Application 091184
- Type
- ANDA
- Sponsor
- ALKEM
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | METFORMIN HYDROCHLORIDE | METFORMIN HYDROCHLORIDE | TABLET;ORAL | 500MG | No | No |
| 002 | METFORMIN HYDROCHLORIDE | METFORMIN HYDROCHLORIDE | TABLET;ORAL | 850MG | No | No |
| 003 | METFORMIN HYDROCHLORIDE | METFORMIN HYDROCHLORIDE | TABLET;ORAL | 1GM | No | No |
Orange Book products#
| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|---|---|---|---|---|---|---|
| A091184-001 | METFORMIN HYDROCHLORIDE | METFORMIN HYDROCHLORIDE | 500MG | TABLET / ORAL | AB | 2010-11-01 | |
| A091184-002 | METFORMIN HYDROCHLORIDE | METFORMIN HYDROCHLORIDE | 850MG | TABLET / ORAL | AB | 2010-11-01 | |
| A091184-003 | METFORMIN HYDROCHLORIDE | METFORMIN HYDROCHLORIDE | 1GM | TABLET / ORAL | AB | 2010-11-01 |
Therapeutic equivalence codes#
| Application-product | TE code |
|---|---|
| A091184-001 | AB |
| A091184-002 | AB |
| A091184-003 | AB |
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 |
|---|---|---|---|---|---|---|---|---|---|
| 2026-11-14 07:37:17 | 2026-10 | A091184-001 | METFORMIN HYDROCHLORIDE | 500MG | TABLET / ORAL | AB | 2010-11-01 | d4dbc9d85df4… | |
| 2026-11-14 07:37:17 | 2026-10 | A091184-002 | METFORMIN HYDROCHLORIDE | 850MG | TABLET / ORAL | AB | 2010-11-01 | d4dbc9d85df4… | |
| 2026-11-14 07:37:17 | 2026-10 | A091184-003 | METFORMIN HYDROCHLORIDE | 1GM | TABLET / ORAL | AB | 2010-11-01 | d4dbc9d85df4… | |
| 2026-10-15 13:18:30 | 2026-09 | A091184-001 | METFORMIN HYDROCHLORIDE | 500MG | TABLET / ORAL | AB | 2010-11-01 | c2088c7a36db… | |
| 2026-10-15 13:18:30 | 2026-09 | A091184-002 | METFORMIN HYDROCHLORIDE | 850MG | TABLET / ORAL | AB | 2010-11-01 | c2088c7a36db… | |
| 2026-10-15 13:18:30 | 2026-09 | A091184-003 | METFORMIN HYDROCHLORIDE | 1GM | TABLET / ORAL | AB | 2010-11-01 | c2088c7a36db… | |
| 2026-09-14 22:38:34 | 2026-08 | A091184-001 | METFORMIN HYDROCHLORIDE | 500MG | TABLET / ORAL | AB | 2010-11-01 | 84e616aacf4f… | |
| 2026-09-14 22:38:34 | 2026-08 | A091184-002 | METFORMIN HYDROCHLORIDE | 850MG | TABLET / ORAL | AB | 2010-11-01 | 84e616aacf4f… | |
| 2026-09-14 22:38:34 | 2026-08 | A091184-003 | METFORMIN HYDROCHLORIDE | 1GM | TABLET / ORAL | AB | 2010-11-01 | 84e616aacf4f… | |
| 2026-08-18 06:07:40 | 2026-07 | A091184-001 | METFORMIN HYDROCHLORIDE | 500MG | TABLET / ORAL | AB | 2010-11-01 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | A091184-002 | METFORMIN HYDROCHLORIDE | 850MG | TABLET / ORAL | AB | 2010-11-01 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | A091184-003 | METFORMIN HYDROCHLORIDE | 1GM | TABLET / ORAL | AB | 2010-11-01 | caaa826d4ba7… | |
| 2026-02-19 14:30 UTC | 2026-02 | A091184-001 | METFORMIN HYDROCHLORIDE | 500MG | TABLET / ORAL | AB | 2010-11-01 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | A091184-002 | METFORMIN HYDROCHLORIDE | 850MG | TABLET / ORAL | AB | 2010-11-01 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | A091184-003 | METFORMIN HYDROCHLORIDE | 1GM | TABLET / ORAL | AB | 2010-11-01 | 011fe1cb6892… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A091184-001 | METFORMIN HYDROCHLORIDE | 500MG | TABLET / ORAL | AB | 2010-11-01 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A091184-002 | METFORMIN HYDROCHLORIDE | 850MG | TABLET / ORAL | AB | 2010-11-01 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A091184-003 | METFORMIN HYDROCHLORIDE | 1GM | TABLET / ORAL | AB | 2010-11-01 | 31067a03dcf5… | |
| 2025-08-23 18:47 UTC | 2025-08 | A091184-001 | METFORMIN HYDROCHLORIDE | 500MG | TABLET / ORAL | AB | 2010-11-01 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | A091184-002 | METFORMIN HYDROCHLORIDE | 850MG | TABLET / ORAL | AB | 2010-11-01 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | A091184-003 | METFORMIN HYDROCHLORIDE | 1GM | TABLET / ORAL | AB | 2010-11-01 | 6a471c1ec25d… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A091184-001 | METFORMIN HYDROCHLORIDE | 500MG | TABLET / ORAL | AB | 2010-11-01 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A091184-002 | METFORMIN HYDROCHLORIDE | 850MG | TABLET / ORAL | AB | 2010-11-01 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A091184-003 | METFORMIN HYDROCHLORIDE | 1GM | TABLET / ORAL | AB | 2010-11-01 | fd3edfee7708… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A091184-001 | METFORMIN HYDROCHLORIDE | 500MG | TABLET / ORAL | AB | 2010-11-01 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A091184-002 | METFORMIN HYDROCHLORIDE | 850MG | TABLET / ORAL | AB | 2010-11-01 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A091184-003 | METFORMIN HYDROCHLORIDE | 1GM | TABLET / ORAL | AB | 2010-11-01 | b8a1b40f171c… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A091184-001 | METFORMIN HYDROCHLORIDE | 500MG | TABLET / ORAL | AB | 2010-11-01 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A091184-002 | METFORMIN HYDROCHLORIDE | 850MG | TABLET / ORAL | AB | 2010-11-01 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A091184-003 | METFORMIN HYDROCHLORIDE | 1GM | TABLET / ORAL | AB | 2010-11-01 | 03ed91905a0d… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A091184-001 | METFORMIN HYDROCHLORIDE | 500MG | TABLET / ORAL | AB | 2010-11-01 | 2680178bc6a6… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A091184-002 | METFORMIN HYDROCHLORIDE | 850MG | TABLET / ORAL | AB | 2010-11-01 | 2680178bc6a6… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A091184-003 | METFORMIN HYDROCHLORIDE | 1GM | TABLET / ORAL | AB | 2010-11-01 | 2680178bc6a6… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A091184-001 | METFORMIN HYDROCHLORIDE | 500MG | TABLET / ORAL | AB | 2010-11-01 | 5bbf6a4d5a75… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A091184-002 | METFORMIN HYDROCHLORIDE | 850MG | TABLET / ORAL | AB | 2010-11-01 | 5bbf6a4d5a75… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A091184-003 | METFORMIN HYDROCHLORIDE | 1GM | TABLET / ORAL | AB | 2010-11-01 | 5bbf6a4d5a75… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A091184-001 | METFORMIN HYDROCHLORIDE | 500MG | TABLET / ORAL | AB | 2010-11-01 | d8e5a09893c0… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A091184-002 | METFORMIN HYDROCHLORIDE | 850MG | TABLET / ORAL | AB | 2010-11-01 | d8e5a09893c0… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A091184-003 | METFORMIN HYDROCHLORIDE | 1GM | TABLET / ORAL | AB | 2010-11-01 | d8e5a09893c0… | |
| 2024-10-29 15:01 UTC | 2024-10 | A091184-001 | METFORMIN HYDROCHLORIDE | 500MG | TABLET / ORAL | AB | 2010-11-01 | d06236e962d9… |
Observed Orange Book normalized TE history#
| Captured | Edition | Application-product | TE code | Order | Source SHA-256 |
|---|---|---|---|---|---|
| 2026-11-14 07:37:17 | 2026-10 | A091184-001 | AB | 1 | d4dbc9d85df4… |
| 2026-11-14 07:37:17 | 2026-10 | A091184-002 | AB | 1 | d4dbc9d85df4… |
| 2026-11-14 07:37:17 | 2026-10 | A091184-003 | AB | 1 | d4dbc9d85df4… |
| 2026-10-15 13:18:30 | 2026-09 | A091184-001 | AB | 1 | c2088c7a36db… |
| 2026-10-15 13:18:30 | 2026-09 | A091184-002 | AB | 1 | c2088c7a36db… |
| 2026-10-15 13:18:30 | 2026-09 | A091184-003 | AB | 1 | c2088c7a36db… |
| 2026-09-14 22:38:34 | 2026-08 | A091184-001 | AB | 1 | 84e616aacf4f… |
| 2026-09-14 22:38:34 | 2026-08 | A091184-002 | AB | 1 | 84e616aacf4f… |
| 2026-09-14 22:38:34 | 2026-08 | A091184-003 | AB | 1 | 84e616aacf4f… |
| 2026-08-18 06:07:40 | 2026-07 | A091184-001 | AB | 1 | caaa826d4ba7… |
| 2026-08-18 06:07:40 | 2026-07 | A091184-002 | AB | 1 | caaa826d4ba7… |
| 2026-08-18 06:07:40 | 2026-07 | A091184-003 | AB | 1 | caaa826d4ba7… |
| 2026-02-19 14:30 UTC | 2026-02 | A091184-001 | AB | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | A091184-002 | AB | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | A091184-003 | AB | 1 | 011fe1cb6892… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A091184-001 | AB | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A091184-002 | AB | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A091184-003 | AB | 1 | 31067a03dcf5… |
| 2025-08-23 18:47 UTC | 2025-08 | A091184-001 | AB | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | A091184-002 | AB | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | A091184-003 | AB | 1 | 6a471c1ec25d… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A091184-001 | AB | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A091184-002 | AB | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A091184-003 | AB | 1 | fd3edfee7708… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A091184-001 | AB | 1 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A091184-002 | AB | 1 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A091184-003 | AB | 1 | b8a1b40f171c… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A091184-001 | AB | 1 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A091184-002 | AB | 1 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A091184-003 | AB | 1 | 03ed91905a0d… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A091184-001 | AB | 1 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A091184-002 | AB | 1 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A091184-003 | AB | 1 | 2680178bc6a6… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A091184-001 | AB | 1 | 5bbf6a4d5a75… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A091184-002 | AB | 1 | 5bbf6a4d5a75… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A091184-003 | AB | 1 | 5bbf6a4d5a75… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A091184-001 | AB | 1 | d8e5a09893c0… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A091184-002 | AB | 1 | d8e5a09893c0… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A091184-003 | AB | 1 | d8e5a09893c0… |
| 2024-10-29 15:01 UTC | 2024-10 | A091184-001 | AB | 1 | d06236e962d9… |
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 | QPharma Inc | 53bde438-4277-f418-e063-6394a90a5ea2 | 2026-06-08 | Boxed warning, Warnings, Adverse reactions | METFORMIN HYDROCHLORIDE 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 |
| 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 | METFORMIN HYDROCHLORIDE | Bryant Ranch Prepack | 1e7ab8da-4ece-499c-b0fb-34e37d991c1c | 2026-05-20 | Boxed warning, Warnings, Adverse reactions | METFORMIN HYDROCHLORIDE 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 | 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 | METFORMIN HYDROCHLORIDE | Bryant Ranch Prepack | be023bca-511e-4801-bd2b-e30dd1408772 | 2026-05-07 | Boxed warning, Warnings, Adverse reactions | Metformin Hydrochloride 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 | METFORMIN HYDROCHLORIDE | Granules Pharmaceuticals Inc. | 2387a618-24d8-4813-aa83-9114edb35374 | 2026-04-16 | Boxed warning, Warnings, Adverse reactions | Metformin Hydrochloride 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 | METFORMIN HYDROCHLORIDE | Precision Dose, Inc. | 60142fb2-16da-4f54-a542-74f9a70b9c8b | 2026-04-08 | Boxed warning, Warnings, Adverse reactions | Metformin Hydrochloride 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 |
| Metformin Hydrochloride Oral Solution | METFORMIN HYDROCHLORIDE | MICRO LABS LIMITED | fb90693a-074a-45be-94f4-ed6298b1f4e4 | 2026-03-16 | Boxed warning, Warnings, Adverse reactions | METFORMIN HYDROCHLORIDE |
| METFORMIN HYDROCHLORIDE | METFORMIN HYDROCHLORIDE | PD-Rx Pharmaceuticals, Inc. | abd0dad9-5f29-4102-a099-dce7bdddb98b | 2026-03-13 | Boxed warning, Warnings, Adverse reactions | METFORMIN HYDROCHLORIDE METFORMIN HYDROCHLORIDE |
| Metformin hydrochloride | METFORMIN HYDROCHLORIDE | Legacy Pharmaceutical Packaging, LLC | b51da8d7-ab4a-4c40-97c9-88bd379366d1 | 2026-03-11 | Boxed warning, Warnings, Adverse reactions | Metformin hydrochloride METFORMIN HYDROCHLORIDE |
| METFORMIN HYDROCHLORIDE | METFORMIN HYDROCHLORIDE | direct rx | c33e24e9-0441-6b94-e053-2a95a90a9c68 | 2026-03-05 | Boxed warning, Warnings, Adverse reactions | METFORMIN HYDROCHLORIDE METFORMIN HYDROCHLORIDE |
| METFORMIN HYDROCHLORIDE | METFORMIN HYDROCHLORIDE | A-S Medication Solutions | 75b25738-31e6-4b58-9d2b-f4a1ab4ab090 | 2026-03-03 | Boxed warning, Warnings, Adverse reactions | METFORMIN HYDROCHLORIDE METFORMIN HYDROCHLORIDE |
| Metformin Hydrochloride Oral Solution | METFORMIN HYDROCHLORIDE | Bionpharma Inc., | 3ab005d4-bc99-4fdb-e063-6394a90a5124 | 2026-02-25 | Boxed warning, Warnings, Adverse reactions | METFORMIN HYDROCHLORIDE |
| Metformin Hydrochloride | METFORMIN HYDROCHLORIDE | Method Pharmaceuticals, LLC. | 4aa880a4-7ec0-9155-e063-6394a90a8f3e | 2026-02-09 | 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 |
|---|---|---|---|---|---|
| 0440-5739 | Metformin Hydrochloride | Metformin Hydrochloride | Liberty Pharmaceuticals, Inc. | ANDA | Current |
| 0440-5745 | Metformin Hydrochloride | Metformin Hydrochloride | Liberty Pharmaceuticals, Inc. | ANDA | Current |
| 0440-5746 | Metformin Hydrochloride | Metformin Hydrochloride | Liberty Pharmaceuticals, Inc. | ANDA | Current |
| 0904-6326 | Metformin Hydrochloride | Metformin Hydrochloride | Major Pharmaceuticals | ANDA | Current |
| 0904-6327 | Metformin Hydrochloride | Metformin Hydrochloride | Major Pharmaceuticals | ANDA | Current |
| 0904-6328 | Metformin Hydrochloride | Metformin Hydrochloride | Major Pharmaceuticals | ANDA | Current |
| 12634-756 | Metformin Hydrochloride | Metformin Hydrochloride | Apotheca Inc. | ANDA | Current |
| 12634-757 | Metformin Hydrochloride | Metformin Hydrochloride | Apotheca Inc. | ANDA | Current |
| 12634-789 | Metformin Hydrochloride | Metformin Hydrochloride | Apotheca Inc. | ANDA | Current |
| 42708-117 | Metformin Hydrochloride | Metformin Hydrochloride | QPharma Inc | ANDA | Current |
| 42708-117 | Metformin Hydrochloride | Metformin Hydrochloride | QPharma Inc | ANDA | Current |
| 43353-128 | Metformin Hydrochloride | Metformin Hydrochloride | Aphena Pharma Solutions - Tennessee, LLC | ANDA | Current |
| 50090-2410 | Metformin Hydrochloride | Metformin Hydrochloride | A-S Medication Solutions | ANDA | Current |
| 50090-2612 | Metformin Hydrochloride | Metformin Hydrochloride | A-S Medication Solutions | ANDA | Current |
| 50090-2635 | Metformin Hydrochloride | Metformin Hydrochloride | A-S Medication Solutions | ANDA | Current |
| 50090-3088 | Metformin Hydrochloride | Metformin Hydrochloride | A-S Medication Solutions | ANDA | Current |
| 53808-1033 | Metformin Hydrochloride | Metformin Hydrochloride | State of Florida DOH Central Pharmacy | ANDA | Current |
| 55154-5888 | Metformin Hydrochloride | Metformin Hydrochloride | Cardinal Health | ANDA | Current |
| 55154-5888 | Metformin Hydrochloride | Metformin Hydrochloride | Cardinal Health | ANDA | Current |
| 55700-475 | Metformin Hydrochloride | Metformin Hydrochloride | Lake Erie Medical DBA Quality Care Products LLC | ANDA | Current |
| 67877-217 | Metformin Hydrochloride | Metformin Hydrochloride | Ascend Laboratories, LLC | ANDA | Current |
| 67877-217 | Metformin Hydrochloride | Metformin Hydrochloride | Ascend Laboratories, LLC | ANDA | Current |
| 67877-217 | Metformin Hydrochloride | Metformin Hydrochloride | Ascend Laboratories, LLC | ANDA | Current |
| 67877-218 | Metformin Hydrochloride | Metformin Hydrochloride | Ascend Laboratories, LLC | ANDA | Current |
| 67877-218 | Metformin Hydrochloride | Metformin Hydrochloride | Ascend Laboratories, LLC | ANDA | Current |
| 67877-218 | Metformin Hydrochloride | Metformin Hydrochloride | Ascend Laboratories, LLC | ANDA | Current |
| 67877-221 | Metformin Hydrochloride | Metformin Hydrochloride | Ascend Laboratories, LLC | ANDA | Current |
| 67877-221 | Metformin Hydrochloride | Metformin Hydrochloride | Ascend Laboratories, LLC | ANDA | Current |
| 67877-221 | Metformin Hydrochloride | Metformin Hydrochloride | Ascend Laboratories, LLC | ANDA | Current |
| 68788-6982 | Metformin Hydrochloride | Metformin Hydrochloride | Preferred Pharmaceuticals Inc. | ANDA | Current |
| 68788-6982 | Metformin Hydrochloride | Metformin Hydrochloride | Preferred Pharmaceuticals Inc. | ANDA | Current |
| 68788-6982 | Metformin Hydrochloride | Metformin Hydrochloride | Preferred Pharmaceuticals Inc. | ANDA | Current |
| 68788-7069 | Metformin Hydrochloride | Metformin Hydrochloride | Preferred Pharmaceuticals Inc. | ANDA | Current |
| 68788-7069 | Metformin Hydrochloride | Metformin Hydrochloride | Preferred Pharmaceuticals Inc. | ANDA | Current |
| 68788-7069 | Metformin Hydrochloride | Metformin Hydrochloride | Preferred Pharmaceuticals Inc. | ANDA | Current |
| 70518-0672 | Metformin Hydrochloride | Metformin Hydrochloride | REMEDYREPACK INC. | ANDA | Current |
| 70882-125 | Metformin Hydrochloride | Metformin Hydrochloride | Cambridge Therapeutics Technologies, LLC | ANDA | Current |