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 | PD-Rx Pharmaceuticals, Inc. | 68d0b1a6-c99e-42cf-afdf-b71ee73c4424 | 2026-07-30 | Boxed warning, Warnings, Adverse reactions | Metformin Hydrochloride 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 | METFORMIN HYDROCHLORIDE | REMEDYREPACK INC. | 1503bbe4-0ac5-479b-9900-d38e49236bf0 | 2026-07-28 | Boxed warning, Warnings, Adverse reactions | Metformin Hydrochloride 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 | METFORMIN HYDROCHLORIDE | Chartwell RX, LLC | 4d3dbf6f-1c8a-4daa-8343-8cd8f64a65cd | 2026-07-20 | Boxed warning, Warnings, Adverse reactions | Metformin Hydrochloride 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 | 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 | METFORMIN HYDROCHLORIDE | REMEDYREPACK INC. | 5aa1c86c-f2c8-49b1-8f81-47b11386c5d3 | 2026-07-15 | Boxed warning, Warnings, Adverse reactions | Metformin Hydrochloride 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 | 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 | METFORMIN HYDROCHLORIDE | Aurobindo Pharma Limited | fc466c46-abaa-4675-aef2-4b1a1adfd912 | 2026-07-08 | Boxed warning, Warnings, Adverse reactions | Metformin Hydrochloride 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 | METFORMIN HYDROCHLORIDE | Amneal Pharmaceuticals LLC | dc65065b-cba0-46d7-8fb5-3368f3210b4d | 2026-07-01 | Boxed warning, Warnings, Adverse reactions | Metformin Hydrochloride 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 METFORMIN HYDROCHLORIDE |
| Metformin Hydrochloride | METFORMIN HYDROCHLORIDE | MARKSANS PHARMA LIMITED | d09a2eda-fdd8-44ed-8e2f-ea91ddfd3c68 | 2026-06-29 | Boxed warning, Warnings, Adverse reactions | Metformin Hydrochloride METFORMIN HYDROCHLORIDE |
| Metformin Hydrochloride | METFORMIN HYDROCHLORIDE TABLET | Granules India Ltd | 8cd5555c-f6b2-28d8-e053-2a95a90a5f1e | 2026-06-29 | Boxed warning, Warnings, Adverse reactions | Metformin Hydrochloride |
| Metformin Hydrochloride | METFORMIN HYDROCHLORIDE | Unit Dose Solutions, Inc. | 552ad61d-bafd-478d-e063-6294a90a02f9 | 2026-06-26 | Boxed warning, Warnings, Adverse reactions | Metformin Hydrochloride METFORMIN HYDROCHLORIDE |
| METFORMIN HYDROCHLORIDE | METFORMIN HYDROCHLORIDE | Marlex Pharmaceuticals, Inc. | 3d6f397b-e909-bee9-e063-6294a90aba17 | 2026-06-26 | Boxed warning, Warnings, Adverse reactions | METFORMIN HYDROCHLORIDE METFORMIN HYDROCHLORIDE |
| Metformin Hydrochloride | METFORMIN HYDROCHLORIDE | Viona Pharmaceuticals Inc | 85027e6c-d35b-49eb-a234-dd71aa77aee0 | 2026-06-26 | 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 |