METFORMIN HYDROCHLORIDE
- Product NDC
- 62207-497
- 11-digit product format
- 622070497
- Labeler code
- 62207
- Product ID
- 62207-497_414662c8-b86d-4c80-e063-6294a90a3cb0
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Metformin Hydrochloride
- Dosage form
- TABLET, EXTENDED RELEASE
- Route
- ORAL
- Labeler
- Granules India Ltd
- Application
- ANDA213344
- Marketing category
- ANDA
- Marketing start
- 2021-02-01
- 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 |
|---|---|---|---|---|---|---|---|
| A213344-001 | METFORMIN HYDROCHLORIDE | METFORMIN HYDROCHLORIDE | 500MG | TABLET, EXTENDED RELEASE / ORAL | AB3 | 2021-01-12 | |
| A213344-002 | METFORMIN HYDROCHLORIDE | METFORMIN HYDROCHLORIDE | 1GM | TABLET, EXTENDED RELEASE / ORAL | AB3 | 2021-01-12 |
Therapeutic equivalence codes#
| Application-product | TE code |
|---|---|
| A213344-001 | AB3 |
| A213344-002 | AB3 |
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 |
|---|---|---|---|---|---|---|---|---|---|
| 2026-02-19 14:30 UTC | 2026-02 | A213344-001 | METFORMIN HYDROCHLORIDE | 500MG | TABLET, EXTENDED RELEASE / ORAL | AB3 | 2021-01-12 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | A213344-002 | METFORMIN HYDROCHLORIDE | 1GM | TABLET, EXTENDED RELEASE / ORAL | AB3 | 2021-01-12 | 011fe1cb6892… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A213344-001 | METFORMIN HYDROCHLORIDE | 500MG | TABLET, EXTENDED RELEASE / ORAL | AB3 | 2021-01-12 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A213344-002 | METFORMIN HYDROCHLORIDE | 1GM | TABLET, EXTENDED RELEASE / ORAL | AB3 | 2021-01-12 | 31067a03dcf5… | |
| 2025-08-23 18:47 UTC | 2025-08 | A213344-001 | METFORMIN HYDROCHLORIDE | 500MG | TABLET, EXTENDED RELEASE / ORAL | AB3 | 2021-01-12 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | A213344-002 | METFORMIN HYDROCHLORIDE | 1GM | TABLET, EXTENDED RELEASE / ORAL | AB3 | 2021-01-12 | 6a471c1ec25d… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A213344-001 | METFORMIN HYDROCHLORIDE | 500MG | TABLET, EXTENDED RELEASE / ORAL | AB3 | 2021-01-12 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A213344-002 | METFORMIN HYDROCHLORIDE | 1GM | TABLET, EXTENDED RELEASE / ORAL | AB3 | 2021-01-12 | fd3edfee7708… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A213344-001 | METFORMIN HYDROCHLORIDE | 500MG | TABLET, EXTENDED RELEASE / ORAL | AB3 | 2021-01-12 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A213344-002 | METFORMIN HYDROCHLORIDE | 1GM | TABLET, EXTENDED RELEASE / ORAL | AB3 | 2021-01-12 | b8a1b40f171c… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A213344-001 | METFORMIN HYDROCHLORIDE | 500MG | TABLET, EXTENDED RELEASE / ORAL | AB3 | 2021-01-12 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A213344-002 | METFORMIN HYDROCHLORIDE | 1GM | TABLET, EXTENDED RELEASE / ORAL | AB3 | 2021-01-12 | 03ed91905a0d… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A213344-001 | METFORMIN HYDROCHLORIDE | 500MG | TABLET, EXTENDED RELEASE / ORAL | AB3 | 2021-01-12 | 2680178bc6a6… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A213344-002 | METFORMIN HYDROCHLORIDE | 1GM | TABLET, EXTENDED RELEASE / ORAL | AB3 | 2021-01-12 | 2680178bc6a6… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A213344-001 | METFORMIN HYDROCHLORIDE | 500MG | TABLET, EXTENDED RELEASE / ORAL | AB3 | 2021-01-12 | 5bbf6a4d5a75… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A213344-002 | METFORMIN HYDROCHLORIDE | 1GM | TABLET, EXTENDED RELEASE / ORAL | AB3 | 2021-01-12 | 5bbf6a4d5a75… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A213344-001 | METFORMIN HYDROCHLORIDE | 500MG | TABLET, EXTENDED RELEASE / ORAL | AB3 | 2021-01-12 | d8e5a09893c0… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A213344-002 | METFORMIN HYDROCHLORIDE | 1GM | TABLET, EXTENDED RELEASE / ORAL | AB3 | 2021-01-12 | d8e5a09893c0… | |
| 2024-10-29 15:01 UTC | 2024-10 | A213344-001 | METFORMIN HYDROCHLORIDE | 500MG | TABLET, EXTENDED RELEASE / ORAL | AB3 | 2021-01-12 | d06236e962d9… | |
| 2024-10-29 15:01 UTC | 2024-10 | A213344-002 | METFORMIN HYDROCHLORIDE | 1GM | TABLET, EXTENDED RELEASE / ORAL | AB3 | 2021-01-12 | d06236e962d9… | |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A213344-001 | METFORMIN HYDROCHLORIDE | 500MG | TABLET, EXTENDED RELEASE / ORAL | AB3 | 2021-01-12 | 79d66fd596c7… | |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A213344-002 | METFORMIN HYDROCHLORIDE | 1GM | TABLET, EXTENDED RELEASE / ORAL | AB3 | 2021-01-12 | 79d66fd596c7… | |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A213344-001 | METFORMIN HYDROCHLORIDE | 500MG | TABLET, EXTENDED RELEASE / ORAL | AB3 | 2021-01-12 | 301d65b070ca… | |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A213344-002 | METFORMIN HYDROCHLORIDE | 1GM | TABLET, EXTENDED RELEASE / ORAL | AB3 | 2021-01-12 | 301d65b070ca… | |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A213344-001 | METFORMIN HYDROCHLORIDE | 500MG | TABLET, EXTENDED RELEASE / ORAL | AB3 | 2021-01-12 | 1e350fbaab3a… | |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A213344-002 | METFORMIN HYDROCHLORIDE | 1GM | TABLET, EXTENDED RELEASE / ORAL | AB3 | 2021-01-12 | 1e350fbaab3a… | |
| 2024-05-31 18:47 UTC | 2024-05 | A213344-001 | METFORMIN HYDROCHLORIDE | 500MG | TABLET, EXTENDED RELEASE / ORAL | AB3 | 2021-01-12 | 8072bd15b7f6… | |
| 2024-05-31 18:47 UTC | 2024-05 | A213344-002 | METFORMIN HYDROCHLORIDE | 1GM | TABLET, EXTENDED RELEASE / ORAL | AB3 | 2021-01-12 | 8072bd15b7f6… | |
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | A213344-001 | METFORMIN HYDROCHLORIDE | 500MG | TABLET, EXTENDED RELEASE / ORAL | AB3 | 2021-01-12 | 5c6f7cd8ea54… | |
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | A213344-002 | METFORMIN HYDROCHLORIDE | 1GM | TABLET, EXTENDED RELEASE / ORAL | AB3 | 2021-01-12 | 5c6f7cd8ea54… | |
| 2022-04-08 23:34 UTC | 2022-04 | A213344-001 | METFORMIN HYDROCHLORIDE | 500MG | TABLET, EXTENDED RELEASE / ORAL | AB3 | 2021-01-12 | 5d02ea3f76ae… | |
| 2022-04-08 23:34 UTC | 2022-04 | A213344-002 | METFORMIN HYDROCHLORIDE | 1GM | TABLET, EXTENDED RELEASE / ORAL | AB3 | 2021-01-12 | 5d02ea3f76ae… | |
| 2022-04-04 05:41 UTC | 2022-04 | A213344-001 | METFORMIN HYDROCHLORIDE | 500MG | TABLET, EXTENDED RELEASE / ORAL | AB3 | 2021-01-12 | 4b0b4de00fa7… | |
| 2022-04-04 05:41 UTC | 2022-04 | A213344-002 | METFORMIN HYDROCHLORIDE | 1GM | TABLET, EXTENDED RELEASE / ORAL | AB3 | 2021-01-12 | 4b0b4de00fa7… | |
| 2022-03-09 01:35 UTC | 2022-03 | A213344-001 | METFORMIN HYDROCHLORIDE | 500MG | TABLET, EXTENDED RELEASE / ORAL | AB3 | 2021-01-12 | bb7c543d1eb4… | |
| 2022-03-09 01:35 UTC | 2022-03 | A213344-002 | METFORMIN HYDROCHLORIDE | 1GM | TABLET, EXTENDED RELEASE / ORAL | AB3 | 2021-01-12 | bb7c543d1eb4… | |
| 2021-12-28 21:50 UTC | 2021-12 | A213344-001 | METFORMIN HYDROCHLORIDE | 500MG | TABLET, EXTENDED RELEASE / ORAL | AB3 | 2021-01-12 | 782e0a99824c… | |
| 2021-12-28 21:50 UTC | 2021-12 | A213344-002 | METFORMIN HYDROCHLORIDE | 1GM | TABLET, EXTENDED RELEASE / ORAL | AB3 | 2021-01-12 | 782e0a99824c… | |
| 2021-05-05 16:15 UTC · 3 captures of this ZIP | 2021-05 | A213344-001 | METFORMIN HYDROCHLORIDE | 500MG | TABLET, EXTENDED RELEASE / ORAL | AB3 | 2021-01-12 | 87673890dc5c… | |
| 2021-05-05 16:15 UTC · 3 captures of this ZIP | 2021-05 | A213344-002 | METFORMIN HYDROCHLORIDE | 1GM | TABLET, EXTENDED RELEASE / ORAL | AB3 | 2021-01-12 | 87673890dc5c… |
Observed Orange Book normalized TE history#
| Captured | Edition | Application-product | TE code | Order | Source SHA-256 |
|---|---|---|---|---|---|
| 2026-02-19 14:30 UTC | 2026-02 | A213344-001 | AB3 | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | A213344-002 | AB3 | 1 | 011fe1cb6892… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A213344-001 | AB3 | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A213344-002 | AB3 | 1 | 31067a03dcf5… |
| 2025-08-23 18:47 UTC | 2025-08 | A213344-001 | AB3 | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | A213344-002 | AB3 | 1 | 6a471c1ec25d… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A213344-001 | AB3 | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A213344-002 | AB3 | 1 | fd3edfee7708… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A213344-001 | AB3 | 1 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A213344-002 | AB3 | 1 | b8a1b40f171c… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A213344-001 | AB3 | 1 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A213344-002 | AB3 | 1 | 03ed91905a0d… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A213344-001 | AB3 | 1 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A213344-002 | AB3 | 1 | 2680178bc6a6… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A213344-001 | AB3 | 1 | 5bbf6a4d5a75… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A213344-002 | AB3 | 1 | 5bbf6a4d5a75… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A213344-001 | AB3 | 1 | d8e5a09893c0… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A213344-002 | AB3 | 1 | d8e5a09893c0… |
| 2024-10-29 15:01 UTC | 2024-10 | A213344-001 | AB3 | 1 | d06236e962d9… |
| 2024-10-29 15:01 UTC | 2024-10 | A213344-002 | AB3 | 1 | d06236e962d9… |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A213344-001 | AB3 | 1 | 79d66fd596c7… |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A213344-002 | AB3 | 1 | 79d66fd596c7… |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A213344-001 | AB3 | 1 | 301d65b070ca… |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A213344-002 | AB3 | 1 | 301d65b070ca… |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A213344-001 | AB3 | 1 | 1e350fbaab3a… |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A213344-002 | AB3 | 1 | 1e350fbaab3a… |
| 2024-05-31 18:47 UTC | 2024-05 | A213344-001 | AB3 | 1 | 8072bd15b7f6… |
| 2024-05-31 18:47 UTC | 2024-05 | A213344-002 | AB3 | 1 | 8072bd15b7f6… |
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | A213344-001 | AB3 | 1 | 5c6f7cd8ea54… |
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | A213344-002 | AB3 | 1 | 5c6f7cd8ea54… |
| 2022-04-08 23:34 UTC | 2022-04 | A213344-001 | AB3 | 1 | 5d02ea3f76ae… |
| 2022-04-08 23:34 UTC | 2022-04 | A213344-002 | AB3 | 1 | 5d02ea3f76ae… |
| 2022-04-04 05:41 UTC | 2022-04 | A213344-001 | AB3 | 1 | 4b0b4de00fa7… |
| 2022-04-04 05:41 UTC | 2022-04 | A213344-002 | AB3 | 1 | 4b0b4de00fa7… |
| 2022-03-09 01:35 UTC | 2022-03 | A213344-001 | AB3 | 1 | bb7c543d1eb4… |
| 2022-03-09 01:35 UTC | 2022-03 | A213344-002 | AB3 | 1 | bb7c543d1eb4… |
| 2021-12-28 21:50 UTC | 2021-12 | A213344-001 | AB3 | 1 | 782e0a99824c… |
| 2021-12-28 21:50 UTC | 2021-12 | A213344-002 | AB3 | 1 | 782e0a99824c… |
| 2021-05-05 16:15 UTC · 3 captures of this ZIP | 2021-05 | A213344-001 | AB3 | 1 | 87673890dc5c… |
| 2021-05-05 16:15 UTC · 3 captures of this ZIP | 2021-05 | A213344-002 | AB3 | 1 | 87673890dc5c… |
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#
Harmonized SPL set identifiers#
| Identifier | FDA.report destination |
|---|---|
| 73197cb5-3e23-4ac0-b189-f9bc848bce66 | Available on FDA.report |
DailyMed Product Concepts#
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 62207-497-47 | METFORMIN HYDROCHLORIDE | 500 in 1 BOTTLE | TABLET, EXTENDED RELEASE | 500 | 6 | |
| 62207-497-54 | METFORMIN HYDROCHLORIDE | 30 in 1 BOTTLE | TABLET, EXTENDED RELEASE | 30 | 6 |
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 | REMEDYREPACK INC. | 104b5f5b-cc83-450d-82ec-1fd20c4f7119 | 2026-06-17 | Boxed warning, Warnings, Adverse reactions | 213344 ANDA213344 |
| METFORMIN HYDROCHLORIDE | METFORMIN HYDROCHLORIDE | Granules India Ltd | 73197cb5-3e23-4ac0-b189-f9bc848bce66 | 2025-10-16 | Boxed warning, Warnings, Adverse reactions | 213344 ANDA213344 62207-497 |
| METFORMIN HYDROCHLORIDE | METFORMIN HYDROCHLORIDE | Granules Pharmaceuticals Inc. | a5980bc8-8de8-c456-e053-2a95a90a792e | 2024-07-03 | Boxed warning, Warnings, Adverse reactions | 213344 ANDA213344 |
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | DailyMed | SPL version |
|---|---|---|---|---|
| 1807888 | metFORMIN HCl 1000 MG Modified 24HR Extended Release Oral Tablet | PSN | 73197cb5-3e23-4ac0-b189-f9bc848bce66 | 6 |
| 1807915 | metFORMIN HCl 500 MG Modified 24HR Extended Release Oral Tablet | PSN | 73197cb5-3e23-4ac0-b189-f9bc848bce66 | 6 |
| 1807888 | Modified 24 HR metformin hydrochloride 1000 MG Extended Release Oral Tablet | SCD | 73197cb5-3e23-4ac0-b189-f9bc848bce66 | 6 |
| 1807915 | Modified 24 HR metformin hydrochloride 500 MG Extended Release Oral Tablet | SCD | 73197cb5-3e23-4ac0-b189-f9bc848bce66 | 6 |
| 1807888 | metformin HCl 1000 MG Modified 24 HR Extended Release Oral Tablet | SY | 73197cb5-3e23-4ac0-b189-f9bc848bce66 | 6 |
| 1807915 | metformin HCl 500 MG Modified 24 HR Extended Release Oral Tablet | SY | 73197cb5-3e23-4ac0-b189-f9bc848bce66 | 6 |
Packages#
| Package NDC | 11-digit format | Description | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|
| 62207-497-47 | 62207049747 | 500 TABLET, EXTENDED RELEASE in 1 BOTTLE (62207-497-47) | 2021-02-01 | 0000-00-00 | No | No | Current |
| 62207-497-54 | 62207049754 | 30 TABLET, EXTENDED RELEASE in 1 BOTTLE (62207-497-54) | 2021-02-01 | 0000-00-00 | No | No | Current |