METFORMIN HYDROCHLORIDE
- Product NDC
- 10135-823
- 11-digit product format
- 101350823
- Labeler code
- 10135
- Product ID
- 10135-823_3e9d939c-6815-c5db-e063-6394a90ac9c2
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- METFORMIN HYDROCHLORIDE
- Dosage form
- TABLET, EXTENDED RELEASE
- Route
- ORAL
- Labeler
- Marlex Pharmaceuticals, Inc.
- Application
- ANDA202306
- Marketing category
- ANDA
- Marketing start
- 2025-08-01
- 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
NDC auxiliary status#
These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.
| Dataset | Scope | Product NDC | Package NDC | Code | Status | Reporting period | Source date |
|---|---|---|---|---|---|---|---|
| excluded product | product | 10135-823 | D | Discontinued by firm | 2026-08-11 |
Orange Book products#
| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|---|---|---|---|---|---|---|
| A202306-001 | METFORMIN HYDROCHLORIDE | METFORMIN HYDROCHLORIDE | 500MG | TABLET, EXTENDED RELEASE / ORAL | AB1 | 2017-02-23 | |
| A202306-002 | METFORMIN HYDROCHLORIDE | METFORMIN HYDROCHLORIDE | 750MG | TABLET, EXTENDED RELEASE / ORAL | AB | 2017-02-23 |
Therapeutic equivalence codes#
| Application-product | TE code |
|---|---|
| A202306-001 | AB1 |
| A202306-002 | 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 |
|---|---|---|---|---|---|---|---|---|---|
| 2026-02-19 14:30 UTC | 2026-02 | A202306-001 | METFORMIN HYDROCHLORIDE | 500MG | TABLET, EXTENDED RELEASE / ORAL | AB1 | 2017-02-23 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | A202306-002 | METFORMIN HYDROCHLORIDE | 750MG | TABLET, EXTENDED RELEASE / ORAL | AB | 2017-02-23 | 011fe1cb6892… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A202306-001 | METFORMIN HYDROCHLORIDE | 500MG | TABLET, EXTENDED RELEASE / ORAL | AB1 | 2017-02-23 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A202306-002 | METFORMIN HYDROCHLORIDE | 750MG | TABLET, EXTENDED RELEASE / ORAL | AB | 2017-02-23 | 31067a03dcf5… | |
| 2025-08-23 18:47 UTC | 2025-08 | A202306-001 | METFORMIN HYDROCHLORIDE | 500MG | TABLET, EXTENDED RELEASE / ORAL | AB1 | 2017-02-23 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | A202306-002 | METFORMIN HYDROCHLORIDE | 750MG | TABLET, EXTENDED RELEASE / ORAL | AB | 2017-02-23 | 6a471c1ec25d… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A202306-001 | METFORMIN HYDROCHLORIDE | 500MG | TABLET, EXTENDED RELEASE / ORAL | AB1 | 2017-02-23 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A202306-002 | METFORMIN HYDROCHLORIDE | 750MG | TABLET, EXTENDED RELEASE / ORAL | AB | 2017-02-23 | fd3edfee7708… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A202306-001 | METFORMIN HYDROCHLORIDE | 500MG | TABLET, EXTENDED RELEASE / ORAL | AB1 | 2017-02-23 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A202306-002 | METFORMIN HYDROCHLORIDE | 750MG | TABLET, EXTENDED RELEASE / ORAL | AB | 2017-02-23 | b8a1b40f171c… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A202306-001 | METFORMIN HYDROCHLORIDE | 500MG | TABLET, EXTENDED RELEASE / ORAL | AB1 | 2017-02-23 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A202306-002 | METFORMIN HYDROCHLORIDE | 750MG | TABLET, EXTENDED RELEASE / ORAL | AB | 2017-02-23 | 03ed91905a0d… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A202306-001 | METFORMIN HYDROCHLORIDE | 500MG | TABLET, EXTENDED RELEASE / ORAL | AB1 | 2017-02-23 | 2680178bc6a6… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A202306-002 | METFORMIN HYDROCHLORIDE | 750MG | TABLET, EXTENDED RELEASE / ORAL | AB | 2017-02-23 | 2680178bc6a6… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A202306-001 | METFORMIN HYDROCHLORIDE | 500MG | TABLET, EXTENDED RELEASE / ORAL | AB1 | 2017-02-23 | 5bbf6a4d5a75… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A202306-002 | METFORMIN HYDROCHLORIDE | 750MG | TABLET, EXTENDED RELEASE / ORAL | AB | 2017-02-23 | 5bbf6a4d5a75… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A202306-001 | METFORMIN HYDROCHLORIDE | 500MG | TABLET, EXTENDED RELEASE / ORAL | AB1 | 2017-02-23 | d8e5a09893c0… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A202306-002 | METFORMIN HYDROCHLORIDE | 750MG | TABLET, EXTENDED RELEASE / ORAL | AB | 2017-02-23 | d8e5a09893c0… | |
| 2024-10-29 15:01 UTC | 2024-10 | A202306-001 | METFORMIN HYDROCHLORIDE | 500MG | TABLET, EXTENDED RELEASE / ORAL | AB1 | 2017-02-23 | d06236e962d9… | |
| 2024-10-29 15:01 UTC | 2024-10 | A202306-002 | METFORMIN HYDROCHLORIDE | 750MG | TABLET, EXTENDED RELEASE / ORAL | AB | 2017-02-23 | d06236e962d9… | |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A202306-001 | METFORMIN HYDROCHLORIDE | 500MG | TABLET, EXTENDED RELEASE / ORAL | AB1 | 2017-02-23 | 79d66fd596c7… | |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A202306-002 | METFORMIN HYDROCHLORIDE | 750MG | TABLET, EXTENDED RELEASE / ORAL | AB | 2017-02-23 | 79d66fd596c7… | |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A202306-001 | METFORMIN HYDROCHLORIDE | 500MG | TABLET, EXTENDED RELEASE / ORAL | AB1 | 2017-02-23 | 301d65b070ca… | |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A202306-002 | METFORMIN HYDROCHLORIDE | 750MG | TABLET, EXTENDED RELEASE / ORAL | AB | 2017-02-23 | 301d65b070ca… | |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A202306-001 | METFORMIN HYDROCHLORIDE | 500MG | TABLET, EXTENDED RELEASE / ORAL | AB1 | 2017-02-23 | 1e350fbaab3a… | |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A202306-002 | METFORMIN HYDROCHLORIDE | 750MG | TABLET, EXTENDED RELEASE / ORAL | AB | 2017-02-23 | 1e350fbaab3a… | |
| 2024-05-31 18:47 UTC | 2024-05 | A202306-001 | METFORMIN HYDROCHLORIDE | 500MG | TABLET, EXTENDED RELEASE / ORAL | AB1 | 2017-02-23 | 8072bd15b7f6… | |
| 2024-05-31 18:47 UTC | 2024-05 | A202306-002 | METFORMIN HYDROCHLORIDE | 750MG | TABLET, EXTENDED RELEASE / ORAL | AB | 2017-02-23 | 8072bd15b7f6… | |
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | A202306-001 | METFORMIN HYDROCHLORIDE | 500MG | TABLET, EXTENDED RELEASE / ORAL | AB1 | 2017-02-23 | 5c6f7cd8ea54… | |
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | A202306-002 | METFORMIN HYDROCHLORIDE | 750MG | TABLET, EXTENDED RELEASE / ORAL | AB | 2017-02-23 | 5c6f7cd8ea54… | |
| 2022-04-08 23:34 UTC | 2022-04 | A202306-001 | METFORMIN HYDROCHLORIDE | 500MG | TABLET, EXTENDED RELEASE / ORAL | AB1 | 2017-02-23 | 5d02ea3f76ae… | |
| 2022-04-08 23:34 UTC | 2022-04 | A202306-002 | METFORMIN HYDROCHLORIDE | 750MG | TABLET, EXTENDED RELEASE / ORAL | AB | 2017-02-23 | 5d02ea3f76ae… | |
| 2022-04-04 05:41 UTC | 2022-04 | A202306-001 | METFORMIN HYDROCHLORIDE | 500MG | TABLET, EXTENDED RELEASE / ORAL | AB1 | 2017-02-23 | 4b0b4de00fa7… | |
| 2022-04-04 05:41 UTC | 2022-04 | A202306-002 | METFORMIN HYDROCHLORIDE | 750MG | TABLET, EXTENDED RELEASE / ORAL | AB | 2017-02-23 | 4b0b4de00fa7… | |
| 2019-12-13 00:20 UTC | 2019-12 | A202306-001 | METFORMIN HYDROCHLORIDE | 500MG | TABLET, EXTENDED RELEASE / ORAL | AB1 | 2017-02-23 | 74a2ff9319b5… | |
| 2019-12-13 00:20 UTC | 2019-12 | A202306-002 | METFORMIN HYDROCHLORIDE | 750MG | TABLET, EXTENDED RELEASE / ORAL | AB | 2017-02-23 | 74a2ff9319b5… | |
| 2022-03-09 01:35 UTC | 2022-03 | A202306-001 | METFORMIN HYDROCHLORIDE | 500MG | TABLET, EXTENDED RELEASE / ORAL | AB1 | 2017-02-23 | bb7c543d1eb4… | |
| 2022-03-09 01:35 UTC | 2022-03 | A202306-002 | METFORMIN HYDROCHLORIDE | 750MG | TABLET, EXTENDED RELEASE / ORAL | AB | 2017-02-23 | bb7c543d1eb4… | |
| 2021-12-28 21:50 UTC | 2021-12 | A202306-001 | METFORMIN HYDROCHLORIDE | 500MG | TABLET, EXTENDED RELEASE / ORAL | AB1 | 2017-02-23 | 782e0a99824c… | |
| 2021-12-28 21:50 UTC | 2021-12 | A202306-002 | METFORMIN HYDROCHLORIDE | 750MG | TABLET, EXTENDED RELEASE / ORAL | AB | 2017-02-23 | 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 | A202306-001 | AB1 | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | A202306-002 | AB | 1 | 011fe1cb6892… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A202306-001 | AB1 | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A202306-002 | AB | 1 | 31067a03dcf5… |
| 2025-08-23 18:47 UTC | 2025-08 | A202306-001 | AB1 | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | A202306-002 | AB | 1 | 6a471c1ec25d… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A202306-001 | AB1 | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A202306-002 | AB | 1 | fd3edfee7708… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A202306-001 | AB1 | 1 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A202306-002 | AB | 1 | b8a1b40f171c… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A202306-001 | AB1 | 1 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A202306-002 | AB | 1 | 03ed91905a0d… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A202306-001 | AB1 | 1 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A202306-002 | AB | 1 | 2680178bc6a6… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A202306-001 | AB1 | 1 | 5bbf6a4d5a75… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A202306-002 | AB | 1 | 5bbf6a4d5a75… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A202306-001 | AB1 | 1 | d8e5a09893c0… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A202306-002 | AB | 1 | d8e5a09893c0… |
| 2024-10-29 15:01 UTC | 2024-10 | A202306-001 | AB1 | 1 | d06236e962d9… |
| 2024-10-29 15:01 UTC | 2024-10 | A202306-002 | AB | 1 | d06236e962d9… |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A202306-001 | AB1 | 1 | 79d66fd596c7… |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A202306-002 | AB | 1 | 79d66fd596c7… |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A202306-001 | AB1 | 1 | 301d65b070ca… |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A202306-002 | AB | 1 | 301d65b070ca… |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A202306-001 | AB1 | 1 | 1e350fbaab3a… |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A202306-002 | AB | 1 | 1e350fbaab3a… |
| 2024-05-31 18:47 UTC | 2024-05 | A202306-001 | AB1 | 1 | 8072bd15b7f6… |
| 2024-05-31 18:47 UTC | 2024-05 | A202306-002 | AB | 1 | 8072bd15b7f6… |
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | A202306-001 | AB1 | 1 | 5c6f7cd8ea54… |
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | A202306-002 | AB | 1 | 5c6f7cd8ea54… |
| 2022-04-08 23:34 UTC | 2022-04 | A202306-001 | AB1 | 1 | 5d02ea3f76ae… |
| 2022-04-08 23:34 UTC | 2022-04 | A202306-002 | AB | 1 | 5d02ea3f76ae… |
| 2022-04-04 05:41 UTC | 2022-04 | A202306-001 | AB1 | 1 | 4b0b4de00fa7… |
| 2022-04-04 05:41 UTC | 2022-04 | A202306-002 | AB | 1 | 4b0b4de00fa7… |
| 2019-12-13 00:20 UTC | 2019-12 | A202306-001 | AB1 | 1 | 74a2ff9319b5… |
| 2019-12-13 00:20 UTC | 2019-12 | A202306-002 | AB | 1 | 74a2ff9319b5… |
| 2022-03-09 01:35 UTC | 2022-03 | A202306-001 | AB1 | 1 | bb7c543d1eb4… |
| 2022-03-09 01:35 UTC | 2022-03 | A202306-002 | AB | 1 | bb7c543d1eb4… |
| 2021-12-28 21:50 UTC | 2021-12 | A202306-001 | AB1 | 1 | 782e0a99824c… |
| 2021-12-28 21:50 UTC | 2021-12 | A202306-002 | AB | 1 | 782e0a99824c… |
DailyMed Product Concepts#
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 10135-823-05 | METFORMIN HYDROCHLORIDE | 500 in 1 BOTTLE | TABLET, EXTENDED RELEASE | 500 | 2 | |
| 10135-823-10 | METFORMIN HYDROCHLORIDE | 1000 in 1 BOTTLE | TABLET, EXTENDED RELEASE | 1000 | 2 | |
| 10135-823-30 | METFORMIN HYDROCHLORIDE | 30 in 1 BOTTLE | TABLET, EXTENDED RELEASE | 30 | 2 | |
| 10135-823-32 | METFORMIN HYDROCHLORIDE | 180 in 1 BOTTLE | TABLET, EXTENDED RELEASE | 180 | 2 | |
| 10135-823-33 | METFORMIN HYDROCHLORIDE | 360 in 1 BOTTLE | TABLET, EXTENDED RELEASE | 360 | 2 | |
| 10135-823-60 | METFORMIN HYDROCHLORIDE | 60 in 1 BOTTLE | TABLET, EXTENDED RELEASE | 60 | 2 | |
| 10135-823-62 | METFORMIN HYDROCHLORIDE | 120 in 1 BOTTLE | TABLET, EXTENDED RELEASE | 120 | 2 | |
| 10135-823-90 | METFORMIN HYDROCHLORIDE | 90 in 1 BOTTLE | TABLET, EXTENDED RELEASE | 90 | 2 |
DailyMed Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 10135-823-05 | EA - Each | 10135-823 | bd0962cc-4012-48ee-9ed2-cf766e92c324 | 1 | 2025-10-14 |
| 10135-823-30 | EA - Each | 10135-823 | 0d142492-0645-4795-9b9e-8ebbcd3f246b | 1 | 2025-10-14 |
| 10135-823-32 | EA - Each | 10135-823 | be0fcd9c-764c-4165-8a1f-617688e5fe61 | 1 | 2025-10-14 |
| 10135-823-33 | EA - Each | 10135-823 | fac3fc8e-3fac-434b-a1ad-51f69232f31f | 1 | 2025-10-14 |
| 10135-823-60 | EA - Each | 10135-823 | 5263911f-a91a-4c31-8cf8-95625694fb76 | 1 | 2025-10-14 |
| 10135-823-62 | EA - Each | 10135-823 | 391c8087-f617-4638-b98b-b232b1e17247 | 1 | 2025-10-14 |
| 10135-823-90 | EA - Each | 10135-823 | 83283ae1-2b45-4133-a4e1-3d06a8c36025 | 1 | 2025-10-14 |
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | DailyMed | SPL version |
|---|---|---|---|---|
| 860975 | metFORMIN HCl 500 MG 24HR Extended Release Oral Tablet | PSN | 3d6f397b-e909-bee9-e063-6294a90aba17 | 2 |
| 860981 | metFORMIN HCl 750 MG 24HR Extended Release Oral Tablet | PSN | 3d6f397b-e909-bee9-e063-6294a90aba17 | 2 |
| 860975 | 24 HR metformin hydrochloride 500 MG Extended Release Oral Tablet | SCD | 3d6f397b-e909-bee9-e063-6294a90aba17 | 2 |
| 860981 | 24 HR metformin hydrochloride 750 MG Extended Release Oral Tablet | SCD | 3d6f397b-e909-bee9-e063-6294a90aba17 | 2 |
| 860975 | metformin HCl 500 MG 24 HR Extended Release Oral Tablet | SY | 3d6f397b-e909-bee9-e063-6294a90aba17 | 2 |
| 860981 | metformin HCl 750 MG 24 HR Extended Release Oral Tablet | SY | 3d6f397b-e909-bee9-e063-6294a90aba17 | 2 |
Packages#
| Package NDC | 11-digit format | Description | Marketing start | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|
| 10135-823-05 | 10135082305 | 500 TABLET, EXTENDED RELEASE in 1 BOTTLE (10135-823-05) | 2025-08-01 | No | No | Historical |
| 10135-823-10 | 10135082310 | 1000 TABLET, EXTENDED RELEASE in 1 BOTTLE (10135-823-10) | 2025-08-01 | No | No | Historical |
| 10135-823-30 | 10135082330 | 30 TABLET, EXTENDED RELEASE in 1 BOTTLE (10135-823-30) | 2025-08-01 | No | No | Historical |
| 10135-823-32 | 10135082332 | 180 TABLET, EXTENDED RELEASE in 1 BOTTLE (10135-823-32) | 2025-08-01 | No | No | Historical |
| 10135-823-33 | 10135082333 | 360 TABLET, EXTENDED RELEASE in 1 BOTTLE (10135-823-33) | 2025-08-01 | No | No | Historical |
| 10135-823-60 | 10135082360 | 60 TABLET, EXTENDED RELEASE in 1 BOTTLE (10135-823-60) | 2025-08-01 | No | No | Historical |
| 10135-823-62 | 10135082362 | 120 TABLET, EXTENDED RELEASE in 1 BOTTLE (10135-823-62) | 2025-08-01 | No | No | Historical |
| 10135-823-90 | 10135082390 | 90 TABLET, EXTENDED RELEASE in 1 BOTTLE (10135-823-90) | 2025-08-01 | No | No | Historical |