metformin hydrochloride
- Product NDC
- 42806-405
- Requested package NDC
- 42806-405-60
- 11-digit product format
- 428060405
- Labeler code
- 42806
- Product ID
- 42806-405_1edb3813-b7cb-4501-ad91-eae58624c836
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- metformin hydrochloride tablets
- Dosage form
- TABLET, FILM COATED, EXTENDED RELEASE
- Route
- ORAL
- Labeler
- EPIC PHARMA, LLC
- Application
- ANDA209993
- Marketing category
- ANDA
- Marketing start
- 2019-01-04
- 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 |
|---|---|---|---|---|---|---|---|
| A209993-001 | METFORMIN HYDROCHLORIDE | METFORMIN HYDROCHLORIDE | 500MG | TABLET, EXTENDED RELEASE / ORAL | AB2 | 2018-12-27 | |
| A209993-002 | METFORMIN HYDROCHLORIDE | METFORMIN HYDROCHLORIDE | 1GM | TABLET, EXTENDED RELEASE / ORAL | AB2 | 2018-12-27 |
Therapeutic equivalence codes#
| Application-product | TE code |
|---|---|
| A209993-001 | AB2 |
| A209993-002 | AB2 |
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 | A209993-001 | METFORMIN HYDROCHLORIDE | 500MG | TABLET, EXTENDED RELEASE / ORAL | AB2 | 2018-12-27 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | A209993-002 | METFORMIN HYDROCHLORIDE | 1GM | TABLET, EXTENDED RELEASE / ORAL | AB2 | 2018-12-27 | 011fe1cb6892… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A209993-001 | METFORMIN HYDROCHLORIDE | 500MG | TABLET, EXTENDED RELEASE / ORAL | AB2 | 2018-12-27 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A209993-002 | METFORMIN HYDROCHLORIDE | 1GM | TABLET, EXTENDED RELEASE / ORAL | AB2 | 2018-12-27 | 31067a03dcf5… | |
| 2025-08-23 18:47 UTC | 2025-08 | A209993-001 | METFORMIN HYDROCHLORIDE | 500MG | TABLET, EXTENDED RELEASE / ORAL | AB2 | 2018-12-27 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | A209993-002 | METFORMIN HYDROCHLORIDE | 1GM | TABLET, EXTENDED RELEASE / ORAL | AB2 | 2018-12-27 | 6a471c1ec25d… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A209993-001 | METFORMIN HYDROCHLORIDE | 500MG | TABLET, EXTENDED RELEASE / ORAL | AB2 | 2018-12-27 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A209993-002 | METFORMIN HYDROCHLORIDE | 1GM | TABLET, EXTENDED RELEASE / ORAL | AB2 | 2018-12-27 | fd3edfee7708… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A209993-001 | METFORMIN HYDROCHLORIDE | 500MG | TABLET, EXTENDED RELEASE / ORAL | AB2 | 2018-12-27 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A209993-002 | METFORMIN HYDROCHLORIDE | 1GM | TABLET, EXTENDED RELEASE / ORAL | AB2 | 2018-12-27 | b8a1b40f171c… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A209993-001 | METFORMIN HYDROCHLORIDE | 500MG | TABLET, EXTENDED RELEASE / ORAL | AB2 | 2018-12-27 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A209993-002 | METFORMIN HYDROCHLORIDE | 1GM | TABLET, EXTENDED RELEASE / ORAL | AB2 | 2018-12-27 | 03ed91905a0d… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A209993-001 | METFORMIN HYDROCHLORIDE | 500MG | TABLET, EXTENDED RELEASE / ORAL | AB2 | 2018-12-27 | 2680178bc6a6… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A209993-002 | METFORMIN HYDROCHLORIDE | 1GM | TABLET, EXTENDED RELEASE / ORAL | AB2 | 2018-12-27 | 2680178bc6a6… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A209993-001 | METFORMIN HYDROCHLORIDE | 500MG | TABLET, EXTENDED RELEASE / ORAL | AB2 | 2018-12-27 | 5bbf6a4d5a75… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A209993-002 | METFORMIN HYDROCHLORIDE | 1GM | TABLET, EXTENDED RELEASE / ORAL | AB2 | 2018-12-27 | 5bbf6a4d5a75… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A209993-001 | METFORMIN HYDROCHLORIDE | 500MG | TABLET, EXTENDED RELEASE / ORAL | AB2 | 2018-12-27 | d8e5a09893c0… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A209993-002 | METFORMIN HYDROCHLORIDE | 1GM | TABLET, EXTENDED RELEASE / ORAL | AB2 | 2018-12-27 | d8e5a09893c0… | |
| 2024-10-29 15:01 UTC | 2024-10 | A209993-001 | METFORMIN HYDROCHLORIDE | 500MG | TABLET, EXTENDED RELEASE / ORAL | AB2 | 2018-12-27 | d06236e962d9… | |
| 2024-10-29 15:01 UTC | 2024-10 | A209993-002 | METFORMIN HYDROCHLORIDE | 1GM | TABLET, EXTENDED RELEASE / ORAL | AB2 | 2018-12-27 | d06236e962d9… | |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A209993-001 | METFORMIN HYDROCHLORIDE | 500MG | TABLET, EXTENDED RELEASE / ORAL | AB2 | 2018-12-27 | 79d66fd596c7… | |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A209993-002 | METFORMIN HYDROCHLORIDE | 1GM | TABLET, EXTENDED RELEASE / ORAL | AB2 | 2018-12-27 | 79d66fd596c7… | |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A209993-001 | METFORMIN HYDROCHLORIDE | 500MG | TABLET, EXTENDED RELEASE / ORAL | AB2 | 2018-12-27 | 301d65b070ca… | |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A209993-002 | METFORMIN HYDROCHLORIDE | 1GM | TABLET, EXTENDED RELEASE / ORAL | AB2 | 2018-12-27 | 301d65b070ca… | |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A209993-001 | METFORMIN HYDROCHLORIDE | 500MG | TABLET, EXTENDED RELEASE / ORAL | AB2 | 2018-12-27 | 1e350fbaab3a… | |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A209993-002 | METFORMIN HYDROCHLORIDE | 1GM | TABLET, EXTENDED RELEASE / ORAL | AB2 | 2018-12-27 | 1e350fbaab3a… | |
| 2024-05-31 18:47 UTC | 2024-05 | A209993-001 | METFORMIN HYDROCHLORIDE | 500MG | TABLET, EXTENDED RELEASE / ORAL | AB2 | 2018-12-27 | 8072bd15b7f6… | |
| 2024-05-31 18:47 UTC | 2024-05 | A209993-002 | METFORMIN HYDROCHLORIDE | 1GM | TABLET, EXTENDED RELEASE / ORAL | AB2 | 2018-12-27 | 8072bd15b7f6… | |
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | A209993-001 | METFORMIN HYDROCHLORIDE | 500MG | TABLET, EXTENDED RELEASE / ORAL | AB2 | 2018-12-27 | 5c6f7cd8ea54… | |
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | A209993-002 | METFORMIN HYDROCHLORIDE | 1GM | TABLET, EXTENDED RELEASE / ORAL | AB2 | 2018-12-27 | 5c6f7cd8ea54… | |
| 2022-04-08 23:34 UTC | 2022-04 | A209993-001 | METFORMIN HYDROCHLORIDE | 500MG | TABLET, EXTENDED RELEASE / ORAL | AB2 | 2018-12-27 | 5d02ea3f76ae… | |
| 2022-04-08 23:34 UTC | 2022-04 | A209993-002 | METFORMIN HYDROCHLORIDE | 1GM | TABLET, EXTENDED RELEASE / ORAL | AB2 | 2018-12-27 | 5d02ea3f76ae… | |
| 2022-04-04 05:41 UTC | 2022-04 | A209993-001 | METFORMIN HYDROCHLORIDE | 500MG | TABLET, EXTENDED RELEASE / ORAL | AB2 | 2018-12-27 | 4b0b4de00fa7… | |
| 2022-04-04 05:41 UTC | 2022-04 | A209993-002 | METFORMIN HYDROCHLORIDE | 1GM | TABLET, EXTENDED RELEASE / ORAL | AB2 | 2018-12-27 | 4b0b4de00fa7… | |
| 2019-12-13 00:20 UTC | 2019-12 | A209993-001 | METFORMIN HYDROCHLORIDE | 500MG | TABLET, EXTENDED RELEASE / ORAL | AB2 | 2018-12-27 | 74a2ff9319b5… | |
| 2019-12-13 00:20 UTC | 2019-12 | A209993-002 | METFORMIN HYDROCHLORIDE | 1GM | TABLET, EXTENDED RELEASE / ORAL | AB2 | 2018-12-27 | 74a2ff9319b5… | |
| 2022-03-09 01:35 UTC | 2022-03 | A209993-001 | METFORMIN HYDROCHLORIDE | 500MG | TABLET, EXTENDED RELEASE / ORAL | AB2 | 2018-12-27 | bb7c543d1eb4… | |
| 2022-03-09 01:35 UTC | 2022-03 | A209993-002 | METFORMIN HYDROCHLORIDE | 1GM | TABLET, EXTENDED RELEASE / ORAL | AB2 | 2018-12-27 | bb7c543d1eb4… | |
| 2021-12-28 21:50 UTC | 2021-12 | A209993-001 | METFORMIN HYDROCHLORIDE | 500MG | TABLET, EXTENDED RELEASE / ORAL | AB2 | 2018-12-27 | 782e0a99824c… | |
| 2021-12-28 21:50 UTC | 2021-12 | A209993-002 | METFORMIN HYDROCHLORIDE | 1GM | TABLET, EXTENDED RELEASE / ORAL | AB2 | 2018-12-27 | 782e0a99824c… |
Observed Orange Book normalized TE history#
| Captured | Edition | Application-product | TE code | Order | Source SHA-256 |
|---|---|---|---|---|---|
| 2026-02-19 14:30 UTC | 2026-02 | A209993-001 | AB2 | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | A209993-002 | AB2 | 1 | 011fe1cb6892… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A209993-001 | AB2 | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A209993-002 | AB2 | 1 | 31067a03dcf5… |
| 2025-08-23 18:47 UTC | 2025-08 | A209993-001 | AB2 | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | A209993-002 | AB2 | 1 | 6a471c1ec25d… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A209993-001 | AB2 | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A209993-002 | AB2 | 1 | fd3edfee7708… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A209993-001 | AB2 | 1 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A209993-002 | AB2 | 1 | b8a1b40f171c… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A209993-001 | AB2 | 1 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A209993-002 | AB2 | 1 | 03ed91905a0d… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A209993-001 | AB2 | 1 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A209993-002 | AB2 | 1 | 2680178bc6a6… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A209993-001 | AB2 | 1 | 5bbf6a4d5a75… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A209993-002 | AB2 | 1 | 5bbf6a4d5a75… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A209993-001 | AB2 | 1 | d8e5a09893c0… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A209993-002 | AB2 | 1 | d8e5a09893c0… |
| 2024-10-29 15:01 UTC | 2024-10 | A209993-001 | AB2 | 1 | d06236e962d9… |
| 2024-10-29 15:01 UTC | 2024-10 | A209993-002 | AB2 | 1 | d06236e962d9… |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A209993-001 | AB2 | 1 | 79d66fd596c7… |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A209993-002 | AB2 | 1 | 79d66fd596c7… |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A209993-001 | AB2 | 1 | 301d65b070ca… |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A209993-002 | AB2 | 1 | 301d65b070ca… |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A209993-001 | AB2 | 1 | 1e350fbaab3a… |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A209993-002 | AB2 | 1 | 1e350fbaab3a… |
| 2024-05-31 18:47 UTC | 2024-05 | A209993-001 | AB2 | 1 | 8072bd15b7f6… |
| 2024-05-31 18:47 UTC | 2024-05 | A209993-002 | AB2 | 1 | 8072bd15b7f6… |
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | A209993-001 | AB2 | 1 | 5c6f7cd8ea54… |
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | A209993-002 | AB2 | 1 | 5c6f7cd8ea54… |
| 2022-04-08 23:34 UTC | 2022-04 | A209993-001 | AB2 | 1 | 5d02ea3f76ae… |
| 2022-04-08 23:34 UTC | 2022-04 | A209993-002 | AB2 | 1 | 5d02ea3f76ae… |
| 2022-04-04 05:41 UTC | 2022-04 | A209993-001 | AB2 | 1 | 4b0b4de00fa7… |
| 2022-04-04 05:41 UTC | 2022-04 | A209993-002 | AB2 | 1 | 4b0b4de00fa7… |
| 2019-12-13 00:20 UTC | 2019-12 | A209993-001 | AB2 | 1 | 74a2ff9319b5… |
| 2019-12-13 00:20 UTC | 2019-12 | A209993-002 | AB2 | 1 | 74a2ff9319b5… |
| 2022-03-09 01:35 UTC | 2022-03 | A209993-001 | AB2 | 1 | bb7c543d1eb4… |
| 2022-03-09 01:35 UTC | 2022-03 | A209993-002 | AB2 | 1 | bb7c543d1eb4… |
| 2021-12-28 21:50 UTC | 2021-12 | A209993-001 | AB2 | 1 | 782e0a99824c… |
| 2021-12-28 21:50 UTC | 2021-12 | A209993-002 | AB2 | 1 | 782e0a99824c… |
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 |
|---|---|
| 356b02d0-d239-4441-bb33-c4c54166fcd7 | Available on FDA.report |
DailyMed Product Concepts#
FDA-Initiated Inactive NDC Indexing#
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 42806-405-60 | metformin hydrochloride | 60 in 1 BOTTLE | TABLET, FILM COATED, EXTENDED RE | 60 | 6 |
DailyMed Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 42806-405-60 | EA - Each | 42806-405 | 7ced3599-f493-4815-9e0d-5f0cee1714a3 | 1 | 2019-04-11 |
DailyMed Dashboard NDC Coverage#
| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|---|---|---|---|
| 42806-405 | METFORMIN HYDROCHLORIDE (METFORMIN HYDROCHLORIDE TABLETS) TABLET, FILM COATED, EXTENDED RELEASE METFORMIN HYDROCHLORIDE (METFORMIN HYDROCHLORIDE TABLET) TABLET, FILM COATED, EXTENDED RELEASE [EPIC PHARMA, LLC] | 4 | Current NDC, Legacy NDC, 1 package rows | 20241222_356b02d0-d239-4441-bb33-c4c54166fcd7.zip |
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 EXTENDED-RELEASE TABLETS | AiPing Pharmaceutical, Inc. | 96c8a89d-99db-24b1-e053-2a95a90ac2b8 | 2026-06-25 | Boxed warning, Warnings, Adverse reactions | 209993 ANDA209993 |
| Metformin Hydrochloride | METFORMIN HYDROCHLORIDE EXTENDED-RELEASE TABLETS | Qingdao BAHEAL Pharmaceutical Co. Ltd. | 7ea6e623-4073-4671-e053-2a91aa0a3ca3 | 2026-06-10 | Boxed warning, Warnings, Adverse reactions | 209993 ANDA209993 |
| metformin hydrochloride | METFORMIN HYDROCHLORIDE TABLETS | EPIC PHARMA, LLC | 356b02d0-d239-4441-bb33-c4c54166fcd7 | 2026-01-15 | Boxed warning, Warnings, Adverse reactions | 209993 ANDA209993 42806-405-60 42806-405 42806040560 |
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | DailyMed | SPL version |
|---|---|---|---|---|
| 1807894 | metFORMIN HCl 1000 MG Osmotic 24HR Extended Release Oral Tablet | PSN | 356b02d0-d239-4441-bb33-c4c54166fcd7 | 6 |
| 1807917 | metFORMIN HCl 500 MG Osmotic 24HR Extended Release Oral Tablet | PSN | 356b02d0-d239-4441-bb33-c4c54166fcd7 | 6 |
| 1807894 | Osmotic 24 HR metformin hydrochloride 1000 MG Extended Release Oral Tablet | SCD | 356b02d0-d239-4441-bb33-c4c54166fcd7 | 6 |
| 1807917 | Osmotic 24 HR metformin hydrochloride 500 MG Extended Release Oral Tablet | SCD | 356b02d0-d239-4441-bb33-c4c54166fcd7 | 6 |
| 1807894 | metformin HCl 1000 MG Osmotic 24 HR Extended Release Oral Tablet | SY | 356b02d0-d239-4441-bb33-c4c54166fcd7 | 6 |
| 1807917 | metformin HCl 500 MG Osmotic 24HR Extended Release Oral Tablet | SY | 356b02d0-d239-4441-bb33-c4c54166fcd7 | 6 |
Packages#
| Package NDC | 11-digit format | Description | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|
| 42806-405-60 | 42806040560 | 60 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (42806-405-60) | 2019-01-04 | 0000-00-00 | No | No | Current |