METFORMIN HYDROCHLORIDE
- Product NDC
- 71610-447
- 11-digit product format
- 716100447
- Labeler code
- 71610
- Product ID
- 71610-447_f2b2e161-6f49-4a65-970e-017b5c4dcd74
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- METFORMIN HYDROCHLORIDE
- Dosage form
- TABLET, EXTENDED RELEASE
- Route
- ORAL
- Labeler
- Aphena Pharma Solutions - Tennessee, LLC
- Application
- ANDA077336
- Marketing category
- ANDA
- Marketing start
- 2006-02-09
- Substance
- METFORMIN HYDROCHLORIDE
- Active strength
- 500 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 |
|---|---|---|---|---|---|---|---|
| A077336-001 | METFORMIN HYDROCHLORIDE | METFORMIN HYDROCHLORIDE | 500MG | TABLET, EXTENDED RELEASE / ORAL | 2006-02-09 | ||
| A077336-002 | METFORMIN HYDROCHLORIDE | METFORMIN HYDROCHLORIDE | 750MG | TABLET, EXTENDED RELEASE / ORAL | 2006-02-09 |
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 |
|---|---|---|---|---|---|---|---|---|---|
| 2026-10-15 13:18:30 | 2026-09 | A077336-001 | METFORMIN HYDROCHLORIDE | 500MG | TABLET, EXTENDED RELEASE / ORAL | 2006-02-09 | c2088c7a36db… | ||
| 2026-10-15 13:18:30 | 2026-09 | A077336-002 | METFORMIN HYDROCHLORIDE | 750MG | TABLET, EXTENDED RELEASE / ORAL | 2006-02-09 | c2088c7a36db… | ||
| 2026-09-14 22:38:34 | 2026-08 | A077336-001 | METFORMIN HYDROCHLORIDE | 500MG | TABLET, EXTENDED RELEASE / ORAL | 2006-02-09 | 84e616aacf4f… | ||
| 2026-09-14 22:38:34 | 2026-08 | A077336-002 | METFORMIN HYDROCHLORIDE | 750MG | TABLET, EXTENDED RELEASE / ORAL | 2006-02-09 | 84e616aacf4f… | ||
| 2026-08-18 06:07:40 | 2026-07 | A077336-001 | METFORMIN HYDROCHLORIDE | 500MG | TABLET, EXTENDED RELEASE / ORAL | 2006-02-09 | caaa826d4ba7… | ||
| 2026-08-18 06:07:40 | 2026-07 | A077336-002 | METFORMIN HYDROCHLORIDE | 750MG | TABLET, EXTENDED RELEASE / ORAL | 2006-02-09 | caaa826d4ba7… | ||
| 2026-02-19 14:30 UTC | 2026-02 | A077336-001 | METFORMIN HYDROCHLORIDE | 500MG | TABLET, EXTENDED RELEASE / ORAL | 2006-02-09 | 011fe1cb6892… | ||
| 2026-02-19 14:30 UTC | 2026-02 | A077336-002 | METFORMIN HYDROCHLORIDE | 750MG | TABLET, EXTENDED RELEASE / ORAL | 2006-02-09 | 011fe1cb6892… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A077336-001 | METFORMIN HYDROCHLORIDE | 500MG | TABLET, EXTENDED RELEASE / ORAL | 2006-02-09 | 31067a03dcf5… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A077336-002 | METFORMIN HYDROCHLORIDE | 750MG | TABLET, EXTENDED RELEASE / ORAL | 2006-02-09 | 31067a03dcf5… | ||
| 2025-08-23 18:47 UTC | 2025-08 | A077336-001 | METFORMIN HYDROCHLORIDE | 500MG | TABLET, EXTENDED RELEASE / ORAL | AB1 | 2006-02-09 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | A077336-002 | METFORMIN HYDROCHLORIDE | 750MG | TABLET, EXTENDED RELEASE / ORAL | AB | 2006-02-09 | 6a471c1ec25d… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A077336-001 | METFORMIN HYDROCHLORIDE | 500MG | TABLET, EXTENDED RELEASE / ORAL | AB1 | 2006-02-09 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A077336-002 | METFORMIN HYDROCHLORIDE | 750MG | TABLET, EXTENDED RELEASE / ORAL | AB | 2006-02-09 | fd3edfee7708… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A077336-001 | METFORMIN HYDROCHLORIDE | 500MG | TABLET, EXTENDED RELEASE / ORAL | AB1 | 2006-02-09 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A077336-002 | METFORMIN HYDROCHLORIDE | 750MG | TABLET, EXTENDED RELEASE / ORAL | AB | 2006-02-09 | b8a1b40f171c… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A077336-001 | METFORMIN HYDROCHLORIDE | 500MG | TABLET, EXTENDED RELEASE / ORAL | AB1 | 2006-02-09 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A077336-002 | METFORMIN HYDROCHLORIDE | 750MG | TABLET, EXTENDED RELEASE / ORAL | AB | 2006-02-09 | 03ed91905a0d… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A077336-001 | METFORMIN HYDROCHLORIDE | 500MG | TABLET, EXTENDED RELEASE / ORAL | AB1 | 2006-02-09 | 2680178bc6a6… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A077336-002 | METFORMIN HYDROCHLORIDE | 750MG | TABLET, EXTENDED RELEASE / ORAL | AB | 2006-02-09 | 2680178bc6a6… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A077336-001 | METFORMIN HYDROCHLORIDE | 500MG | TABLET, EXTENDED RELEASE / ORAL | AB1 | 2006-02-09 | 5bbf6a4d5a75… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A077336-002 | METFORMIN HYDROCHLORIDE | 750MG | TABLET, EXTENDED RELEASE / ORAL | AB | 2006-02-09 | 5bbf6a4d5a75… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A077336-001 | METFORMIN HYDROCHLORIDE | 500MG | TABLET, EXTENDED RELEASE / ORAL | AB1 | 2006-02-09 | d8e5a09893c0… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A077336-002 | METFORMIN HYDROCHLORIDE | 750MG | TABLET, EXTENDED RELEASE / ORAL | AB | 2006-02-09 | d8e5a09893c0… | |
| 2024-10-29 15:01 UTC | 2024-10 | A077336-001 | METFORMIN HYDROCHLORIDE | 500MG | TABLET, EXTENDED RELEASE / ORAL | AB1 | 2006-02-09 | d06236e962d9… | |
| 2024-10-29 15:01 UTC | 2024-10 | A077336-002 | METFORMIN HYDROCHLORIDE | 750MG | TABLET, EXTENDED RELEASE / ORAL | AB | 2006-02-09 | d06236e962d9… | |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A077336-001 | METFORMIN HYDROCHLORIDE | 500MG | TABLET, EXTENDED RELEASE / ORAL | AB1 | 2006-02-09 | 79d66fd596c7… | |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A077336-002 | METFORMIN HYDROCHLORIDE | 750MG | TABLET, EXTENDED RELEASE / ORAL | AB | 2006-02-09 | 79d66fd596c7… | |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A077336-001 | METFORMIN HYDROCHLORIDE | 500MG | TABLET, EXTENDED RELEASE / ORAL | AB1 | 2006-02-09 | 301d65b070ca… | |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A077336-002 | METFORMIN HYDROCHLORIDE | 750MG | TABLET, EXTENDED RELEASE / ORAL | AB | 2006-02-09 | 301d65b070ca… | |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A077336-001 | METFORMIN HYDROCHLORIDE | 500MG | TABLET, EXTENDED RELEASE / ORAL | AB1 | 2006-02-09 | 1e350fbaab3a… | |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A077336-002 | METFORMIN HYDROCHLORIDE | 750MG | TABLET, EXTENDED RELEASE / ORAL | AB | 2006-02-09 | 1e350fbaab3a… | |
| 2024-05-31 18:47 UTC | 2024-05 | A077336-001 | METFORMIN HYDROCHLORIDE | 500MG | TABLET, EXTENDED RELEASE / ORAL | AB1 | 2006-02-09 | 8072bd15b7f6… | |
| 2024-05-31 18:47 UTC | 2024-05 | A077336-002 | METFORMIN HYDROCHLORIDE | 750MG | TABLET, EXTENDED RELEASE / ORAL | AB | 2006-02-09 | 8072bd15b7f6… | |
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | A077336-001 | METFORMIN HYDROCHLORIDE | 500MG | TABLET, EXTENDED RELEASE / ORAL | AB1 | 2006-02-09 | 5c6f7cd8ea54… | |
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | A077336-002 | METFORMIN HYDROCHLORIDE | 750MG | TABLET, EXTENDED RELEASE / ORAL | AB | 2006-02-09 | 5c6f7cd8ea54… | |
| 2022-04-08 23:34 UTC | 2022-04 | A077336-001 | METFORMIN HYDROCHLORIDE | 500MG | TABLET, EXTENDED RELEASE / ORAL | AB1 | 2006-02-09 | 5d02ea3f76ae… | |
| 2022-04-08 23:34 UTC | 2022-04 | A077336-002 | METFORMIN HYDROCHLORIDE | 750MG | TABLET, EXTENDED RELEASE / ORAL | AB | 2006-02-09 | 5d02ea3f76ae… | |
| 2022-04-04 05:41 UTC | 2022-04 | A077336-001 | METFORMIN HYDROCHLORIDE | 500MG | TABLET, EXTENDED RELEASE / ORAL | AB1 | 2006-02-09 | 4b0b4de00fa7… | |
| 2022-04-04 05:41 UTC | 2022-04 | A077336-002 | METFORMIN HYDROCHLORIDE | 750MG | TABLET, EXTENDED RELEASE / ORAL | AB | 2006-02-09 | 4b0b4de00fa7… |
Observed Orange Book normalized TE history#
| Captured | Edition | Application-product | TE code | Order | Source SHA-256 |
|---|---|---|---|---|---|
| 2020-12-22 03:56 UTC | 2020-12 | A077336-001 | AB1 | 1 | 8869cabd3fbd… |
| 2020-12-22 03:56 UTC | 2020-12 | A077336-002 | AB | 1 | 8869cabd3fbd… |
| 2020-11-12 02:37 UTC | 2020-11 | A077336-001 | AB1 | 1 | c0c555d07b60… |
| 2020-11-12 02:37 UTC | 2020-11 | A077336-002 | AB | 1 | c0c555d07b60… |
| 2019-12-14 00:12 UTC | 2019-12 | A077336-001 | AB1 | 1 | 3f01610625f2… |
| 2019-12-14 00:12 UTC | 2019-12 | A077336-002 | AB | 1 | 3f01610625f2… |
| 2019-09-15 20:21 UTC | 2019-09 | A077336-001 | AB1 | 1 | b00525d2431f… |
| 2019-09-15 20:21 UTC | 2019-09 | A077336-002 | AB | 1 | b00525d2431f… |
| 2019-07-19 19:46 UTC | 2019-07 | A077336-001 | AB1 | 1 | ea99ee380514… |
| 2019-07-19 19:46 UTC | 2019-07 | A077336-002 | AB | 1 | ea99ee380514… |
| 2024-03-16 18:09 UTC · 4 captures of this ZIP | 2024-03 | A077336-001 | AB1 | 1 | 6a51e52b5d6a… |
| 2024-03-16 18:09 UTC · 4 captures of this ZIP | 2024-03 | A077336-002 | AB | 1 | 6a51e52b5d6a… |
| 2024-02-18 07:12 UTC | 2024-02 | A077336-001 | AB1 | 1 | 1c564ffb4f44… |
| 2024-02-18 07:12 UTC | 2024-02 | A077336-002 | AB | 1 | 1c564ffb4f44… |
| 2023-12-20 04:57 UTC | 2023-12 | A077336-001 | AB1 | 1 | ea1830bbd6c7… |
| 2023-12-20 04:57 UTC | 2023-12 | A077336-002 | AB | 1 | ea1830bbd6c7… |
| 2023-11-28 05:40 UTC · 2 captures of this ZIP | 2023-11 | A077336-001 | AB1 | 1 | a72a2bbeb626… |
| 2023-11-28 05:40 UTC · 2 captures of this ZIP | 2023-11 | A077336-002 | AB | 1 | a72a2bbeb626… |
| 2023-10-25 00:34 UTC · 2 captures of this ZIP | 2023-10 | A077336-001 | AB1 | 1 | 9b2671bbb829… |
| 2023-10-25 00:34 UTC · 2 captures of this ZIP | 2023-10 | A077336-002 | AB | 1 | 9b2671bbb829… |
| 2023-07-15 15:27 UTC · 2 captures of this ZIP | 2023-07 | A077336-001 | AB1 | 1 | a67488948f0b… |
| 2023-07-15 15:27 UTC · 2 captures of this ZIP | 2023-07 | A077336-002 | AB | 1 | a67488948f0b… |
| 2023-06-13 01:57 UTC · 3 captures of this ZIP | 2023-06 | A077336-001 | AB1 | 1 | 3f0d92c62455… |
| 2023-06-13 01:57 UTC · 3 captures of this ZIP | 2023-06 | A077336-002 | AB | 1 | 3f0d92c62455… |
| 2023-05-13 08:27 UTC | 2023-05 | A077336-001 | AB1 | 1 | 053a50430f4f… |
| 2023-05-13 08:27 UTC | 2023-05 | A077336-002 | AB | 1 | 053a50430f4f… |
| 2023-01-26 05:58 UTC | 2023-01 | A077336-001 | AB1 | 1 | 3bdfa0b2c4d7… |
| 2023-01-26 05:58 UTC | 2023-01 | A077336-002 | AB | 1 | 3bdfa0b2c4d7… |
| 2022-11-12 20:34 UTC · 5 captures of this ZIP | 2022-11 | A077336-001 | AB1 | 1 | 3a93d1ddd44b… |
| 2022-11-12 20:34 UTC · 5 captures of this ZIP | 2022-11 | A077336-002 | AB | 1 | 3a93d1ddd44b… |
| 2022-10-28 04:53 UTC | 2022-10 | A077336-001 | AB1 | 1 | f41ea6bd6efb… |
| 2022-10-28 04:53 UTC | 2022-10 | A077336-002 | AB | 1 | f41ea6bd6efb… |
| 2022-09-29 23:25 UTC | 2022-09 | A077336-001 | AB1 | 1 | e64feba35796… |
| 2022-09-29 23:25 UTC | 2022-09 | A077336-002 | AB | 1 | e64feba35796… |
| 2022-07-09 03:26 UTC · 3 captures of this ZIP | 2022-07 | A077336-001 | AB1 | 1 | cb3db0bc1861… |
| 2022-07-09 03:26 UTC · 3 captures of this ZIP | 2022-07 | A077336-002 | AB | 1 | cb3db0bc1861… |
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 | 500 mg/1 |
Harmonized UNII identifiers#
| Identifier | FDA.report destination |
|---|---|
| 786Z46389E | Internal UNII lookup |
Harmonized RxCUI identifiers#
| Identifier | FDA.report destination |
|---|---|
| 860975 | Internal RxNorm lookup |
Harmonized SPL set identifiers#
| Identifier | FDA.report destination |
|---|---|
| 439bb230-94d8-4522-ad79-5cce5fad965b | Available on FDA.report |
DailyMed Product Concepts#
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 71610-447-30 | METFORMIN HYDROCHLORIDE | 30 in 1 BOTTLE | TABLET, EXTENDED RELEASE | 30 | 2 | |
| 71610-447-53 | METFORMIN HYDROCHLORIDE | 60 in 1 BOTTLE | TABLET, EXTENDED RELEASE | 60 | 2 | |
| 71610-447-60 | METFORMIN HYDROCHLORIDE | 90 in 1 BOTTLE | TABLET, EXTENDED RELEASE | 90 | 2 | |
| 71610-447-70 | METFORMIN HYDROCHLORIDE | 120 in 1 BOTTLE | TABLET, EXTENDED RELEASE | 120 | 2 | |
| 71610-447-80 | METFORMIN HYDROCHLORIDE | 180 in 1 BOTTLE | TABLET, EXTENDED RELEASE | 180 | 2 | |
| 71610-447-94 | METFORMIN HYDROCHLORIDE | 360 in 1 BOTTLE | TABLET, EXTENDED RELEASE | 360 | 2 |
DailyMed Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 71610-447-30 | EA - Each | 71610-447 | ec51b5f7-77ea-497a-8875-e39cb5a47789 | 1 | 2020-09-14 |
| 71610-447-53 | EA - Each | 71610-447 | 5a760c57-c71f-452c-9ed3-8911e865ffd0 | 1 | 2020-09-14 |
| 71610-447-60 | EA - Each | 71610-447 | 34968cba-ebc2-46c5-8029-da3fca97079d | 1 | 2020-09-14 |
| 71610-447-70 | EA - Each | 71610-447 | ae4277d8-607d-43e0-baf3-de2a58b7dd73 | 1 | 2020-09-14 |
| 71610-447-80 | EA - Each | 71610-447 | fb4b2ecb-c950-4286-a6f8-7002aee32673 | 1 | 2020-09-14 |
| 71610-447-94 | EA - Each | 71610-447 | ecf63456-009c-44e6-ba1e-3e7654d96746 | 1 | 2021-05-05 |
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 | Sun Pharmaceutical Industries, Inc. | 41a8bb80-7b0b-476c-8134-5d161c3239c8 | 2026-06-25 | Boxed warning, Warnings, Adverse reactions | 077336 ANDA077336 |
| METFORMIN HYDROCHLORIDE | METFORMIN HYDROCHLORIDE | Aphena Pharma Solutions - Tennessee, LLC | 439bb230-94d8-4522-ad79-5cce5fad965b | 2021-04-27 | Boxed warning, Warnings, Adverse reactions | 077336 ANDA077336 71610-447 |
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | DailyMed | SPL version |
|---|---|---|---|---|
| 860975 | metFORMIN HCl 500 MG 24HR Extended Release Oral Tablet | PSN | 439bb230-94d8-4522-ad79-5cce5fad965b | 2 |
| 860975 | 24 HR metformin hydrochloride 500 MG Extended Release Oral Tablet | SCD | 439bb230-94d8-4522-ad79-5cce5fad965b | 2 |
| 860975 | metformin HCl 500 MG 24 HR Extended Release Oral Tablet | SY | 439bb230-94d8-4522-ad79-5cce5fad965b | 2 |
Packages#
| Package NDC | 11-digit format | Description | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|
| 71610-447-30 | 71610044730 | 30 TABLET, EXTENDED RELEASE in 1 BOTTLE (71610-447-30) | 2020-07-24 | 0000-00-00 | No | No | Current |
| 71610-447-53 | 71610044753 | 60 TABLET, EXTENDED RELEASE in 1 BOTTLE (71610-447-53) | 2020-07-24 | 0000-00-00 | No | No | Current |
| 71610-447-60 | 71610044760 | 90 TABLET, EXTENDED RELEASE in 1 BOTTLE (71610-447-60) | 2020-07-24 | 0000-00-00 | No | No | Current |
| 71610-447-70 | 71610044770 | 120 TABLET, EXTENDED RELEASE in 1 BOTTLE (71610-447-70) | 2020-07-24 | 0000-00-00 | No | No | Current |
| 71610-447-80 | 71610044780 | 180 TABLET, EXTENDED RELEASE in 1 BOTTLE (71610-447-80) | 2020-07-24 | 0000-00-00 | No | No | Current |
| 71610-447-94 | 71610044794 | 360 TABLET, EXTENDED RELEASE in 1 BOTTLE (71610-447-94) | 2021-03-11 | 0000-00-00 | No | No | Current |