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| TABLET, EXTENDED RELEASE;ORAL | 500MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** | Yes | No |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| TABLET, EXTENDED RELEASE;ORAL | 1GM **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** | Yes | No |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| FORTAMET | METFORMIN HYDROCHLORIDE | 500MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET, EXTENDED RELEASE / ORAL | RLD | 2004-04-27 | |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| 2026-08 | N021574-001 | FORTAMET | 500MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET, EXTENDED RELEASE / ORAL | RLD | 2004-04-27 | 84e616aacf4f… | |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| 2026-07 | N021574-001 | FORTAMET | 500MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET, EXTENDED RELEASE / ORAL | RLD | 2004-04-27 | caaa826d4ba7… | |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 | PD-Rx Pharmaceuticals, Inc. | 1d0b74de-ef4c-4dd2-8019-2ddb409c60b4 | 2026-08-03 | Boxed warning, Warnings, Adverse reactions | METFORMIN HYDROCHLORIDE |
| Metformin Hydrochloride | METFORMIN HYDROCHLORIDE | REMEDYREPACK INC. | 59a4ccda-5487-4ac4-9373-0c0fc8b7c88b | 2026-08-03 | Boxed warning, Warnings, Adverse reactions | METFORMIN HYDROCHLORIDE |
| METFORMIN HYDROCHLORIDE | METFORMIN HYDROCHLORIDE | PD-Rx Pharmaceuticals, Inc. | f55a245b-a786-4a4a-b11c-c61d48294b01 | 2026-07-31 | Boxed warning, Warnings, Adverse reactions | METFORMIN HYDROCHLORIDE |
| Metformin Hydrochloride | METFORMIN HYDROCHLORIDE | PD-Rx Pharmaceuticals, Inc. | 41408f64-d366-403e-9595-464ab25c6f97 | 2026-07-30 | Boxed warning, Warnings, Adverse reactions | METFORMIN HYDROCHLORIDE |
| Metformin Hydrochloride | METFORMIN HYDROCHLORIDE | PD-Rx Pharmaceuticals, Inc. | 68d0b1a6-c99e-42cf-afdf-b71ee73c4424 | 2026-07-30 | Boxed warning, Warnings, Adverse reactions | METFORMIN HYDROCHLORIDE |
| METFORMIN HYDROCHLORIDE | METFORMIN HYDROCHLORIDE | PD-Rx Pharmaceuticals, Inc. | 9171d369-d35a-40e4-a9ad-26484e66fc5e | 2026-07-29 | Boxed warning, Warnings, Adverse reactions | METFORMIN HYDROCHLORIDE |
| Metformin Hydrochloride | METFORMIN HYDROCHLORIDE | REMEDYREPACK INC. | 30658e19-8e6e-49aa-a007-e414224797c5 | 2026-07-29 | Boxed warning, Warnings, Adverse reactions | METFORMIN HYDROCHLORIDE |
| Metformin Hydrochloride | METFORMIN HYDROCHLORIDE | REMEDYREPACK INC. | 1503bbe4-0ac5-479b-9900-d38e49236bf0 | 2026-07-28 | Boxed warning, Warnings, Adverse reactions | METFORMIN HYDROCHLORIDE |
| Metformin Hydrochloride | METFORMIN HYDROCHLORIDE | Cardinal Health 107, LLC | 46cb7e3f-c739-433d-9dbe-427c2d95bef1 | 2026-07-24 | Boxed warning, Warnings, Adverse reactions | METFORMIN HYDROCHLORIDE |
| Metformin Hydrochloride | METFORMIN HYDROCHLORIDE | Chartwell RX, LLC | 4d3dbf6f-1c8a-4daa-8343-8cd8f64a65cd | 2026-07-20 | Boxed warning, Warnings, Adverse reactions | METFORMIN HYDROCHLORIDE |
| Metformin Hydrochloride | METFORMIN HYDROCHLORIDE | REMEDYREPACK INC. | 13235d8e-ac3a-45b4-9c5d-9a9012951dfe | 2026-07-16 | Boxed warning, Warnings, Adverse reactions | METFORMIN HYDROCHLORIDE |
| METFORMIN HYDROCHLORIDE | METFORMIN HYDROCHLORIDE | Zydus Pharmaceuticals USA Inc. | c82a10fa-1e8e-46b6-890a-737de3f34ee1 | 2026-07-15 | Boxed warning, Warnings, Adverse reactions | METFORMIN HYDROCHLORIDE |
| Metformin Hydrochloride | METFORMIN HYDROCHLORIDE | REMEDYREPACK INC. | 5aa1c86c-f2c8-49b1-8f81-47b11386c5d3 | 2026-07-15 | Boxed warning, Warnings, Adverse reactions | METFORMIN HYDROCHLORIDE |
| Metformin Hydrochloride | METFORMIN HYDROCHLORIDE | Aurobindo Pharma Limited | 4ac6d01a-af26-44e7-ae2e-3618de0080aa | 2026-07-15 | Boxed warning, Warnings, Adverse reactions | METFORMIN HYDROCHLORIDE |
| Metformin Hydrochloride | METFORMIN HYDROCHLORIDE | Advanced Rx of Tennessee, LLC | 5647230e-5bc6-1802-e063-6394a90a2724 | 2026-07-10 | Boxed warning, Warnings, Adverse reactions | METFORMIN HYDROCHLORIDE |
| Metformin Hydrochloride | METFORMIN HYDROCHLORIDE | Aurobindo Pharma Limited | fc466c46-abaa-4675-aef2-4b1a1adfd912 | 2026-07-08 | Boxed warning, Warnings, Adverse reactions | METFORMIN HYDROCHLORIDE |
| METFORMIN HYDROCHLORIDE EXTENDED RELEASE | METFORMIN HYDROCHLORIDE | PD-Rx Pharmaceuticals, Inc. | 14f3091c-f243-4364-b433-727c7d4ef8d5 | 2026-07-07 | Boxed warning, Warnings, Adverse reactions | METFORMIN HYDROCHLORIDE |
| Metformin hydrochloride | METFORMIN HYDROCHLORIDE | PD-Rx Pharmaceuticals, Inc. | 17050df5-9e95-4e1b-ac75-34add289b139 | 2026-07-07 | Boxed warning, Warnings, Adverse reactions | METFORMIN HYDROCHLORIDE |
| Metformin Hydrochloride | METFORMIN HYDROCHLORIDE | Amneal Pharmaceuticals LLC | dc65065b-cba0-46d7-8fb5-3368f3210b4d | 2026-07-01 | Boxed warning, Warnings, Adverse reactions | METFORMIN HYDROCHLORIDE |
| Metformin Hydrochloride | METFORMIN HYDROCHLORIDE | Unichem Pharmaceuticals (USA), Inc. | 9eebed09-2562-4d21-b3b3-c06562fe3f99 | 2026-07-01 | 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 |