METFORMIN HYDROCHLORIDE
- Product NDC
- 50090-7586
- 11-digit product format
- 500907586
- Labeler code
- 50090
- Product ID
- 50090-7586_3c65d28f-1edf-441f-a292-9f977232793f
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- METFORMIN HYDROCHLORIDE
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- A-S Medication Solutions
- Application
- ANDA203769
- Marketing category
- ANDA
- Marketing start
- 2015-02-01
- Substance
- METFORMIN HYDROCHLORIDE
- Active strength
- 1000 mg/1
- Pharmacologic classes
- Biguanide [EPC], Biguanides [CS]
- NDC exclude flag
- No
- Listing certified through
- 2026-12-31
- Current FDA listing
- Yes
Orange Book products#
| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|---|---|---|---|---|---|---|
| A203769-001 | METFORMIN HYDROCHLORIDE | METFORMIN HYDROCHLORIDE | 500MG | TABLET / ORAL | AB | 2013-09-11 | |
| A203769-002 | METFORMIN HYDROCHLORIDE | METFORMIN HYDROCHLORIDE | 850MG | TABLET / ORAL | AB | 2013-09-11 | |
| A203769-003 | METFORMIN HYDROCHLORIDE | METFORMIN HYDROCHLORIDE | 1GM | TABLET / ORAL | AB | 2013-09-11 | |
| A203769-004 | METFORMIN HYDROCHLORIDE | METFORMIN HYDROCHLORIDE | 625MG | TABLET / ORAL | AB | 2026-02-09 | |
| A203769-005 | METFORMIN HYDROCHLORIDE | METFORMIN HYDROCHLORIDE | 750MG | TABLET / ORAL | AB | 2026-02-09 |
Therapeutic equivalence codes#
| Application-product | TE code |
|---|---|
| A203769-001 | AB |
| A203769-002 | AB |
| A203769-003 | AB |
| A203769-004 | AB |
| A203769-005 | 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 | A203769-001 | METFORMIN HYDROCHLORIDE | 500MG | TABLET / ORAL | AB | 2013-09-11 | 84e616aacf4f… | |
| 2026-09-14 22:38:34 | 2026-08 | A203769-002 | METFORMIN HYDROCHLORIDE | 850MG | TABLET / ORAL | AB | 2013-09-11 | 84e616aacf4f… | |
| 2026-09-14 22:38:34 | 2026-08 | A203769-003 | METFORMIN HYDROCHLORIDE | 1GM | TABLET / ORAL | AB | 2013-09-11 | 84e616aacf4f… | |
| 2026-09-14 22:38:34 | 2026-08 | A203769-004 | METFORMIN HYDROCHLORIDE | 625MG | TABLET / ORAL | AB | 2026-02-09 | 84e616aacf4f… | |
| 2026-09-14 22:38:34 | 2026-08 | A203769-005 | METFORMIN HYDROCHLORIDE | 750MG | TABLET / ORAL | AB | 2026-02-09 | 84e616aacf4f… | |
| 2026-08-18 06:07:40 | 2026-07 | A203769-001 | METFORMIN HYDROCHLORIDE | 500MG | TABLET / ORAL | AB | 2013-09-11 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | A203769-002 | METFORMIN HYDROCHLORIDE | 850MG | TABLET / ORAL | AB | 2013-09-11 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | A203769-003 | METFORMIN HYDROCHLORIDE | 1GM | TABLET / ORAL | AB | 2013-09-11 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | A203769-004 | METFORMIN HYDROCHLORIDE | 625MG | TABLET / ORAL | AB | 2026-02-09 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | A203769-005 | METFORMIN HYDROCHLORIDE | 750MG | TABLET / ORAL | AB | 2026-02-09 | caaa826d4ba7… | |
| 2026-02-19 14:30 UTC | 2026-02 | A203769-001 | METFORMIN HYDROCHLORIDE | 500MG | TABLET / ORAL | AB | 2013-09-11 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | A203769-002 | METFORMIN HYDROCHLORIDE | 850MG | TABLET / ORAL | AB | 2013-09-11 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | A203769-003 | METFORMIN HYDROCHLORIDE | 1GM | TABLET / ORAL | AB | 2013-09-11 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | A203769-004 | METFORMIN HYDROCHLORIDE | 625MG | TABLET / ORAL | AB | 2026-02-09 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | A203769-005 | METFORMIN HYDROCHLORIDE | 750MG | TABLET / ORAL | AB | 2026-02-09 | 011fe1cb6892… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A203769-001 | METFORMIN HYDROCHLORIDE | 500MG | TABLET / ORAL | AB | 2013-09-11 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A203769-002 | METFORMIN HYDROCHLORIDE | 850MG | TABLET / ORAL | AB | 2013-09-11 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A203769-003 | METFORMIN HYDROCHLORIDE | 1GM | TABLET / ORAL | AB | 2013-09-11 | 31067a03dcf5… | |
| 2025-08-23 18:47 UTC | 2025-08 | A203769-001 | METFORMIN HYDROCHLORIDE | 500MG | TABLET / ORAL | AB | 2013-09-11 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | A203769-002 | METFORMIN HYDROCHLORIDE | 850MG | TABLET / ORAL | AB | 2013-09-11 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | A203769-003 | METFORMIN HYDROCHLORIDE | 1GM | TABLET / ORAL | AB | 2013-09-11 | 6a471c1ec25d… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A203769-001 | METFORMIN HYDROCHLORIDE | 500MG | TABLET / ORAL | AB | 2013-09-11 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A203769-002 | METFORMIN HYDROCHLORIDE | 850MG | TABLET / ORAL | AB | 2013-09-11 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A203769-003 | METFORMIN HYDROCHLORIDE | 1GM | TABLET / ORAL | AB | 2013-09-11 | fd3edfee7708… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A203769-001 | METFORMIN HYDROCHLORIDE | 500MG | TABLET / ORAL | AB | 2013-09-11 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A203769-002 | METFORMIN HYDROCHLORIDE | 850MG | TABLET / ORAL | AB | 2013-09-11 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A203769-003 | METFORMIN HYDROCHLORIDE | 1GM | TABLET / ORAL | AB | 2013-09-11 | b8a1b40f171c… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A203769-001 | METFORMIN HYDROCHLORIDE | 500MG | TABLET / ORAL | AB | 2013-09-11 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A203769-002 | METFORMIN HYDROCHLORIDE | 850MG | TABLET / ORAL | AB | 2013-09-11 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A203769-003 | METFORMIN HYDROCHLORIDE | 1GM | TABLET / ORAL | AB | 2013-09-11 | 03ed91905a0d… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A203769-001 | METFORMIN HYDROCHLORIDE | 500MG | TABLET / ORAL | AB | 2013-09-11 | 2680178bc6a6… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A203769-002 | METFORMIN HYDROCHLORIDE | 850MG | TABLET / ORAL | AB | 2013-09-11 | 2680178bc6a6… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A203769-003 | METFORMIN HYDROCHLORIDE | 1GM | TABLET / ORAL | AB | 2013-09-11 | 2680178bc6a6… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A203769-001 | METFORMIN HYDROCHLORIDE | 500MG | TABLET / ORAL | AB | 2013-09-11 | 5bbf6a4d5a75… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A203769-002 | METFORMIN HYDROCHLORIDE | 850MG | TABLET / ORAL | AB | 2013-09-11 | 5bbf6a4d5a75… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A203769-003 | METFORMIN HYDROCHLORIDE | 1GM | TABLET / ORAL | AB | 2013-09-11 | 5bbf6a4d5a75… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A203769-001 | METFORMIN HYDROCHLORIDE | 500MG | TABLET / ORAL | AB | 2013-09-11 | d8e5a09893c0… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A203769-002 | METFORMIN HYDROCHLORIDE | 850MG | TABLET / ORAL | AB | 2013-09-11 | d8e5a09893c0… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A203769-003 | METFORMIN HYDROCHLORIDE | 1GM | TABLET / ORAL | AB | 2013-09-11 | d8e5a09893c0… | |
| 2024-10-29 15:01 UTC | 2024-10 | A203769-001 | METFORMIN HYDROCHLORIDE | 500MG | TABLET / ORAL | AB | 2013-09-11 | d06236e962d9… |
Observed Orange Book normalized TE history#
| Captured | Edition | Application-product | TE code | Order | Source SHA-256 |
|---|---|---|---|---|---|
| 2026-09-14 22:38:34 | 2026-08 | A203769-001 | AB | 1 | 84e616aacf4f… |
| 2026-09-14 22:38:34 | 2026-08 | A203769-002 | AB | 1 | 84e616aacf4f… |
| 2026-09-14 22:38:34 | 2026-08 | A203769-003 | AB | 1 | 84e616aacf4f… |
| 2026-09-14 22:38:34 | 2026-08 | A203769-004 | AB | 1 | 84e616aacf4f… |
| 2026-09-14 22:38:34 | 2026-08 | A203769-005 | AB | 1 | 84e616aacf4f… |
| 2026-08-18 06:07:40 | 2026-07 | A203769-001 | AB | 1 | caaa826d4ba7… |
| 2026-08-18 06:07:40 | 2026-07 | A203769-002 | AB | 1 | caaa826d4ba7… |
| 2026-08-18 06:07:40 | 2026-07 | A203769-003 | AB | 1 | caaa826d4ba7… |
| 2026-08-18 06:07:40 | 2026-07 | A203769-004 | AB | 1 | caaa826d4ba7… |
| 2026-08-18 06:07:40 | 2026-07 | A203769-005 | AB | 1 | caaa826d4ba7… |
| 2026-02-19 14:30 UTC | 2026-02 | A203769-001 | AB | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | A203769-002 | AB | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | A203769-003 | AB | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | A203769-004 | AB | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | A203769-005 | AB | 1 | 011fe1cb6892… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A203769-001 | AB | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A203769-002 | AB | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A203769-003 | AB | 1 | 31067a03dcf5… |
| 2025-08-23 18:47 UTC | 2025-08 | A203769-001 | AB | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | A203769-002 | AB | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | A203769-003 | AB | 1 | 6a471c1ec25d… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A203769-001 | AB | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A203769-002 | AB | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A203769-003 | AB | 1 | fd3edfee7708… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A203769-001 | AB | 1 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A203769-002 | AB | 1 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A203769-003 | AB | 1 | b8a1b40f171c… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A203769-001 | AB | 1 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A203769-002 | AB | 1 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A203769-003 | AB | 1 | 03ed91905a0d… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A203769-001 | AB | 1 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A203769-002 | AB | 1 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A203769-003 | AB | 1 | 2680178bc6a6… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A203769-001 | AB | 1 | 5bbf6a4d5a75… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A203769-002 | AB | 1 | 5bbf6a4d5a75… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A203769-003 | AB | 1 | 5bbf6a4d5a75… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A203769-001 | AB | 1 | d8e5a09893c0… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A203769-002 | AB | 1 | d8e5a09893c0… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A203769-003 | AB | 1 | d8e5a09893c0… |
| 2024-10-29 15:01 UTC | 2024-10 | A203769-001 | AB | 1 | d06236e962d9… |
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
- 2026-12-31
Active Ingredients#
| Ingredient | Strength |
|---|---|
| METFORMIN HYDROCHLORIDE | 1000 mg/1 |
Harmonized UNII identifiers#
| Identifier | FDA.report destination |
|---|---|
| 786Z46389E | Internal UNII lookup |
Harmonized RxCUI identifiers#
| Identifier | FDA.report destination |
|---|---|
| 861004 | Internal RxNorm lookup |
Harmonized SPL set identifiers#
| Identifier | FDA.report destination |
|---|---|
| ec3a9070-3745-41fb-b610-8d06129d8fd9 | Available on FDA.report |
DailyMed Product Concepts#
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 50090-7586-0 | METFORMIN HYDROCHLORIDE | 60 in 1 BOTTLE | TABLET | 60 | 2 | |
| 50090-7586-2 | METFORMIN HYDROCHLORIDE | 100 in 1 BOTTLE | TABLET | 100 | 2 | |
| 50090-7586-3 | METFORMIN HYDROCHLORIDE | 30 in 1 BOTTLE | TABLET | 30 | 2 | |
| 50090-7586-4 | METFORMIN HYDROCHLORIDE | 90 in 1 BOTTLE | TABLET | 90 | 2 | |
| 50090-7586-5 | METFORMIN HYDROCHLORIDE | 180 in 1 BOTTLE | TABLET | 180 | 2 |
DailyMed Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 50090-7586-0 | EA - Each | 50090-7586 | fdee0b49-db30-4663-ab9a-8a37251ef2e2 | 1 | 2025-08-11 |
| 50090-7586-2 | EA - Each | 50090-7586 | 37a66e39-b77f-47f3-bd41-aa9a8d731cc0 | 1 | 2025-08-11 |
| 50090-7586-3 | EA - Each | 50090-7586 | bc9b4695-fae9-49ab-a4b7-2401b5767ae6 | 1 | 2025-08-11 |
| 50090-7586-4 | EA - Each | 50090-7586 | a2f3d1b0-9148-4217-9855-2f6a42806223 | 1 | 2025-08-11 |
| 50090-7586-5 | EA - Each | 50090-7586 | 3b4f438b-37db-408c-8765-45fba1ac7088 | 1 | 2025-08-11 |
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 | Golden State Medical Supply, Inc. | f86bda10-8b25-4125-8bb1-1b5917969ff0 | 2023-03-21 | Boxed warning, Warnings, Adverse reactions | 203769 ANDA203769 |
| METFORMIN HYDROCHLORIDE | METFORMIN HYDROCHLORIDE | Bryant Ranch Prepack | 76879512-3ab4-4acf-92e6-bba0fb75dd0e | 2023-03-10 | Boxed warning, Warnings, Adverse reactions | 203769 ANDA203769 |
| METFORMIN HYDROCHLORIDE | METFORMIN HYDROCHLORIDE | Bryant Ranch Prepack | a59327bd-a3ba-417b-9e91-4cd3a941e640 | 2023-03-10 | Boxed warning, Warnings, Adverse reactions | 203769 ANDA203769 |
| METFORMIN HYDROCHLORIDE | METFORMIN HYDROCHLORIDE | Bryant Ranch Prepack | a79d2674-071f-4641-9b11-406e02c5530a | 2023-03-10 | Boxed warning, Warnings, Adverse reactions | 203769 ANDA203769 |
| METFORMIN HYDROCHLORIDE | METFORMIN HYDROCHLORIDE | Aphena Pharma Solutions - Tennessee, LLC | d0bee456-c8cd-46a1-acb3-5313a8cddd30 | 2022-11-03 | Boxed warning, Warnings, Adverse reactions | 203769 ANDA203769 |
| Metformin Hydrochloride | METFORMIN HYDROCHLORIDE | Proficient Rx LP | 738402d6-3700-46b2-a90c-2e8f2c354a39 | 2022-03-01 | Boxed warning, Warnings, Adverse reactions | 203769 ANDA203769 |
| METFORMIN HYDROCHLORIDE | METFORMIN HYDROCHLORIDE | Bryant Ranch Prepack | 9632456f-57c2-444b-9f43-d9ca862681fe | 2021-03-10 | Boxed warning, Warnings, Adverse reactions | 203769 ANDA203769 |
| METFORMIN HYDROCHLORIDE | METFORMIN HYDROCHLORIDE | ACI Healthcare USA, Inc. | e18b60f9-721e-4db6-9f61-d3437e18faf2 | 2020-12-26 | Boxed warning, Warnings, Adverse reactions | 203769 ANDA203769 |
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | DailyMed | SPL version |
|---|---|---|---|---|
| 861004 | metFORMIN HCl 1000 MG Oral Tablet | PSN | ec3a9070-3745-41fb-b610-8d06129d8fd9 | 2 |
| 861004 | metformin hydrochloride 1000 MG Oral Tablet | SCD | ec3a9070-3745-41fb-b610-8d06129d8fd9 | 2 |
| 861004 | metformin HCl 1 GM Oral Tablet | SY | ec3a9070-3745-41fb-b610-8d06129d8fd9 | 2 |
Packages#
| Package NDC | 11-digit format | Description | Units | Marketing start | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|
| 50090-7586-0 | 50090758600 | 60 TABLET in 1 BOTTLE (50090-7586-0) | 60 tablet | 2025-06-30 | No | No | Current |
| 50090-7586-2 | 50090758602 | 100 TABLET in 1 BOTTLE (50090-7586-2) | 100 tablet | 2025-06-30 | No | No | Current |
| 50090-7586-3 | 50090758603 | 30 TABLET in 1 BOTTLE (50090-7586-3) | 30 tablet | 2025-06-30 | No | No | Current |
| 50090-7586-4 | 50090758604 | 90 TABLET in 1 BOTTLE (50090-7586-4) | 90 tablet | 2025-06-30 | No | No | Current |
| 50090-7586-5 | 50090758605 | 180 TABLET in 1 BOTTLE (50090-7586-5) | 180 tablet | 2025-06-30 | No | No | Current |