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| TABLET, EXTENDED RELEASE;ORAL | 500MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** | Yes | No |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| TABLET, EXTENDED RELEASE;ORAL | 1GM **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** | Yes | No |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| FORTAMET | METFORMIN HYDROCHLORIDE | 500MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET, EXTENDED RELEASE / ORAL | RLD | 2004-04-27 | |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| 2026-08 | N021574-001 | FORTAMET | 500MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET, EXTENDED RELEASE / ORAL | RLD | 2004-04-27 | 84e616aacf4f… | |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| 2026-07 | N021574-001 | FORTAMET | 500MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET, EXTENDED RELEASE / ORAL | RLD | 2004-04-27 | caaa826d4ba7… | |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 | AvPAK | d9bac244-1725-5bf3-e053-2a95a90ac823 | 2026-01-08 | Boxed warning, Warnings, Adverse reactions | METFORMIN HYDROCHLORIDE |
| Metformin Hydrochloride | METFORMIN HYDROCHLORIDE | AvPAK | de09f7a1-1e9f-60f4-e053-2a95a90a93d8 | 2026-01-08 | Boxed warning, Warnings, Adverse reactions | METFORMIN HYDROCHLORIDE |
| Metformin hydrochloride | METFORMIN HYDROCHLORIDE | Proficient Rx LP | 3ba957ea-28ed-4a61-a318-98064ea4944d | 2026-01-01 | Boxed warning, Warnings, Adverse reactions | METFORMIN HYDROCHLORIDE |
| Metformin Hydrochloride | METFORMIN HYDROCHLORIDE | Northwind Health Company, LLC | ab80521b-5014-cc2a-e053-2a95a90a2003 | 2026-01-01 | Boxed warning, Warnings, Adverse reactions | METFORMIN HYDROCHLORIDE |
| Metformin Hydrochloride | METFORMIN HYDROCHLORIDE | Northwind Health Company, LLC | f31c08fc-cda1-349c-e053-2a95a90aba15 | 2026-01-01 | Boxed warning, Warnings, Adverse reactions | METFORMIN HYDROCHLORIDE |
| Metformin Hydrochloride | METFORMIN HYDROCHLORIDE | Northwind Health Company, LLC | dae7b1c1-7ff1-883c-e053-2a95a90a1a2b | 2026-01-01 | Boxed warning, Warnings, Adverse reactions | METFORMIN HYDROCHLORIDE |
| Metformin Hydrochloride | METFORMIN HYDROCHLORIDE | Northwind Health Company, LLC | f2a27d7a-ade4-421f-e053-2a95a90a01a9 | 2026-01-01 | Boxed warning, Warnings, Adverse reactions | METFORMIN HYDROCHLORIDE |
| METFORMIN HYDROCHLORIDE | METFORMIN HYDROCHLORIDE | Northwind Health Company, LLC | 07d8a69f-30d9-7511-e063-6394a90a95ca | 2026-01-01 | Boxed warning, Warnings, Adverse reactions | METFORMIN HYDROCHLORIDE |
| Metformin Hydrochloride | METFORMIN HYDROCHLORIDE | Northwind Health Company, LLC | 0178b9dd-bafa-9e81-e063-6294a90a88b0 | 2026-01-01 | Boxed warning, Warnings, Adverse reactions | METFORMIN HYDROCHLORIDE |
| Metformin Hydrochloride | METFORMIN HYDROCHLORIDE | Northwind Health Company, LLC | f5ef117c-27ff-c21e-e053-2995a90ae145 | 2026-01-01 | Boxed warning, Warnings, Adverse reactions | METFORMIN HYDROCHLORIDE |
| Metformin Hydrochloride | METFORMIN HYDROCHLORIDE | Northwind Health Company, LLC | db113f46-6fac-9005-e053-2995a90a017a | 2026-01-01 | Boxed warning, Warnings, Adverse reactions | METFORMIN HYDROCHLORIDE |
| METFORMIN HYDROCHLORIDE EXTENDED RELEASE | METFORMIN HYDROCHLORIDE | Northwind Health Company, LLC | 4e5a19c6-6ac6-ffc0-e063-6394a90a9827 | 2026-01-01 | Boxed warning, Warnings, Adverse reactions | METFORMIN HYDROCHLORIDE |
| Metformin Hydrochloride | METFORMIN HYDROCHLORIDE | Micro Labs Limited | cc070735-5e8d-4bb3-9caa-e84d29bb8943 | 2025-12-21 | Boxed warning, Warnings, Adverse reactions | METFORMIN HYDROCHLORIDE |
| Metformin Hydrochloride | METFORMIN HYDROCHLORIDE | Ascend Laboratories, LLC | 0ff1ba75-3c86-4baf-a6b1-1bb883839866 | 2025-12-18 | Boxed warning, Warnings, Adverse reactions | METFORMIN HYDROCHLORIDE |
| METFORMIN HYDROCHLORIDE | METFORMIN HYDROCHLORIDE | Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc. | b63bfafa-db4c-4fb8-84cd-ff73a5e7d320 | 2025-12-17 | Boxed warning, Warnings, Adverse reactions | METFORMIN HYDROCHLORIDE |
| Metformin Hydrochloride | METFORMIN HYDROCHLORIDE | Precision Dose, Inc. | 37ff1b8e-a434-41c0-82e1-4583842921a5 | 2025-12-02 | Boxed warning, Warnings, Adverse reactions | METFORMIN HYDROCHLORIDE |
| Metformin hydrochloride ER | METFORMIN HYDROCHLORIDE | AvKARE | 1aa40000-877f-8ea4-e063-6394a90a0e31 | 2025-11-04 | Boxed warning, Warnings, Adverse reactions | METFORMIN HYDROCHLORIDE |
| Metformin Hydrochloride | METFORMIN HYDROCHLORIDE | Mullan Pharmaceutical Inc. | 082b4de9-e452-fe71-e063-6394a90ac863 | 2025-10-28 | Boxed warning, Warnings, Adverse reactions | METFORMIN HYDROCHLORIDE |
| Metformin Hydrochloride | METFORMIN HYDROCHLORIDE | PD-Rx Pharmaceuticals, Inc. | 0230a3c3-34cf-478b-88c3-4d96e5300018 | 2025-10-15 | Boxed warning, Warnings, Adverse reactions | METFORMIN HYDROCHLORIDE |
| Metformin Hydrochloride | METFORMIN HYDROCHLORIDE | PD-Rx Pharmaceuticals, Inc. | c72cfd1a-dce9-43a3-88e2-3cf1d9078b52 | 2025-10-15 | 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 |