Application 021574
- Type
- NDA
- Sponsor
- ANDRX LABS LLC
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | FORTAMET | METFORMIN HYDROCHLORIDE | TABLET, EXTENDED RELEASE;ORAL | 500MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** | Yes | No |
| 002 | FORTAMET | METFORMIN HYDROCHLORIDE | TABLET, EXTENDED RELEASE;ORAL | 1GM **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** | Yes | No |
Orange Book products#
| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|---|---|---|---|---|---|---|
| N021574-001 | FORTAMET | METFORMIN HYDROCHLORIDE | 500MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET, EXTENDED RELEASE / ORAL | RLD | 2004-04-27 | |
| N021574-002 | FORTAMET | METFORMIN HYDROCHLORIDE | 1GM | TABLET, EXTENDED RELEASE / ORAL | RLD | 2004-04-27 |
Observed Orange Book product history#
Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.
| Captured | Edition | Application-product | Trade name | Strength | Dosage form / route | Product TE source text | RLD / RS | Approval date | Source SHA-256 |
|---|---|---|---|---|---|---|---|---|---|
| 2026-09-14 22:38:34 | 2026-08 | N021574-001 | FORTAMET | 500MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET, EXTENDED RELEASE / ORAL | RLD | 2004-04-27 | 84e616aacf4f… | |
| 2026-09-14 22:38:34 | 2026-08 | N021574-002 | FORTAMET | 1GM | TABLET, EXTENDED RELEASE / ORAL | RLD | 2004-04-27 | 84e616aacf4f… | |
| 2026-08-18 06:07:40 | 2026-07 | N021574-001 | FORTAMET | 500MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET, EXTENDED RELEASE / ORAL | RLD | 2004-04-27 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | N021574-002 | FORTAMET | 1GM | TABLET, EXTENDED RELEASE / ORAL | RLD | 2004-04-27 | caaa826d4ba7… | |
| 2026-02-19 14:30 UTC | 2026-02 | N021574-001 | FORTAMET | 500MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET, EXTENDED RELEASE / ORAL | RLD | 2004-04-27 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | N021574-002 | FORTAMET | 1GM | TABLET, EXTENDED RELEASE / ORAL | RLD | 2004-04-27 | 011fe1cb6892… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N021574-001 | FORTAMET | 500MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET, EXTENDED RELEASE / ORAL | RLD | 2004-04-27 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N021574-002 | FORTAMET | 1GM **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET, EXTENDED RELEASE / ORAL | RLD | 2004-04-27 | 31067a03dcf5… | |
| 2025-08-23 18:47 UTC | 2025-08 | N021574-001 | FORTAMET | 500MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET, EXTENDED RELEASE / ORAL | RLD | 2004-04-27 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | N021574-002 | FORTAMET | 1GM **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET, EXTENDED RELEASE / ORAL | RLD | 2004-04-27 | 6a471c1ec25d… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N021574-001 | FORTAMET | 500MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET, EXTENDED RELEASE / ORAL | RLD | 2004-04-27 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N021574-002 | FORTAMET | 1GM **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET, EXTENDED RELEASE / ORAL | AB2 | RLD | 2004-04-27 | fd3edfee7708… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N021574-001 | FORTAMET | 500MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET, EXTENDED RELEASE / ORAL | RLD | 2004-04-27 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N021574-002 | FORTAMET | 1GM **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET, EXTENDED RELEASE / ORAL | AB2 | RLD | 2004-04-27 | b8a1b40f171c… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N021574-001 | FORTAMET | 500MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET, EXTENDED RELEASE / ORAL | RLD | 2004-04-27 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N021574-002 | FORTAMET | 1GM **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET, EXTENDED RELEASE / ORAL | AB2 | RLD | 2004-04-27 | 03ed91905a0d… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N021574-001 | FORTAMET | 500MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET, EXTENDED RELEASE / ORAL | RLD | 2004-04-27 | 2680178bc6a6… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N021574-002 | FORTAMET | 1GM **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET, EXTENDED RELEASE / ORAL | AB2 | RLD | 2004-04-27 | 2680178bc6a6… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | N021574-001 | FORTAMET | 500MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET, EXTENDED RELEASE / ORAL | RLD | 2004-04-27 | 5bbf6a4d5a75… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | N021574-002 | FORTAMET | 1GM **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET, EXTENDED RELEASE / ORAL | AB2 | RLD | 2004-04-27 | 5bbf6a4d5a75… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | N021574-001 | FORTAMET | 500MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET, EXTENDED RELEASE / ORAL | RLD | 2004-04-27 | d8e5a09893c0… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | N021574-002 | FORTAMET | 1GM **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET, EXTENDED RELEASE / ORAL | AB2 | RLD | 2004-04-27 | d8e5a09893c0… |
| 2024-10-29 15:01 UTC | 2024-10 | N021574-001 | FORTAMET | 500MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET, EXTENDED RELEASE / ORAL | RLD | 2004-04-27 | d06236e962d9… | |
| 2024-10-29 15:01 UTC | 2024-10 | N021574-002 | FORTAMET | 1GM **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET, EXTENDED RELEASE / ORAL | AB2 | RLD | 2004-04-27 | d06236e962d9… |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | N021574-001 | FORTAMET | 500MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET, EXTENDED RELEASE / ORAL | RLD | 2004-04-27 | 79d66fd596c7… | |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | N021574-002 | FORTAMET | 1GM **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET, EXTENDED RELEASE / ORAL | AB2 | RLD | 2004-04-27 | 79d66fd596c7… |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | N021574-001 | FORTAMET | 500MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET, EXTENDED RELEASE / ORAL | RLD | 2004-04-27 | 301d65b070ca… | |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | N021574-002 | FORTAMET | 1GM **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET, EXTENDED RELEASE / ORAL | AB2 | RLD | 2004-04-27 | 301d65b070ca… |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | N021574-001 | FORTAMET | 500MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET, EXTENDED RELEASE / ORAL | RLD | 2004-04-27 | 1e350fbaab3a… | |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | N021574-002 | FORTAMET | 1GM **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET, EXTENDED RELEASE / ORAL | AB2 | RLD | 2004-04-27 | 1e350fbaab3a… |
| 2024-05-31 18:47 UTC | 2024-05 | N021574-001 | FORTAMET | 500MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET, EXTENDED RELEASE / ORAL | RLD | 2004-04-27 | 8072bd15b7f6… | |
| 2024-05-31 18:47 UTC | 2024-05 | N021574-002 | FORTAMET | 1GM **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET, EXTENDED RELEASE / ORAL | AB2 | RLD | 2004-04-27 | 8072bd15b7f6… |
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | N021574-001 | FORTAMET | 500MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET, EXTENDED RELEASE / ORAL | RLD | 2004-04-27 | 5c6f7cd8ea54… | |
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | N021574-002 | FORTAMET | 1GM **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET, EXTENDED RELEASE / ORAL | AB2 | RLD | 2004-04-27 | 5c6f7cd8ea54… |
| 2022-04-08 23:34 UTC | 2022-04 | N021574-001 | FORTAMET | 500MG | TABLET, EXTENDED RELEASE / ORAL | RLD | 2004-04-27 | 5d02ea3f76ae… | |
| 2022-04-08 23:34 UTC | 2022-04 | N021574-002 | FORTAMET | 1GM | TABLET, EXTENDED RELEASE / ORAL | AB2 | RLD | 2004-04-27 | 5d02ea3f76ae… |
| 2022-04-04 05:41 UTC | 2022-04 | N021574-001 | FORTAMET | 500MG | TABLET, EXTENDED RELEASE / ORAL | RLD | 2004-04-27 | 4b0b4de00fa7… | |
| 2022-04-04 05:41 UTC | 2022-04 | N021574-002 | FORTAMET | 1GM | TABLET, EXTENDED RELEASE / ORAL | AB2 | RLD | 2004-04-27 | 4b0b4de00fa7… |
| 2019-12-13 00:20 UTC | 2019-12 | N021574-001 | FORTAMET | 500MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** | TABLET, EXTENDED RELEASE / ORAL | RLD | 2004-04-27 | 74a2ff9319b5… | |
| 2019-12-13 00:20 UTC | 2019-12 | N021574-002 | FORTAMET | 1GM **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** | TABLET, EXTENDED RELEASE / ORAL | RLD | 2004-04-27 | 74a2ff9319b5… |
Observed Orange Book normalized TE history#
| Captured | Edition | Application-product | TE code | Order | Source SHA-256 |
|---|---|---|---|---|---|
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N021574-002 | AB2 | 1 | fd3edfee7708… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N021574-002 | AB2 | 1 | b8a1b40f171c… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N021574-002 | AB2 | 1 | 03ed91905a0d… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N021574-002 | AB2 | 1 | 2680178bc6a6… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | N021574-002 | AB2 | 1 | 5bbf6a4d5a75… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | N021574-002 | AB2 | 1 | d8e5a09893c0… |
| 2024-10-29 15:01 UTC | 2024-10 | N021574-002 | AB2 | 1 | d06236e962d9… |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | N021574-002 | AB2 | 1 | 79d66fd596c7… |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | N021574-002 | AB2 | 1 | 301d65b070ca… |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | N021574-002 | AB2 | 1 | 1e350fbaab3a… |
| 2024-05-31 18:47 UTC | 2024-05 | N021574-002 | AB2 | 1 | 8072bd15b7f6… |
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | N021574-002 | AB2 | 1 | 5c6f7cd8ea54… |
| 2022-04-08 23:34 UTC | 2022-04 | N021574-002 | AB2 | 1 | 5d02ea3f76ae… |
| 2022-04-04 05:41 UTC | 2022-04 | N021574-002 | AB2 | 1 | 4b0b4de00fa7… |
| 2022-03-09 01:35 UTC | 2022-03 | N021574-002 | AB2 | 1 | bb7c543d1eb4… |
| 2021-12-28 21:50 UTC | 2021-12 | N021574-002 | AB2 | 1 | 782e0a99824c… |
| 2021-05-05 16:15 UTC · 3 captures of this ZIP | 2021-05 | N021574-002 | AB2 | 1 | 87673890dc5c… |
| 2021-03-12 10:30 UTC | 2021-03 | N021574-002 | AB2 | 1 | 5aa47cf7b7d7… |
| 2020-12-22 03:56 UTC | 2020-12 | N021574-002 | AB2 | 1 | 8869cabd3fbd… |
| 2020-11-12 02:37 UTC | 2020-11 | N021574-002 | AB2 | 1 | c0c555d07b60… |
| 2024-03-16 18:09 UTC · 4 captures of this ZIP | 2024-03 | N021574-002 | AB2 | 1 | 6a51e52b5d6a… |
| 2024-02-18 07:12 UTC | 2024-02 | N021574-002 | AB2 | 1 | 1c564ffb4f44… |
| 2023-12-20 04:57 UTC | 2023-12 | N021574-002 | AB2 | 1 | ea1830bbd6c7… |
| 2023-11-28 05:40 UTC · 2 captures of this ZIP | 2023-11 | N021574-002 | AB2 | 1 | a72a2bbeb626… |
| 2023-10-25 00:34 UTC · 2 captures of this ZIP | 2023-10 | N021574-002 | AB2 | 1 | 9b2671bbb829… |
| 2023-07-15 15:27 UTC · 2 captures of this ZIP | 2023-07 | N021574-002 | AB2 | 1 | a67488948f0b… |
| 2023-06-13 01:57 UTC · 3 captures of this ZIP | 2023-06 | N021574-002 | AB2 | 1 | 3f0d92c62455… |
| 2023-05-13 08:27 UTC | 2023-05 | N021574-002 | AB2 | 1 | 053a50430f4f… |
| 2023-01-26 05:58 UTC | 2023-01 | N021574-002 | AB2 | 1 | 3bdfa0b2c4d7… |
| 2022-11-12 20:34 UTC · 5 captures of this ZIP | 2022-11 | N021574-002 | AB2 | 1 | 3a93d1ddd44b… |
| 2022-10-28 04:53 UTC | 2022-10 | N021574-002 | AB2 | 1 | f41ea6bd6efb… |
| 2022-09-29 23:25 UTC | 2022-09 | N021574-002 | AB2 | 1 | e64feba35796… |
| 2022-07-09 03:26 UTC · 3 captures of this ZIP | 2022-07 | N021574-002 | AB2 | 1 | cb3db0bc1861… |
Observed Orange Book patent history#
| Captured | Edition | Application-product | Patent | Expiration | Use code | Coverage / status | Submission date | Source SHA-256 |
|---|---|---|---|---|---|---|---|---|
| 2019-12-13 00:20 UTC | 2019-12 | N021574-001 | 6790459 | 2021-03-17 | U-604 | 74a2ff9319b5… | ||
| 2019-12-13 00:20 UTC | 2019-12 | N021574-001 | 6866866 | 2021-03-17 | Drug product | 74a2ff9319b5… | ||
| 2019-12-13 00:20 UTC | 2019-12 | N021574-002 | 6790459 | 2021-03-17 | U-604 | 74a2ff9319b5… | ||
| 2019-12-13 00:20 UTC | 2019-12 | N021574-002 | 6866866 | 2021-03-17 | Drug product | 74a2ff9319b5… | ||
| 2021-12-28 21:50 UTC | 2021-12 | N021574-001 | 6790459 | 2021-03-17 | U-604 | 782e0a99824c… | ||
| 2021-12-28 21:50 UTC | 2021-12 | N021574-001 | 6866866 | 2021-03-17 | Drug product | 782e0a99824c… | ||
| 2021-12-28 21:50 UTC | 2021-12 | N021574-002 | 6790459 | 2021-03-17 | U-604 | 782e0a99824c… | ||
| 2021-12-28 21:50 UTC | 2021-12 | N021574-002 | 6866866 | 2021-03-17 | Drug product | 782e0a99824c… | ||
| 2021-05-05 16:15 UTC · 3 captures of this ZIP | 2021-05 | N021574-001 | 6790459 | 2021-03-17 | U-604 | 87673890dc5c… | ||
| 2021-05-05 16:15 UTC · 3 captures of this ZIP | 2021-05 | N021574-001 | 6866866 | 2021-03-17 | Drug product | 87673890dc5c… | ||
| 2021-05-05 16:15 UTC · 3 captures of this ZIP | 2021-05 | N021574-002 | 6790459 | 2021-03-17 | U-604 | 87673890dc5c… | ||
| 2021-05-05 16:15 UTC · 3 captures of this ZIP | 2021-05 | N021574-002 | 6866866 | 2021-03-17 | Drug product | 87673890dc5c… | ||
| 2021-03-12 10:30 UTC | 2021-03 | N021574-001 | 6790459 | 2021-03-17 | U-604 | 5aa47cf7b7d7… | ||
| 2021-03-12 10:30 UTC | 2021-03 | N021574-001 | 6866866 | 2021-03-17 | Drug product | 5aa47cf7b7d7… | ||
| 2021-03-12 10:30 UTC | 2021-03 | N021574-002 | 6790459 | 2021-03-17 | U-604 | 5aa47cf7b7d7… | ||
| 2021-03-12 10:30 UTC | 2021-03 | N021574-002 | 6866866 | 2021-03-17 | Drug product | 5aa47cf7b7d7… | ||
| 2020-12-22 03:56 UTC | 2020-12 | N021574-001 | 6790459 | 2021-03-17 | U-604 | 8869cabd3fbd… | ||
| 2020-12-22 03:56 UTC | 2020-12 | N021574-001 | 6866866 | 2021-03-17 | Drug product | 8869cabd3fbd… | ||
| 2020-12-22 03:56 UTC | 2020-12 | N021574-002 | 6790459 | 2021-03-17 | U-604 | 8869cabd3fbd… | ||
| 2020-12-22 03:56 UTC | 2020-12 | N021574-002 | 6866866 | 2021-03-17 | Drug product | 8869cabd3fbd… | ||
| 2020-11-12 02:37 UTC | 2020-11 | N021574-001 | 6790459 | 2021-03-17 | U-604 | c0c555d07b60… | ||
| 2020-11-12 02:37 UTC | 2020-11 | N021574-001 | 6866866 | 2021-03-17 | Drug product | c0c555d07b60… | ||
| 2020-11-12 02:37 UTC | 2020-11 | N021574-002 | 6790459 | 2021-03-17 | U-604 | c0c555d07b60… | ||
| 2020-11-12 02:37 UTC | 2020-11 | N021574-002 | 6866866 | 2021-03-17 | Drug product | c0c555d07b60… | ||
| 2019-12-14 00:12 UTC | 2019-12 | N021574-001 | 6790459 | 2021-03-17 | U-604 | 3f01610625f2… | ||
| 2019-12-14 00:12 UTC | 2019-12 | N021574-001 | 6866866 | 2021-03-17 | Drug product | 3f01610625f2… | ||
| 2019-12-14 00:12 UTC | 2019-12 | N021574-002 | 6790459 | 2021-03-17 | U-604 | 3f01610625f2… | ||
| 2019-12-14 00:12 UTC | 2019-12 | N021574-002 | 6866866 | 2021-03-17 | Drug product | 3f01610625f2… | ||
| 2019-09-15 20:21 UTC | 2019-09 | N021574-001 | 6790459 | 2021-03-17 | U-604 | b00525d2431f… | ||
| 2019-09-15 20:21 UTC | 2019-09 | N021574-001 | 6866866 | 2021-03-17 | Drug product | b00525d2431f… | ||
| 2019-09-15 20:21 UTC | 2019-09 | N021574-002 | 6790459 | 2021-03-17 | U-604 | b00525d2431f… | ||
| 2019-09-15 20:21 UTC | 2019-09 | N021574-002 | 6866866 | 2021-03-17 | Drug product | b00525d2431f… | ||
| 2019-07-19 19:46 UTC | 2019-07 | N021574-001 | 6790459 | 2021-03-17 | U-604 | ea99ee380514… | ||
| 2019-07-19 19:46 UTC | 2019-07 | N021574-001 | 6866866 | 2021-03-17 | Drug product | ea99ee380514… | ||
| 2019-07-19 19:46 UTC | 2019-07 | N021574-002 | 6790459 | 2021-03-17 | U-604 | ea99ee380514… | ||
| 2019-07-19 19:46 UTC | 2019-07 | N021574-002 | 6866866 | 2021-03-17 | Drug product | ea99ee380514… |
openFDA label cross-check#
OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.
| Brand | Generic | Manufacturer | SPL set ID | Effective date | Available safety fields | Join |
|---|---|---|---|---|---|---|
| Metformin Hydrochloride | METFORMIN HYDROCHLORIDE | Coupler LLC | 53e950f5-c58f-78e3-e063-6294a90a53e9 | 2026-06-10 | Boxed warning, Warnings, Adverse reactions | METFORMIN HYDROCHLORIDE |
| Metformin Hydrochloride | METFORMIN HYDROCHLORIDE | Aurobindo Pharma Limited | ef77c7dd-a65f-4adc-a0d9-a93779b459a0 | 2026-06-09 | Boxed warning, Warnings, Adverse reactions | METFORMIN HYDROCHLORIDE |
| Metformin Hydrochloride | METFORMIN HYDROCHLORIDE | MARKSANS PHARMA LIMITED | b8004451-7b26-425b-b5ea-cbb1b08e30e3 | 2026-06-09 | Boxed warning, Warnings, Adverse reactions | METFORMIN HYDROCHLORIDE |
| METFORMIN HYDROCHLORIDE | METFORMIN HYDROCHLORIDE | QPharma Inc | 5269e91f-7e93-9405-e063-6294a90a3217 | 2026-06-08 | Boxed warning, Warnings, Adverse reactions | METFORMIN HYDROCHLORIDE |
| METFORMIN HYDROCHLORIDE | METFORMIN HYDROCHLORIDE | QPharma Inc | 53bde438-4277-f418-e063-6394a90a5ea2 | 2026-06-08 | Boxed warning, Warnings, Adverse reactions | METFORMIN HYDROCHLORIDE |
| Metformin Hydrochloride | METFORMIN HYDROCHLORIDE | Mylan Pharmaceuticals Inc. | 4f70f907-08d5-4c2e-a4be-32c6124faa7b | 2026-06-08 | Boxed warning, Warnings, Adverse reactions | METFORMIN HYDROCHLORIDE |
| METFORMIN HYDROCHLORIDE EXTENDED RELEASE | METFORMIN HYDROCHLORIDE | PD-Rx Pharmaceuticals, Inc. | d1d7204a-7e8a-4f76-bf9f-3e798c2632ba | 2026-05-22 | Boxed warning, Warnings, Adverse reactions | METFORMIN HYDROCHLORIDE |
| Metformin Hydrochloride | METFORMIN HYDROCHLORIDE | Westminster Pharmaceuticals, LLC | 836f3647-bfef-40d1-b475-c0d240241a67 | 2026-05-22 | Boxed warning, Warnings, Adverse reactions | METFORMIN HYDROCHLORIDE |
| METFORMIN HYDROCHLORIDE | METFORMIN HYDROCHLORIDE | Bryant Ranch Prepack | 1e7ab8da-4ece-499c-b0fb-34e37d991c1c | 2026-05-20 | Boxed warning, Warnings, Adverse reactions | METFORMIN HYDROCHLORIDE |
| METFORMIN HYDROCHLORIDE | METFORMIN HYDROCHLORIDE | Laurus Labs Limited | 0e7b02cc-2ddc-4394-a80c-128e6452d697 | 2026-05-19 | Boxed warning, Warnings, Adverse reactions | METFORMIN HYDROCHLORIDE |
| Metformin Hydrochloride | METFORMIN HYDROCHLORIDE | Laurus Labs Limited | c3dfa8a1-d10a-4a1a-8eba-5f4e2a5a2949 | 2026-05-15 | Boxed warning, Warnings, Adverse reactions | METFORMIN HYDROCHLORIDE |
| Metformin Hydrochloride | METFORMIN HYDROCHLORIDE | Golden State Medical Supply, Inc. | 1cb2b2be-595c-4e72-8d2c-c1edc7f85682 | 2026-05-14 | Boxed warning, Warnings, Adverse reactions | METFORMIN HYDROCHLORIDE |
| Metformin hydrochloride | METFORMIN HYDROCHLORIDE | UNICHEM PHARMACEUTICALS (USA), INC. | 93c8deae-3103-4cbf-a5d1-fe0d37e76df8 | 2026-05-11 | Boxed warning, Warnings, Adverse reactions | METFORMIN HYDROCHLORIDE |
| Metformin Hydrochloride | METFORMIN HYDROCHLORIDE | Bryant Ranch Prepack | be023bca-511e-4801-bd2b-e30dd1408772 | 2026-05-07 | Boxed warning, Warnings, Adverse reactions | METFORMIN HYDROCHLORIDE |
| Metformin Hydrochloride | METFORMIN HYDROCHLORIDE | Coupler LLC | 51285096-e2ce-0f3c-e063-6394a90a35d4 | 2026-05-06 | Boxed warning, Warnings, Adverse reactions | METFORMIN HYDROCHLORIDE |
| Metformin Hydrochloride | METFORMIN HYDROCHLORIDE | Granules Pharmaceuticals Inc. | 2387a618-24d8-4813-aa83-9114edb35374 | 2026-04-16 | Boxed warning, Warnings, Adverse reactions | METFORMIN HYDROCHLORIDE |
| Metformin Hydrochloride | METFORMIN HYDROCHLORIDE | NCS HealthCare of KY, LLC dba Vangard Labs | 0448c618-2f0d-4ed3-866f-74b413cf902d | 2026-04-16 | Boxed warning, Warnings, Adverse reactions | METFORMIN HYDROCHLORIDE |
| Metformin Hydrochloride | METFORMIN HYDROCHLORIDE | Precision Dose, Inc. | 60142fb2-16da-4f54-a542-74f9a70b9c8b | 2026-04-08 | Boxed warning, Warnings, Adverse reactions | METFORMIN HYDROCHLORIDE |
| METFORMIN HYDROCHLORIDE | METFORMIN HYDROCHLORIDE | Aphena Pharma Solutions - Tennessee, LLC | 388ee1e0-a0d2-324d-e063-6394a90a1664 | 2026-03-25 | Boxed warning, Warnings, Adverse reactions | METFORMIN HYDROCHLORIDE |
| Metformin Hydrochloride Oral Solution | METFORMIN HYDROCHLORIDE | MICRO LABS LIMITED | fb90693a-074a-45be-94f4-ed6298b1f4e4 | 2026-03-16 | Boxed warning, Warnings, Adverse reactions | METFORMIN HYDROCHLORIDE |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.
NDC Listings For This Application#
| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|---|---|---|---|---|
| 0591-2719 | Metformin Hydrochloride | Metformin Hydrochloride | Actavis Pharma, Inc. | NDA AUTHORIZED GENERIC | Current |
| 0591-2720 | Metformin Hydrochloride | Metformin Hydrochloride | Actavis Pharma, Inc. | NDA AUTHORIZED GENERIC | Current |
| 59630-574 | FORTAMET | metformin hydrochloride | Shionogi Inc. | NDA | Current |
| 59630-574 | FORTAMET | metformin hydrochloride | Shionogi Inc. | NDA | Current |
| 59630-574 | FORTAMET | metformin hydrochloride | Shionogi Inc. | NDA | Current |
| 59630-575 | FORTAMET | metformin hydrochloride | Shionogi Inc. | NDA | Current |
| 59630-575 | FORTAMET | metformin hydrochloride | Shionogi Inc. | NDA | Current |
| 59630-575 | FORTAMET | metformin hydrochloride | Shionogi Inc. | NDA | Current |