Application 213247
- Type
- ANDA
- Sponsor
- TWI PHARMS
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | METFORMIN HYDROCHLORIDE | METFORMIN HYDROCHLORIDE | TABLET, EXTENDED RELEASE;ORAL | 500MG | No | No |
| 002 | METFORMIN HYDROCHLORIDE | METFORMIN HYDROCHLORIDE | TABLET, EXTENDED RELEASE;ORAL | 1GM | No | No |
Orange Book products#
| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|---|---|---|---|---|---|---|
| A213247-001 | METFORMIN HYDROCHLORIDE | METFORMIN HYDROCHLORIDE | 500MG | TABLET, EXTENDED RELEASE / ORAL | 2021-09-29 | ||
| A213247-002 | METFORMIN HYDROCHLORIDE | METFORMIN HYDROCHLORIDE | 1GM | TABLET, EXTENDED RELEASE / ORAL | 2021-09-29 |
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 | A213247-001 | METFORMIN HYDROCHLORIDE | 500MG | TABLET, EXTENDED RELEASE / ORAL | 2021-09-29 | 84e616aacf4f… | ||
| 2026-09-14 22:38:34 | 2026-08 | A213247-002 | METFORMIN HYDROCHLORIDE | 1GM | TABLET, EXTENDED RELEASE / ORAL | 2021-09-29 | 84e616aacf4f… | ||
| 2026-08-18 06:07:40 | 2026-07 | A213247-001 | METFORMIN HYDROCHLORIDE | 500MG | TABLET, EXTENDED RELEASE / ORAL | 2021-09-29 | caaa826d4ba7… | ||
| 2026-08-18 06:07:40 | 2026-07 | A213247-002 | METFORMIN HYDROCHLORIDE | 1GM | TABLET, EXTENDED RELEASE / ORAL | 2021-09-29 | caaa826d4ba7… | ||
| 2026-02-19 14:30 UTC | 2026-02 | A213247-001 | METFORMIN HYDROCHLORIDE | 500MG | TABLET, EXTENDED RELEASE / ORAL | 2021-09-29 | 011fe1cb6892… | ||
| 2026-02-19 14:30 UTC | 2026-02 | A213247-002 | METFORMIN HYDROCHLORIDE | 1GM | TABLET, EXTENDED RELEASE / ORAL | 2021-09-29 | 011fe1cb6892… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A213247-001 | METFORMIN HYDROCHLORIDE | 500MG | TABLET, EXTENDED RELEASE / ORAL | 2021-09-29 | 31067a03dcf5… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A213247-002 | METFORMIN HYDROCHLORIDE | 1GM | TABLET, EXTENDED RELEASE / ORAL | 2021-09-29 | 31067a03dcf5… | ||
| 2025-08-23 18:47 UTC | 2025-08 | A213247-001 | METFORMIN HYDROCHLORIDE | 500MG | TABLET, EXTENDED RELEASE / ORAL | AB2 | 2021-09-29 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | A213247-002 | METFORMIN HYDROCHLORIDE | 1GM | TABLET, EXTENDED RELEASE / ORAL | AB2 | 2021-09-29 | 6a471c1ec25d… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A213247-001 | METFORMIN HYDROCHLORIDE | 500MG | TABLET, EXTENDED RELEASE / ORAL | AB2 | 2021-09-29 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A213247-002 | METFORMIN HYDROCHLORIDE | 1GM | TABLET, EXTENDED RELEASE / ORAL | AB2 | 2021-09-29 | fd3edfee7708… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A213247-001 | METFORMIN HYDROCHLORIDE | 500MG | TABLET, EXTENDED RELEASE / ORAL | AB2 | 2021-09-29 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A213247-002 | METFORMIN HYDROCHLORIDE | 1GM | TABLET, EXTENDED RELEASE / ORAL | AB2 | 2021-09-29 | b8a1b40f171c… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A213247-001 | METFORMIN HYDROCHLORIDE | 500MG | TABLET, EXTENDED RELEASE / ORAL | AB2 | 2021-09-29 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A213247-002 | METFORMIN HYDROCHLORIDE | 1GM | TABLET, EXTENDED RELEASE / ORAL | AB2 | 2021-09-29 | 03ed91905a0d… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A213247-001 | METFORMIN HYDROCHLORIDE | 500MG | TABLET, EXTENDED RELEASE / ORAL | AB2 | 2021-09-29 | 2680178bc6a6… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A213247-002 | METFORMIN HYDROCHLORIDE | 1GM | TABLET, EXTENDED RELEASE / ORAL | AB2 | 2021-09-29 | 2680178bc6a6… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A213247-001 | METFORMIN HYDROCHLORIDE | 500MG | TABLET, EXTENDED RELEASE / ORAL | AB2 | 2021-09-29 | 5bbf6a4d5a75… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A213247-002 | METFORMIN HYDROCHLORIDE | 1GM | TABLET, EXTENDED RELEASE / ORAL | AB2 | 2021-09-29 | 5bbf6a4d5a75… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A213247-001 | METFORMIN HYDROCHLORIDE | 500MG | TABLET, EXTENDED RELEASE / ORAL | AB2 | 2021-09-29 | d8e5a09893c0… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A213247-002 | METFORMIN HYDROCHLORIDE | 1GM | TABLET, EXTENDED RELEASE / ORAL | AB2 | 2021-09-29 | d8e5a09893c0… | |
| 2024-10-29 15:01 UTC | 2024-10 | A213247-001 | METFORMIN HYDROCHLORIDE | 500MG | TABLET, EXTENDED RELEASE / ORAL | AB2 | 2021-09-29 | d06236e962d9… | |
| 2024-10-29 15:01 UTC | 2024-10 | A213247-002 | METFORMIN HYDROCHLORIDE | 1GM | TABLET, EXTENDED RELEASE / ORAL | AB2 | 2021-09-29 | d06236e962d9… | |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A213247-001 | METFORMIN HYDROCHLORIDE | 500MG | TABLET, EXTENDED RELEASE / ORAL | AB2 | 2021-09-29 | 79d66fd596c7… | |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A213247-002 | METFORMIN HYDROCHLORIDE | 1GM | TABLET, EXTENDED RELEASE / ORAL | AB2 | 2021-09-29 | 79d66fd596c7… | |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A213247-001 | METFORMIN HYDROCHLORIDE | 500MG | TABLET, EXTENDED RELEASE / ORAL | AB2 | 2021-09-29 | 301d65b070ca… | |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A213247-002 | METFORMIN HYDROCHLORIDE | 1GM | TABLET, EXTENDED RELEASE / ORAL | AB2 | 2021-09-29 | 301d65b070ca… | |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A213247-001 | METFORMIN HYDROCHLORIDE | 500MG | TABLET, EXTENDED RELEASE / ORAL | AB2 | 2021-09-29 | 1e350fbaab3a… | |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A213247-002 | METFORMIN HYDROCHLORIDE | 1GM | TABLET, EXTENDED RELEASE / ORAL | AB2 | 2021-09-29 | 1e350fbaab3a… | |
| 2024-05-31 18:47 UTC | 2024-05 | A213247-001 | METFORMIN HYDROCHLORIDE | 500MG | TABLET, EXTENDED RELEASE / ORAL | AB2 | 2021-09-29 | 8072bd15b7f6… | |
| 2024-05-31 18:47 UTC | 2024-05 | A213247-002 | METFORMIN HYDROCHLORIDE | 1GM | TABLET, EXTENDED RELEASE / ORAL | AB2 | 2021-09-29 | 8072bd15b7f6… | |
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | A213247-001 | METFORMIN HYDROCHLORIDE | 500MG | TABLET, EXTENDED RELEASE / ORAL | AB2 | 2021-09-29 | 5c6f7cd8ea54… | |
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | A213247-002 | METFORMIN HYDROCHLORIDE | 1GM | TABLET, EXTENDED RELEASE / ORAL | AB2 | 2021-09-29 | 5c6f7cd8ea54… | |
| 2022-04-08 23:34 UTC | 2022-04 | A213247-001 | METFORMIN HYDROCHLORIDE | 500MG | TABLET, EXTENDED RELEASE / ORAL | AB2 | 2021-09-29 | 5d02ea3f76ae… | |
| 2022-04-08 23:34 UTC | 2022-04 | A213247-002 | METFORMIN HYDROCHLORIDE | 1GM | TABLET, EXTENDED RELEASE / ORAL | AB2 | 2021-09-29 | 5d02ea3f76ae… | |
| 2022-04-04 05:41 UTC | 2022-04 | A213247-001 | METFORMIN HYDROCHLORIDE | 500MG | TABLET, EXTENDED RELEASE / ORAL | AB2 | 2021-09-29 | 4b0b4de00fa7… | |
| 2022-04-04 05:41 UTC | 2022-04 | A213247-002 | METFORMIN HYDROCHLORIDE | 1GM | TABLET, EXTENDED RELEASE / ORAL | AB2 | 2021-09-29 | 4b0b4de00fa7… | |
| 2022-03-09 01:35 UTC | 2022-03 | A213247-001 | METFORMIN HYDROCHLORIDE | 500MG | TABLET, EXTENDED RELEASE / ORAL | AB2 | 2021-09-29 | bb7c543d1eb4… | |
| 2022-03-09 01:35 UTC | 2022-03 | A213247-002 | METFORMIN HYDROCHLORIDE | 1GM | TABLET, EXTENDED RELEASE / ORAL | AB2 | 2021-09-29 | bb7c543d1eb4… |
Observed Orange Book normalized TE history#
| Captured | Edition | Application-product | TE code | Order | Source SHA-256 |
|---|---|---|---|---|---|
| 2025-08-23 18:47 UTC | 2025-08 | A213247-001 | AB2 | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | A213247-002 | AB2 | 1 | 6a471c1ec25d… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A213247-001 | AB2 | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A213247-002 | AB2 | 1 | fd3edfee7708… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A213247-001 | AB2 | 1 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A213247-002 | AB2 | 1 | b8a1b40f171c… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A213247-001 | AB2 | 1 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A213247-002 | AB2 | 1 | 03ed91905a0d… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A213247-001 | AB2 | 1 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A213247-002 | AB2 | 1 | 2680178bc6a6… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A213247-001 | AB2 | 1 | 5bbf6a4d5a75… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A213247-002 | AB2 | 1 | 5bbf6a4d5a75… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A213247-001 | AB2 | 1 | d8e5a09893c0… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A213247-002 | AB2 | 1 | d8e5a09893c0… |
| 2024-10-29 15:01 UTC | 2024-10 | A213247-001 | AB2 | 1 | d06236e962d9… |
| 2024-10-29 15:01 UTC | 2024-10 | A213247-002 | AB2 | 1 | d06236e962d9… |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A213247-001 | AB2 | 1 | 79d66fd596c7… |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A213247-002 | AB2 | 1 | 79d66fd596c7… |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A213247-001 | AB2 | 1 | 301d65b070ca… |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A213247-002 | AB2 | 1 | 301d65b070ca… |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A213247-001 | AB2 | 1 | 1e350fbaab3a… |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A213247-002 | AB2 | 1 | 1e350fbaab3a… |
| 2024-05-31 18:47 UTC | 2024-05 | A213247-001 | AB2 | 1 | 8072bd15b7f6… |
| 2024-05-31 18:47 UTC | 2024-05 | A213247-002 | AB2 | 1 | 8072bd15b7f6… |
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | A213247-001 | AB2 | 1 | 5c6f7cd8ea54… |
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | A213247-002 | AB2 | 1 | 5c6f7cd8ea54… |
| 2022-04-08 23:34 UTC | 2022-04 | A213247-001 | AB2 | 1 | 5d02ea3f76ae… |
| 2022-04-08 23:34 UTC | 2022-04 | A213247-002 | AB2 | 1 | 5d02ea3f76ae… |
| 2022-04-04 05:41 UTC | 2022-04 | A213247-001 | AB2 | 1 | 4b0b4de00fa7… |
| 2022-04-04 05:41 UTC | 2022-04 | A213247-002 | AB2 | 1 | 4b0b4de00fa7… |
| 2022-03-09 01:35 UTC | 2022-03 | A213247-001 | AB2 | 1 | bb7c543d1eb4… |
| 2022-03-09 01:35 UTC | 2022-03 | A213247-002 | AB2 | 1 | bb7c543d1eb4… |
| 2021-12-28 21:50 UTC | 2021-12 | A213247-001 | AB2 | 1 | 782e0a99824c… |
| 2021-12-28 21:50 UTC | 2021-12 | A213247-002 | AB2 | 1 | 782e0a99824c… |
| 2024-03-16 18:09 UTC · 4 captures of this ZIP | 2024-03 | A213247-001 | AB2 | 1 | 6a51e52b5d6a… |
| 2024-03-16 18:09 UTC · 4 captures of this ZIP | 2024-03 | A213247-002 | AB2 | 1 | 6a51e52b5d6a… |
| 2024-02-18 07:12 UTC | 2024-02 | A213247-001 | AB2 | 1 | 1c564ffb4f44… |
| 2024-02-18 07:12 UTC | 2024-02 | A213247-002 | AB2 | 1 | 1c564ffb4f44… |
| 2023-12-20 04:57 UTC | 2023-12 | A213247-001 | AB2 | 1 | ea1830bbd6c7… |
| 2023-12-20 04:57 UTC | 2023-12 | A213247-002 | AB2 | 1 | ea1830bbd6c7… |
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 | Aphena Pharma Solutions - Tennessee, LLC | 3982b985-9184-0e17-e063-6394a90aae05 | 2025-07-09 | Boxed warning, Warnings, Adverse reactions | METFORMIN HYDROCHLORIDE METFORMIN HYDROCHLORIDE |
| Metformin Hydrochloride | METFORMIN HYDROCHLORIDE | A-S Medication Solutions | bb62088f-e9af-4644-9f57-cb90bab0f199 | 2025-07-09 | Boxed warning, Warnings, Adverse reactions | Metformin Hydrochloride METFORMIN HYDROCHLORIDE |
| Metformin Hydrochloride | METFORMIN HYDROCHLORIDE | A-S Medication Solutions | 59743092-bae1-4725-ac4b-c8a8b0a81c1e | 2025-07-09 | Boxed warning, Warnings, Adverse reactions | Metformin Hydrochloride METFORMIN HYDROCHLORIDE |
| METFORMIN HYDROCHLORIDE | METFORMIN HYDROCHLORIDE | Aphena Pharma Solutions - Tennessee, LLC | 3890b116-7c3c-e48e-e063-6294a90a0c8a | 2025-07-03 | Boxed warning, Warnings, Adverse reactions | METFORMIN HYDROCHLORIDE METFORMIN HYDROCHLORIDE |
| Metformin Hydrochloride | METFORMIN HYDROCHLORIDE | Aphena Pharma Solutions - Tennessee, LLC | 390c3bdf-bfaf-203e-e063-6394a90a7d20 | 2025-07-03 | Boxed warning, Warnings, Adverse reactions | Metformin Hydrochloride METFORMIN HYDROCHLORIDE |
| METFORMIN HYDROCHLORIDE | METFORMIN HYDROCHLORIDE | A-S Medication Solutions | ec3a9070-3745-41fb-b610-8d06129d8fd9 | 2025-07-01 | Boxed warning, Warnings, Adverse reactions | METFORMIN HYDROCHLORIDE METFORMIN HYDROCHLORIDE |
| METFORMIN HYDROCHLORIDE | METFORMIN HYDROCHLORIDE | A-S Medication Solutions | 51e1fe6e-a7fa-47a5-bbd5-73b275230c7f | 2025-07-01 | Boxed warning, Warnings, Adverse reactions | METFORMIN HYDROCHLORIDE METFORMIN HYDROCHLORIDE |
| METFORMIN HYDROCHLORIDE | METFORMIN HYDROCHLORIDE | Westminster Pharmaceuticals, LLC | 07b4ee2a-8435-4d38-a6b0-b919e3424153 | 2025-06-30 | Boxed warning, Warnings, Adverse reactions | METFORMIN HYDROCHLORIDE METFORMIN HYDROCHLORIDE |
| METFORMIN HYDROCHLORIDE EXTENDED RELEASE | METFORMIN HYDROCHLORIDE | TIME CAP LABORATORIES, INC | 1d8b8970-c2a1-4780-be87-ab8ccfd401fa | 2025-06-30 | Boxed warning, Warnings, Adverse reactions | METFORMIN HYDROCHLORIDE |
| METFORMIN HYDROCHLORIDE | METFORMIN HYDROCHLORIDE | A-S Medication Solutions | 0cd086d6-3ae2-476e-b93e-29055e67e8fc | 2025-06-18 | Boxed warning, Warnings, Adverse reactions | METFORMIN HYDROCHLORIDE METFORMIN HYDROCHLORIDE |
| METFORMIN HYDROCHLORIDE | METFORMIN HYDROCHLORIDE | A-S Medication Solutions | a434b937-2648-4509-8ce8-94a28582ec77 | 2025-06-17 | Boxed warning, Warnings, Adverse reactions | METFORMIN HYDROCHLORIDE METFORMIN HYDROCHLORIDE |
| METFORMIN HYDROCHLORIDE | METFORMIN HYDROCHLORIDE | A-S Medication Solutions | 784a6bbd-4f13-45ed-89c1-154b06721ed0 | 2025-06-17 | Boxed warning, Warnings, Adverse reactions | METFORMIN HYDROCHLORIDE METFORMIN HYDROCHLORIDE |
| Metformin Hydrochloride | METFORMIN HYDROCHLORIDE | A-S Medication Solutions | f6581ce6-0f9f-4887-ae83-4c6ecde619f3 | 2025-06-17 | Boxed warning, Warnings, Adverse reactions | Metformin Hydrochloride METFORMIN HYDROCHLORIDE |
| METFORMIN HYDROCHLORIDE | METFORMIN HYDROCHLORIDE | A-S Medication Solutions | 9fed67ea-7a15-4634-80cf-c975b8812ebe | 2025-06-11 | Boxed warning, Warnings, Adverse reactions | METFORMIN HYDROCHLORIDE METFORMIN HYDROCHLORIDE |
| METFORMIN HYDROCHLORIDE | METFORMIN HYDROCHLORIDE | A-S Medication Solutions | 2d68fd88-c591-4577-a7c3-901338bdaf90 | 2025-06-11 | Boxed warning, Warnings, Adverse reactions | METFORMIN HYDROCHLORIDE METFORMIN HYDROCHLORIDE |
| Metformin Hydrochloride | METFORMIN HYDROCHLORIDE | Bryant Ranch Prepack | 52eecdbd-e07e-447f-bf38-b3c347b60662 | 2025-06-02 | Boxed warning, Warnings, Adverse reactions | Metformin Hydrochloride METFORMIN HYDROCHLORIDE |
| METFORMIN HYDROCHLORIDE | METFORMIN HYDROCHLORIDE | Coupler LLC | 33ec9f6e-16d9-40ba-e063-6294a90ae87b | 2025-04-29 | Boxed warning, Warnings, Adverse reactions | METFORMIN HYDROCHLORIDE METFORMIN HYDROCHLORIDE |
| METFORMIN HYDROCHLORIDE | METFORMIN HYDROCHLORIDE | Preferred Pharmaceuticals Inc. | 103080cb-6381-44f6-8a31-1fc81e7c890f | 2025-04-23 | Boxed warning, Warnings, Adverse reactions | METFORMIN HYDROCHLORIDE METFORMIN HYDROCHLORIDE |
| Metformin Hydrochloride | METFORMIN HYDROCHLORIDE | NuCare Pharmaceuticals,Inc. | 33155746-c2ef-12f4-e063-6294a90a039c | 2025-04-18 | Boxed warning, Warnings, Adverse reactions | Metformin Hydrochloride METFORMIN HYDROCHLORIDE |
| Metformin Hydrochloride | METFORMIN HYDROCHLORIDE | TAGI Pharma, Inc. | dd0ee2bf-f658-42dc-976d-49af0b1f32b5 | 2025-04-18 | Boxed warning, Warnings, Adverse reactions | Metformin Hydrochloride 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 |
|---|---|---|---|---|---|
| 24979-146 | metformin hydrochloride | metformin hydrochloride | TWi Pharmaceuticals, Inc. | ANDA | Current |
| 24979-146 | metformin hydrochloride | metformin hydrochloride | TWi Pharmaceuticals, Inc. | ANDA | Current |
| 24979-153 | metformin hydrochloride | metformin hydrochloride | TWi Pharmaceuticals, Inc. | ANDA | Current |
| 24979-153 | metformin hydrochloride | metformin hydrochloride | TWi Pharmaceuticals, Inc. | ANDA | Current |
| 71205-859 | metformin hydrochloride | metformin hydrochloride | Proficient Rx LP | ANDA | Current |
| 71205-860 | metformin hydrochloride | metformin hydrochloride | Proficient Rx LP | ANDA | Current |