Application 075967
- Type
- ANDA
- Sponsor
- SUN PHARM INDS INC
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 |
|---|---|---|---|---|---|---|---|
| A075967-001 | METFORMIN HYDROCHLORIDE | METFORMIN HYDROCHLORIDE | 500MG | TABLET / ORAL | 2002-01-29 | ||
| A075967-002 | METFORMIN HYDROCHLORIDE | METFORMIN HYDROCHLORIDE | 850MG | TABLET / ORAL | 2002-01-29 | ||
| A075967-003 | METFORMIN HYDROCHLORIDE | METFORMIN HYDROCHLORIDE | 1GM | TABLET / ORAL | 2002-01-29 |
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 | A075967-001 | METFORMIN HYDROCHLORIDE | 500MG | TABLET / ORAL | 2002-01-29 | 84e616aacf4f… | ||
| 2026-09-14 22:38:34 | 2026-08 | A075967-002 | METFORMIN HYDROCHLORIDE | 850MG | TABLET / ORAL | 2002-01-29 | 84e616aacf4f… | ||
| 2026-09-14 22:38:34 | 2026-08 | A075967-003 | METFORMIN HYDROCHLORIDE | 1GM | TABLET / ORAL | 2002-01-29 | 84e616aacf4f… | ||
| 2026-08-18 06:07:40 | 2026-07 | A075967-001 | METFORMIN HYDROCHLORIDE | 500MG | TABLET / ORAL | 2002-01-29 | caaa826d4ba7… | ||
| 2026-08-18 06:07:40 | 2026-07 | A075967-002 | METFORMIN HYDROCHLORIDE | 850MG | TABLET / ORAL | 2002-01-29 | caaa826d4ba7… | ||
| 2026-08-18 06:07:40 | 2026-07 | A075967-003 | METFORMIN HYDROCHLORIDE | 1GM | TABLET / ORAL | 2002-01-29 | caaa826d4ba7… | ||
| 2026-02-19 14:30 UTC | 2026-02 | A075967-001 | METFORMIN HYDROCHLORIDE | 500MG | TABLET / ORAL | 2002-01-29 | 011fe1cb6892… | ||
| 2026-02-19 14:30 UTC | 2026-02 | A075967-002 | METFORMIN HYDROCHLORIDE | 850MG | TABLET / ORAL | 2002-01-29 | 011fe1cb6892… | ||
| 2026-02-19 14:30 UTC | 2026-02 | A075967-003 | METFORMIN HYDROCHLORIDE | 1GM | TABLET / ORAL | 2002-01-29 | 011fe1cb6892… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A075967-001 | METFORMIN HYDROCHLORIDE | 500MG | TABLET / ORAL | 2002-01-29 | 31067a03dcf5… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A075967-002 | METFORMIN HYDROCHLORIDE | 850MG | TABLET / ORAL | 2002-01-29 | 31067a03dcf5… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A075967-003 | METFORMIN HYDROCHLORIDE | 1GM | TABLET / ORAL | 2002-01-29 | 31067a03dcf5… | ||
| 2025-08-23 18:47 UTC | 2025-08 | A075967-001 | METFORMIN HYDROCHLORIDE | 500MG | TABLET / ORAL | 2002-01-29 | 6a471c1ec25d… | ||
| 2025-08-23 18:47 UTC | 2025-08 | A075967-002 | METFORMIN HYDROCHLORIDE | 850MG | TABLET / ORAL | 2002-01-29 | 6a471c1ec25d… | ||
| 2025-08-23 18:47 UTC | 2025-08 | A075967-003 | METFORMIN HYDROCHLORIDE | 1GM | TABLET / ORAL | 2002-01-29 | 6a471c1ec25d… | ||
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A075967-001 | METFORMIN HYDROCHLORIDE | 500MG | TABLET / ORAL | 2002-01-29 | fd3edfee7708… | ||
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A075967-002 | METFORMIN HYDROCHLORIDE | 850MG | TABLET / ORAL | 2002-01-29 | fd3edfee7708… | ||
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A075967-003 | METFORMIN HYDROCHLORIDE | 1GM | TABLET / ORAL | 2002-01-29 | fd3edfee7708… | ||
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A075967-001 | METFORMIN HYDROCHLORIDE | 500MG | TABLET / ORAL | 2002-01-29 | b8a1b40f171c… | ||
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A075967-002 | METFORMIN HYDROCHLORIDE | 850MG | TABLET / ORAL | 2002-01-29 | b8a1b40f171c… | ||
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A075967-003 | METFORMIN HYDROCHLORIDE | 1GM | TABLET / ORAL | 2002-01-29 | b8a1b40f171c… | ||
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A075967-001 | METFORMIN HYDROCHLORIDE | 500MG | TABLET / ORAL | 2002-01-29 | 03ed91905a0d… | ||
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A075967-002 | METFORMIN HYDROCHLORIDE | 850MG | TABLET / ORAL | 2002-01-29 | 03ed91905a0d… | ||
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A075967-003 | METFORMIN HYDROCHLORIDE | 1GM | TABLET / ORAL | 2002-01-29 | 03ed91905a0d… | ||
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A075967-001 | METFORMIN HYDROCHLORIDE | 500MG | TABLET / ORAL | 2002-01-29 | 2680178bc6a6… | ||
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A075967-002 | METFORMIN HYDROCHLORIDE | 850MG | TABLET / ORAL | 2002-01-29 | 2680178bc6a6… | ||
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A075967-003 | METFORMIN HYDROCHLORIDE | 1GM | TABLET / ORAL | 2002-01-29 | 2680178bc6a6… | ||
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A075967-001 | METFORMIN HYDROCHLORIDE | 500MG | TABLET / ORAL | 2002-01-29 | 5bbf6a4d5a75… | ||
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A075967-002 | METFORMIN HYDROCHLORIDE | 850MG | TABLET / ORAL | 2002-01-29 | 5bbf6a4d5a75… | ||
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A075967-003 | METFORMIN HYDROCHLORIDE | 1GM | TABLET / ORAL | 2002-01-29 | 5bbf6a4d5a75… | ||
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A075967-001 | METFORMIN HYDROCHLORIDE | 500MG | TABLET / ORAL | 2002-01-29 | d8e5a09893c0… | ||
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A075967-002 | METFORMIN HYDROCHLORIDE | 850MG | TABLET / ORAL | 2002-01-29 | d8e5a09893c0… | ||
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A075967-003 | METFORMIN HYDROCHLORIDE | 1GM | TABLET / ORAL | 2002-01-29 | d8e5a09893c0… | ||
| 2024-10-29 15:01 UTC | 2024-10 | A075967-001 | METFORMIN HYDROCHLORIDE | 500MG | TABLET / ORAL | 2002-01-29 | d06236e962d9… | ||
| 2024-10-29 15:01 UTC | 2024-10 | A075967-002 | METFORMIN HYDROCHLORIDE | 850MG | TABLET / ORAL | 2002-01-29 | d06236e962d9… | ||
| 2024-10-29 15:01 UTC | 2024-10 | A075967-003 | METFORMIN HYDROCHLORIDE | 1GM | TABLET / ORAL | 2002-01-29 | d06236e962d9… | ||
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A075967-001 | METFORMIN HYDROCHLORIDE | 500MG | TABLET / ORAL | 2002-01-29 | 79d66fd596c7… | ||
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A075967-002 | METFORMIN HYDROCHLORIDE | 850MG | TABLET / ORAL | 2002-01-29 | 79d66fd596c7… | ||
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A075967-003 | METFORMIN HYDROCHLORIDE | 1GM | TABLET / ORAL | 2002-01-29 | 79d66fd596c7… | ||
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A075967-001 | METFORMIN HYDROCHLORIDE | 500MG | TABLET / ORAL | 2002-01-29 | 301d65b070ca… |
Observed Orange Book normalized TE history#
| Captured | Edition | Application-product | TE code | Order | Source SHA-256 |
|---|---|---|---|---|---|
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | A075967-001 | AB | 1 | 5c6f7cd8ea54… |
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | A075967-002 | AB | 1 | 5c6f7cd8ea54… |
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | A075967-003 | AB | 1 | 5c6f7cd8ea54… |
| 2022-04-08 23:34 UTC | 2022-04 | A075967-001 | AB | 1 | 5d02ea3f76ae… |
| 2022-04-08 23:34 UTC | 2022-04 | A075967-002 | AB | 1 | 5d02ea3f76ae… |
| 2022-04-08 23:34 UTC | 2022-04 | A075967-003 | AB | 1 | 5d02ea3f76ae… |
| 2022-04-04 05:41 UTC | 2022-04 | A075967-001 | AB | 1 | 4b0b4de00fa7… |
| 2022-04-04 05:41 UTC | 2022-04 | A075967-002 | AB | 1 | 4b0b4de00fa7… |
| 2022-04-04 05:41 UTC | 2022-04 | A075967-003 | AB | 1 | 4b0b4de00fa7… |
| 2019-12-13 00:20 UTC | 2019-12 | A075967-001 | AB | 1 | 74a2ff9319b5… |
| 2019-12-13 00:20 UTC | 2019-12 | A075967-002 | AB | 1 | 74a2ff9319b5… |
| 2019-12-13 00:20 UTC | 2019-12 | A075967-003 | AB | 1 | 74a2ff9319b5… |
| 2022-03-09 01:35 UTC | 2022-03 | A075967-001 | AB | 1 | bb7c543d1eb4… |
| 2022-03-09 01:35 UTC | 2022-03 | A075967-002 | AB | 1 | bb7c543d1eb4… |
| 2022-03-09 01:35 UTC | 2022-03 | A075967-003 | AB | 1 | bb7c543d1eb4… |
| 2021-12-28 21:50 UTC | 2021-12 | A075967-001 | AB | 1 | 782e0a99824c… |
| 2021-12-28 21:50 UTC | 2021-12 | A075967-002 | AB | 1 | 782e0a99824c… |
| 2021-12-28 21:50 UTC | 2021-12 | A075967-003 | AB | 1 | 782e0a99824c… |
| 2021-05-05 16:15 UTC · 3 captures of this ZIP | 2021-05 | A075967-001 | AB | 1 | 87673890dc5c… |
| 2021-05-05 16:15 UTC · 3 captures of this ZIP | 2021-05 | A075967-002 | AB | 1 | 87673890dc5c… |
| 2021-05-05 16:15 UTC · 3 captures of this ZIP | 2021-05 | A075967-003 | AB | 1 | 87673890dc5c… |
| 2021-03-12 10:30 UTC | 2021-03 | A075967-001 | AB | 1 | 5aa47cf7b7d7… |
| 2021-03-12 10:30 UTC | 2021-03 | A075967-002 | AB | 1 | 5aa47cf7b7d7… |
| 2021-03-12 10:30 UTC | 2021-03 | A075967-003 | AB | 1 | 5aa47cf7b7d7… |
| 2020-12-22 03:56 UTC | 2020-12 | A075967-001 | AB | 1 | 8869cabd3fbd… |
| 2020-12-22 03:56 UTC | 2020-12 | A075967-002 | AB | 1 | 8869cabd3fbd… |
| 2020-12-22 03:56 UTC | 2020-12 | A075967-003 | AB | 1 | 8869cabd3fbd… |
| 2020-11-12 02:37 UTC | 2020-11 | A075967-001 | AB | 1 | c0c555d07b60… |
| 2020-11-12 02:37 UTC | 2020-11 | A075967-002 | AB | 1 | c0c555d07b60… |
| 2020-11-12 02:37 UTC | 2020-11 | A075967-003 | AB | 1 | c0c555d07b60… |
| 2019-12-14 00:12 UTC | 2019-12 | A075967-001 | AB | 1 | 3f01610625f2… |
| 2019-12-14 00:12 UTC | 2019-12 | A075967-002 | AB | 1 | 3f01610625f2… |
| 2019-12-14 00:12 UTC | 2019-12 | A075967-003 | AB | 1 | 3f01610625f2… |
| 2019-09-15 20:21 UTC | 2019-09 | A075967-001 | AB | 1 | b00525d2431f… |
| 2019-09-15 20:21 UTC | 2019-09 | A075967-002 | AB | 1 | b00525d2431f… |
| 2019-09-15 20:21 UTC | 2019-09 | A075967-003 | AB | 1 | b00525d2431f… |
| 2019-07-19 19:46 UTC | 2019-07 | A075967-001 | AB | 1 | ea99ee380514… |
| 2019-07-19 19:46 UTC | 2019-07 | A075967-002 | AB | 1 | ea99ee380514… |
| 2019-07-19 19:46 UTC | 2019-07 | A075967-003 | AB | 1 | ea99ee380514… |
| 2023-07-15 15:27 UTC · 2 captures of this ZIP | 2023-07 | A075967-001 | AB | 1 | a67488948f0b… |
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 | 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 |
| METFORMIN HYDROCHLORIDE | METFORMIN HYDROCHLORIDE | A-S Medication Solutions | 239834b0-121a-4903-b3ee-90bb4db4753b | 2026-02-04 | Boxed warning, Warnings, Adverse reactions | METFORMIN HYDROCHLORIDE METFORMIN HYDROCHLORIDE |
| METFORMIN HYDROCHLORIDE | METFORMIN HYDROCHLORIDE | A-S Medication Solutions | 5f2023d2-05ae-489d-9e18-fb75057496bc | 2026-02-04 | Boxed warning, Warnings, Adverse reactions | METFORMIN HYDROCHLORIDE METFORMIN HYDROCHLORIDE |
| Metformin Hydrochloride | METFORMIN HYDROCHLORIDE | A-S Medication Solutions | 1d7556eb-82b4-4085-b0b1-dc061b216feb | 2026-02-02 | Boxed warning, Warnings, Adverse reactions | Metformin Hydrochloride METFORMIN HYDROCHLORIDE |
| METFORMIN HYDROCHLORIDE | METFORMIN HYDROCHLORIDE | GLENMARK PHARMACEUTICALS INC., USA | 0ef9de1a-b786-4b6c-a250-3f5ac532b16a | 2026-01-31 | Boxed warning, Warnings, Adverse reactions | METFORMIN HYDROCHLORIDE METFORMIN HYDROCHLORIDE |
| Metformin Hydrochloride | METFORMIN HYDROCHLORIDE | Quallent Pharmaceuticals Health LLC | 6864ff5a-7512-4a4f-ad26-b2b9c5843414 | 2026-01-30 | Boxed warning, Warnings, Adverse reactions | Metformin Hydrochloride METFORMIN HYDROCHLORIDE |
| Metformin Hydrochloride | METFORMIN HYDROCHLORIDE | A-S Medication Solutions | 8c248958-6c01-455e-89f5-959facb272ed | 2026-01-29 | Boxed warning, Warnings, Adverse reactions | Metformin Hydrochloride METFORMIN HYDROCHLORIDE |
| Metformin Hydrochloride | METFORMIN HYDROCHLORIDE | A-S Medication Solutions | f59ceea4-a84a-4082-8e73-7c6f340c28d6 | 2026-01-28 | Boxed warning, Warnings, Adverse reactions | Metformin Hydrochloride METFORMIN HYDROCHLORIDE |
| Metformin Hydrochloride | METFORMIN HYDROCHLORIDE | A-S Medication Solutions | 192970d3-826a-4b69-a525-9742794dc19c | 2026-01-28 | Boxed warning, Warnings, Adverse reactions | Metformin Hydrochloride METFORMIN HYDROCHLORIDE |
| METFORMIN HYDROCHLORIDE | METFORMIN HYDROCHLORIDE | Preferred Pharmaceuticals Inc | dfac4d9c-2f20-417c-a1be-4f1c2738f351 | 2026-01-27 | Boxed warning, Warnings, Adverse reactions | METFORMIN HYDROCHLORIDE METFORMIN HYDROCHLORIDE |
| METFORMIN HYDROCHLORIDE | METFORMIN HYDROCHLORIDE | Aphena Pharma Solutions - Tennessee, LLC | 273d86b0-9d30-48c9-8918-c5e1ececa951 | 2026-01-22 | 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 |
|---|---|---|---|---|---|
| 21695-471 | METFORMIN HYDROCHLORIDE | METFORMIN HYDROCHLORIDE | Rebel Distributors Corp. | ANDA | Current |
| 21695-472 | METFORMIN HYDROCHLORIDE | METFORMIN HYDROCHLORIDE | Rebel Distributors Corp. | ANDA | Current |
| 21695-473 | METFORMIN HYDROCHLORIDE | METFORMIN HYDROCHLORIDE | Rebel Distributors Corp. | ANDA | Current |
| 33261-145 | METFORMIN HYDROCHLORIDE | METFORMIN HYDROCHLORIDE | Aidarex Pharmaceuticals LLC | ANDA | Current |
| 33261-157 | METFORMIN HYDROCHLORIDE | METFORMIN HYDROCHLORIDE | Aidarex Pharmaceuticals LLC | ANDA | Current |
| 50090-0771 | Metformin Hydrochloride | Metformin Hydrochloride | A-S Medication Solutions | ANDA | Current |
| 50090-0771 | Metformin Hydrochloride | Metformin Hydrochloride | A-S Medication Solutions | ANDA | Current |
| 50090-0777 | Metformin Hydrochloride | Metformin Hydrochloride | A-S Medication Solutions | ANDA | Current |
| 51138-074 | METFORMIN HYDROCHLORIDE | METFORMIN HYDROCHLORIDE | Med-Health Pharma, LLC | ANDA | Current |
| 51138-075 | METFORMIN HYDROCHLORIDE | METFORMIN HYDROCHLORIDE | Med-Health Pharma, LLC | ANDA | Current |
| 51138-076 | METFORMIN HYDROCHLORIDE | METFORMIN HYDROCHLORIDE | Med-Health Pharma, LLC | ANDA | Current |
| 51655-549 | Metformin Hydrochloride | Metformin Hydrochloride | Northwind Pharmaceuticals | ANDA | Current |
| 53808-0713 | METFORMIN HYDROCHLORIDE | METFORMIN HYDROCHLORIDE | State of Florida DOH Central Pharmacy | ANDA | Current |
| 53808-0718 | METFORMIN HYDROCHLORIDE | METFORMIN HYDROCHLORIDE | State of Florida DOH Central Pharmacy | ANDA | Current |
| 53808-0720 | METFORMIN HYDROCHLORIDE | METFORMIN HYDROCHLORIDE | State of Florida DOH Central Pharmacy | ANDA | Current |
| 57664-397 | Metformin Hydrochloride | Metformin Hydrochloride | Sun Pharmaceutical Industries, Inc. | ANDA | Current |
| 57664-435 | Metformin Hydrochloride | Metformin Hydrochloride | Sun Pharmaceutical Industries, Inc. | ANDA | Current |
| 57664-474 | Metformin Hydrochloride | Metformin Hydrochloride | Sun Pharmaceutical Industries, Inc. | ANDA | Current |
| 63629-1397 | Metformin Hydrochloride | Metformin Hydrochloride | Bryant Ranch Prepack | ANDA | Current |
| 63629-1397 | Metformin Hydrochloride | Metformin Hydrochloride | Bryant Ranch Prepack | ANDA | Current |
| 64725-0397 | METFORMIN HYDROCHLORIDE | METFORMIN HYDROCHLORIDE | TYA Pharmaceuticals | ANDA | Current |
| 66267-493 | Metformin Hydrochloride | Metformin Hydrochloride | NuCare Pharmaceuticals, Inc. | ANDA | Current |
| 66267-493 | Metformin Hydrochloride | Metformin Hydrochloride | NuCare Pharmaceuticals, Inc. | ANDA | Current |
| 67296-0712 | Metformin Hydrochloride | Metformin Hydrochloride | RedPharm Drug, Inc. | ANDA | Current |
| 67296-0712 | Metformin Hydrochloride | Metformin Hydrochloride | RedPharm Drug, Inc. | ANDA | Current |
| 67296-0712 | Metformin Hydrochloride | Metformin Hydrochloride | RedPharm Drug, Inc. | ANDA | Current |
| 68788-0397 | METFORMIN HYDROCHLORIDE | METFORMIN HYDROCHLORIDE | Preferred Pharmaceuticals, Inc. | ANDA | Current |
| 68788-0435 | METFORMIN HYDROCHLORIDE | METFORMIN HYDROCHLORIDE | Preferred Pharmaceuticals, Inc. | ANDA | Current |
| 68788-0474 | METFORMIN HYDROCHLORIDE | METFORMIN HYDROCHLORIDE | Preferred Pharmaceuticals, Inc. | ANDA | Current |
| 70518-0034 | Metformin Hydrochloride | Metformin Hydrochloride | REMEDYREPACK INC. | ANDA | Current |
| 70518-0237 | Metformin Hydrochloride | Metformin Hydrochloride | REMEDYREPACK INC. | ANDA | Current |
| 70518-0435 | Metformin Hydrochloride | Metformin Hydrochloride | REMEDYREPACK INC. | ANDA | Current |
| 70518-0606 | Metformin Hydrochloride | Metformin Hydrochloride | REMEDYREPACK INC. | ANDA | Current |
| 70518-0994 | Metformin Hydrochloride | Metformin Hydrochloride | REMEDYREPACK INC. | ANDA | Current |
| 70518-0994 | Metformin Hydrochloride | Metformin Hydrochloride | REMEDYREPACK INC. | ANDA | Current |
| 71335-0592 | Metformin Hydrochloride | Metformin Hydrochloride | Bryant Ranch Prepack | ANDA | Current |
| 75921-397 | Metformin Hydrochloride | metformin hydrochloride | Life Line Home Care Services, Inc. | ANDA | Current |