NDC properties for "tinidazole 500 MG Oral Tablet" (RxCUI 199519)
About this data
The tables show NDC propoerties for tinidazole 500 MG Oral Tablet with the RxCUI 199519
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 tinidazole 500 MG Oral Tablet (RxCUI 199519)
| ANDA | ANDA201172 |
|---|---|
| ANDA | ANDA202044 |
| ANDA | ANDA202489 |
| ANDA | ANDA203808 |
| MMSL_CODE | BD9302 |
| MMSL_CODE | CD9302 |
| RxCUI | 199519 |
| SNOMEDCT | 324554008 |
| SPL_SET_ID | 32167dd7-5d37-457b-9b00-cd735de6b060 |
| SPL_SET_ID | 45fa3ebd-52da-4987-82a1-4a64f99785a7 |
| SPL_SET_ID | 4e03b4ac-c88a-4044-9d58-0cfcda3db53c |
| SPL_SET_ID | 6f3ce597-64c1-4204-a67a-8b6f6e7e8bca |
| SPL_SET_ID | 95ab57b2-5d7e-4986-abcd-65edf1728383 |
| SPL_SET_ID | 9719883b-496d-42bb-e053-2995a90a1ab1 |
| SPL_SET_ID | b39bc167-f1c4-4169-8b46-e6c2eafe6bbf |
| SPL_SET_ID | ebe89ab6-24c0-4214-853f-67e2e0c7daa9 |
| SPL_SET_ID | f4235736-3050-1ee0-e053-2a95a90a421c |
| VUID | 4017102 |
| Prescribable Synonym | tinidazole 500 MG Oral Tablet |
| RXNAV_STR | tinidazole 500 MG Oral Tablet |
| RxNorm Name | tinidazole 500 MG Oral Tablet |
| Related queries | Interactions (for RxCUI 199519) |
NDC Properties
NDC Item 00054034807
| NDC 9 | 0054-0348 |
|---|---|
| NDC 10 | 0054-0348-07 |
| NDC Item | 00054034807 |
| Packaging | 20 TABLET, FILM COATED in 1 BOTTLE (0054-0348-07) |
| ANDA | ANDA201172 |
| COLORTEXT | WHITE(Off White) |
| Color | C48325 __ |
| FDA SPL set id | 611868 |
| Imprint code | 54455 |
| Labeler | Hikma Pharmaceuticals USA Inc. |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time high | 2021-10-31 |
| Marketing effective time low | 2012-04-30 |
| Marketing status | COMPLETED |
| Score | 2 |
| Shapetext | Modified |
| Shape | C48345 |
| Size | 16 mm |
| Related queries | Properties for NDC 9 0054-0348 |
NDC Item 00054034821
| NDC 9 | 0054-0348 |
|---|---|
| NDC 10 | 0054-0348-21 |
| NDC Item | 00054034821 |
| Packaging | 60 TABLET, FILM COATED in 1 BOTTLE (0054-0348-21) |
| ANDA | ANDA201172 |
| COLORTEXT | WHITE(Off White) |
| Color | C48325 __ |
| FDA SPL set id | 611868 |
| Imprint code | 54455 |
| Labeler | Hikma Pharmaceuticals USA Inc. |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time high | 2021-10-31 |
| Marketing effective time low | 2012-04-30 |
| Marketing status | COMPLETED |
| Score | 2 |
| Shapetext | Modified |
| Shape | C48345 |
| Size | 16 mm |
| Related queries | Properties for NDC 9 0054-0348 |
NDC Item 16571021506
| NDC 9 | 16571-215 |
|---|---|
| NDC 10 | 16571-215-06 |
| NDC Item | 16571021506 |
| Packaging | 60 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (16571-215-06) |
| ANDA | ANDA202489 |
| COLORTEXT | PINK |
| Color | C48328 __ |
| FDA SPL set id | 114445 |
| Imprint code | TP;500 |
| Labeler | Rising Pharma Holdings, Inc. |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time high | 2013-10-10 |
| Marketing effective time low | 2013-10-09 |
| Marketing status | COMPLETED |
| Score | 2 |
| Shapetext | Capsule Shaped |
| Shape | C48336 |
| Size | 16 mm |
| Related queries | Properties for NDC 9 16571-215 |
NDC Item 42799020801
| NDC 9 | 42799-208 |
|---|---|
| NDC 10 | 42799-208-01 |
| NDC Item | 42799020801 |
| Packaging | 20 TABLET in 1 BOTTLE (42799-208-01) |
| ANDA | ANDA203808 |
| COLORTEXT | YELLOW |
| Color | C48330 __ |
| FDA SPL set id | 624893 |
| Imprint code | 208 |
| Labeler | Edenbridge Pharmaceuticals LLC. |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2019-12-20 |
| Marketing status | ACTIVE |
| Score | 2 |
| Shape | C48345 |
| Size | 16 mm |
| Related queries | Properties for NDC 9 42799-208 |
NDC Item 42799020802
| NDC 9 | 42799-208 |
|---|---|
| NDC 10 | 42799-208-02 |
| NDC Item | 42799020802 |
| Packaging | 60 TABLET in 1 BOTTLE (42799-208-02) |
| ANDA | ANDA203808 |
| COLORTEXT | YELLOW |
| Color | C48330 __ |
| FDA SPL set id | 624893 |
| Imprint code | 208 |
| Labeler | Edenbridge Pharmaceuticals LLC. |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2019-12-20 |
| Marketing status | ACTIVE |
| Score | 2 |
| Shape | C48345 |
| Size | 16 mm |
| Related queries | Properties for NDC 9 42799-208 |
NDC Item 43386055102
| NDC 9 | 43386-551 |
|---|---|
| NDC 10 | 43386-551-02 |
| NDC Item | 43386055102 |
| Packaging | 20 TABLET in 1 BOTTLE (43386-551-02) |
| ANDA | ANDA202044 |
| COLORTEXT | PINK |
| Color | C48328 __ |
| FDA SPL set id | 716141 |
| Imprint code | NL;551 |
| Labeler | Lupin Pharmaceuticals,Inc. |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2012-04-30 |
| Marketing status | ACTIVE |
| Score | 2 |
| Shape | C48345 |
| Size | 16 mm |
| Related queries | Properties for NDC 9 43386-551 |
NDC Item 43386055106
| NDC 9 | 43386-551 |
|---|---|
| NDC 10 | 43386-551-06 |
| NDC Item | 43386055106 |
| Packaging | 60 TABLET in 1 BOTTLE (43386-551-06) |
| ANDA | ANDA202044 |
| COLORTEXT | PINK |
| Color | C48328 __ |
| FDA SPL set id | 716141 |
| Imprint code | NL;551 |
| Labeler | Lupin Pharmaceuticals,Inc. |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2012-04-30 |
| Marketing status | ACTIVE |
| Score | 2 |
| Shape | C48345 |
| Size | 16 mm |
| Related queries | Properties for NDC 9 43386-551 |
NDC Item 44523045020
| NDC 9 | 44523-450 |
|---|---|
| NDC 10 | 44523-450-20 |
| NDC Item | 44523045020 |
| Packaging | 20 TABLET in 1 BOTTLE (44523-450-20) |
| COLORTEXT | PINK |
| Color | C48328 __ |
| FDA SPL set id | 71195 |
| Imprint code | TM;500 |
| Labeler | Biocomp Pharma, Inc. |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | NDA AUTHORIZED GENERIC |
| Marketing effective time high | 2019-02-05 |
| Marketing effective time low | 2012-06-07 |
| Marketing status | COMPLETED |
| NDA_AUTHORIZED_GENERIC | NDA021618 |
| Score | 2 |
| Shape | C48345 |
| Size | 14 mm |
| Related queries | Properties for NDC 9 44523-450 |
NDC Item 62135083520
| NDC 9 | 62135-835 |
|---|---|
| NDC 10 | 62135-835-20 |
| NDC Item | 62135083520 |
| Packaging | 20 TABLET, FILM COATED in 1 BOTTLE (62135-835-20) |
| ANDA | ANDA202044 |
| COLORTEXT | white(white to off-white) |
| Color | C48325 __ |
| FDA SPL set id | 798224 |
| Imprint code | C;E;205 |
| Labeler | Chartwell RX, LLC |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2012-04-30 |
| Marketing status | active |
| Score | 2 |
| Shape | C48345 |
| Size | 16 mm |
| Related queries | Properties for NDC 9 62135-835 |
NDC Item 64980042712
| NDC 9 | 64980-427 |
|---|---|
| NDC 10 | 64980-427-12 |
| NDC Item | 64980042712 |
| Packaging | 12 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (64980-427-12) |
| ANDA | ANDA202489 |
| COLORTEXT | PINK |
| Color | C48328 __ |
| FDA SPL set id | 717670 |
| Imprint code | TP;500 |
| Labeler | Rising Pharma Holdings, Inc. |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2013-10-09 |
| Marketing status | ACTIVE |
| Score | 2 |
| Shapetext | Capsule Shaped |
| Shape | C48336 |
| Size | 16 mm |
| Related queries | Properties for NDC 9 64980-427 |
NDC Item 67296183608
| NDC 9 | 67296-1836 |
|---|---|
| NDC 10 | 67296-1836-8 |
| NDC Item | 67296183608 |
| Packaging | 8 TABLET, FILM COATED in 1 BOTTLE (67296-1836-8) |
| ANDA | ANDA202489 |
| COLORTEXT | pink |
| Color | C48328 __ |
| FDA SPL set id | 798328 |
| Imprint code | TP;500 |
| Labeler | Redpharm Drug, Inc. |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2013-10-09 |
| Marketing status | ACTIVE |
| Score | 2 |
| Shapetext | Capsule Shaped |
| Shape | C48336 |
| Size | 16 mm |
| Related queries | Properties for NDC 9 67296-1836 |
NDC Item 70518417200
| NDC 9 | 70518-4172 |
|---|---|
| NDC 10 | 70518-4172-0 |
| NDC Item | 70518417200 |
| Packaging | 8 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (70518-4172-0) |
| ANDA | ANDA202489 |
| COLORTEXT | pink |
| Color | C48328 __ |
| FDA SPL set id | 807843 |
| Imprint code | TP;500 |
| Labeler | REMEDYREPACK INC. |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2024-08-30 |
| Marketing status | active |
| Score | 2 |
| Shapetext | Capsule Shaped |
| Shape | C48336 |
| Size | 16 mm |
| Related queries | Properties for NDC 9 70518-4172 |
NDC Item 70518417201
| NDC 9 | 70518-4172 |
|---|---|
| NDC 10 | 70518-4172-1 |
| NDC Item | 70518417201 |
| Packaging | 10 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (70518-4172-1) |
| ANDA | ANDA202489 |
| COLORTEXT | pink |
| Color | C48328 __ |
| FDA SPL set id | 807843 |
| Imprint code | TP;500 |
| Labeler | REMEDYREPACK INC. |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2024-08-30 |
| Marketing status | active |
| Score | 2 |
| Shapetext | Capsule Shaped |
| Shape | C48336 |
| Size | 16 mm |
| Related queries | Properties for NDC 9 70518-4172 |
NDC Item 00054034807
| NDC 9 | 0054-0348 |
|---|---|
| NDC 10 | 0054-0348-07 |
| NDC Item | 00054034807 |
| Packaging | 20 TABLET, FILM COATED in 1 BOTTLE (0054-0348-07) |
| ANDA | ANDA201172 |
| COLORTEXT | WHITE(Off White) |
| Color | C48325 __ |
| FDA SPL set id | 611868 |
| Imprint code | 54455 |
| Labeler | Hikma Pharmaceuticals USA Inc. |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time high | 2021-10-31 |
| Marketing effective time low | 2012-04-30 |
| Marketing status | COMPLETED |
| Score | 2 |
| Shapetext | Modified |
| Shape | C48345 |
| Size | 16 mm |
| Related queries | Properties for NDC 9 0054-0348 |
NDC Item 00054034821
| NDC 9 | 0054-0348 |
|---|---|
| NDC 10 | 0054-0348-21 |
| NDC Item | 00054034821 |
| Packaging | 60 TABLET, FILM COATED in 1 BOTTLE (0054-0348-21) |
| ANDA | ANDA201172 |
| COLORTEXT | WHITE(Off White) |
| Color | C48325 __ |
| FDA SPL set id | 611868 |
| Imprint code | 54455 |
| Labeler | Hikma Pharmaceuticals USA Inc. |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time high | 2021-10-31 |
| Marketing effective time low | 2012-04-30 |
| Marketing status | COMPLETED |
| Score | 2 |
| Shapetext | Modified |
| Shape | C48345 |
| Size | 16 mm |
| Related queries | Properties for NDC 9 0054-0348 |
NDC Item 16571021506
| NDC 9 | 16571-215 |
|---|---|
| NDC 10 | 16571-215-06 |
| NDC Item | 16571021506 |
| Packaging | 60 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (16571-215-06) |
| ANDA | ANDA202489 |
| COLORTEXT | PINK |
| Color | C48328 __ |
| FDA SPL set id | 114445 |
| Imprint code | TP;500 |
| Labeler | Rising Pharma Holdings, Inc. |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time high | 2013-10-10 |
| Marketing effective time low | 2013-10-09 |
| Marketing status | COMPLETED |
| Score | 2 |
| Shapetext | Capsule Shaped |
| Shape | C48336 |
| Size | 16 mm |
| Related queries | Properties for NDC 9 16571-215 |
NDC Item 42799020801
| NDC 9 | 42799-208 |
|---|---|
| NDC 10 | 42799-208-01 |
| NDC Item | 42799020801 |
| Packaging | 20 TABLET in 1 BOTTLE (42799-208-01) |
| ANDA | ANDA203808 |
| COLORTEXT | YELLOW |
| Color | C48330 __ |
| FDA SPL set id | 624893 |
| Imprint code | 208 |
| Labeler | Edenbridge Pharmaceuticals LLC. |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2019-12-20 |
| Marketing status | ACTIVE |
| Score | 2 |
| Shape | C48345 |
| Size | 16 mm |
| Related queries | Properties for NDC 9 42799-208 |
NDC Item 42799020802
| NDC 9 | 42799-208 |
|---|---|
| NDC 10 | 42799-208-02 |
| NDC Item | 42799020802 |
| Packaging | 60 TABLET in 1 BOTTLE (42799-208-02) |
| ANDA | ANDA203808 |
| COLORTEXT | YELLOW |
| Color | C48330 __ |
| FDA SPL set id | 624893 |
| Imprint code | 208 |
| Labeler | Edenbridge Pharmaceuticals LLC. |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2019-12-20 |
| Marketing status | ACTIVE |
| Score | 2 |
| Shape | C48345 |
| Size | 16 mm |
| Related queries | Properties for NDC 9 42799-208 |
NDC Item 43386055102
| NDC 9 | 43386-551 |
|---|---|
| NDC 10 | 43386-551-02 |
| NDC Item | 43386055102 |
| Packaging | 20 TABLET in 1 BOTTLE (43386-551-02) |
| ANDA | ANDA202044 |
| COLORTEXT | PINK |
| Color | C48328 __ |
| FDA SPL set id | 716141 |
| Imprint code | NL;551 |
| Labeler | Lupin Pharmaceuticals,Inc. |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2012-04-30 |
| Marketing status | ACTIVE |
| Score | 2 |
| Shape | C48345 |
| Size | 16 mm |
| Related queries | Properties for NDC 9 43386-551 |
NDC Item 43386055106
| NDC 9 | 43386-551 |
|---|---|
| NDC 10 | 43386-551-06 |
| NDC Item | 43386055106 |
| Packaging | 60 TABLET in 1 BOTTLE (43386-551-06) |
| ANDA | ANDA202044 |
| COLORTEXT | PINK |
| Color | C48328 __ |
| FDA SPL set id | 716141 |
| Imprint code | NL;551 |
| Labeler | Lupin Pharmaceuticals,Inc. |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2012-04-30 |
| Marketing status | ACTIVE |
| Score | 2 |
| Shape | C48345 |
| Size | 16 mm |
| Related queries | Properties for NDC 9 43386-551 |
NDC Item 44523045020
| NDC 9 | 44523-450 |
|---|---|
| NDC 10 | 44523-450-20 |
| NDC Item | 44523045020 |
| Packaging | 20 TABLET in 1 BOTTLE (44523-450-20) |
| COLORTEXT | PINK |
| Color | C48328 __ |
| FDA SPL set id | 71195 |
| Imprint code | TM;500 |
| Labeler | Biocomp Pharma, Inc. |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | NDA AUTHORIZED GENERIC |
| Marketing effective time high | 2019-02-05 |
| Marketing effective time low | 2012-06-07 |
| Marketing status | COMPLETED |
| NDA_AUTHORIZED_GENERIC | NDA021618 |
| Score | 2 |
| Shape | C48345 |
| Size | 14 mm |
| Related queries | Properties for NDC 9 44523-450 |
NDC Item 62135083520
| NDC 9 | 62135-835 |
|---|---|
| NDC 10 | 62135-835-20 |
| NDC Item | 62135083520 |
| Packaging | 20 TABLET, FILM COATED in 1 BOTTLE (62135-835-20) |
| ANDA | ANDA202044 |
| COLORTEXT | white(white to off-white) |
| Color | C48325 __ |
| FDA SPL set id | 798224 |
| Imprint code | C;E;205 |
| Labeler | Chartwell RX, LLC |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2012-04-30 |
| Marketing status | active |
| Score | 2 |
| Shape | C48345 |
| Size | 16 mm |
| Related queries | Properties for NDC 9 62135-835 |
NDC Item 64980042712
| NDC 9 | 64980-427 |
|---|---|
| NDC 10 | 64980-427-12 |
| NDC Item | 64980042712 |
| Packaging | 12 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (64980-427-12) |
| ANDA | ANDA202489 |
| COLORTEXT | PINK |
| Color | C48328 __ |
| FDA SPL set id | 717670 |
| Imprint code | TP;500 |
| Labeler | Rising Pharma Holdings, Inc. |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2013-10-09 |
| Marketing status | ACTIVE |
| Score | 2 |
| Shapetext | Capsule Shaped |
| Shape | C48336 |
| Size | 16 mm |
| Related queries | Properties for NDC 9 64980-427 |
NDC Item 67296183608
| NDC 9 | 67296-1836 |
|---|---|
| NDC 10 | 67296-1836-8 |
| NDC Item | 67296183608 |
| Packaging | 8 TABLET, FILM COATED in 1 BOTTLE (67296-1836-8) |
| ANDA | ANDA202489 |
| COLORTEXT | pink |
| Color | C48328 __ |
| FDA SPL set id | 798328 |
| Imprint code | TP;500 |
| Labeler | Redpharm Drug, Inc. |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2013-10-09 |
| Marketing status | ACTIVE |
| Score | 2 |
| Shapetext | Capsule Shaped |
| Shape | C48336 |
| Size | 16 mm |
| Related queries | Properties for NDC 9 67296-1836 |
NDC Item 70518417200
| NDC 9 | 70518-4172 |
|---|---|
| NDC 10 | 70518-4172-0 |
| NDC Item | 70518417200 |
| Packaging | 8 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (70518-4172-0) |
| ANDA | ANDA202489 |
| COLORTEXT | pink |
| Color | C48328 __ |
| FDA SPL set id | 807843 |
| Imprint code | TP;500 |
| Labeler | REMEDYREPACK INC. |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2024-08-30 |
| Marketing status | active |
| Score | 2 |
| Shapetext | Capsule Shaped |
| Shape | C48336 |
| Size | 16 mm |
| Related queries | Properties for NDC 9 70518-4172 |
NDC Item 70518417201
| NDC 9 | 70518-4172 |
|---|---|
| NDC 10 | 70518-4172-1 |
| NDC Item | 70518417201 |
| Packaging | 10 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (70518-4172-1) |
| ANDA | ANDA202489 |
| COLORTEXT | pink |
| Color | C48328 __ |
| FDA SPL set id | 807843 |
| Imprint code | TP;500 |
| Labeler | REMEDYREPACK INC. |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2024-08-30 |
| Marketing status | active |
| Score | 2 |
| Shapetext | Capsule Shaped |
| Shape | C48336 |
| Size | 16 mm |
| Related queries | Properties for NDC 9 70518-4172 |
NDC Item 00054034807
| NDC 9 | 0054-0348 |
|---|---|
| NDC 10 | 0054-0348-07 |
| NDC Item | 00054034807 |
| Packaging | 20 TABLET, FILM COATED in 1 BOTTLE (0054-0348-07) |
| ANDA | ANDA201172 |
| COLORTEXT | WHITE(Off White) |
| Color | C48325 __ |
| FDA SPL set id | 611868 |
| Imprint code | 54455 |
| Labeler | Hikma Pharmaceuticals USA Inc. |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time high | 2021-10-31 |
| Marketing effective time low | 2012-04-30 |
| Marketing status | COMPLETED |
| Score | 2 |
| Shapetext | Modified |
| Shape | C48345 |
| Size | 16 mm |
| Related queries | Properties for NDC 9 0054-0348 |
NDC Item 00054034821
| NDC 9 | 0054-0348 |
|---|---|
| NDC 10 | 0054-0348-21 |
| NDC Item | 00054034821 |
| Packaging | 60 TABLET, FILM COATED in 1 BOTTLE (0054-0348-21) |
| ANDA | ANDA201172 |
| COLORTEXT | WHITE(Off White) |
| Color | C48325 __ |
| FDA SPL set id | 611868 |
| Imprint code | 54455 |
| Labeler | Hikma Pharmaceuticals USA Inc. |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time high | 2021-10-31 |
| Marketing effective time low | 2012-04-30 |
| Marketing status | COMPLETED |
| Score | 2 |
| Shapetext | Modified |
| Shape | C48345 |
| Size | 16 mm |
| Related queries | Properties for NDC 9 0054-0348 |
NDC Item 16571021506
| NDC 9 | 16571-215 |
|---|---|
| NDC 10 | 16571-215-06 |
| NDC Item | 16571021506 |
| Packaging | 60 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (16571-215-06) |
| ANDA | ANDA202489 |
| COLORTEXT | PINK |
| Color | C48328 __ |
| FDA SPL set id | 114445 |
| Imprint code | TP;500 |
| Labeler | Rising Pharma Holdings, Inc. |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time high | 2013-10-10 |
| Marketing effective time low | 2013-10-09 |
| Marketing status | COMPLETED |
| Score | 2 |
| Shapetext | Capsule Shaped |
| Shape | C48336 |
| Size | 16 mm |
| Related queries | Properties for NDC 9 16571-215 |
NDC Item 42799020801
| NDC 9 | 42799-208 |
|---|---|
| NDC 10 | 42799-208-01 |
| NDC Item | 42799020801 |
| Packaging | 20 TABLET in 1 BOTTLE (42799-208-01) |
| ANDA | ANDA203808 |
| COLORTEXT | YELLOW |
| Color | C48330 __ |
| FDA SPL set id | 624893 |
| Imprint code | 208 |
| Labeler | Edenbridge Pharmaceuticals LLC. |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2019-12-20 |
| Marketing status | ACTIVE |
| Score | 2 |
| Shape | C48345 |
| Size | 16 mm |
| Related queries | Properties for NDC 9 42799-208 |
NDC Item 42799020802
| NDC 9 | 42799-208 |
|---|---|
| NDC 10 | 42799-208-02 |
| NDC Item | 42799020802 |
| Packaging | 60 TABLET in 1 BOTTLE (42799-208-02) |
| ANDA | ANDA203808 |
| COLORTEXT | YELLOW |
| Color | C48330 __ |
| FDA SPL set id | 624893 |
| Imprint code | 208 |
| Labeler | Edenbridge Pharmaceuticals LLC. |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2019-12-20 |
| Marketing status | ACTIVE |
| Score | 2 |
| Shape | C48345 |
| Size | 16 mm |
| Related queries | Properties for NDC 9 42799-208 |
NDC Item 43386055102
| NDC 9 | 43386-551 |
|---|---|
| NDC 10 | 43386-551-02 |
| NDC Item | 43386055102 |
| Packaging | 20 TABLET in 1 BOTTLE (43386-551-02) |
| ANDA | ANDA202044 |
| COLORTEXT | PINK |
| Color | C48328 __ |
| FDA SPL set id | 716141 |
| Imprint code | NL;551 |
| Labeler | Lupin Pharmaceuticals,Inc. |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2012-04-30 |
| Marketing status | ACTIVE |
| Score | 2 |
| Shape | C48345 |
| Size | 16 mm |
| Related queries | Properties for NDC 9 43386-551 |
NDC Item 43386055106
| NDC 9 | 43386-551 |
|---|---|
| NDC 10 | 43386-551-06 |
| NDC Item | 43386055106 |
| Packaging | 60 TABLET in 1 BOTTLE (43386-551-06) |
| ANDA | ANDA202044 |
| COLORTEXT | PINK |
| Color | C48328 __ |
| FDA SPL set id | 716141 |
| Imprint code | NL;551 |
| Labeler | Lupin Pharmaceuticals,Inc. |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2012-04-30 |
| Marketing status | ACTIVE |
| Score | 2 |
| Shape | C48345 |
| Size | 16 mm |
| Related queries | Properties for NDC 9 43386-551 |
NDC Item 44523045020
| NDC 9 | 44523-450 |
|---|---|
| NDC 10 | 44523-450-20 |
| NDC Item | 44523045020 |
| Packaging | 20 TABLET in 1 BOTTLE (44523-450-20) |
| COLORTEXT | PINK |
| Color | C48328 __ |
| FDA SPL set id | 71195 |
| Imprint code | TM;500 |
| Labeler | Biocomp Pharma, Inc. |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | NDA AUTHORIZED GENERIC |
| Marketing effective time high | 2019-02-05 |
| Marketing effective time low | 2012-06-07 |
| Marketing status | COMPLETED |
| NDA_AUTHORIZED_GENERIC | NDA021618 |
| Score | 2 |
| Shape | C48345 |
| Size | 14 mm |
| Related queries | Properties for NDC 9 44523-450 |
NDC Item 62135083520
| NDC 9 | 62135-835 |
|---|---|
| NDC 10 | 62135-835-20 |
| NDC Item | 62135083520 |
| Packaging | 20 TABLET, FILM COATED in 1 BOTTLE (62135-835-20) |
| ANDA | ANDA202044 |
| COLORTEXT | white(white to off-white) |
| Color | C48325 __ |
| FDA SPL set id | 798224 |
| Imprint code | C;E;205 |
| Labeler | Chartwell RX, LLC |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2012-04-30 |
| Marketing status | active |
| Score | 2 |
| Shape | C48345 |
| Size | 16 mm |
| Related queries | Properties for NDC 9 62135-835 |
NDC Item 64980042712
| NDC 9 | 64980-427 |
|---|---|
| NDC 10 | 64980-427-12 |
| NDC Item | 64980042712 |
| Packaging | 12 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (64980-427-12) |
| ANDA | ANDA202489 |
| COLORTEXT | PINK |
| Color | C48328 __ |
| FDA SPL set id | 717670 |
| Imprint code | TP;500 |
| Labeler | Rising Pharma Holdings, Inc. |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2013-10-09 |
| Marketing status | ACTIVE |
| Score | 2 |
| Shapetext | Capsule Shaped |
| Shape | C48336 |
| Size | 16 mm |
| Related queries | Properties for NDC 9 64980-427 |
NDC Item 67296183608
| NDC 9 | 67296-1836 |
|---|---|
| NDC 10 | 67296-1836-8 |
| NDC Item | 67296183608 |
| Packaging | 8 TABLET, FILM COATED in 1 BOTTLE (67296-1836-8) |
| ANDA | ANDA202489 |
| COLORTEXT | pink |
| Color | C48328 __ |
| FDA SPL set id | 798328 |
| Imprint code | TP;500 |
| Labeler | Redpharm Drug, Inc. |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2013-10-09 |
| Marketing status | ACTIVE |
| Score | 2 |
| Shapetext | Capsule Shaped |
| Shape | C48336 |
| Size | 16 mm |
| Related queries | Properties for NDC 9 67296-1836 |
NDC Item 70518417200
| NDC 9 | 70518-4172 |
|---|---|
| NDC 10 | 70518-4172-0 |
| NDC Item | 70518417200 |
| Packaging | 8 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (70518-4172-0) |
| ANDA | ANDA202489 |
| COLORTEXT | pink |
| Color | C48328 __ |
| FDA SPL set id | 807843 |
| Imprint code | TP;500 |
| Labeler | REMEDYREPACK INC. |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2024-08-30 |
| Marketing status | active |
| Score | 2 |
| Shapetext | Capsule Shaped |
| Shape | C48336 |
| Size | 16 mm |
| Related queries | Properties for NDC 9 70518-4172 |
NDC Item 70518417201
| NDC 9 | 70518-4172 |
|---|---|
| NDC 10 | 70518-4172-1 |
| NDC Item | 70518417201 |
| Packaging | 10 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (70518-4172-1) |
| ANDA | ANDA202489 |
| COLORTEXT | pink |
| Color | C48328 __ |
| FDA SPL set id | 807843 |
| Imprint code | TP;500 |
| Labeler | REMEDYREPACK INC. |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2024-08-30 |
| Marketing status | active |
| Score | 2 |
| Shapetext | Capsule Shaped |
| Shape | C48336 |
| Size | 16 mm |
| Related queries | Properties for NDC 9 70518-4172 |
NDC Item 00054034807
| NDC 9 | 0054-0348 |
|---|---|
| NDC 10 | 0054-0348-07 |
| NDC Item | 00054034807 |
| Packaging | 20 TABLET, FILM COATED in 1 BOTTLE (0054-0348-07) |
| ANDA | ANDA201172 |
| COLORTEXT | WHITE(Off White) |
| Color | C48325 __ |
| FDA SPL set id | 611868 |
| Imprint code | 54455 |
| Labeler | Hikma Pharmaceuticals USA Inc. |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time high | 2021-10-31 |
| Marketing effective time low | 2012-04-30 |
| Marketing status | COMPLETED |
| Score | 2 |
| Shapetext | Modified |
| Shape | C48345 |
| Size | 16 mm |
| Related queries | Properties for NDC 9 0054-0348 |
NDC Item 00054034821
| NDC 9 | 0054-0348 |
|---|---|
| NDC 10 | 0054-0348-21 |
| NDC Item | 00054034821 |
| Packaging | 60 TABLET, FILM COATED in 1 BOTTLE (0054-0348-21) |
| ANDA | ANDA201172 |
| COLORTEXT | WHITE(Off White) |
| Color | C48325 __ |
| FDA SPL set id | 611868 |
| Imprint code | 54455 |
| Labeler | Hikma Pharmaceuticals USA Inc. |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time high | 2021-10-31 |
| Marketing effective time low | 2012-04-30 |
| Marketing status | COMPLETED |
| Score | 2 |
| Shapetext | Modified |
| Shape | C48345 |
| Size | 16 mm |
| Related queries | Properties for NDC 9 0054-0348 |
NDC Item 16571021506
| NDC 9 | 16571-215 |
|---|---|
| NDC 10 | 16571-215-06 |
| NDC Item | 16571021506 |
| Packaging | 60 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (16571-215-06) |
| ANDA | ANDA202489 |
| COLORTEXT | PINK |
| Color | C48328 __ |
| FDA SPL set id | 114445 |
| Imprint code | TP;500 |
| Labeler | Rising Pharma Holdings, Inc. |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time high | 2013-10-10 |
| Marketing effective time low | 2013-10-09 |
| Marketing status | COMPLETED |
| Score | 2 |
| Shapetext | Capsule Shaped |
| Shape | C48336 |
| Size | 16 mm |
| Related queries | Properties for NDC 9 16571-215 |
NDC Item 42799020801
| NDC 9 | 42799-208 |
|---|---|
| NDC 10 | 42799-208-01 |
| NDC Item | 42799020801 |
| Packaging | 20 TABLET in 1 BOTTLE (42799-208-01) |
| ANDA | ANDA203808 |
| COLORTEXT | YELLOW |
| Color | C48330 __ |
| FDA SPL set id | 624893 |
| Imprint code | 208 |
| Labeler | Edenbridge Pharmaceuticals LLC. |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2019-12-20 |
| Marketing status | ACTIVE |
| Score | 2 |
| Shape | C48345 |
| Size | 16 mm |
| Related queries | Properties for NDC 9 42799-208 |
NDC Item 42799020802
| NDC 9 | 42799-208 |
|---|---|
| NDC 10 | 42799-208-02 |
| NDC Item | 42799020802 |
| Packaging | 60 TABLET in 1 BOTTLE (42799-208-02) |
| ANDA | ANDA203808 |
| COLORTEXT | YELLOW |
| Color | C48330 __ |
| FDA SPL set id | 624893 |
| Imprint code | 208 |
| Labeler | Edenbridge Pharmaceuticals LLC. |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2019-12-20 |
| Marketing status | ACTIVE |
| Score | 2 |
| Shape | C48345 |
| Size | 16 mm |
| Related queries | Properties for NDC 9 42799-208 |
NDC Item 43386055102
| NDC 9 | 43386-551 |
|---|---|
| NDC 10 | 43386-551-02 |
| NDC Item | 43386055102 |
| Packaging | 20 TABLET in 1 BOTTLE (43386-551-02) |
| ANDA | ANDA202044 |
| COLORTEXT | PINK |
| Color | C48328 __ |
| FDA SPL set id | 716141 |
| Imprint code | NL;551 |
| Labeler | Lupin Pharmaceuticals,Inc. |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2012-04-30 |
| Marketing status | ACTIVE |
| Score | 2 |
| Shape | C48345 |
| Size | 16 mm |
| Related queries | Properties for NDC 9 43386-551 |
NDC Item 43386055106
| NDC 9 | 43386-551 |
|---|---|
| NDC 10 | 43386-551-06 |
| NDC Item | 43386055106 |
| Packaging | 60 TABLET in 1 BOTTLE (43386-551-06) |
| ANDA | ANDA202044 |
| COLORTEXT | PINK |
| Color | C48328 __ |
| FDA SPL set id | 716141 |
| Imprint code | NL;551 |
| Labeler | Lupin Pharmaceuticals,Inc. |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2012-04-30 |
| Marketing status | ACTIVE |
| Score | 2 |
| Shape | C48345 |
| Size | 16 mm |
| Related queries | Properties for NDC 9 43386-551 |
NDC Item 44523045020
| NDC 9 | 44523-450 |
|---|---|
| NDC 10 | 44523-450-20 |
| NDC Item | 44523045020 |
| Packaging | 20 TABLET in 1 BOTTLE (44523-450-20) |
| COLORTEXT | PINK |
| Color | C48328 __ |
| FDA SPL set id | 71195 |
| Imprint code | TM;500 |
| Labeler | Biocomp Pharma, Inc. |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | NDA AUTHORIZED GENERIC |
| Marketing effective time high | 2019-02-05 |
| Marketing effective time low | 2012-06-07 |
| Marketing status | COMPLETED |
| NDA_AUTHORIZED_GENERIC | NDA021618 |
| Score | 2 |
| Shape | C48345 |
| Size | 14 mm |
| Related queries | Properties for NDC 9 44523-450 |
NDC Item 62135083520
| NDC 9 | 62135-835 |
|---|---|
| NDC 10 | 62135-835-20 |
| NDC Item | 62135083520 |
| Packaging | 20 TABLET, FILM COATED in 1 BOTTLE (62135-835-20) |
| ANDA | ANDA202044 |
| COLORTEXT | white(white to off-white) |
| Color | C48325 __ |
| FDA SPL set id | 798224 |
| Imprint code | C;E;205 |
| Labeler | Chartwell RX, LLC |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2012-04-30 |
| Marketing status | active |
| Score | 2 |
| Shape | C48345 |
| Size | 16 mm |
| Related queries | Properties for NDC 9 62135-835 |
NDC Item 64980042712
| NDC 9 | 64980-427 |
|---|---|
| NDC 10 | 64980-427-12 |
| NDC Item | 64980042712 |
| Packaging | 12 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (64980-427-12) |
| ANDA | ANDA202489 |
| COLORTEXT | PINK |
| Color | C48328 __ |
| FDA SPL set id | 717670 |
| Imprint code | TP;500 |
| Labeler | Rising Pharma Holdings, Inc. |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2013-10-09 |
| Marketing status | ACTIVE |
| Score | 2 |
| Shapetext | Capsule Shaped |
| Shape | C48336 |
| Size | 16 mm |
| Related queries | Properties for NDC 9 64980-427 |
NDC Item 67296183608
| NDC 9 | 67296-1836 |
|---|---|
| NDC 10 | 67296-1836-8 |
| NDC Item | 67296183608 |
| Packaging | 8 TABLET, FILM COATED in 1 BOTTLE (67296-1836-8) |
| ANDA | ANDA202489 |
| COLORTEXT | pink |
| Color | C48328 __ |
| FDA SPL set id | 798328 |
| Imprint code | TP;500 |
| Labeler | Redpharm Drug, Inc. |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2013-10-09 |
| Marketing status | ACTIVE |
| Score | 2 |
| Shapetext | Capsule Shaped |
| Shape | C48336 |
| Size | 16 mm |
| Related queries | Properties for NDC 9 67296-1836 |
NDC Item 70518417200
| NDC 9 | 70518-4172 |
|---|---|
| NDC 10 | 70518-4172-0 |
| NDC Item | 70518417200 |
| Packaging | 8 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (70518-4172-0) |
| ANDA | ANDA202489 |
| COLORTEXT | pink |
| Color | C48328 __ |
| FDA SPL set id | 807843 |
| Imprint code | TP;500 |
| Labeler | REMEDYREPACK INC. |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2024-08-30 |
| Marketing status | active |
| Score | 2 |
| Shapetext | Capsule Shaped |
| Shape | C48336 |
| Size | 16 mm |
| Related queries | Properties for NDC 9 70518-4172 |
NDC Item 70518417201
| NDC 9 | 70518-4172 |
|---|---|
| NDC 10 | 70518-4172-1 |
| NDC Item | 70518417201 |
| Packaging | 10 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (70518-4172-1) |
| ANDA | ANDA202489 |
| COLORTEXT | pink |
| Color | C48328 __ |
| FDA SPL set id | 807843 |
| Imprint code | TP;500 |
| Labeler | REMEDYREPACK INC. |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2024-08-30 |
| Marketing status | active |
| Score | 2 |
| Shapetext | Capsule Shaped |
| Shape | C48336 |
| Size | 16 mm |
| Related queries | Properties for NDC 9 70518-4172 |
NDC Item 00054034807
| NDC 9 | 0054-0348 |
|---|---|
| NDC 10 | 0054-0348-07 |
| NDC Item | 00054034807 |
| Packaging | 20 TABLET, FILM COATED in 1 BOTTLE (0054-0348-07) |
| ANDA | ANDA201172 |
| COLORTEXT | WHITE(Off White) |
| Color | C48325 __ |
| FDA SPL set id | 611868 |
| Imprint code | 54455 |
| Labeler | Hikma Pharmaceuticals USA Inc. |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time high | 2021-10-31 |
| Marketing effective time low | 2012-04-30 |
| Marketing status | COMPLETED |
| Score | 2 |
| Shapetext | Modified |
| Shape | C48345 |
| Size | 16 mm |
| Related queries | Properties for NDC 9 0054-0348 |
NDC Item 00054034821
| NDC 9 | 0054-0348 |
|---|---|
| NDC 10 | 0054-0348-21 |
| NDC Item | 00054034821 |
| Packaging | 60 TABLET, FILM COATED in 1 BOTTLE (0054-0348-21) |
| ANDA | ANDA201172 |
| COLORTEXT | WHITE(Off White) |
| Color | C48325 __ |
| FDA SPL set id | 611868 |
| Imprint code | 54455 |
| Labeler | Hikma Pharmaceuticals USA Inc. |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time high | 2021-10-31 |
| Marketing effective time low | 2012-04-30 |
| Marketing status | COMPLETED |
| Score | 2 |
| Shapetext | Modified |
| Shape | C48345 |
| Size | 16 mm |
| Related queries | Properties for NDC 9 0054-0348 |
NDC Item 16571021506
| NDC 9 | 16571-215 |
|---|---|
| NDC 10 | 16571-215-06 |
| NDC Item | 16571021506 |
| Packaging | 60 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (16571-215-06) |
| ANDA | ANDA202489 |
| COLORTEXT | PINK |
| Color | C48328 __ |
| FDA SPL set id | 114445 |
| Imprint code | TP;500 |
| Labeler | Rising Pharma Holdings, Inc. |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time high | 2013-10-10 |
| Marketing effective time low | 2013-10-09 |
| Marketing status | COMPLETED |
| Score | 2 |
| Shapetext | Capsule Shaped |
| Shape | C48336 |
| Size | 16 mm |
| Related queries | Properties for NDC 9 16571-215 |
NDC Item 42799020801
| NDC 9 | 42799-208 |
|---|---|
| NDC 10 | 42799-208-01 |
| NDC Item | 42799020801 |
| Packaging | 20 TABLET in 1 BOTTLE (42799-208-01) |
| ANDA | ANDA203808 |
| COLORTEXT | YELLOW |
| Color | C48330 __ |
| FDA SPL set id | 624893 |
| Imprint code | 208 |
| Labeler | Edenbridge Pharmaceuticals LLC. |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2019-12-20 |
| Marketing status | ACTIVE |
| Score | 2 |
| Shape | C48345 |
| Size | 16 mm |
| Related queries | Properties for NDC 9 42799-208 |
NDC Item 42799020802
| NDC 9 | 42799-208 |
|---|---|
| NDC 10 | 42799-208-02 |
| NDC Item | 42799020802 |
| Packaging | 60 TABLET in 1 BOTTLE (42799-208-02) |
| ANDA | ANDA203808 |
| COLORTEXT | YELLOW |
| Color | C48330 __ |
| FDA SPL set id | 624893 |
| Imprint code | 208 |
| Labeler | Edenbridge Pharmaceuticals LLC. |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2019-12-20 |
| Marketing status | ACTIVE |
| Score | 2 |
| Shape | C48345 |
| Size | 16 mm |
| Related queries | Properties for NDC 9 42799-208 |
NDC Item 43386055102
| NDC 9 | 43386-551 |
|---|---|
| NDC 10 | 43386-551-02 |
| NDC Item | 43386055102 |
| Packaging | 20 TABLET in 1 BOTTLE (43386-551-02) |
| ANDA | ANDA202044 |
| COLORTEXT | PINK |
| Color | C48328 __ |
| FDA SPL set id | 716141 |
| Imprint code | NL;551 |
| Labeler | Lupin Pharmaceuticals,Inc. |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2012-04-30 |
| Marketing status | ACTIVE |
| Score | 2 |
| Shape | C48345 |
| Size | 16 mm |
| Related queries | Properties for NDC 9 43386-551 |
NDC Item 43386055106
| NDC 9 | 43386-551 |
|---|---|
| NDC 10 | 43386-551-06 |
| NDC Item | 43386055106 |
| Packaging | 60 TABLET in 1 BOTTLE (43386-551-06) |
| ANDA | ANDA202044 |
| COLORTEXT | PINK |
| Color | C48328 __ |
| FDA SPL set id | 716141 |
| Imprint code | NL;551 |
| Labeler | Lupin Pharmaceuticals,Inc. |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2012-04-30 |
| Marketing status | ACTIVE |
| Score | 2 |
| Shape | C48345 |
| Size | 16 mm |
| Related queries | Properties for NDC 9 43386-551 |
NDC Item 44523045020
| NDC 9 | 44523-450 |
|---|---|
| NDC 10 | 44523-450-20 |
| NDC Item | 44523045020 |
| Packaging | 20 TABLET in 1 BOTTLE (44523-450-20) |
| COLORTEXT | PINK |
| Color | C48328 __ |
| FDA SPL set id | 71195 |
| Imprint code | TM;500 |
| Labeler | Biocomp Pharma, Inc. |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | NDA AUTHORIZED GENERIC |
| Marketing effective time high | 2019-02-05 |
| Marketing effective time low | 2012-06-07 |
| Marketing status | COMPLETED |
| NDA_AUTHORIZED_GENERIC | NDA021618 |
| Score | 2 |
| Shape | C48345 |
| Size | 14 mm |
| Related queries | Properties for NDC 9 44523-450 |
NDC Item 62135083520
| NDC 9 | 62135-835 |
|---|---|
| NDC 10 | 62135-835-20 |
| NDC Item | 62135083520 |
| Packaging | 20 TABLET, FILM COATED in 1 BOTTLE (62135-835-20) |
| ANDA | ANDA202044 |
| COLORTEXT | white(white to off-white) |
| Color | C48325 __ |
| FDA SPL set id | 798224 |
| Imprint code | C;E;205 |
| Labeler | Chartwell RX, LLC |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2012-04-30 |
| Marketing status | active |
| Score | 2 |
| Shape | C48345 |
| Size | 16 mm |
| Related queries | Properties for NDC 9 62135-835 |
NDC Item 64980042712
| NDC 9 | 64980-427 |
|---|---|
| NDC 10 | 64980-427-12 |
| NDC Item | 64980042712 |
| Packaging | 12 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (64980-427-12) |
| ANDA | ANDA202489 |
| COLORTEXT | PINK |
| Color | C48328 __ |
| FDA SPL set id | 717670 |
| Imprint code | TP;500 |
| Labeler | Rising Pharma Holdings, Inc. |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2013-10-09 |
| Marketing status | ACTIVE |
| Score | 2 |
| Shapetext | Capsule Shaped |
| Shape | C48336 |
| Size | 16 mm |
| Related queries | Properties for NDC 9 64980-427 |
NDC Item 67296183608
| NDC 9 | 67296-1836 |
|---|---|
| NDC 10 | 67296-1836-8 |
| NDC Item | 67296183608 |
| Packaging | 8 TABLET, FILM COATED in 1 BOTTLE (67296-1836-8) |
| ANDA | ANDA202489 |
| COLORTEXT | pink |
| Color | C48328 __ |
| FDA SPL set id | 798328 |
| Imprint code | TP;500 |
| Labeler | Redpharm Drug, Inc. |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2013-10-09 |
| Marketing status | ACTIVE |
| Score | 2 |
| Shapetext | Capsule Shaped |
| Shape | C48336 |
| Size | 16 mm |
| Related queries | Properties for NDC 9 67296-1836 |
NDC Item 70518417200
| NDC 9 | 70518-4172 |
|---|---|
| NDC 10 | 70518-4172-0 |
| NDC Item | 70518417200 |
| Packaging | 8 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (70518-4172-0) |
| ANDA | ANDA202489 |
| COLORTEXT | pink |
| Color | C48328 __ |
| FDA SPL set id | 807843 |
| Imprint code | TP;500 |
| Labeler | REMEDYREPACK INC. |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2024-08-30 |
| Marketing status | active |
| Score | 2 |
| Shapetext | Capsule Shaped |
| Shape | C48336 |
| Size | 16 mm |
| Related queries | Properties for NDC 9 70518-4172 |
NDC Item 70518417201
| NDC 9 | 70518-4172 |
|---|---|
| NDC 10 | 70518-4172-1 |
| NDC Item | 70518417201 |
| Packaging | 10 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (70518-4172-1) |
| ANDA | ANDA202489 |
| COLORTEXT | pink |
| Color | C48328 __ |
| FDA SPL set id | 807843 |
| Imprint code | TP;500 |
| Labeler | REMEDYREPACK INC. |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2024-08-30 |
| Marketing status | active |
| Score | 2 |
| Shapetext | Capsule Shaped |
| Shape | C48336 |
| Size | 16 mm |
| Related queries | Properties for NDC 9 70518-4172 |
NDC Item 00054034807
| NDC 9 | 0054-0348 |
|---|---|
| NDC 10 | 0054-0348-07 |
| NDC Item | 00054034807 |
| Packaging | 20 TABLET, FILM COATED in 1 BOTTLE (0054-0348-07) |
| ANDA | ANDA201172 |
| COLORTEXT | WHITE(Off White) |
| Color | C48325 __ |
| FDA SPL set id | 611868 |
| Imprint code | 54455 |
| Labeler | Hikma Pharmaceuticals USA Inc. |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time high | 2021-10-31 |
| Marketing effective time low | 2012-04-30 |
| Marketing status | COMPLETED |
| Score | 2 |
| Shapetext | Modified |
| Shape | C48345 |
| Size | 16 mm |
| Related queries | Properties for NDC 9 0054-0348 |
NDC Item 00054034821
| NDC 9 | 0054-0348 |
|---|---|
| NDC 10 | 0054-0348-21 |
| NDC Item | 00054034821 |
| Packaging | 60 TABLET, FILM COATED in 1 BOTTLE (0054-0348-21) |
| ANDA | ANDA201172 |
| COLORTEXT | WHITE(Off White) |
| Color | C48325 __ |
| FDA SPL set id | 611868 |
| Imprint code | 54455 |
| Labeler | Hikma Pharmaceuticals USA Inc. |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time high | 2021-10-31 |
| Marketing effective time low | 2012-04-30 |
| Marketing status | COMPLETED |
| Score | 2 |
| Shapetext | Modified |
| Shape | C48345 |
| Size | 16 mm |
| Related queries | Properties for NDC 9 0054-0348 |
NDC Item 16571021506
| NDC 9 | 16571-215 |
|---|---|
| NDC 10 | 16571-215-06 |
| NDC Item | 16571021506 |
| Packaging | 60 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (16571-215-06) |
| ANDA | ANDA202489 |
| COLORTEXT | PINK |
| Color | C48328 __ |
| FDA SPL set id | 114445 |
| Imprint code | TP;500 |
| Labeler | Rising Pharma Holdings, Inc. |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time high | 2013-10-10 |
| Marketing effective time low | 2013-10-09 |
| Marketing status | COMPLETED |
| Score | 2 |
| Shapetext | Capsule Shaped |
| Shape | C48336 |
| Size | 16 mm |
| Related queries | Properties for NDC 9 16571-215 |
NDC Item 42799020801
| NDC 9 | 42799-208 |
|---|---|
| NDC 10 | 42799-208-01 |
| NDC Item | 42799020801 |
| Packaging | 20 TABLET in 1 BOTTLE (42799-208-01) |
| ANDA | ANDA203808 |
| COLORTEXT | YELLOW |
| Color | C48330 __ |
| FDA SPL set id | 624893 |
| Imprint code | 208 |
| Labeler | Edenbridge Pharmaceuticals LLC. |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2019-12-20 |
| Marketing status | ACTIVE |
| Score | 2 |
| Shape | C48345 |
| Size | 16 mm |
| Related queries | Properties for NDC 9 42799-208 |
NDC Item 42799020802
| NDC 9 | 42799-208 |
|---|---|
| NDC 10 | 42799-208-02 |
| NDC Item | 42799020802 |
| Packaging | 60 TABLET in 1 BOTTLE (42799-208-02) |
| ANDA | ANDA203808 |
| COLORTEXT | YELLOW |
| Color | C48330 __ |
| FDA SPL set id | 624893 |
| Imprint code | 208 |
| Labeler | Edenbridge Pharmaceuticals LLC. |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2019-12-20 |
| Marketing status | ACTIVE |
| Score | 2 |
| Shape | C48345 |
| Size | 16 mm |
| Related queries | Properties for NDC 9 42799-208 |
NDC Item 43386055102
| NDC 9 | 43386-551 |
|---|---|
| NDC 10 | 43386-551-02 |
| NDC Item | 43386055102 |
| Packaging | 20 TABLET in 1 BOTTLE (43386-551-02) |
| ANDA | ANDA202044 |
| COLORTEXT | PINK |
| Color | C48328 __ |
| FDA SPL set id | 716141 |
| Imprint code | NL;551 |
| Labeler | Lupin Pharmaceuticals,Inc. |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2012-04-30 |
| Marketing status | ACTIVE |
| Score | 2 |
| Shape | C48345 |
| Size | 16 mm |
| Related queries | Properties for NDC 9 43386-551 |
NDC Item 43386055106
| NDC 9 | 43386-551 |
|---|---|
| NDC 10 | 43386-551-06 |
| NDC Item | 43386055106 |
| Packaging | 60 TABLET in 1 BOTTLE (43386-551-06) |
| ANDA | ANDA202044 |
| COLORTEXT | PINK |
| Color | C48328 __ |
| FDA SPL set id | 716141 |
| Imprint code | NL;551 |
| Labeler | Lupin Pharmaceuticals,Inc. |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2012-04-30 |
| Marketing status | ACTIVE |
| Score | 2 |
| Shape | C48345 |
| Size | 16 mm |
| Related queries | Properties for NDC 9 43386-551 |
NDC Item 44523045020
| NDC 9 | 44523-450 |
|---|---|
| NDC 10 | 44523-450-20 |
| NDC Item | 44523045020 |
| Packaging | 20 TABLET in 1 BOTTLE (44523-450-20) |
| COLORTEXT | PINK |
| Color | C48328 __ |
| FDA SPL set id | 71195 |
| Imprint code | TM;500 |
| Labeler | Biocomp Pharma, Inc. |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | NDA AUTHORIZED GENERIC |
| Marketing effective time high | 2019-02-05 |
| Marketing effective time low | 2012-06-07 |
| Marketing status | COMPLETED |
| NDA_AUTHORIZED_GENERIC | NDA021618 |
| Score | 2 |
| Shape | C48345 |
| Size | 14 mm |
| Related queries | Properties for NDC 9 44523-450 |
NDC Item 62135083520
| NDC 9 | 62135-835 |
|---|---|
| NDC 10 | 62135-835-20 |
| NDC Item | 62135083520 |
| Packaging | 20 TABLET, FILM COATED in 1 BOTTLE (62135-835-20) |
| ANDA | ANDA202044 |
| COLORTEXT | white(white to off-white) |
| Color | C48325 __ |
| FDA SPL set id | 798224 |
| Imprint code | C;E;205 |
| Labeler | Chartwell RX, LLC |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2012-04-30 |
| Marketing status | active |
| Score | 2 |
| Shape | C48345 |
| Size | 16 mm |
| Related queries | Properties for NDC 9 62135-835 |
NDC Item 64980042712
| NDC 9 | 64980-427 |
|---|---|
| NDC 10 | 64980-427-12 |
| NDC Item | 64980042712 |
| Packaging | 12 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (64980-427-12) |
| ANDA | ANDA202489 |
| COLORTEXT | PINK |
| Color | C48328 __ |
| FDA SPL set id | 717670 |
| Imprint code | TP;500 |
| Labeler | Rising Pharma Holdings, Inc. |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2013-10-09 |
| Marketing status | ACTIVE |
| Score | 2 |
| Shapetext | Capsule Shaped |
| Shape | C48336 |
| Size | 16 mm |
| Related queries | Properties for NDC 9 64980-427 |
NDC Item 67296183608
| NDC 9 | 67296-1836 |
|---|---|
| NDC 10 | 67296-1836-8 |
| NDC Item | 67296183608 |
| Packaging | 8 TABLET, FILM COATED in 1 BOTTLE (67296-1836-8) |
| ANDA | ANDA202489 |
| COLORTEXT | pink |
| Color | C48328 __ |
| FDA SPL set id | 798328 |
| Imprint code | TP;500 |
| Labeler | Redpharm Drug, Inc. |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2013-10-09 |
| Marketing status | ACTIVE |
| Score | 2 |
| Shapetext | Capsule Shaped |
| Shape | C48336 |
| Size | 16 mm |
| Related queries | Properties for NDC 9 67296-1836 |
NDC Item 70518417200
| NDC 9 | 70518-4172 |
|---|---|
| NDC 10 | 70518-4172-0 |
| NDC Item | 70518417200 |
| Packaging | 8 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (70518-4172-0) |
| ANDA | ANDA202489 |
| COLORTEXT | pink |
| Color | C48328 __ |
| FDA SPL set id | 807843 |
| Imprint code | TP;500 |
| Labeler | REMEDYREPACK INC. |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2024-08-30 |
| Marketing status | active |
| Score | 2 |
| Shapetext | Capsule Shaped |
| Shape | C48336 |
| Size | 16 mm |
| Related queries | Properties for NDC 9 70518-4172 |
NDC Item 70518417201
| NDC 9 | 70518-4172 |
|---|---|
| NDC 10 | 70518-4172-1 |
| NDC Item | 70518417201 |
| Packaging | 10 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (70518-4172-1) |
| ANDA | ANDA202489 |
| COLORTEXT | pink |
| Color | C48328 __ |
| FDA SPL set id | 807843 |
| Imprint code | TP;500 |
| Labeler | REMEDYREPACK INC. |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2024-08-30 |
| Marketing status | active |
| Score | 2 |
| Shapetext | Capsule Shaped |
| Shape | C48336 |
| Size | 16 mm |
| Related queries | Properties for NDC 9 70518-4172 |
NDC Item 00054034807
| NDC 9 | 0054-0348 |
|---|---|
| NDC 10 | 0054-0348-07 |
| NDC Item | 00054034807 |
| Packaging | 20 TABLET, FILM COATED in 1 BOTTLE (0054-0348-07) |
| ANDA | ANDA201172 |
| COLORTEXT | WHITE(Off White) |
| Color | C48325 __ |
| FDA SPL set id | 611868 |
| Imprint code | 54455 |
| Labeler | Hikma Pharmaceuticals USA Inc. |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time high | 2021-10-31 |
| Marketing effective time low | 2012-04-30 |
| Marketing status | COMPLETED |
| Score | 2 |
| Shapetext | Modified |
| Shape | C48345 |
| Size | 16 mm |
| Related queries | Properties for NDC 9 0054-0348 |
NDC Item 00054034821
| NDC 9 | 0054-0348 |
|---|---|
| NDC 10 | 0054-0348-21 |
| NDC Item | 00054034821 |
| Packaging | 60 TABLET, FILM COATED in 1 BOTTLE (0054-0348-21) |
| ANDA | ANDA201172 |
| COLORTEXT | WHITE(Off White) |
| Color | C48325 __ |
| FDA SPL set id | 611868 |
| Imprint code | 54455 |
| Labeler | Hikma Pharmaceuticals USA Inc. |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time high | 2021-10-31 |
| Marketing effective time low | 2012-04-30 |
| Marketing status | COMPLETED |
| Score | 2 |
| Shapetext | Modified |
| Shape | C48345 |
| Size | 16 mm |
| Related queries | Properties for NDC 9 0054-0348 |
NDC Item 16571021506
| NDC 9 | 16571-215 |
|---|---|
| NDC 10 | 16571-215-06 |
| NDC Item | 16571021506 |
| Packaging | 60 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (16571-215-06) |
| ANDA | ANDA202489 |
| COLORTEXT | PINK |
| Color | C48328 __ |
| FDA SPL set id | 114445 |
| Imprint code | TP;500 |
| Labeler | Rising Pharma Holdings, Inc. |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time high | 2013-10-10 |
| Marketing effective time low | 2013-10-09 |
| Marketing status | COMPLETED |
| Score | 2 |
| Shapetext | Capsule Shaped |
| Shape | C48336 |
| Size | 16 mm |
| Related queries | Properties for NDC 9 16571-215 |
NDC Item 42799020801
| NDC 9 | 42799-208 |
|---|---|
| NDC 10 | 42799-208-01 |
| NDC Item | 42799020801 |
| Packaging | 20 TABLET in 1 BOTTLE (42799-208-01) |
| ANDA | ANDA203808 |
| COLORTEXT | YELLOW |
| Color | C48330 __ |
| FDA SPL set id | 624893 |
| Imprint code | 208 |
| Labeler | Edenbridge Pharmaceuticals LLC. |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2019-12-20 |
| Marketing status | ACTIVE |
| Score | 2 |
| Shape | C48345 |
| Size | 16 mm |
| Related queries | Properties for NDC 9 42799-208 |
NDC Item 42799020802
| NDC 9 | 42799-208 |
|---|---|
| NDC 10 | 42799-208-02 |
| NDC Item | 42799020802 |
| Packaging | 60 TABLET in 1 BOTTLE (42799-208-02) |
| ANDA | ANDA203808 |
| COLORTEXT | YELLOW |
| Color | C48330 __ |
| FDA SPL set id | 624893 |
| Imprint code | 208 |
| Labeler | Edenbridge Pharmaceuticals LLC. |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2019-12-20 |
| Marketing status | ACTIVE |
| Score | 2 |
| Shape | C48345 |
| Size | 16 mm |
| Related queries | Properties for NDC 9 42799-208 |
NDC Item 43386055102
| NDC 9 | 43386-551 |
|---|---|
| NDC 10 | 43386-551-02 |
| NDC Item | 43386055102 |
| Packaging | 20 TABLET in 1 BOTTLE (43386-551-02) |
| ANDA | ANDA202044 |
| COLORTEXT | PINK |
| Color | C48328 __ |
| FDA SPL set id | 716141 |
| Imprint code | NL;551 |
| Labeler | Lupin Pharmaceuticals,Inc. |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2012-04-30 |
| Marketing status | ACTIVE |
| Score | 2 |
| Shape | C48345 |
| Size | 16 mm |
| Related queries | Properties for NDC 9 43386-551 |
NDC Item 43386055106
| NDC 9 | 43386-551 |
|---|---|
| NDC 10 | 43386-551-06 |
| NDC Item | 43386055106 |
| Packaging | 60 TABLET in 1 BOTTLE (43386-551-06) |
| ANDA | ANDA202044 |
| COLORTEXT | PINK |
| Color | C48328 __ |
| FDA SPL set id | 716141 |
| Imprint code | NL;551 |
| Labeler | Lupin Pharmaceuticals,Inc. |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2012-04-30 |
| Marketing status | ACTIVE |
| Score | 2 |
| Shape | C48345 |
| Size | 16 mm |
| Related queries | Properties for NDC 9 43386-551 |
NDC Item 44523045020
| NDC 9 | 44523-450 |
|---|---|
| NDC 10 | 44523-450-20 |
| NDC Item | 44523045020 |
| Packaging | 20 TABLET in 1 BOTTLE (44523-450-20) |
| COLORTEXT | PINK |
| Color | C48328 __ |
| FDA SPL set id | 71195 |
| Imprint code | TM;500 |
| Labeler | Biocomp Pharma, Inc. |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | NDA AUTHORIZED GENERIC |
| Marketing effective time high | 2019-02-05 |
| Marketing effective time low | 2012-06-07 |
| Marketing status | COMPLETED |
| NDA_AUTHORIZED_GENERIC | NDA021618 |
| Score | 2 |
| Shape | C48345 |
| Size | 14 mm |
| Related queries | Properties for NDC 9 44523-450 |
NDC Item 62135083520
| NDC 9 | 62135-835 |
|---|---|
| NDC 10 | 62135-835-20 |
| NDC Item | 62135083520 |
| Packaging | 20 TABLET, FILM COATED in 1 BOTTLE (62135-835-20) |
| ANDA | ANDA202044 |
| COLORTEXT | white(white to off-white) |
| Color | C48325 __ |
| FDA SPL set id | 798224 |
| Imprint code | C;E;205 |
| Labeler | Chartwell RX, LLC |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2012-04-30 |
| Marketing status | active |
| Score | 2 |
| Shape | C48345 |
| Size | 16 mm |
| Related queries | Properties for NDC 9 62135-835 |
NDC Item 64980042712
| NDC 9 | 64980-427 |
|---|---|
| NDC 10 | 64980-427-12 |
| NDC Item | 64980042712 |
| Packaging | 12 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (64980-427-12) |
| ANDA | ANDA202489 |
| COLORTEXT | PINK |
| Color | C48328 __ |
| FDA SPL set id | 717670 |
| Imprint code | TP;500 |
| Labeler | Rising Pharma Holdings, Inc. |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2013-10-09 |
| Marketing status | ACTIVE |
| Score | 2 |
| Shapetext | Capsule Shaped |
| Shape | C48336 |
| Size | 16 mm |
| Related queries | Properties for NDC 9 64980-427 |
NDC Item 67296183608
| NDC 9 | 67296-1836 |
|---|---|
| NDC 10 | 67296-1836-8 |
| NDC Item | 67296183608 |
| Packaging | 8 TABLET, FILM COATED in 1 BOTTLE (67296-1836-8) |
| ANDA | ANDA202489 |
| COLORTEXT | pink |
| Color | C48328 __ |
| FDA SPL set id | 798328 |
| Imprint code | TP;500 |
| Labeler | Redpharm Drug, Inc. |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2013-10-09 |
| Marketing status | ACTIVE |
| Score | 2 |
| Shapetext | Capsule Shaped |
| Shape | C48336 |
| Size | 16 mm |
| Related queries | Properties for NDC 9 67296-1836 |
NDC Item 70518417200
| NDC 9 | 70518-4172 |
|---|---|
| NDC 10 | 70518-4172-0 |
| NDC Item | 70518417200 |
| Packaging | 8 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (70518-4172-0) |
| ANDA | ANDA202489 |
| COLORTEXT | pink |
| Color | C48328 __ |
| FDA SPL set id | 807843 |
| Imprint code | TP;500 |
| Labeler | REMEDYREPACK INC. |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2024-08-30 |
| Marketing status | active |
| Score | 2 |
| Shapetext | Capsule Shaped |
| Shape | C48336 |
| Size | 16 mm |
| Related queries | Properties for NDC 9 70518-4172 |
NDC Item 70518417201
| NDC 9 | 70518-4172 |
|---|---|
| NDC 10 | 70518-4172-1 |
| NDC Item | 70518417201 |
| Packaging | 10 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (70518-4172-1) |
| ANDA | ANDA202489 |
| COLORTEXT | pink |
| Color | C48328 __ |
| FDA SPL set id | 807843 |
| Imprint code | TP;500 |
| Labeler | REMEDYREPACK INC. |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2024-08-30 |
| Marketing status | active |
| Score | 2 |
| Shapetext | Capsule Shaped |
| Shape | C48336 |
| Size | 16 mm |
| Related queries | Properties for NDC 9 70518-4172 |
NDC Item 00054034807
| NDC 9 | 0054-0348 |
|---|---|
| NDC 10 | 0054-0348-07 |
| NDC Item | 00054034807 |
| Packaging | 20 TABLET, FILM COATED in 1 BOTTLE (0054-0348-07) |
| ANDA | ANDA201172 |
| COLORTEXT | WHITE(Off White) |
| Color | C48325 __ |
| FDA SPL set id | 611868 |
| Imprint code | 54455 |
| Labeler | Hikma Pharmaceuticals USA Inc. |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time high | 2021-10-31 |
| Marketing effective time low | 2012-04-30 |
| Marketing status | COMPLETED |
| Score | 2 |
| Shapetext | Modified |
| Shape | C48345 |
| Size | 16 mm |
| Related queries | Properties for NDC 9 0054-0348 |
NDC Item 00054034821
| NDC 9 | 0054-0348 |
|---|---|
| NDC 10 | 0054-0348-21 |
| NDC Item | 00054034821 |
| Packaging | 60 TABLET, FILM COATED in 1 BOTTLE (0054-0348-21) |
| ANDA | ANDA201172 |
| COLORTEXT | WHITE(Off White) |
| Color | C48325 __ |
| FDA SPL set id | 611868 |
| Imprint code | 54455 |
| Labeler | Hikma Pharmaceuticals USA Inc. |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time high | 2021-10-31 |
| Marketing effective time low | 2012-04-30 |
| Marketing status | COMPLETED |
| Score | 2 |
| Shapetext | Modified |
| Shape | C48345 |
| Size | 16 mm |
| Related queries | Properties for NDC 9 0054-0348 |
NDC Item 16571021506
| NDC 9 | 16571-215 |
|---|---|
| NDC 10 | 16571-215-06 |
| NDC Item | 16571021506 |
| Packaging | 60 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (16571-215-06) |
| ANDA | ANDA202489 |
| COLORTEXT | PINK |
| Color | C48328 __ |
| FDA SPL set id | 114445 |
| Imprint code | TP;500 |
| Labeler | Rising Pharma Holdings, Inc. |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time high | 2013-10-10 |
| Marketing effective time low | 2013-10-09 |
| Marketing status | COMPLETED |
| Score | 2 |
| Shapetext | Capsule Shaped |
| Shape | C48336 |
| Size | 16 mm |
| Related queries | Properties for NDC 9 16571-215 |
NDC Item 42799020801
| NDC 9 | 42799-208 |
|---|---|
| NDC 10 | 42799-208-01 |
| NDC Item | 42799020801 |
| Packaging | 20 TABLET in 1 BOTTLE (42799-208-01) |
| ANDA | ANDA203808 |
| COLORTEXT | YELLOW |
| Color | C48330 __ |
| FDA SPL set id | 624893 |
| Imprint code | 208 |
| Labeler | Edenbridge Pharmaceuticals LLC. |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2019-12-20 |
| Marketing status | ACTIVE |
| Score | 2 |
| Shape | C48345 |
| Size | 16 mm |
| Related queries | Properties for NDC 9 42799-208 |
NDC Item 42799020802
| NDC 9 | 42799-208 |
|---|---|
| NDC 10 | 42799-208-02 |
| NDC Item | 42799020802 |
| Packaging | 60 TABLET in 1 BOTTLE (42799-208-02) |
| ANDA | ANDA203808 |
| COLORTEXT | YELLOW |
| Color | C48330 __ |
| FDA SPL set id | 624893 |
| Imprint code | 208 |
| Labeler | Edenbridge Pharmaceuticals LLC. |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2019-12-20 |
| Marketing status | ACTIVE |
| Score | 2 |
| Shape | C48345 |
| Size | 16 mm |
| Related queries | Properties for NDC 9 42799-208 |
NDC Item 43386055102
| NDC 9 | 43386-551 |
|---|---|
| NDC 10 | 43386-551-02 |
| NDC Item | 43386055102 |
| Packaging | 20 TABLET in 1 BOTTLE (43386-551-02) |
| ANDA | ANDA202044 |
| COLORTEXT | PINK |
| Color | C48328 __ |
| FDA SPL set id | 716141 |
| Imprint code | NL;551 |
| Labeler | Lupin Pharmaceuticals,Inc. |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2012-04-30 |
| Marketing status | ACTIVE |
| Score | 2 |
| Shape | C48345 |
| Size | 16 mm |
| Related queries | Properties for NDC 9 43386-551 |
NDC Item 43386055106
| NDC 9 | 43386-551 |
|---|---|
| NDC 10 | 43386-551-06 |
| NDC Item | 43386055106 |
| Packaging | 60 TABLET in 1 BOTTLE (43386-551-06) |
| ANDA | ANDA202044 |
| COLORTEXT | PINK |
| Color | C48328 __ |
| FDA SPL set id | 716141 |
| Imprint code | NL;551 |
| Labeler | Lupin Pharmaceuticals,Inc. |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2012-04-30 |
| Marketing status | ACTIVE |
| Score | 2 |
| Shape | C48345 |
| Size | 16 mm |
| Related queries | Properties for NDC 9 43386-551 |
NDC Item 44523045020
| NDC 9 | 44523-450 |
|---|---|
| NDC 10 | 44523-450-20 |
| NDC Item | 44523045020 |
| Packaging | 20 TABLET in 1 BOTTLE (44523-450-20) |
| COLORTEXT | PINK |
| Color | C48328 __ |
| FDA SPL set id | 71195 |
| Imprint code | TM;500 |
| Labeler | Biocomp Pharma, Inc. |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | NDA AUTHORIZED GENERIC |
| Marketing effective time high | 2019-02-05 |
| Marketing effective time low | 2012-06-07 |
| Marketing status | COMPLETED |
| NDA_AUTHORIZED_GENERIC | NDA021618 |
| Score | 2 |
| Shape | C48345 |
| Size | 14 mm |
| Related queries | Properties for NDC 9 44523-450 |
NDC Item 62135083520
| NDC 9 | 62135-835 |
|---|---|
| NDC 10 | 62135-835-20 |
| NDC Item | 62135083520 |
| Packaging | 20 TABLET, FILM COATED in 1 BOTTLE (62135-835-20) |
| ANDA | ANDA202044 |
| COLORTEXT | white(white to off-white) |
| Color | C48325 __ |
| FDA SPL set id | 798224 |
| Imprint code | C;E;205 |
| Labeler | Chartwell RX, LLC |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2012-04-30 |
| Marketing status | active |
| Score | 2 |
| Shape | C48345 |
| Size | 16 mm |
| Related queries | Properties for NDC 9 62135-835 |
NDC Item 64980042712
| NDC 9 | 64980-427 |
|---|---|
| NDC 10 | 64980-427-12 |
| NDC Item | 64980042712 |
| Packaging | 12 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (64980-427-12) |
| ANDA | ANDA202489 |
| COLORTEXT | PINK |
| Color | C48328 __ |
| FDA SPL set id | 717670 |
| Imprint code | TP;500 |
| Labeler | Rising Pharma Holdings, Inc. |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2013-10-09 |
| Marketing status | ACTIVE |
| Score | 2 |
| Shapetext | Capsule Shaped |
| Shape | C48336 |
| Size | 16 mm |
| Related queries | Properties for NDC 9 64980-427 |
NDC Item 67296183608
| NDC 9 | 67296-1836 |
|---|---|
| NDC 10 | 67296-1836-8 |
| NDC Item | 67296183608 |
| Packaging | 8 TABLET, FILM COATED in 1 BOTTLE (67296-1836-8) |
| ANDA | ANDA202489 |
| COLORTEXT | pink |
| Color | C48328 __ |
| FDA SPL set id | 798328 |
| Imprint code | TP;500 |
| Labeler | Redpharm Drug, Inc. |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2013-10-09 |
| Marketing status | ACTIVE |
| Score | 2 |
| Shapetext | Capsule Shaped |
| Shape | C48336 |
| Size | 16 mm |
| Related queries | Properties for NDC 9 67296-1836 |
NDC Item 70518417200
| NDC 9 | 70518-4172 |
|---|---|
| NDC 10 | 70518-4172-0 |
| NDC Item | 70518417200 |
| Packaging | 8 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (70518-4172-0) |
| ANDA | ANDA202489 |
| COLORTEXT | pink |
| Color | C48328 __ |
| FDA SPL set id | 807843 |
| Imprint code | TP;500 |
| Labeler | REMEDYREPACK INC. |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2024-08-30 |
| Marketing status | active |
| Score | 2 |
| Shapetext | Capsule Shaped |
| Shape | C48336 |
| Size | 16 mm |
| Related queries | Properties for NDC 9 70518-4172 |
NDC Item 70518417201
| NDC 9 | 70518-4172 |
|---|---|
| NDC 10 | 70518-4172-1 |
| NDC Item | 70518417201 |
| Packaging | 10 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (70518-4172-1) |
| ANDA | ANDA202489 |
| COLORTEXT | pink |
| Color | C48328 __ |
| FDA SPL set id | 807843 |
| Imprint code | TP;500 |
| Labeler | REMEDYREPACK INC. |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2024-08-30 |
| Marketing status | active |
| Score | 2 |
| Shapetext | Capsule Shaped |
| Shape | C48336 |
| Size | 16 mm |
| Related queries | Properties for NDC 9 70518-4172 |
NDC Item 00054034807
| NDC 9 | 0054-0348 |
|---|---|
| NDC 10 | 0054-0348-07 |
| NDC Item | 00054034807 |
| Packaging | 20 TABLET, FILM COATED in 1 BOTTLE (0054-0348-07) |
| ANDA | ANDA201172 |
| COLORTEXT | WHITE(Off White) |
| Color | C48325 __ |
| FDA SPL set id | 611868 |
| Imprint code | 54455 |
| Labeler | Hikma Pharmaceuticals USA Inc. |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time high | 2021-10-31 |
| Marketing effective time low | 2012-04-30 |
| Marketing status | COMPLETED |
| Score | 2 |
| Shapetext | Modified |
| Shape | C48345 |
| Size | 16 mm |
| Related queries | Properties for NDC 9 0054-0348 |
NDC Item 00054034821
| NDC 9 | 0054-0348 |
|---|---|
| NDC 10 | 0054-0348-21 |
| NDC Item | 00054034821 |
| Packaging | 60 TABLET, FILM COATED in 1 BOTTLE (0054-0348-21) |
| ANDA | ANDA201172 |
| COLORTEXT | WHITE(Off White) |
| Color | C48325 __ |
| FDA SPL set id | 611868 |
| Imprint code | 54455 |
| Labeler | Hikma Pharmaceuticals USA Inc. |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time high | 2021-10-31 |
| Marketing effective time low | 2012-04-30 |
| Marketing status | COMPLETED |
| Score | 2 |
| Shapetext | Modified |
| Shape | C48345 |
| Size | 16 mm |
| Related queries | Properties for NDC 9 0054-0348 |
NDC Item 16571021506
| NDC 9 | 16571-215 |
|---|---|
| NDC 10 | 16571-215-06 |
| NDC Item | 16571021506 |
| Packaging | 60 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (16571-215-06) |
| ANDA | ANDA202489 |
| COLORTEXT | PINK |
| Color | C48328 __ |
| FDA SPL set id | 114445 |
| Imprint code | TP;500 |
| Labeler | Rising Pharma Holdings, Inc. |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time high | 2013-10-10 |
| Marketing effective time low | 2013-10-09 |
| Marketing status | COMPLETED |
| Score | 2 |
| Shapetext | Capsule Shaped |
| Shape | C48336 |
| Size | 16 mm |
| Related queries | Properties for NDC 9 16571-215 |
NDC Item 42799020801
| NDC 9 | 42799-208 |
|---|---|
| NDC 10 | 42799-208-01 |
| NDC Item | 42799020801 |
| Packaging | 20 TABLET in 1 BOTTLE (42799-208-01) |
| ANDA | ANDA203808 |
| COLORTEXT | YELLOW |
| Color | C48330 __ |
| FDA SPL set id | 624893 |
| Imprint code | 208 |
| Labeler | Edenbridge Pharmaceuticals LLC. |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2019-12-20 |
| Marketing status | ACTIVE |
| Score | 2 |
| Shape | C48345 |
| Size | 16 mm |
| Related queries | Properties for NDC 9 42799-208 |
NDC Item 42799020802
| NDC 9 | 42799-208 |
|---|---|
| NDC 10 | 42799-208-02 |
| NDC Item | 42799020802 |
| Packaging | 60 TABLET in 1 BOTTLE (42799-208-02) |
| ANDA | ANDA203808 |
| COLORTEXT | YELLOW |
| Color | C48330 __ |
| FDA SPL set id | 624893 |
| Imprint code | 208 |
| Labeler | Edenbridge Pharmaceuticals LLC. |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2019-12-20 |
| Marketing status | ACTIVE |
| Score | 2 |
| Shape | C48345 |
| Size | 16 mm |
| Related queries | Properties for NDC 9 42799-208 |
NDC Item 43386055102
| NDC 9 | 43386-551 |
|---|---|
| NDC 10 | 43386-551-02 |
| NDC Item | 43386055102 |
| Packaging | 20 TABLET in 1 BOTTLE (43386-551-02) |
| ANDA | ANDA202044 |
| COLORTEXT | PINK |
| Color | C48328 __ |
| FDA SPL set id | 716141 |
| Imprint code | NL;551 |
| Labeler | Lupin Pharmaceuticals,Inc. |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2012-04-30 |
| Marketing status | ACTIVE |
| Score | 2 |
| Shape | C48345 |
| Size | 16 mm |
| Related queries | Properties for NDC 9 43386-551 |
NDC Item 43386055106
| NDC 9 | 43386-551 |
|---|---|
| NDC 10 | 43386-551-06 |
| NDC Item | 43386055106 |
| Packaging | 60 TABLET in 1 BOTTLE (43386-551-06) |
| ANDA | ANDA202044 |
| COLORTEXT | PINK |
| Color | C48328 __ |
| FDA SPL set id | 716141 |
| Imprint code | NL;551 |
| Labeler | Lupin Pharmaceuticals,Inc. |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2012-04-30 |
| Marketing status | ACTIVE |
| Score | 2 |
| Shape | C48345 |
| Size | 16 mm |
| Related queries | Properties for NDC 9 43386-551 |
NDC Item 44523045020
| NDC 9 | 44523-450 |
|---|---|
| NDC 10 | 44523-450-20 |
| NDC Item | 44523045020 |
| Packaging | 20 TABLET in 1 BOTTLE (44523-450-20) |
| COLORTEXT | PINK |
| Color | C48328 __ |
| FDA SPL set id | 71195 |
| Imprint code | TM;500 |
| Labeler | Biocomp Pharma, Inc. |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | NDA AUTHORIZED GENERIC |
| Marketing effective time high | 2019-02-05 |
| Marketing effective time low | 2012-06-07 |
| Marketing status | COMPLETED |
| NDA_AUTHORIZED_GENERIC | NDA021618 |
| Score | 2 |
| Shape | C48345 |
| Size | 14 mm |
| Related queries | Properties for NDC 9 44523-450 |
NDC Item 62135083520
| NDC 9 | 62135-835 |
|---|---|
| NDC 10 | 62135-835-20 |
| NDC Item | 62135083520 |
| Packaging | 20 TABLET, FILM COATED in 1 BOTTLE (62135-835-20) |
| ANDA | ANDA202044 |
| COLORTEXT | white(white to off-white) |
| Color | C48325 __ |
| FDA SPL set id | 798224 |
| Imprint code | C;E;205 |
| Labeler | Chartwell RX, LLC |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2012-04-30 |
| Marketing status | active |
| Score | 2 |
| Shape | C48345 |
| Size | 16 mm |
| Related queries | Properties for NDC 9 62135-835 |
NDC Item 64980042712
| NDC 9 | 64980-427 |
|---|---|
| NDC 10 | 64980-427-12 |
| NDC Item | 64980042712 |
| Packaging | 12 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (64980-427-12) |
| ANDA | ANDA202489 |
| COLORTEXT | PINK |
| Color | C48328 __ |
| FDA SPL set id | 717670 |
| Imprint code | TP;500 |
| Labeler | Rising Pharma Holdings, Inc. |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2013-10-09 |
| Marketing status | ACTIVE |
| Score | 2 |
| Shapetext | Capsule Shaped |
| Shape | C48336 |
| Size | 16 mm |
| Related queries | Properties for NDC 9 64980-427 |
NDC Item 67296183608
| NDC 9 | 67296-1836 |
|---|---|
| NDC 10 | 67296-1836-8 |
| NDC Item | 67296183608 |
| Packaging | 8 TABLET, FILM COATED in 1 BOTTLE (67296-1836-8) |
| ANDA | ANDA202489 |
| COLORTEXT | pink |
| Color | C48328 __ |
| FDA SPL set id | 798328 |
| Imprint code | TP;500 |
| Labeler | Redpharm Drug, Inc. |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2013-10-09 |
| Marketing status | ACTIVE |
| Score | 2 |
| Shapetext | Capsule Shaped |
| Shape | C48336 |
| Size | 16 mm |
| Related queries | Properties for NDC 9 67296-1836 |
NDC Item 70518417200
| NDC 9 | 70518-4172 |
|---|---|
| NDC 10 | 70518-4172-0 |
| NDC Item | 70518417200 |
| Packaging | 8 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (70518-4172-0) |
| ANDA | ANDA202489 |
| COLORTEXT | pink |
| Color | C48328 __ |
| FDA SPL set id | 807843 |
| Imprint code | TP;500 |
| Labeler | REMEDYREPACK INC. |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2024-08-30 |
| Marketing status | active |
| Score | 2 |
| Shapetext | Capsule Shaped |
| Shape | C48336 |
| Size | 16 mm |
| Related queries | Properties for NDC 9 70518-4172 |
NDC Item 70518417201
| NDC 9 | 70518-4172 |
|---|---|
| NDC 10 | 70518-4172-1 |
| NDC Item | 70518417201 |
| Packaging | 10 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (70518-4172-1) |
| ANDA | ANDA202489 |
| COLORTEXT | pink |
| Color | C48328 __ |
| FDA SPL set id | 807843 |
| Imprint code | TP;500 |
| Labeler | REMEDYREPACK INC. |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2024-08-30 |
| Marketing status | active |
| Score | 2 |
| Shapetext | Capsule Shaped |
| Shape | C48336 |
| Size | 16 mm |
| Related queries | Properties for NDC 9 70518-4172 |
NDC Item 00054034807
| NDC 9 | 0054-0348 |
|---|---|
| NDC 10 | 0054-0348-07 |
| NDC Item | 00054034807 |
| Packaging | 20 TABLET, FILM COATED in 1 BOTTLE (0054-0348-07) |
| ANDA | ANDA201172 |
| COLORTEXT | WHITE(Off White) |
| Color | C48325 __ |
| FDA SPL set id | 611868 |
| Imprint code | 54455 |
| Labeler | Hikma Pharmaceuticals USA Inc. |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time high | 2021-10-31 |
| Marketing effective time low | 2012-04-30 |
| Marketing status | COMPLETED |
| Score | 2 |
| Shapetext | Modified |
| Shape | C48345 |
| Size | 16 mm |
| Related queries | Properties for NDC 9 0054-0348 |
NDC Item 00054034821
| NDC 9 | 0054-0348 |
|---|---|
| NDC 10 | 0054-0348-21 |
| NDC Item | 00054034821 |
| Packaging | 60 TABLET, FILM COATED in 1 BOTTLE (0054-0348-21) |
| ANDA | ANDA201172 |
| COLORTEXT | WHITE(Off White) |
| Color | C48325 __ |
| FDA SPL set id | 611868 |
| Imprint code | 54455 |
| Labeler | Hikma Pharmaceuticals USA Inc. |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time high | 2021-10-31 |
| Marketing effective time low | 2012-04-30 |
| Marketing status | COMPLETED |
| Score | 2 |
| Shapetext | Modified |
| Shape | C48345 |
| Size | 16 mm |
| Related queries | Properties for NDC 9 0054-0348 |
NDC Item 16571021506
| NDC 9 | 16571-215 |
|---|---|
| NDC 10 | 16571-215-06 |
| NDC Item | 16571021506 |
| Packaging | 60 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (16571-215-06) |
| ANDA | ANDA202489 |
| COLORTEXT | PINK |
| Color | C48328 __ |
| FDA SPL set id | 114445 |
| Imprint code | TP;500 |
| Labeler | Rising Pharma Holdings, Inc. |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time high | 2013-10-10 |
| Marketing effective time low | 2013-10-09 |
| Marketing status | COMPLETED |
| Score | 2 |
| Shapetext | Capsule Shaped |
| Shape | C48336 |
| Size | 16 mm |
| Related queries | Properties for NDC 9 16571-215 |
NDC Item 42799020801
| NDC 9 | 42799-208 |
|---|---|
| NDC 10 | 42799-208-01 |
| NDC Item | 42799020801 |
| Packaging | 20 TABLET in 1 BOTTLE (42799-208-01) |
| ANDA | ANDA203808 |
| COLORTEXT | YELLOW |
| Color | C48330 __ |
| FDA SPL set id | 624893 |
| Imprint code | 208 |
| Labeler | Edenbridge Pharmaceuticals LLC. |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2019-12-20 |
| Marketing status | ACTIVE |
| Score | 2 |
| Shape | C48345 |
| Size | 16 mm |
| Related queries | Properties for NDC 9 42799-208 |
NDC Item 42799020802
| NDC 9 | 42799-208 |
|---|---|
| NDC 10 | 42799-208-02 |
| NDC Item | 42799020802 |
| Packaging | 60 TABLET in 1 BOTTLE (42799-208-02) |
| ANDA | ANDA203808 |
| COLORTEXT | YELLOW |
| Color | C48330 __ |
| FDA SPL set id | 624893 |
| Imprint code | 208 |
| Labeler | Edenbridge Pharmaceuticals LLC. |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2019-12-20 |
| Marketing status | ACTIVE |
| Score | 2 |
| Shape | C48345 |
| Size | 16 mm |
| Related queries | Properties for NDC 9 42799-208 |
NDC Item 43386055102
| NDC 9 | 43386-551 |
|---|---|
| NDC 10 | 43386-551-02 |
| NDC Item | 43386055102 |
| Packaging | 20 TABLET in 1 BOTTLE (43386-551-02) |
| ANDA | ANDA202044 |
| COLORTEXT | PINK |
| Color | C48328 __ |
| FDA SPL set id | 716141 |
| Imprint code | NL;551 |
| Labeler | Lupin Pharmaceuticals,Inc. |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2012-04-30 |
| Marketing status | ACTIVE |
| Score | 2 |
| Shape | C48345 |
| Size | 16 mm |
| Related queries | Properties for NDC 9 43386-551 |
NDC Item 43386055106
| NDC 9 | 43386-551 |
|---|---|
| NDC 10 | 43386-551-06 |
| NDC Item | 43386055106 |
| Packaging | 60 TABLET in 1 BOTTLE (43386-551-06) |
| ANDA | ANDA202044 |
| COLORTEXT | PINK |
| Color | C48328 __ |
| FDA SPL set id | 716141 |
| Imprint code | NL;551 |
| Labeler | Lupin Pharmaceuticals,Inc. |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2012-04-30 |
| Marketing status | ACTIVE |
| Score | 2 |
| Shape | C48345 |
| Size | 16 mm |
| Related queries | Properties for NDC 9 43386-551 |
NDC Item 44523045020
| NDC 9 | 44523-450 |
|---|---|
| NDC 10 | 44523-450-20 |
| NDC Item | 44523045020 |
| Packaging | 20 TABLET in 1 BOTTLE (44523-450-20) |
| COLORTEXT | PINK |
| Color | C48328 __ |
| FDA SPL set id | 71195 |
| Imprint code | TM;500 |
| Labeler | Biocomp Pharma, Inc. |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | NDA AUTHORIZED GENERIC |
| Marketing effective time high | 2019-02-05 |
| Marketing effective time low | 2012-06-07 |
| Marketing status | COMPLETED |
| NDA_AUTHORIZED_GENERIC | NDA021618 |
| Score | 2 |
| Shape | C48345 |
| Size | 14 mm |
| Related queries | Properties for NDC 9 44523-450 |
NDC Item 62135083520
| NDC 9 | 62135-835 |
|---|---|
| NDC 10 | 62135-835-20 |
| NDC Item | 62135083520 |
| Packaging | 20 TABLET, FILM COATED in 1 BOTTLE (62135-835-20) |
| ANDA | ANDA202044 |
| COLORTEXT | white(white to off-white) |
| Color | C48325 __ |
| FDA SPL set id | 798224 |
| Imprint code | C;E;205 |
| Labeler | Chartwell RX, LLC |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2012-04-30 |
| Marketing status | active |
| Score | 2 |
| Shape | C48345 |
| Size | 16 mm |
| Related queries | Properties for NDC 9 62135-835 |
NDC Item 64980042712
| NDC 9 | 64980-427 |
|---|---|
| NDC 10 | 64980-427-12 |
| NDC Item | 64980042712 |
| Packaging | 12 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (64980-427-12) |
| ANDA | ANDA202489 |
| COLORTEXT | PINK |
| Color | C48328 __ |
| FDA SPL set id | 717670 |
| Imprint code | TP;500 |
| Labeler | Rising Pharma Holdings, Inc. |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2013-10-09 |
| Marketing status | ACTIVE |
| Score | 2 |
| Shapetext | Capsule Shaped |
| Shape | C48336 |
| Size | 16 mm |
| Related queries | Properties for NDC 9 64980-427 |
NDC Item 67296183608
| NDC 9 | 67296-1836 |
|---|---|
| NDC 10 | 67296-1836-8 |
| NDC Item | 67296183608 |
| Packaging | 8 TABLET, FILM COATED in 1 BOTTLE (67296-1836-8) |
| ANDA | ANDA202489 |
| COLORTEXT | pink |
| Color | C48328 __ |
| FDA SPL set id | 798328 |
| Imprint code | TP;500 |
| Labeler | Redpharm Drug, Inc. |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2013-10-09 |
| Marketing status | ACTIVE |
| Score | 2 |
| Shapetext | Capsule Shaped |
| Shape | C48336 |
| Size | 16 mm |
| Related queries | Properties for NDC 9 67296-1836 |
NDC Item 70518417200
| NDC 9 | 70518-4172 |
|---|---|
| NDC 10 | 70518-4172-0 |
| NDC Item | 70518417200 |
| Packaging | 8 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (70518-4172-0) |
| ANDA | ANDA202489 |
| COLORTEXT | pink |
| Color | C48328 __ |
| FDA SPL set id | 807843 |
| Imprint code | TP;500 |
| Labeler | REMEDYREPACK INC. |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2024-08-30 |
| Marketing status | active |
| Score | 2 |
| Shapetext | Capsule Shaped |
| Shape | C48336 |
| Size | 16 mm |
| Related queries | Properties for NDC 9 70518-4172 |
NDC Item 70518417201
| NDC 9 | 70518-4172 |
|---|---|
| NDC 10 | 70518-4172-1 |
| NDC Item | 70518417201 |
| Packaging | 10 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (70518-4172-1) |
| ANDA | ANDA202489 |
| COLORTEXT | pink |
| Color | C48328 __ |
| FDA SPL set id | 807843 |
| Imprint code | TP;500 |
| Labeler | REMEDYREPACK INC. |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2024-08-30 |
| Marketing status | active |
| Score | 2 |
| Shapetext | Capsule Shaped |
| Shape | C48336 |
| Size | 16 mm |
| Related queries | Properties for NDC 9 70518-4172 |
NDC Item 00054034807
| NDC 9 | 0054-0348 |
|---|---|
| NDC 10 | 0054-0348-07 |
| NDC Item | 00054034807 |
| Packaging | 20 TABLET, FILM COATED in 1 BOTTLE (0054-0348-07) |
| ANDA | ANDA201172 |
| COLORTEXT | WHITE(Off White) |
| Color | C48325 __ |
| FDA SPL set id | 611868 |
| Imprint code | 54455 |
| Labeler | Hikma Pharmaceuticals USA Inc. |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time high | 2021-10-31 |
| Marketing effective time low | 2012-04-30 |
| Marketing status | COMPLETED |
| Score | 2 |
| Shapetext | Modified |
| Shape | C48345 |
| Size | 16 mm |
| Related queries | Properties for NDC 9 0054-0348 |
NDC Item 00054034821
| NDC 9 | 0054-0348 |
|---|---|
| NDC 10 | 0054-0348-21 |
| NDC Item | 00054034821 |
| Packaging | 60 TABLET, FILM COATED in 1 BOTTLE (0054-0348-21) |
| ANDA | ANDA201172 |
| COLORTEXT | WHITE(Off White) |
| Color | C48325 __ |
| FDA SPL set id | 611868 |
| Imprint code | 54455 |
| Labeler | Hikma Pharmaceuticals USA Inc. |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time high | 2021-10-31 |
| Marketing effective time low | 2012-04-30 |
| Marketing status | COMPLETED |
| Score | 2 |
| Shapetext | Modified |
| Shape | C48345 |
| Size | 16 mm |
| Related queries | Properties for NDC 9 0054-0348 |
NDC Item 16571021506
| NDC 9 | 16571-215 |
|---|---|
| NDC 10 | 16571-215-06 |
| NDC Item | 16571021506 |
| Packaging | 60 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (16571-215-06) |
| ANDA | ANDA202489 |
| COLORTEXT | PINK |
| Color | C48328 __ |
| FDA SPL set id | 114445 |
| Imprint code | TP;500 |
| Labeler | Rising Pharma Holdings, Inc. |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time high | 2013-10-10 |
| Marketing effective time low | 2013-10-09 |
| Marketing status | COMPLETED |
| Score | 2 |
| Shapetext | Capsule Shaped |
| Shape | C48336 |
| Size | 16 mm |
| Related queries | Properties for NDC 9 16571-215 |
NDC Item 42799020801
| NDC 9 | 42799-208 |
|---|---|
| NDC 10 | 42799-208-01 |
| NDC Item | 42799020801 |
| Packaging | 20 TABLET in 1 BOTTLE (42799-208-01) |
| ANDA | ANDA203808 |
| COLORTEXT | YELLOW |
| Color | C48330 __ |
| FDA SPL set id | 624893 |
| Imprint code | 208 |
| Labeler | Edenbridge Pharmaceuticals LLC. |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2019-12-20 |
| Marketing status | ACTIVE |
| Score | 2 |
| Shape | C48345 |
| Size | 16 mm |
| Related queries | Properties for NDC 9 42799-208 |
NDC Item 42799020802
| NDC 9 | 42799-208 |
|---|---|
| NDC 10 | 42799-208-02 |
| NDC Item | 42799020802 |
| Packaging | 60 TABLET in 1 BOTTLE (42799-208-02) |
| ANDA | ANDA203808 |
| COLORTEXT | YELLOW |
| Color | C48330 __ |
| FDA SPL set id | 624893 |
| Imprint code | 208 |
| Labeler | Edenbridge Pharmaceuticals LLC. |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2019-12-20 |
| Marketing status | ACTIVE |
| Score | 2 |
| Shape | C48345 |
| Size | 16 mm |
| Related queries | Properties for NDC 9 42799-208 |
NDC Item 43386055102
| NDC 9 | 43386-551 |
|---|---|
| NDC 10 | 43386-551-02 |
| NDC Item | 43386055102 |
| Packaging | 20 TABLET in 1 BOTTLE (43386-551-02) |
| ANDA | ANDA202044 |
| COLORTEXT | PINK |
| Color | C48328 __ |
| FDA SPL set id | 716141 |
| Imprint code | NL;551 |
| Labeler | Lupin Pharmaceuticals,Inc. |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2012-04-30 |
| Marketing status | ACTIVE |
| Score | 2 |
| Shape | C48345 |
| Size | 16 mm |
| Related queries | Properties for NDC 9 43386-551 |
NDC Item 43386055106
| NDC 9 | 43386-551 |
|---|---|
| NDC 10 | 43386-551-06 |
| NDC Item | 43386055106 |
| Packaging | 60 TABLET in 1 BOTTLE (43386-551-06) |
| ANDA | ANDA202044 |
| COLORTEXT | PINK |
| Color | C48328 __ |
| FDA SPL set id | 716141 |
| Imprint code | NL;551 |
| Labeler | Lupin Pharmaceuticals,Inc. |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2012-04-30 |
| Marketing status | ACTIVE |
| Score | 2 |
| Shape | C48345 |
| Size | 16 mm |
| Related queries | Properties for NDC 9 43386-551 |
NDC Item 44523045020
| NDC 9 | 44523-450 |
|---|---|
| NDC 10 | 44523-450-20 |
| NDC Item | 44523045020 |
| Packaging | 20 TABLET in 1 BOTTLE (44523-450-20) |
| COLORTEXT | PINK |
| Color | C48328 __ |
| FDA SPL set id | 71195 |
| Imprint code | TM;500 |
| Labeler | Biocomp Pharma, Inc. |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | NDA AUTHORIZED GENERIC |
| Marketing effective time high | 2019-02-05 |
| Marketing effective time low | 2012-06-07 |
| Marketing status | COMPLETED |
| NDA_AUTHORIZED_GENERIC | NDA021618 |
| Score | 2 |
| Shape | C48345 |
| Size | 14 mm |
| Related queries | Properties for NDC 9 44523-450 |
NDC Item 62135083520
| NDC 9 | 62135-835 |
|---|---|
| NDC 10 | 62135-835-20 |
| NDC Item | 62135083520 |
| Packaging | 20 TABLET, FILM COATED in 1 BOTTLE (62135-835-20) |
| ANDA | ANDA202044 |
| COLORTEXT | white(white to off-white) |
| Color | C48325 __ |
| FDA SPL set id | 798224 |
| Imprint code | C;E;205 |
| Labeler | Chartwell RX, LLC |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2012-04-30 |
| Marketing status | active |
| Score | 2 |
| Shape | C48345 |
| Size | 16 mm |
| Related queries | Properties for NDC 9 62135-835 |
NDC Item 64980042712
| NDC 9 | 64980-427 |
|---|---|
| NDC 10 | 64980-427-12 |
| NDC Item | 64980042712 |
| Packaging | 12 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (64980-427-12) |
| ANDA | ANDA202489 |
| COLORTEXT | PINK |
| Color | C48328 __ |
| FDA SPL set id | 717670 |
| Imprint code | TP;500 |
| Labeler | Rising Pharma Holdings, Inc. |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2013-10-09 |
| Marketing status | ACTIVE |
| Score | 2 |
| Shapetext | Capsule Shaped |
| Shape | C48336 |
| Size | 16 mm |
| Related queries | Properties for NDC 9 64980-427 |
NDC Item 67296183608
| NDC 9 | 67296-1836 |
|---|---|
| NDC 10 | 67296-1836-8 |
| NDC Item | 67296183608 |
| Packaging | 8 TABLET, FILM COATED in 1 BOTTLE (67296-1836-8) |
| ANDA | ANDA202489 |
| COLORTEXT | pink |
| Color | C48328 __ |
| FDA SPL set id | 798328 |
| Imprint code | TP;500 |
| Labeler | Redpharm Drug, Inc. |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2013-10-09 |
| Marketing status | ACTIVE |
| Score | 2 |
| Shapetext | Capsule Shaped |
| Shape | C48336 |
| Size | 16 mm |
| Related queries | Properties for NDC 9 67296-1836 |
NDC Item 70518417200
| NDC 9 | 70518-4172 |
|---|---|
| NDC 10 | 70518-4172-0 |
| NDC Item | 70518417200 |
| Packaging | 8 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (70518-4172-0) |
| ANDA | ANDA202489 |
| COLORTEXT | pink |
| Color | C48328 __ |
| FDA SPL set id | 807843 |
| Imprint code | TP;500 |
| Labeler | REMEDYREPACK INC. |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2024-08-30 |
| Marketing status | active |
| Score | 2 |
| Shapetext | Capsule Shaped |
| Shape | C48336 |
| Size | 16 mm |
| Related queries | Properties for NDC 9 70518-4172 |
NDC Item 70518417201
| NDC 9 | 70518-4172 |
|---|---|
| NDC 10 | 70518-4172-1 |
| NDC Item | 70518417201 |
| Packaging | 10 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (70518-4172-1) |
| ANDA | ANDA202489 |
| COLORTEXT | pink |
| Color | C48328 __ |
| FDA SPL set id | 807843 |
| Imprint code | TP;500 |
| Labeler | REMEDYREPACK INC. |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2024-08-30 |
| Marketing status | active |
| Score | 2 |
| Shapetext | Capsule Shaped |
| Shape | C48336 |
| Size | 16 mm |
| Related queries | Properties for NDC 9 70518-4172 |
NDC Item 00054034807
| NDC 9 | 0054-0348 |
|---|---|
| NDC 10 | 0054-0348-07 |
| NDC Item | 00054034807 |
| Packaging | 20 TABLET, FILM COATED in 1 BOTTLE (0054-0348-07) |
| ANDA | ANDA201172 |
| COLORTEXT | WHITE(Off White) |
| Color | C48325 __ |
| FDA SPL set id | 611868 |
| Imprint code | 54455 |
| Labeler | Hikma Pharmaceuticals USA Inc. |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time high | 2021-10-31 |
| Marketing effective time low | 2012-04-30 |
| Marketing status | COMPLETED |
| Score | 2 |
| Shapetext | Modified |
| Shape | C48345 |
| Size | 16 mm |
| Related queries | Properties for NDC 9 0054-0348 |
NDC Item 00054034821
| NDC 9 | 0054-0348 |
|---|---|
| NDC 10 | 0054-0348-21 |
| NDC Item | 00054034821 |
| Packaging | 60 TABLET, FILM COATED in 1 BOTTLE (0054-0348-21) |
| ANDA | ANDA201172 |
| COLORTEXT | WHITE(Off White) |
| Color | C48325 __ |
| FDA SPL set id | 611868 |
| Imprint code | 54455 |
| Labeler | Hikma Pharmaceuticals USA Inc. |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time high | 2021-10-31 |
| Marketing effective time low | 2012-04-30 |
| Marketing status | COMPLETED |
| Score | 2 |
| Shapetext | Modified |
| Shape | C48345 |
| Size | 16 mm |
| Related queries | Properties for NDC 9 0054-0348 |
NDC Item 16571021506
| NDC 9 | 16571-215 |
|---|---|
| NDC 10 | 16571-215-06 |
| NDC Item | 16571021506 |
| Packaging | 60 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (16571-215-06) |
| ANDA | ANDA202489 |
| COLORTEXT | PINK |
| Color | C48328 __ |
| FDA SPL set id | 114445 |
| Imprint code | TP;500 |
| Labeler | Rising Pharma Holdings, Inc. |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time high | 2013-10-10 |
| Marketing effective time low | 2013-10-09 |
| Marketing status | COMPLETED |
| Score | 2 |
| Shapetext | Capsule Shaped |
| Shape | C48336 |
| Size | 16 mm |
| Related queries | Properties for NDC 9 16571-215 |
NDC Item 42799020801
| NDC 9 | 42799-208 |
|---|---|
| NDC 10 | 42799-208-01 |
| NDC Item | 42799020801 |
| Packaging | 20 TABLET in 1 BOTTLE (42799-208-01) |
| ANDA | ANDA203808 |
| COLORTEXT | YELLOW |
| Color | C48330 __ |
| FDA SPL set id | 624893 |
| Imprint code | 208 |
| Labeler | Edenbridge Pharmaceuticals LLC. |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2019-12-20 |
| Marketing status | ACTIVE |
| Score | 2 |
| Shape | C48345 |
| Size | 16 mm |
| Related queries | Properties for NDC 9 42799-208 |
NDC Item 42799020802
| NDC 9 | 42799-208 |
|---|---|
| NDC 10 | 42799-208-02 |
| NDC Item | 42799020802 |
| Packaging | 60 TABLET in 1 BOTTLE (42799-208-02) |
| ANDA | ANDA203808 |
| COLORTEXT | YELLOW |
| Color | C48330 __ |
| FDA SPL set id | 624893 |
| Imprint code | 208 |
| Labeler | Edenbridge Pharmaceuticals LLC. |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2019-12-20 |
| Marketing status | ACTIVE |
| Score | 2 |
| Shape | C48345 |
| Size | 16 mm |
| Related queries | Properties for NDC 9 42799-208 |
NDC Item 43386055102
| NDC 9 | 43386-551 |
|---|---|
| NDC 10 | 43386-551-02 |
| NDC Item | 43386055102 |
| Packaging | 20 TABLET in 1 BOTTLE (43386-551-02) |
| ANDA | ANDA202044 |
| COLORTEXT | PINK |
| Color | C48328 __ |
| FDA SPL set id | 716141 |
| Imprint code | NL;551 |
| Labeler | Lupin Pharmaceuticals,Inc. |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2012-04-30 |
| Marketing status | ACTIVE |
| Score | 2 |
| Shape | C48345 |
| Size | 16 mm |
| Related queries | Properties for NDC 9 43386-551 |
NDC Item 43386055106
| NDC 9 | 43386-551 |
|---|---|
| NDC 10 | 43386-551-06 |
| NDC Item | 43386055106 |
| Packaging | 60 TABLET in 1 BOTTLE (43386-551-06) |
| ANDA | ANDA202044 |
| COLORTEXT | PINK |
| Color | C48328 __ |
| FDA SPL set id | 716141 |
| Imprint code | NL;551 |
| Labeler | Lupin Pharmaceuticals,Inc. |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2012-04-30 |
| Marketing status | ACTIVE |
| Score | 2 |
| Shape | C48345 |
| Size | 16 mm |
| Related queries | Properties for NDC 9 43386-551 |
NDC Item 44523045020
| NDC 9 | 44523-450 |
|---|---|
| NDC 10 | 44523-450-20 |
| NDC Item | 44523045020 |
| Packaging | 20 TABLET in 1 BOTTLE (44523-450-20) |
| COLORTEXT | PINK |
| Color | C48328 __ |
| FDA SPL set id | 71195 |
| Imprint code | TM;500 |
| Labeler | Biocomp Pharma, Inc. |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | NDA AUTHORIZED GENERIC |
| Marketing effective time high | 2019-02-05 |
| Marketing effective time low | 2012-06-07 |
| Marketing status | COMPLETED |
| NDA_AUTHORIZED_GENERIC | NDA021618 |
| Score | 2 |
| Shape | C48345 |
| Size | 14 mm |
| Related queries | Properties for NDC 9 44523-450 |
NDC Item 62135083520
| NDC 9 | 62135-835 |
|---|---|
| NDC 10 | 62135-835-20 |
| NDC Item | 62135083520 |
| Packaging | 20 TABLET, FILM COATED in 1 BOTTLE (62135-835-20) |
| ANDA | ANDA202044 |
| COLORTEXT | white(white to off-white) |
| Color | C48325 __ |
| FDA SPL set id | 798224 |
| Imprint code | C;E;205 |
| Labeler | Chartwell RX, LLC |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2012-04-30 |
| Marketing status | active |
| Score | 2 |
| Shape | C48345 |
| Size | 16 mm |
| Related queries | Properties for NDC 9 62135-835 |
NDC Item 64980042712
| NDC 9 | 64980-427 |
|---|---|
| NDC 10 | 64980-427-12 |
| NDC Item | 64980042712 |
| Packaging | 12 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (64980-427-12) |
| ANDA | ANDA202489 |
| COLORTEXT | PINK |
| Color | C48328 __ |
| FDA SPL set id | 717670 |
| Imprint code | TP;500 |
| Labeler | Rising Pharma Holdings, Inc. |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2013-10-09 |
| Marketing status | ACTIVE |
| Score | 2 |
| Shapetext | Capsule Shaped |
| Shape | C48336 |
| Size | 16 mm |
| Related queries | Properties for NDC 9 64980-427 |
NDC Item 67296183608
| NDC 9 | 67296-1836 |
|---|---|
| NDC 10 | 67296-1836-8 |
| NDC Item | 67296183608 |
| Packaging | 8 TABLET, FILM COATED in 1 BOTTLE (67296-1836-8) |
| ANDA | ANDA202489 |
| COLORTEXT | pink |
| Color | C48328 __ |
| FDA SPL set id | 798328 |
| Imprint code | TP;500 |
| Labeler | Redpharm Drug, Inc. |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2013-10-09 |
| Marketing status | ACTIVE |
| Score | 2 |
| Shapetext | Capsule Shaped |
| Shape | C48336 |
| Size | 16 mm |
| Related queries | Properties for NDC 9 67296-1836 |
NDC Item 70518417200
| NDC 9 | 70518-4172 |
|---|---|
| NDC 10 | 70518-4172-0 |
| NDC Item | 70518417200 |
| Packaging | 8 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (70518-4172-0) |
| ANDA | ANDA202489 |
| COLORTEXT | pink |
| Color | C48328 __ |
| FDA SPL set id | 807843 |
| Imprint code | TP;500 |
| Labeler | REMEDYREPACK INC. |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2024-08-30 |
| Marketing status | active |
| Score | 2 |
| Shapetext | Capsule Shaped |
| Shape | C48336 |
| Size | 16 mm |
| Related queries | Properties for NDC 9 70518-4172 |
NDC Item 70518417201
| NDC 9 | 70518-4172 |
|---|---|
| NDC 10 | 70518-4172-1 |
| NDC Item | 70518417201 |
| Packaging | 10 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (70518-4172-1) |
| ANDA | ANDA202489 |
| COLORTEXT | pink |
| Color | C48328 __ |
| FDA SPL set id | 807843 |
| Imprint code | TP;500 |
| Labeler | REMEDYREPACK INC. |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2024-08-30 |
| Marketing status | active |
| Score | 2 |
| Shapetext | Capsule Shaped |
| Shape | C48336 |
| Size | 16 mm |
| Related queries | Properties for NDC 9 70518-4172 |
NDC Item 00054034807
| NDC 9 | 0054-0348 |
|---|---|
| NDC 10 | 0054-0348-07 |
| NDC Item | 00054034807 |
| Packaging | 20 TABLET, FILM COATED in 1 BOTTLE (0054-0348-07) |
| ANDA | ANDA201172 |
| COLORTEXT | WHITE(Off White) |
| Color | C48325 __ |
| FDA SPL set id | 611868 |
| Imprint code | 54455 |
| Labeler | Hikma Pharmaceuticals USA Inc. |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time high | 2021-10-31 |
| Marketing effective time low | 2012-04-30 |
| Marketing status | COMPLETED |
| Score | 2 |
| Shapetext | Modified |
| Shape | C48345 |
| Size | 16 mm |
| Related queries | Properties for NDC 9 0054-0348 |
NDC Item 00054034821
| NDC 9 | 0054-0348 |
|---|---|
| NDC 10 | 0054-0348-21 |
| NDC Item | 00054034821 |
| Packaging | 60 TABLET, FILM COATED in 1 BOTTLE (0054-0348-21) |
| ANDA | ANDA201172 |
| COLORTEXT | WHITE(Off White) |
| Color | C48325 __ |
| FDA SPL set id | 611868 |
| Imprint code | 54455 |
| Labeler | Hikma Pharmaceuticals USA Inc. |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time high | 2021-10-31 |
| Marketing effective time low | 2012-04-30 |
| Marketing status | COMPLETED |
| Score | 2 |
| Shapetext | Modified |
| Shape | C48345 |
| Size | 16 mm |
| Related queries | Properties for NDC 9 0054-0348 |
NDC Item 16571021506
| NDC 9 | 16571-215 |
|---|---|
| NDC 10 | 16571-215-06 |
| NDC Item | 16571021506 |
| Packaging | 60 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (16571-215-06) |
| ANDA | ANDA202489 |
| COLORTEXT | PINK |
| Color | C48328 __ |
| FDA SPL set id | 114445 |
| Imprint code | TP;500 |
| Labeler | Rising Pharma Holdings, Inc. |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time high | 2013-10-10 |
| Marketing effective time low | 2013-10-09 |
| Marketing status | COMPLETED |
| Score | 2 |
| Shapetext | Capsule Shaped |
| Shape | C48336 |
| Size | 16 mm |
| Related queries | Properties for NDC 9 16571-215 |
NDC Item 42799020801
| NDC 9 | 42799-208 |
|---|---|
| NDC 10 | 42799-208-01 |
| NDC Item | 42799020801 |
| Packaging | 20 TABLET in 1 BOTTLE (42799-208-01) |
| ANDA | ANDA203808 |
| COLORTEXT | YELLOW |
| Color | C48330 __ |
| FDA SPL set id | 624893 |
| Imprint code | 208 |
| Labeler | Edenbridge Pharmaceuticals LLC. |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2019-12-20 |
| Marketing status | ACTIVE |
| Score | 2 |
| Shape | C48345 |
| Size | 16 mm |
| Related queries | Properties for NDC 9 42799-208 |
NDC Item 42799020802
| NDC 9 | 42799-208 |
|---|---|
| NDC 10 | 42799-208-02 |
| NDC Item | 42799020802 |
| Packaging | 60 TABLET in 1 BOTTLE (42799-208-02) |
| ANDA | ANDA203808 |
| COLORTEXT | YELLOW |
| Color | C48330 __ |
| FDA SPL set id | 624893 |
| Imprint code | 208 |
| Labeler | Edenbridge Pharmaceuticals LLC. |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2019-12-20 |
| Marketing status | ACTIVE |
| Score | 2 |
| Shape | C48345 |
| Size | 16 mm |
| Related queries | Properties for NDC 9 42799-208 |
NDC Item 43386055102
| NDC 9 | 43386-551 |
|---|---|
| NDC 10 | 43386-551-02 |
| NDC Item | 43386055102 |
| Packaging | 20 TABLET in 1 BOTTLE (43386-551-02) |
| ANDA | ANDA202044 |
| COLORTEXT | PINK |
| Color | C48328 __ |
| FDA SPL set id | 716141 |
| Imprint code | NL;551 |
| Labeler | Lupin Pharmaceuticals,Inc. |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2012-04-30 |
| Marketing status | ACTIVE |
| Score | 2 |
| Shape | C48345 |
| Size | 16 mm |
| Related queries | Properties for NDC 9 43386-551 |
NDC Item 43386055106
| NDC 9 | 43386-551 |
|---|---|
| NDC 10 | 43386-551-06 |
| NDC Item | 43386055106 |
| Packaging | 60 TABLET in 1 BOTTLE (43386-551-06) |
| ANDA | ANDA202044 |
| COLORTEXT | PINK |
| Color | C48328 __ |
| FDA SPL set id | 716141 |
| Imprint code | NL;551 |
| Labeler | Lupin Pharmaceuticals,Inc. |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2012-04-30 |
| Marketing status | ACTIVE |
| Score | 2 |
| Shape | C48345 |
| Size | 16 mm |
| Related queries | Properties for NDC 9 43386-551 |
NDC Item 44523045020
| NDC 9 | 44523-450 |
|---|---|
| NDC 10 | 44523-450-20 |
| NDC Item | 44523045020 |
| Packaging | 20 TABLET in 1 BOTTLE (44523-450-20) |
| COLORTEXT | PINK |
| Color | C48328 __ |
| FDA SPL set id | 71195 |
| Imprint code | TM;500 |
| Labeler | Biocomp Pharma, Inc. |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | NDA AUTHORIZED GENERIC |
| Marketing effective time high | 2019-02-05 |
| Marketing effective time low | 2012-06-07 |
| Marketing status | COMPLETED |
| NDA_AUTHORIZED_GENERIC | NDA021618 |
| Score | 2 |
| Shape | C48345 |
| Size | 14 mm |
| Related queries | Properties for NDC 9 44523-450 |
NDC Item 62135083520
| NDC 9 | 62135-835 |
|---|---|
| NDC 10 | 62135-835-20 |
| NDC Item | 62135083520 |
| Packaging | 20 TABLET, FILM COATED in 1 BOTTLE (62135-835-20) |
| ANDA | ANDA202044 |
| COLORTEXT | white(white to off-white) |
| Color | C48325 __ |
| FDA SPL set id | 798224 |
| Imprint code | C;E;205 |
| Labeler | Chartwell RX, LLC |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2012-04-30 |
| Marketing status | active |
| Score | 2 |
| Shape | C48345 |
| Size | 16 mm |
| Related queries | Properties for NDC 9 62135-835 |
NDC Item 64980042712
| NDC 9 | 64980-427 |
|---|---|
| NDC 10 | 64980-427-12 |
| NDC Item | 64980042712 |
| Packaging | 12 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (64980-427-12) |
| ANDA | ANDA202489 |
| COLORTEXT | PINK |
| Color | C48328 __ |
| FDA SPL set id | 717670 |
| Imprint code | TP;500 |
| Labeler | Rising Pharma Holdings, Inc. |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2013-10-09 |
| Marketing status | ACTIVE |
| Score | 2 |
| Shapetext | Capsule Shaped |
| Shape | C48336 |
| Size | 16 mm |
| Related queries | Properties for NDC 9 64980-427 |
NDC Item 67296183608
| NDC 9 | 67296-1836 |
|---|---|
| NDC 10 | 67296-1836-8 |
| NDC Item | 67296183608 |
| Packaging | 8 TABLET, FILM COATED in 1 BOTTLE (67296-1836-8) |
| ANDA | ANDA202489 |
| COLORTEXT | pink |
| Color | C48328 __ |
| FDA SPL set id | 798328 |
| Imprint code | TP;500 |
| Labeler | Redpharm Drug, Inc. |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2013-10-09 |
| Marketing status | ACTIVE |
| Score | 2 |
| Shapetext | Capsule Shaped |
| Shape | C48336 |
| Size | 16 mm |
| Related queries | Properties for NDC 9 67296-1836 |
NDC Item 70518417200
| NDC 9 | 70518-4172 |
|---|---|
| NDC 10 | 70518-4172-0 |
| NDC Item | 70518417200 |
| Packaging | 8 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (70518-4172-0) |
| ANDA | ANDA202489 |
| COLORTEXT | pink |
| Color | C48328 __ |
| FDA SPL set id | 807843 |
| Imprint code | TP;500 |
| Labeler | REMEDYREPACK INC. |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2024-08-30 |
| Marketing status | active |
| Score | 2 |
| Shapetext | Capsule Shaped |
| Shape | C48336 |
| Size | 16 mm |
| Related queries | Properties for NDC 9 70518-4172 |
NDC Item 70518417201
| NDC 9 | 70518-4172 |
|---|---|
| NDC 10 | 70518-4172-1 |
| NDC Item | 70518417201 |
| Packaging | 10 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (70518-4172-1) |
| ANDA | ANDA202489 |
| COLORTEXT | pink |
| Color | C48328 __ |
| FDA SPL set id | 807843 |
| Imprint code | TP;500 |
| Labeler | REMEDYREPACK INC. |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2024-08-30 |
| Marketing status | active |
| Score | 2 |
| Shapetext | Capsule Shaped |
| Shape | C48336 |
| Size | 16 mm |
| Related queries | Properties for NDC 9 70518-4172 |