCH (42571-382-71) / .2 mL in 1 VIAL, SINGLE-USE |
| ANDA | ANDA215936 |
| Labeler | Micro Labs Limited |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2022-02-15 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 42571-382 |
NDC Item 50383026161
| NDC 9 | 50383-261 |
|---|---|
| NDC 10 | 50383-261-61 |
| NDC Item | 50383026161 |
| Packaging | 4 POUCH in 1 CARTON (50383-261-61) / 15 VIAL, SINGLE-USE in 1 POUCH / .2 mL in 1 VIAL, SINGLE-USE |
| Labeler | Akorn |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | NDA |
| Marketing effective time low | 2019-02-01 |
| Marketing status | ACTIVE |
| NDA | NDA202667 |
| Related queries | Properties for NDC 9 50383-261 |
NDC Item 50383026191
| NDC 9 | 50383-261 |
|---|---|
| NDC 10 | 50383-261-91 |
| NDC Item | 50383026191 |
| Packaging | 12 POUCH in 1 CARTON (50383-261-91) / 15 VIAL, SINGLE-USE in 1 POUCH / .2 mL in 1 VIAL, SINGLE-USE |
| Labeler | Akorn Operating Company LLC (dba Akorn) |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | NDA |
| Marketing effective time low | 2019-02-01 |
| Marketing status | ACTIVE |
| NDA | NDA202667 |
| Related queries | Properties for NDC 9 50383-261 |
NDC Item 50742032305
| NDC 9 | 50742-323 |
|---|---|
| NDC 10 | 50742-323-05 |
| NDC Item | 50742032305 |
| Packaging | 0.2 mL in 1 VIAL |
| Packaging | 5 in 1 POUCH |
| ANDA | ANDA217260 |
| Labeler | Ingenus Pharmaceuticals, LLC |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2023-05-02 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 50742-323 |
NDC Item 50742032360
| NDC 9 | 50742-323 |
|---|---|
| NDC 10 | 50742-323-60 |
| NDC Item | 50742032360 |
| Packaging | 12 POUCH in 1 CARTON (50742-323-60) / 5 VIAL in 1 POUCH (50742-323-05) / .2 mL in 1 VIAL |
| ANDA | ANDA217260 |
| Labeler | Ingenus Pharmaceuticals, LLC |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2023-05-02 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 50742-323 |
NDC Item 65862094715
| NDC 9 | 65862-947 |
|---|---|
| NDC 10 | 65862-947-15 |
| NDC Item | 65862094715 |
| Packaging | 0.2 mL in 1 VIAL, SINGLE-USE |
| Packaging | 15 in 1 POUCH |
| ANDA | ANDA207630 |
| Labeler | Aurobindo Pharma Limited |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2018-07-24 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 65862-947 |
NDC Item 65862094718
| NDC 9 | 65862-947 |
|---|---|
| NDC 10 | 65862-947-18 |
| NDC Item | 65862094718 |
| Packaging | 12 POUCH in 1 CARTON (65862-947-18) / 15 VIAL, SINGLE-USE in 1 POUCH / .2 mL in 1 VIAL, SINGLE-USE |
| ANDA | ANDA207630 |
| Labeler | Aurobindo Pharma Limited |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2018-07-24 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 65862-947 |
NDC Item 65862094760
| NDC 9 | 65862-947 |
|---|---|
| NDC 10 | 65862-947-60 |
| NDC Item | 65862094760 |
| Packaging | 4 POUCH in 1 CARTON (65862-947-60) / 15 VIAL, SINGLE-USE in 1 POUCH (65862-947-15) / .2 mL in 1 VIAL, SINGLE-USE |
| ANDA | ANDA207630 |
| Labeler | Aurobindo Pharma Limited |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2018-07-24 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 65862-947 |
NDC Item 72162238706
| NDC 9 | 72162-2387 |
|---|---|
| NDC 10 | 72162-2387-6 |
| NDC Item | 72162238706 |
| Packaging | 4 POUCH in 1 CARTON (72162-2387-6) / 15 VIAL, SINGLE-USE in 1 POUCH (72162-2387-7) / .2 mL in 1 VIAL, SINGLE-USE |
| ANDA | ANDA215936 |
| Labeler | Bryant Ranch Prepack |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2022-02-15 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 72162-2387 |
NDC Item 72162238707
| NDC 9 | 72162-2387 |
|---|---|
| NDC 10 | 72162-2387-7 |
| NDC Item | 72162238707 |
| Packaging | 0.2 mL in 1 VIAL, SINGLE-USE |
| Packaging | 15 in 1 POUCH |
| ANDA | ANDA215936 |
| Labeler | Bryant Ranch Prepack |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2022-02-15 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 72162-2387 |
NDC Item 42571038227
| NDC 9 | 42571-382 |
|---|---|
| NDC 10 | 42571-382-27 |
| NDC Item | 42571038227 |
| Packaging | 12 POUCH in 1 CARTON (42571-382-27) / 15 VIAL, SINGLE-USE in 1 POUCH / .2 mL in 1 VIAL, SINGLE-USE |
| ANDA | ANDA215936 |
| Labeler | Micro Labs Limited |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2022-02-15 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 42571-382 |
NDC Item 42571038271
| NDC 9 | 42571-382 |
|---|---|
| NDC 10 | 42571-382-71 |
| NDC Item | 42571038271 |
| Packaging | 0.2 mL in 1 VIAL, SINGLE-USE |
| Packaging | 15 in 1 POUCH |
| ANDA | ANDA215936 |
| Labeler | Micro Labs Limited |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2022-02-15 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 42571-382 |
NDC Item 42571038273
| NDC 9 | 42571-382 |
|---|---|
| NDC 10 | 42571-382-73 |
| NDC Item | 42571038273 |
| Packaging | 4 POUCH in 1 CARTON (42571-382-73) / 15 VIAL, SINGLE-USE in 1 POUCH (42571-382-71) / .2 mL in 1 VIAL, SINGLE-USE |
| ANDA | ANDA215936 |
| Labeler | Micro Labs Limited |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2022-02-15 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 42571-382 |
NDC Item 50383026161
| NDC 9 | 50383-261 |
|---|---|
| NDC 10 | 50383-261-61 |
| NDC Item | 50383026161 |
| Packaging | 4 POUCH in 1 CARTON (50383-261-61) / 15 VIAL, SINGLE-USE in 1 POUCH / .2 mL in 1 VIAL, SINGLE-USE |
| Labeler | Akorn |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | NDA |
| Marketing effective time low | 2019-02-01 |
| Marketing status | ACTIVE |
| NDA | NDA202667 |
| Related queries | Properties for NDC 9 50383-261 |
NDC Item 50383026191
| NDC 9 | 50383-261 |
|---|---|
| NDC 10 | 50383-261-91 |
| NDC Item | 50383026191 |
| Packaging | 12 POUCH in 1 CARTON (50383-261-91) / 15 VIAL, SINGLE-USE in 1 POUCH / .2 mL in 1 VIAL, SINGLE-USE |
| Labeler | Akorn Operating Company LLC (dba Akorn) |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | NDA |
| Marketing effective time low | 2019-02-01 |
| Marketing status | ACTIVE |
| NDA | NDA202667 |
| Related queries | Properties for NDC 9 50383-261 |
NDC Item 50742032305
| NDC 9 | 50742-323 |
|---|---|
| NDC 10 | 50742-323-05 |
| NDC Item | 50742032305 |
| Packaging | 0.2 mL in 1 VIAL |
| Packaging | 5 in 1 POUCH |
| ANDA | ANDA217260 |
| Labeler | Ingenus Pharmaceuticals, LLC |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2023-05-02 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 50742-323 |
NDC Item 50742032360
| NDC 9 | 50742-323 |
|---|---|
| NDC 10 | 50742-323-60 |
| NDC Item | 50742032360 |
| Packaging | 12 POUCH in 1 CARTON (50742-323-60) / 5 VIAL in 1 POUCH (50742-323-05) / .2 mL in 1 VIAL |
| ANDA | ANDA217260 |
| Labeler | Ingenus Pharmaceuticals, LLC |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2023-05-02 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 50742-323 |
NDC Item 65862094715
| NDC 9 | 65862-947 |
|---|---|
| NDC 10 | 65862-947-15 |
| NDC Item | 65862094715 |
| Packaging | 0.2 mL in 1 VIAL, SINGLE-USE |
| Packaging | 15 in 1 POUCH |
| ANDA | ANDA207630 |
| Labeler | Aurobindo Pharma Limited |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2018-07-24 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 65862-947 |
NDC Item 65862094718
| NDC 9 | 65862-947 |
|---|---|
| NDC 10 | 65862-947-18 |
| NDC Item | 65862094718 |
| Packaging | 12 POUCH in 1 CARTON (65862-947-18) / 15 VIAL, SINGLE-USE in 1 POUCH / .2 mL in 1 VIAL, SINGLE-USE |
| ANDA | ANDA207630 |
| Labeler | Aurobindo Pharma Limited |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2018-07-24 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 65862-947 |
NDC Item 65862094760
| NDC 9 | 65862-947 |
|---|---|
| NDC 10 | 65862-947-60 |
| NDC Item | 65862094760 |
| Packaging | 4 POUCH in 1 CARTON (65862-947-60) / 15 VIAL, SINGLE-USE in 1 POUCH (65862-947-15) / .2 mL in 1 VIAL, SINGLE-USE |
| ANDA | ANDA207630 |
| Labeler | Aurobindo Pharma Limited |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2018-07-24 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 65862-947 |
NDC Item 72162238706
| NDC 9 | 72162-2387 |
|---|---|
| NDC 10 | 72162-2387-6 |
| NDC Item | 72162238706 |
| Packaging | 4 POUCH in 1 CARTON (72162-2387-6) / 15 VIAL, SINGLE-USE in 1 POUCH (72162-2387-7) / .2 mL in 1 VIAL, SINGLE-USE |
| ANDA | ANDA215936 |
| Labeler | Bryant Ranch Prepack |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2022-02-15 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 72162-2387 |
NDC Item 72162238707
| NDC 9 | 72162-2387 |
|---|---|
| NDC 10 | 72162-2387-7 |
| NDC Item | 72162238707 |
| Packaging | 0.2 mL in 1 VIAL, SINGLE-USE |
| Packaging | 15 in 1 POUCH |
| ANDA | ANDA215936 |
| Labeler | Bryant Ranch Prepack |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2022-02-15 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 72162-2387 |
NDC Item 42571038227
| NDC 9 | 42571-382 |
|---|---|
| NDC 10 | 42571-382-27 |
| NDC Item | 42571038227 |
| Packaging | 12 POUCH in 1 CARTON (42571-382-27) / 15 VIAL, SINGLE-USE in 1 POUCH / .2 mL in 1 VIAL, SINGLE-USE |
| ANDA | ANDA215936 |
| Labeler | Micro Labs Limited |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2022-02-15 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 42571-382 |
NDC Item 42571038271
| NDC 9 | 42571-382 |
|---|---|
| NDC 10 | 42571-382-71 |
| NDC Item | 42571038271 |
| Packaging | 0.2 mL in 1 VIAL, SINGLE-USE |
| Packaging | 15 in 1 POUCH |
| ANDA | ANDA215936 |
| Labeler | Micro Labs Limited |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2022-02-15 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 42571-382 |
NDC Item 42571038273
| NDC 9 | 42571-382 |
|---|---|
| NDC 10 | 42571-382-73 |
| NDC Item | 42571038273 |
| Packaging | 4 POUCH in 1 CARTON (42571-382-73) / 15 VIAL, SINGLE-USE in 1 POUCH (42571-382-71) / .2 mL in 1 VIAL, SINGLE-USE |
| ANDA | ANDA215936 |
| Labeler | Micro Labs Limited |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2022-02-15 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 42571-382 |
NDC Item 50383026161
| NDC 9 | 50383-261 |
|---|---|
| NDC 10 | 50383-261-61 |
| NDC Item | 50383026161 |
| Packaging | 4 POUCH in 1 CARTON (50383-261-61) / 15 VIAL, SINGLE-USE in 1 POUCH / .2 mL in 1 VIAL, SINGLE-USE |
| Labeler | Akorn |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | NDA |
| Marketing effective time low | 2019-02-01 |
| Marketing status | ACTIVE |
| NDA | NDA202667 |
| Related queries | Properties for NDC 9 50383-261 |
NDC Item 50383026191
| NDC 9 | 50383-261 |
|---|---|
| NDC 10 | 50383-261-91 |
| NDC Item | 50383026191 |
| Packaging | 12 POUCH in 1 CARTON (50383-261-91) / 15 VIAL, SINGLE-USE in 1 POUCH / .2 mL in 1 VIAL, SINGLE-USE |
| Labeler | Akorn Operating Company LLC (dba Akorn) |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | NDA |
| Marketing effective time low | 2019-02-01 |
| Marketing status | ACTIVE |
| NDA | NDA202667 |
| Related queries | Properties for NDC 9 50383-261 |
NDC Item 50742032305
| NDC 9 | 50742-323 |
|---|---|
| NDC 10 | 50742-323-05 |
| NDC Item | 50742032305 |
| Packaging | 0.2 mL in 1 VIAL |
| Packaging | 5 in 1 POUCH |
| ANDA | ANDA217260 |
| Labeler | Ingenus Pharmaceuticals, LLC |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2023-05-02 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 50742-323 |
NDC Item 50742032360
| NDC 9 | 50742-323 |
|---|---|
| NDC 10 | 50742-323-60 |
| NDC Item | 50742032360 |
| Packaging | 12 POUCH in 1 CARTON (50742-323-60) / 5 VIAL in 1 POUCH (50742-323-05) / .2 mL in 1 VIAL |
| ANDA | ANDA217260 |
| Labeler | Ingenus Pharmaceuticals, LLC |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2023-05-02 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 50742-323 |
NDC Item 65862094715
| NDC 9 | 65862-947 |
|---|---|
| NDC 10 | 65862-947-15 |
| NDC Item | 65862094715 |
| Packaging | 0.2 mL in 1 VIAL, SINGLE-USE |
| Packaging | 15 in 1 POUCH |
| ANDA | ANDA207630 |
| Labeler | Aurobindo Pharma Limited |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2018-07-24 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 65862-947 |
NDC Item 65862094718
| NDC 9 | 65862-947 |
|---|---|
| NDC 10 | 65862-947-18 |
| NDC Item | 65862094718 |
| Packaging | 12 POUCH in 1 CARTON (65862-947-18) / 15 VIAL, SINGLE-USE in 1 POUCH / .2 mL in 1 VIAL, SINGLE-USE |
| ANDA | ANDA207630 |
| Labeler | Aurobindo Pharma Limited |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2018-07-24 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 65862-947 |
NDC Item 65862094760
| NDC 9 | 65862-947 |
|---|---|
| NDC 10 | 65862-947-60 |
| NDC Item | 65862094760 |
| Packaging | 4 POUCH in 1 CARTON (65862-947-60) / 15 VIAL, SINGLE-USE in 1 POUCH (65862-947-15) / .2 mL in 1 VIAL, SINGLE-USE |
| ANDA | ANDA207630 |
| Labeler | Aurobindo Pharma Limited |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2018-07-24 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 65862-947 |
NDC Item 72162238706
| NDC 9 | 72162-2387 |
|---|---|
| NDC 10 | 72162-2387-6 |
| NDC Item | 72162238706 |
| Packaging | 4 POUCH in 1 CARTON (72162-2387-6) / 15 VIAL, SINGLE-USE in 1 POUCH (72162-2387-7) / .2 mL in 1 VIAL, SINGLE-USE |
| ANDA | ANDA215936 |
| Labeler | Bryant Ranch Prepack |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2022-02-15 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 72162-2387 |
NDC Item 72162238707
| NDC 9 | 72162-2387 |
|---|---|
| NDC 10 | 72162-2387-7 |
| NDC Item | 72162238707 |
| Packaging | 0.2 mL in 1 VIAL, SINGLE-USE |
| Packaging | 15 in 1 POUCH |
| ANDA | ANDA215936 |
| Labeler | Bryant Ranch Prepack |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2022-02-15 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 72162-2387 |
NDC Item 42571038227
| NDC 9 | 42571-382 |
|---|---|
| NDC 10 | 42571-382-27 |
| NDC Item | 42571038227 |
| Packaging | 12 POUCH in 1 CARTON (42571-382-27) / 15 VIAL, SINGLE-USE in 1 POUCH / .2 mL in 1 VIAL, SINGLE-USE |
| ANDA | ANDA215936 |
| Labeler | Micro Labs Limited |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2022-02-15 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 42571-382 |
NDC Item 42571038271
| NDC 9 | 42571-382 |
|---|---|
| NDC 10 | 42571-382-71 |
| NDC Item | 42571038271 |
| Packaging | 0.2 mL in 1 VIAL, SINGLE-USE |
| Packaging | 15 in 1 POUCH |
| ANDA | ANDA215936 |
| Labeler | Micro Labs Limited |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2022-02-15 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 42571-382 |
NDC Item 42571038273
| NDC 9 | 42571-382 |
|---|---|
| NDC 10 | 42571-382-73 |
| NDC Item | 42571038273 |
| Packaging | 4 POUCH in 1 CARTON (42571-382-73) / 15 VIAL, SINGLE-USE in 1 POUCH (42571-382-71) / .2 mL in 1 VIAL, SINGLE-USE |
| ANDA | ANDA215936 |
| Labeler | Micro Labs Limited |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2022-02-15 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 42571-382 |
NDC Item 50383026161
| NDC 9 | 50383-261 |
|---|---|
| NDC 10 | 50383-261-61 |
| NDC Item | 50383026161 |
| Packaging | 4 POUCH in 1 CARTON (50383-261-61) / 15 VIAL, SINGLE-USE in 1 POUCH / .2 mL in 1 VIAL, SINGLE-USE |
| Labeler | Akorn |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | NDA |
| Marketing effective time low | 2019-02-01 |
| Marketing status | ACTIVE |
| NDA | NDA202667 |
| Related queries | Properties for NDC 9 50383-261 |
NDC Item 50383026191
| NDC 9 | 50383-261 |
|---|---|
| NDC 10 | 50383-261-91 |
| NDC Item | 50383026191 |
| Packaging | 12 POUCH in 1 CARTON (50383-261-91) / 15 VIAL, SINGLE-USE in 1 POUCH / .2 mL in 1 VIAL, SINGLE-USE |
| Labeler | Akorn Operating Company LLC (dba Akorn) |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | NDA |
| Marketing effective time low | 2019-02-01 |
| Marketing status | ACTIVE |
| NDA | NDA202667 |
| Related queries | Properties for NDC 9 50383-261 |
NDC Item 50742032305
| NDC 9 | 50742-323 |
|---|---|
| NDC 10 | 50742-323-05 |
| NDC Item | 50742032305 |
| Packaging | 0.2 mL in 1 VIAL |
| Packaging | 5 in 1 POUCH |
| ANDA | ANDA217260 |
| Labeler | Ingenus Pharmaceuticals, LLC |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2023-05-02 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 50742-323 |
NDC Item 50742032360
| NDC 9 | 50742-323 |
|---|---|
| NDC 10 | 50742-323-60 |
| NDC Item | 50742032360 |
| Packaging | 12 POUCH in 1 CARTON (50742-323-60) / 5 VIAL in 1 POUCH (50742-323-05) / .2 mL in 1 VIAL |
| ANDA | ANDA217260 |
| Labeler | Ingenus Pharmaceuticals, LLC |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2023-05-02 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 50742-323 |
NDC Item 65862094715
| NDC 9 | 65862-947 |
|---|---|
| NDC 10 | 65862-947-15 |
| NDC Item | 65862094715 |
| Packaging | 0.2 mL in 1 VIAL, SINGLE-USE |
| Packaging | 15 in 1 POUCH |
| ANDA | ANDA207630 |
| Labeler | Aurobindo Pharma Limited |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2018-07-24 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 65862-947 |
NDC Item 65862094718
| NDC 9 | 65862-947 |
|---|---|
| NDC 10 | 65862-947-18 |
| NDC Item | 65862094718 |
| Packaging | 12 POUCH in 1 CARTON (65862-947-18) / 15 VIAL, SINGLE-USE in 1 POUCH / .2 mL in 1 VIAL, SINGLE-USE |
| ANDA | ANDA207630 |
| Labeler | Aurobindo Pharma Limited |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2018-07-24 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 65862-947 |
NDC Item 65862094760
| NDC 9 | 65862-947 |
|---|---|
| NDC 10 | 65862-947-60 |
| NDC Item | 65862094760 |
| Packaging | 4 POUCH in 1 CARTON (65862-947-60) / 15 VIAL, SINGLE-USE in 1 POUCH (65862-947-15) / .2 mL in 1 VIAL, SINGLE-USE |
| ANDA | ANDA207630 |
| Labeler | Aurobindo Pharma Limited |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2018-07-24 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 65862-947 |
NDC Item 72162238706
| NDC 9 | 72162-2387 |
|---|---|
| NDC 10 | 72162-2387-6 |
| NDC Item | 72162238706 |
| Packaging | 4 POUCH in 1 CARTON (72162-2387-6) / 15 VIAL, SINGLE-USE in 1 POUCH (72162-2387-7) / .2 mL in 1 VIAL, SINGLE-USE |
| ANDA | ANDA215936 |
| Labeler | Bryant Ranch Prepack |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2022-02-15 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 72162-2387 |
NDC Item 72162238707
| NDC 9 | 72162-2387 |
|---|---|
| NDC 10 | 72162-2387-7 |
| NDC Item | 72162238707 |
| Packaging | 0.2 mL in 1 VIAL, SINGLE-USE |
| Packaging | 15 in 1 POUCH |
| ANDA | ANDA215936 |
| Labeler | Bryant Ranch Prepack |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2022-02-15 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 72162-2387 |
NDC Item 42571038227
| NDC 9 | 42571-382 |
|---|---|
| NDC 10 | 42571-382-27 |
| NDC Item | 42571038227 |
| Packaging | 12 POUCH in 1 CARTON (42571-382-27) / 15 VIAL, SINGLE-USE in 1 POUCH / .2 mL in 1 VIAL, SINGLE-USE |
| ANDA | ANDA215936 |
| Labeler | Micro Labs Limited |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2022-02-15 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 42571-382 |
NDC Item 42571038271
| NDC 9 | 42571-382 |
|---|---|
| NDC 10 | 42571-382-71 |
| NDC Item | 42571038271 |
| Packaging | 0.2 mL in 1 VIAL, SINGLE-USE |
| Packaging | 15 in 1 POUCH |
| ANDA | ANDA215936 |
| Labeler | Micro Labs Limited |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2022-02-15 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 42571-382 |
NDC Item 42571038273
| NDC 9 | 42571-382 |
|---|---|
| NDC 10 | 42571-382-73 |
| NDC Item | 42571038273 |
| Packaging | 4 POUCH in 1 CARTON (42571-382-73) / 15 VIAL, SINGLE-USE in 1 POUCH (42571-382-71) / .2 mL in 1 VIAL, SINGLE-USE |
| ANDA | ANDA215936 |
| Labeler | Micro Labs Limited |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2022-02-15 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 42571-382 |
NDC Item 50383026161
| NDC 9 | 50383-261 |
|---|---|
| NDC 10 | 50383-261-61 |
| NDC Item | 50383026161 |
| Packaging | 4 POUCH in 1 CARTON (50383-261-61) / 15 VIAL, SINGLE-USE in 1 POUCH / .2 mL in 1 VIAL, SINGLE-USE |
| Labeler | Akorn |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | NDA |
| Marketing effective time low | 2019-02-01 |
| Marketing status | ACTIVE |
| NDA | NDA202667 |
| Related queries | Properties for NDC 9 50383-261 |
NDC Item 50383026191
| NDC 9 | 50383-261 |
|---|---|
| NDC 10 | 50383-261-91 |
| NDC Item | 50383026191 |
| Packaging | 12 POUCH in 1 CARTON (50383-261-91) / 15 VIAL, SINGLE-USE in 1 POUCH / .2 mL in 1 VIAL, SINGLE-USE |
| Labeler | Akorn Operating Company LLC (dba Akorn) |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | NDA |
| Marketing effective time low | 2019-02-01 |
| Marketing status | ACTIVE |
| NDA | NDA202667 |
| Related queries | Properties for NDC 9 50383-261 |
NDC Item 50742032305
| NDC 9 | 50742-323 |
|---|---|
| NDC 10 | 50742-323-05 |
| NDC Item | 50742032305 |
| Packaging | 0.2 mL in 1 VIAL |
| Packaging | 5 in 1 POUCH |
| ANDA | ANDA217260 |
| Labeler | Ingenus Pharmaceuticals, LLC |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2023-05-02 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 50742-323 |
NDC Item 50742032360
| NDC 9 | 50742-323 |
|---|---|
| NDC 10 | 50742-323-60 |
| NDC Item | 50742032360 |
| Packaging | 12 POUCH in 1 CARTON (50742-323-60) / 5 VIAL in 1 POUCH (50742-323-05) / .2 mL in 1 VIAL |
| ANDA | ANDA217260 |
| Labeler | Ingenus Pharmaceuticals, LLC |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2023-05-02 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 50742-323 |
NDC Item 65862094715
| NDC 9 | 65862-947 |
|---|---|
| NDC 10 | 65862-947-15 |
| NDC Item | 65862094715 |
| Packaging | 0.2 mL in 1 VIAL, SINGLE-USE |
| Packaging | 15 in 1 POUCH |
| ANDA | ANDA207630 |
| Labeler | Aurobindo Pharma Limited |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2018-07-24 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 65862-947 |
NDC Item 65862094718
| NDC 9 | 65862-947 |
|---|---|
| NDC 10 | 65862-947-18 |
| NDC Item | 65862094718 |
| Packaging | 12 POUCH in 1 CARTON (65862-947-18) / 15 VIAL, SINGLE-USE in 1 POUCH / .2 mL in 1 VIAL, SINGLE-USE |
| ANDA | ANDA207630 |
| Labeler | Aurobindo Pharma Limited |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2018-07-24 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 65862-947 |
NDC Item 65862094760
| NDC 9 | 65862-947 |
|---|---|
| NDC 10 | 65862-947-60 |
| NDC Item | 65862094760 |
| Packaging | 4 POUCH in 1 CARTON (65862-947-60) / 15 VIAL, SINGLE-USE in 1 POUCH (65862-947-15) / .2 mL in 1 VIAL, SINGLE-USE |
| ANDA | ANDA207630 |
| Labeler | Aurobindo Pharma Limited |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2018-07-24 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 65862-947 |
NDC Item 72162238706
| NDC 9 | 72162-2387 |
|---|---|
| NDC 10 | 72162-2387-6 |
| NDC Item | 72162238706 |
| Packaging | 4 POUCH in 1 CARTON (72162-2387-6) / 15 VIAL, SINGLE-USE in 1 POUCH (72162-2387-7) / .2 mL in 1 VIAL, SINGLE-USE |
| ANDA | ANDA215936 |
| Labeler | Bryant Ranch Prepack |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2022-02-15 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 72162-2387 |
NDC Item 72162238707
| NDC 9 | 72162-2387 |
|---|---|
| NDC 10 | 72162-2387-7 |
| NDC Item | 72162238707 |
| Packaging | 0.2 mL in 1 VIAL, SINGLE-USE |
| Packaging | 15 in 1 POUCH |
| ANDA | ANDA215936 |
| Labeler | Bryant Ranch Prepack |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2022-02-15 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 72162-2387 |