Metformin Hydrochloride
- Product NDC
- 71205-784
- 11-digit product format
- 712050784
- Labeler code
- 71205
- Product ID
- 71205-784_ab4b854a-723a-416f-9eff-9c9e7dbac29f
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- METFORMIN HYDROCHLORIDE
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- Proficient Rx LP
- Application
- ANDA203769
- Marketing category
- ANDA
- Marketing start
- 2017-11-21
- Substance
- METFORMIN HYDROCHLORIDE
- Active strength
- 500 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 |
|---|---|---|---|---|---|---|---|
| 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
- 2027-12-31
Active Ingredients#
| Ingredient | Strength |
|---|---|
| METFORMIN HYDROCHLORIDE | 500 mg/1 |
Harmonized UNII identifiers#
| Identifier | FDA.report destination |
|---|---|
| 786Z46389E | Internal UNII lookup |
Harmonized RxCUI identifiers#
Harmonized SPL set identifiers#
| Identifier | FDA.report destination |
|---|---|
| 928ef685-80cb-42a9-a155-3c21c9b1dd67 | Available on FDA.report |
DailyMed Product Concepts#
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 71205-784-30 | Metformin Hydrochloride | 30 in 1 BOTTLE, PLASTIC | TABLET, FILM COATED | 30 | 2 | |
| 71205-784-60 | Metformin Hydrochloride | 60 in 1 BOTTLE, PLASTIC | TABLET, FILM COATED | 60 | 2 | |
| 71205-784-78 | Metformin Hydrochloride | 180 in 1 BOTTLE, PLASTIC | TABLET, FILM COATED | 180 | 2 | |
| 71205-784-90 | Metformin Hydrochloride | 90 in 1 BOTTLE, PLASTIC | TABLET, FILM COATED | 90 | 2 |
DailyMed Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 71205-784-78 | EA - Each | 71205-784 | 7b7f759e-ef77-4bcb-85b8-c87b5e967eef | 1 | 2024-06-10 |
| 71205-784-90 | EA - Each | 71205-784 | 3db6f2da-8fc5-4673-a78b-a1dc37704da5 | 1 | 2024-06-10 |
DailyMed Dashboard NDC Coverage#
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 | 928ef685-80cb-42a9-a155-3c21c9b1dd67 | 2 |
| 861007 | metFORMIN HCl 500 MG Oral Tablet | PSN | 928ef685-80cb-42a9-a155-3c21c9b1dd67 | 2 |
| 861004 | metformin hydrochloride 1000 MG Oral Tablet | SCD | 928ef685-80cb-42a9-a155-3c21c9b1dd67 | 2 |
| 861007 | metformin hydrochloride 500 MG Oral Tablet | SCD | 928ef685-80cb-42a9-a155-3c21c9b1dd67 | 2 |
| 861004 | metformin HCl 1 GM Oral Tablet | SY | 928ef685-80cb-42a9-a155-3c21c9b1dd67 | 2 |
Packages#
| Package NDC | 11-digit format | Description | Marketing start | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|
| 71205-784-30 | 71205078430 | 30 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (71205-784-30) | 2023-03-29 | No | No | Current |
| 71205-784-60 | 71205078460 | 60 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (71205-784-60) | 2023-03-29 | No | No | Current |
| 71205-784-78 | 71205078478 | 180 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (71205-784-78) | 2024-03-25 | No | No | Current |
| 71205-784-90 | 71205078490 | 90 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (71205-784-90) | 2023-03-29 | No | No | Current |