Metformin Hydrochloride
- Product NDC
- 67046-0804
- 11-digit product format
- 670460804
- Labeler code
- 67046
- Product ID
- 67046-0804_53e95044-dbc5-18f0-e063-6394a90a059a
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Metformin Hydrochloride
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- Coupler LLC
- Application
- ANDA090564
- Marketing category
- ANDA
- Marketing start
- 2026-06-10
- Substance
- METFORMIN HYDROCHLORIDE
- Active strength
- 850 mg/1
- Pharmacologic classes
- Biguanide [EPC], Biguanides [CS]
- NDC exclude flag
- No
- Listing certified through
- 2027-12-31
- Current FDA listing
- Yes
Orange Book products#
| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|---|---|---|---|---|---|---|
| A090564-001 | METFORMIN HYDROCHLORIDE | METFORMIN HYDROCHLORIDE | 500MG | TABLET / ORAL | AB | 2010-04-22 | |
| A090564-002 | METFORMIN HYDROCHLORIDE | METFORMIN HYDROCHLORIDE | 850MG | TABLET / ORAL | AB | 2010-04-22 | |
| A090564-003 | METFORMIN HYDROCHLORIDE | METFORMIN HYDROCHLORIDE | 1GM | TABLET / ORAL | AB | RS | 2010-04-22 |
Therapeutic equivalence codes#
| Application-product | TE code |
|---|---|
| A090564-001 | AB |
| A090564-002 | AB |
| A090564-003 | 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 |
|---|---|---|---|---|---|---|---|---|---|
| 2026-09-14 22:38:34 | 2026-08 | A090564-001 | METFORMIN HYDROCHLORIDE | 500MG | TABLET / ORAL | AB | 2010-04-22 | 84e616aacf4f… | |
| 2026-09-14 22:38:34 | 2026-08 | A090564-002 | METFORMIN HYDROCHLORIDE | 850MG | TABLET / ORAL | AB | 2010-04-22 | 84e616aacf4f… | |
| 2026-09-14 22:38:34 | 2026-08 | A090564-003 | METFORMIN HYDROCHLORIDE | 1GM | TABLET / ORAL | AB | RS | 2010-04-22 | 84e616aacf4f… |
| 2026-08-18 06:07:40 | 2026-07 | A090564-001 | METFORMIN HYDROCHLORIDE | 500MG | TABLET / ORAL | AB | 2010-04-22 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | A090564-002 | METFORMIN HYDROCHLORIDE | 850MG | TABLET / ORAL | AB | 2010-04-22 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | A090564-003 | METFORMIN HYDROCHLORIDE | 1GM | TABLET / ORAL | AB | RS | 2010-04-22 | caaa826d4ba7… |
| 2026-02-19 14:30 UTC | 2026-02 | A090564-001 | METFORMIN HYDROCHLORIDE | 500MG | TABLET / ORAL | AB | 2010-04-22 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | A090564-002 | METFORMIN HYDROCHLORIDE | 850MG | TABLET / ORAL | AB | 2010-04-22 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | A090564-003 | METFORMIN HYDROCHLORIDE | 1GM | TABLET / ORAL | AB | RS | 2010-04-22 | 011fe1cb6892… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A090564-001 | METFORMIN HYDROCHLORIDE | 500MG | TABLET / ORAL | AB | 2010-04-22 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A090564-002 | METFORMIN HYDROCHLORIDE | 850MG | TABLET / ORAL | AB | 2010-04-22 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A090564-003 | METFORMIN HYDROCHLORIDE | 1GM | TABLET / ORAL | AB | RS | 2010-04-22 | 31067a03dcf5… |
| 2025-08-23 18:47 UTC | 2025-08 | A090564-001 | METFORMIN HYDROCHLORIDE | 500MG | TABLET / ORAL | AB | 2010-04-22 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | A090564-002 | METFORMIN HYDROCHLORIDE | 850MG | TABLET / ORAL | AB | 2010-04-22 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | A090564-003 | METFORMIN HYDROCHLORIDE | 1GM | TABLET / ORAL | AB | RS | 2010-04-22 | 6a471c1ec25d… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A090564-001 | METFORMIN HYDROCHLORIDE | 500MG | TABLET / ORAL | AB | 2010-04-22 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A090564-002 | METFORMIN HYDROCHLORIDE | 850MG | TABLET / ORAL | AB | 2010-04-22 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A090564-003 | METFORMIN HYDROCHLORIDE | 1GM | TABLET / ORAL | AB | RS | 2010-04-22 | fd3edfee7708… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A090564-001 | METFORMIN HYDROCHLORIDE | 500MG | TABLET / ORAL | AB | 2010-04-22 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A090564-002 | METFORMIN HYDROCHLORIDE | 850MG | TABLET / ORAL | AB | 2010-04-22 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A090564-003 | METFORMIN HYDROCHLORIDE | 1GM | TABLET / ORAL | AB | RS | 2010-04-22 | b8a1b40f171c… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A090564-001 | METFORMIN HYDROCHLORIDE | 500MG | TABLET / ORAL | AB | 2010-04-22 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A090564-002 | METFORMIN HYDROCHLORIDE | 850MG | TABLET / ORAL | AB | 2010-04-22 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A090564-003 | METFORMIN HYDROCHLORIDE | 1GM | TABLET / ORAL | AB | RS | 2010-04-22 | 03ed91905a0d… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A090564-001 | METFORMIN HYDROCHLORIDE | 500MG | TABLET / ORAL | AB | 2010-04-22 | 2680178bc6a6… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A090564-002 | METFORMIN HYDROCHLORIDE | 850MG | TABLET / ORAL | AB | 2010-04-22 | 2680178bc6a6… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A090564-003 | METFORMIN HYDROCHLORIDE | 1GM | TABLET / ORAL | AB | RS | 2010-04-22 | 2680178bc6a6… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A090564-001 | METFORMIN HYDROCHLORIDE | 500MG | TABLET / ORAL | AB | 2010-04-22 | 5bbf6a4d5a75… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A090564-002 | METFORMIN HYDROCHLORIDE | 850MG | TABLET / ORAL | AB | 2010-04-22 | 5bbf6a4d5a75… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A090564-003 | METFORMIN HYDROCHLORIDE | 1GM | TABLET / ORAL | AB | RS | 2010-04-22 | 5bbf6a4d5a75… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A090564-001 | METFORMIN HYDROCHLORIDE | 500MG | TABLET / ORAL | AB | 2010-04-22 | d8e5a09893c0… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A090564-002 | METFORMIN HYDROCHLORIDE | 850MG | TABLET / ORAL | AB | 2010-04-22 | d8e5a09893c0… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A090564-003 | METFORMIN HYDROCHLORIDE | 1GM | TABLET / ORAL | AB | RS | 2010-04-22 | d8e5a09893c0… |
| 2024-10-29 15:01 UTC | 2024-10 | A090564-001 | METFORMIN HYDROCHLORIDE | 500MG | TABLET / ORAL | AB | 2010-04-22 | d06236e962d9… | |
| 2024-10-29 15:01 UTC | 2024-10 | A090564-002 | METFORMIN HYDROCHLORIDE | 850MG | TABLET / ORAL | AB | 2010-04-22 | d06236e962d9… | |
| 2024-10-29 15:01 UTC | 2024-10 | A090564-003 | METFORMIN HYDROCHLORIDE | 1GM | TABLET / ORAL | AB | RS | 2010-04-22 | d06236e962d9… |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A090564-001 | METFORMIN HYDROCHLORIDE | 500MG | TABLET / ORAL | AB | 2010-04-22 | 79d66fd596c7… | |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A090564-002 | METFORMIN HYDROCHLORIDE | 850MG | TABLET / ORAL | AB | 2010-04-22 | 79d66fd596c7… | |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A090564-003 | METFORMIN HYDROCHLORIDE | 1GM | TABLET / ORAL | AB | RS | 2010-04-22 | 79d66fd596c7… |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A090564-001 | METFORMIN HYDROCHLORIDE | 500MG | TABLET / ORAL | AB | 2010-04-22 | 301d65b070ca… |
Observed Orange Book normalized TE history#
| Captured | Edition | Application-product | TE code | Order | Source SHA-256 |
|---|---|---|---|---|---|
| 2026-09-14 22:38:34 | 2026-08 | A090564-001 | AB | 1 | 84e616aacf4f… |
| 2026-09-14 22:38:34 | 2026-08 | A090564-002 | AB | 1 | 84e616aacf4f… |
| 2026-09-14 22:38:34 | 2026-08 | A090564-003 | AB | 1 | 84e616aacf4f… |
| 2026-08-18 06:07:40 | 2026-07 | A090564-001 | AB | 1 | caaa826d4ba7… |
| 2026-08-18 06:07:40 | 2026-07 | A090564-002 | AB | 1 | caaa826d4ba7… |
| 2026-08-18 06:07:40 | 2026-07 | A090564-003 | AB | 1 | caaa826d4ba7… |
| 2026-02-19 14:30 UTC | 2026-02 | A090564-001 | AB | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | A090564-002 | AB | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | A090564-003 | AB | 1 | 011fe1cb6892… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A090564-001 | AB | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A090564-002 | AB | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A090564-003 | AB | 1 | 31067a03dcf5… |
| 2025-08-23 18:47 UTC | 2025-08 | A090564-001 | AB | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | A090564-002 | AB | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | A090564-003 | AB | 1 | 6a471c1ec25d… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A090564-001 | AB | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A090564-002 | AB | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A090564-003 | AB | 1 | fd3edfee7708… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A090564-001 | AB | 1 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A090564-002 | AB | 1 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A090564-003 | AB | 1 | b8a1b40f171c… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A090564-001 | AB | 1 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A090564-002 | AB | 1 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A090564-003 | AB | 1 | 03ed91905a0d… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A090564-001 | AB | 1 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A090564-002 | AB | 1 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A090564-003 | AB | 1 | 2680178bc6a6… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A090564-001 | AB | 1 | 5bbf6a4d5a75… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A090564-002 | AB | 1 | 5bbf6a4d5a75… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A090564-003 | AB | 1 | 5bbf6a4d5a75… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A090564-001 | AB | 1 | d8e5a09893c0… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A090564-002 | AB | 1 | d8e5a09893c0… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A090564-003 | AB | 1 | d8e5a09893c0… |
| 2024-10-29 15:01 UTC | 2024-10 | A090564-001 | AB | 1 | d06236e962d9… |
| 2024-10-29 15:01 UTC | 2024-10 | A090564-002 | AB | 1 | d06236e962d9… |
| 2024-10-29 15:01 UTC | 2024-10 | A090564-003 | AB | 1 | d06236e962d9… |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A090564-001 | AB | 1 | 79d66fd596c7… |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A090564-002 | AB | 1 | 79d66fd596c7… |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A090564-003 | AB | 1 | 79d66fd596c7… |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A090564-001 | AB | 1 | 301d65b070ca… |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Metformin Hydrochloride
- Listing expiration
- 2027-12-31
Active Ingredients#
| Ingredient | Strength |
|---|---|
| METFORMIN HYDROCHLORIDE | 850 mg/1 |
Harmonized UNII identifiers#
| Identifier | FDA.report destination |
|---|---|
| 786Z46389E | Internal UNII lookup |
Harmonized RxCUI identifiers#
| Identifier | FDA.report destination |
|---|---|
| 861010 | Internal RxNorm lookup |
Harmonized SPL set identifiers#
| Identifier | FDA.report destination |
|---|---|
| 53e950f5-c58f-78e3-e063-6294a90a53e9 | Available on FDA.report |
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 | Legacy Pharmaceutical Packaging, LLC | b51da8d7-ab4a-4c40-97c9-88bd379366d1 | 2026-03-11 | Boxed warning, Warnings, Adverse reactions | 090564 ANDA090564 |
| Metformin Hydrochloride | METFORMIN HYDROCHLORIDE | Northwind Health Company, LLC | f31c08fc-cda1-349c-e053-2a95a90aba15 | 2026-01-01 | Boxed warning, Warnings, Adverse reactions | 090564 ANDA090564 |
| Metformin Hydrochloride | METFORMIN HYDROCHLORIDE | Northwind Health Company, LLC | dae7b1c1-7ff1-883c-e053-2a95a90a1a2b | 2026-01-01 | Boxed warning, Warnings, Adverse reactions | 090564 ANDA090564 |
| Metformin HCl | METFORMIN HCL | A-S Medication Solutions | c37b511c-1e33-4941-bd12-df0447a50ca9 | 2025-12-06 | Warnings, Adverse reactions | 090564 ANDA090564 |
| Metformin HCl | METFORMIN HCL | QPharma, Inc. | 06ade2e1-5981-4e3d-b7e9-7ff083eb4551 | 2025-12-05 | Warnings, Adverse reactions | 090564 ANDA090564 |
| Metformin Hydrochloride | METFORMIN HYDROCHLORIDE TABLET | Quallent Pharmaceuticals Health LLC | f39ee08d-73db-71b9-e053-2995a90a877c | 2025-12-04 | Boxed warning, Warnings, Adverse reactions | 090564 ANDA090564 |
| Metformin HCl | METFORMIN HCL | A-S Medication Solutions | d43ccbc3-eb0b-400e-a6fa-31202dec3a71 | 2025-11-10 | Warnings, Adverse reactions | 090564 ANDA090564 |
| Metformin HCl | METFORMIN HCL | A-S Medication Solutions | 21cbb326-9dee-40ec-ac25-0dad79e3302b | 2025-11-07 | Warnings, Adverse reactions | 090564 ANDA090564 |
| Metformin HCl | METFORMIN HCL | A-S Medication Solutions | 397c2bf4-35be-4e75-b5a6-426e3fa09548 | 2025-11-06 | Warnings, Adverse reactions | 090564 ANDA090564 |
| Metformin HCl | METFORMIN HCL | PD-Rx Pharmaceuticals, Inc. | 235680e6-1c3e-45b8-902e-866583f1aef3 | 2025-11-04 | Warnings, Adverse reactions | 090564 ANDA090564 |
| Metformin Hydrochloride | METFORMIN HYDROCHLORIDE | NuCare Pharmaceuticals, Inc. | 403349a1-ec19-8982-e063-6294a90aa060 | 2025-10-02 | Boxed warning, Warnings, Adverse reactions | 090564 ANDA090564 |
| Metformin Hydrochloride | METFORMIN HYDROCHLORIDE | A-S Medication Solutions | bb62088f-e9af-4644-9f57-cb90bab0f199 | 2025-07-09 | Boxed warning, Warnings, Adverse reactions | 090564 ANDA090564 |
| Metformin Hydrochloride | METFORMIN HYDROCHLORIDE | A-S Medication Solutions | 59743092-bae1-4725-ac4b-c8a8b0a81c1e | 2025-07-09 | Boxed warning, Warnings, Adverse reactions | 090564 ANDA090564 |
| Metformin HCl | METFORMIN HCL | NuCare Pharmaceuticals,Inc. | 0b3d7c79-9a5a-a82e-e063-6394a90a3caa | 2025-02-03 | Warnings, Adverse reactions | 090564 ANDA090564 |
| Metformin HCl | METFORMIN HCL | A-S Medication Solutions | 4ba2a76f-6665-4012-84e4-f2849a0246ac | 2024-11-27 | Warnings, Adverse reactions | 090564 ANDA090564 |
| Metformin HCl | METFORMIN HCL | NuCare Pharmaceuticals, Inc. | 242256af-c587-060a-e063-6294a90a68cc | 2024-10-10 | Warnings, Adverse reactions | 090564 ANDA090564 |
| Metformin HCl | METFORMIN HCL | Advanced Rx of Tennessee, LLC | 21b76183-af30-e06f-e063-6394a90a9653 | 2024-09-23 | Warnings, Adverse reactions | 090564 ANDA090564 |
| Metformin Hydrochloride | METFORMIN HYDROCHLORIDE | A-S Medication Solutions | 011de1a5-1ac0-4831-9e8d-26ec79ba2205 | 2024-08-21 | Boxed warning, Warnings, Adverse reactions | 090564 ANDA090564 |
| Metformin Hydrochloride | METFORMIN HYDROCHLORIDE | NuCare Pharmaceuticals,Inc. | 041632fa-9bf4-8d7c-e063-6294a90adefb | 2024-08-05 | Boxed warning, Warnings, Adverse reactions | 090564 ANDA090564 |
| Metformin Hydrochloride | METFORMIN HYDROCHLORIDE | A-S Medication Solutions | 1ef6c527-89f5-4830-8900-7532b0a7ef26 | 2024-06-25 | Boxed warning, Warnings, Adverse reactions | 090564 ANDA090564 |
Packages#
| Package NDC | 11-digit format | Description | Units | Marketing start | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|
| 67046-0804-3 | 67046080403 | 30 TABLET in 1 BLISTER PACK (67046-0804-3) | 30 tablet | 2026-06-10 | No | No | Current |