Metformin Hydrochloride
- Product NDC
- 68788-7205
- 11-digit product format
- 687887205
- Labeler code
- 68788
- Product ID
- 68788-7205_3423012d-3e2a-4f9a-9479-4e12813da6c5
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Metformin Hydrochloride
- Dosage form
- TABLET, EXTENDED RELEASE
- Route
- ORAL
- Labeler
- Preferred Pharmaceuticals Inc.
- Application
- ANDA078321
- Marketing category
- ANDA
- Marketing start
- 2018-07-23
- Marketing end
- 0000-00-00
- Substance
- METFORMIN HYDROCHLORIDE
- Active strength
- 750 mg/1
- Pharmacologic classes
- Biguanide [EPC], Biguanides [CS]
- NDC exclude flag
- No
- Listing certified through
- 2023-12-31
- Current FDA listing
- Historical FDA.report record
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 | 68788-7205 | D | Discontinued by firm | 2026-10-15 | ||
| excluded package | package | 68788-7205 | 68788-7205-1 | D | Discontinued by firm | 2026-10-15 | |
| excluded package | package | 68788-7205 | 68788-7205-3 | D | Discontinued by firm | 2026-10-15 | |
| excluded package | package | 68788-7205 | 68788-7205-6 | D | Discontinued by firm | 2026-10-15 | |
| excluded package | package | 68788-7205 | 68788-7205-8 | D | Discontinued by firm | 2026-10-15 | |
| excluded package | package | 68788-7205 | 68788-7205-9 | D | Discontinued by firm | 2026-10-15 |
Orange Book products#
| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|---|---|---|---|---|---|---|
| A078321-001 | METFORMIN HYDROCHLORIDE | METFORMIN HYDROCHLORIDE | 500MG | TABLET, EXTENDED RELEASE / ORAL | AB1 | 2008-04-17 | |
| A078321-002 | METFORMIN HYDROCHLORIDE | METFORMIN HYDROCHLORIDE | 750MG | TABLET, EXTENDED RELEASE / ORAL | AB | 2008-04-17 |
Therapeutic equivalence codes#
| Application-product | TE code |
|---|---|
| A078321-001 | AB1 |
| A078321-002 | 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 |
|---|---|---|---|---|---|---|---|---|---|
| 2026-10-15 13:18:30 | 2026-09 | A078321-001 | METFORMIN HYDROCHLORIDE | 500MG | TABLET, EXTENDED RELEASE / ORAL | AB1 | 2008-04-17 | c2088c7a36db… | |
| 2026-10-15 13:18:30 | 2026-09 | A078321-002 | METFORMIN HYDROCHLORIDE | 750MG | TABLET, EXTENDED RELEASE / ORAL | AB | 2008-04-17 | c2088c7a36db… | |
| 2026-09-14 22:38:34 | 2026-08 | A078321-001 | METFORMIN HYDROCHLORIDE | 500MG | TABLET, EXTENDED RELEASE / ORAL | AB1 | 2008-04-17 | 84e616aacf4f… | |
| 2026-09-14 22:38:34 | 2026-08 | A078321-002 | METFORMIN HYDROCHLORIDE | 750MG | TABLET, EXTENDED RELEASE / ORAL | AB | 2008-04-17 | 84e616aacf4f… | |
| 2026-08-18 06:07:40 | 2026-07 | A078321-001 | METFORMIN HYDROCHLORIDE | 500MG | TABLET, EXTENDED RELEASE / ORAL | AB1 | 2008-04-17 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | A078321-002 | METFORMIN HYDROCHLORIDE | 750MG | TABLET, EXTENDED RELEASE / ORAL | AB | 2008-04-17 | caaa826d4ba7… | |
| 2026-02-19 14:30 UTC | 2026-02 | A078321-001 | METFORMIN HYDROCHLORIDE | 500MG | TABLET, EXTENDED RELEASE / ORAL | AB1 | 2008-04-17 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | A078321-002 | METFORMIN HYDROCHLORIDE | 750MG | TABLET, EXTENDED RELEASE / ORAL | AB | 2008-04-17 | 011fe1cb6892… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A078321-001 | METFORMIN HYDROCHLORIDE | 500MG | TABLET, EXTENDED RELEASE / ORAL | AB1 | 2008-04-17 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A078321-002 | METFORMIN HYDROCHLORIDE | 750MG | TABLET, EXTENDED RELEASE / ORAL | AB | 2008-04-17 | 31067a03dcf5… | |
| 2025-08-23 18:47 UTC | 2025-08 | A078321-001 | METFORMIN HYDROCHLORIDE | 500MG | TABLET, EXTENDED RELEASE / ORAL | AB1 | 2008-04-17 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | A078321-002 | METFORMIN HYDROCHLORIDE | 750MG | TABLET, EXTENDED RELEASE / ORAL | AB | 2008-04-17 | 6a471c1ec25d… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A078321-001 | METFORMIN HYDROCHLORIDE | 500MG | TABLET, EXTENDED RELEASE / ORAL | AB1 | 2008-04-17 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A078321-002 | METFORMIN HYDROCHLORIDE | 750MG | TABLET, EXTENDED RELEASE / ORAL | AB | 2008-04-17 | fd3edfee7708… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A078321-001 | METFORMIN HYDROCHLORIDE | 500MG | TABLET, EXTENDED RELEASE / ORAL | AB1 | 2008-04-17 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A078321-002 | METFORMIN HYDROCHLORIDE | 750MG | TABLET, EXTENDED RELEASE / ORAL | AB | 2008-04-17 | b8a1b40f171c… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A078321-001 | METFORMIN HYDROCHLORIDE | 500MG | TABLET, EXTENDED RELEASE / ORAL | AB1 | 2008-04-17 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A078321-002 | METFORMIN HYDROCHLORIDE | 750MG | TABLET, EXTENDED RELEASE / ORAL | AB | 2008-04-17 | 03ed91905a0d… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A078321-001 | METFORMIN HYDROCHLORIDE | 500MG | TABLET, EXTENDED RELEASE / ORAL | AB1 | 2008-04-17 | 2680178bc6a6… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A078321-002 | METFORMIN HYDROCHLORIDE | 750MG | TABLET, EXTENDED RELEASE / ORAL | AB | 2008-04-17 | 2680178bc6a6… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A078321-001 | METFORMIN HYDROCHLORIDE | 500MG | TABLET, EXTENDED RELEASE / ORAL | AB1 | 2008-04-17 | 5bbf6a4d5a75… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A078321-002 | METFORMIN HYDROCHLORIDE | 750MG | TABLET, EXTENDED RELEASE / ORAL | AB | 2008-04-17 | 5bbf6a4d5a75… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A078321-001 | METFORMIN HYDROCHLORIDE | 500MG | TABLET, EXTENDED RELEASE / ORAL | AB1 | 2008-04-17 | d8e5a09893c0… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A078321-002 | METFORMIN HYDROCHLORIDE | 750MG | TABLET, EXTENDED RELEASE / ORAL | AB | 2008-04-17 | d8e5a09893c0… | |
| 2024-10-29 15:01 UTC | 2024-10 | A078321-001 | METFORMIN HYDROCHLORIDE | 500MG | TABLET, EXTENDED RELEASE / ORAL | AB1 | 2008-04-17 | d06236e962d9… | |
| 2024-10-29 15:01 UTC | 2024-10 | A078321-002 | METFORMIN HYDROCHLORIDE | 750MG | TABLET, EXTENDED RELEASE / ORAL | AB | 2008-04-17 | d06236e962d9… | |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A078321-001 | METFORMIN HYDROCHLORIDE | 500MG | TABLET, EXTENDED RELEASE / ORAL | AB1 | 2008-04-17 | 79d66fd596c7… | |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A078321-002 | METFORMIN HYDROCHLORIDE | 750MG | TABLET, EXTENDED RELEASE / ORAL | AB | 2008-04-17 | 79d66fd596c7… | |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A078321-001 | METFORMIN HYDROCHLORIDE | 500MG | TABLET, EXTENDED RELEASE / ORAL | AB1 | 2008-04-17 | 301d65b070ca… | |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A078321-002 | METFORMIN HYDROCHLORIDE | 750MG | TABLET, EXTENDED RELEASE / ORAL | AB | 2008-04-17 | 301d65b070ca… | |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A078321-001 | METFORMIN HYDROCHLORIDE | 500MG | TABLET, EXTENDED RELEASE / ORAL | AB1 | 2008-04-17 | 1e350fbaab3a… | |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A078321-002 | METFORMIN HYDROCHLORIDE | 750MG | TABLET, EXTENDED RELEASE / ORAL | AB | 2008-04-17 | 1e350fbaab3a… | |
| 2024-05-31 18:47 UTC | 2024-05 | A078321-001 | METFORMIN HYDROCHLORIDE | 500MG | TABLET, EXTENDED RELEASE / ORAL | AB1 | 2008-04-17 | 8072bd15b7f6… | |
| 2024-05-31 18:47 UTC | 2024-05 | A078321-002 | METFORMIN HYDROCHLORIDE | 750MG | TABLET, EXTENDED RELEASE / ORAL | AB | 2008-04-17 | 8072bd15b7f6… | |
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | A078321-001 | METFORMIN HYDROCHLORIDE | 500MG | TABLET, EXTENDED RELEASE / ORAL | AB1 | 2008-04-17 | 5c6f7cd8ea54… | |
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | A078321-002 | METFORMIN HYDROCHLORIDE | 750MG | TABLET, EXTENDED RELEASE / ORAL | AB | 2008-04-17 | 5c6f7cd8ea54… | |
| 2022-04-08 23:34 UTC | 2022-04 | A078321-001 | METFORMIN HYDROCHLORIDE | 500MG | TABLET, EXTENDED RELEASE / ORAL | AB1 | 2008-04-17 | 5d02ea3f76ae… | |
| 2022-04-08 23:34 UTC | 2022-04 | A078321-002 | METFORMIN HYDROCHLORIDE | 750MG | TABLET, EXTENDED RELEASE / ORAL | AB | 2008-04-17 | 5d02ea3f76ae… | |
| 2022-04-04 05:41 UTC | 2022-04 | A078321-001 | METFORMIN HYDROCHLORIDE | 500MG | TABLET, EXTENDED RELEASE / ORAL | AB1 | 2008-04-17 | 4b0b4de00fa7… | |
| 2022-04-04 05:41 UTC | 2022-04 | A078321-002 | METFORMIN HYDROCHLORIDE | 750MG | TABLET, EXTENDED RELEASE / ORAL | AB | 2008-04-17 | 4b0b4de00fa7… |
Observed Orange Book normalized TE history#
| Captured | Edition | Application-product | TE code | Order | Source SHA-256 |
|---|---|---|---|---|---|
| 2026-10-15 13:18:30 | 2026-09 | A078321-001 | AB1 | 1 | c2088c7a36db… |
| 2026-10-15 13:18:30 | 2026-09 | A078321-002 | AB | 1 | c2088c7a36db… |
| 2026-09-14 22:38:34 | 2026-08 | A078321-001 | AB1 | 1 | 84e616aacf4f… |
| 2026-09-14 22:38:34 | 2026-08 | A078321-002 | AB | 1 | 84e616aacf4f… |
| 2026-08-18 06:07:40 | 2026-07 | A078321-001 | AB1 | 1 | caaa826d4ba7… |
| 2026-08-18 06:07:40 | 2026-07 | A078321-002 | AB | 1 | caaa826d4ba7… |
| 2026-02-19 14:30 UTC | 2026-02 | A078321-001 | AB1 | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | A078321-002 | AB | 1 | 011fe1cb6892… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A078321-001 | AB1 | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A078321-002 | AB | 1 | 31067a03dcf5… |
| 2025-08-23 18:47 UTC | 2025-08 | A078321-001 | AB1 | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | A078321-002 | AB | 1 | 6a471c1ec25d… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A078321-001 | AB1 | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A078321-002 | AB | 1 | fd3edfee7708… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A078321-001 | AB1 | 1 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A078321-002 | AB | 1 | b8a1b40f171c… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A078321-001 | AB1 | 1 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A078321-002 | AB | 1 | 03ed91905a0d… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A078321-001 | AB1 | 1 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A078321-002 | AB | 1 | 2680178bc6a6… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A078321-001 | AB1 | 1 | 5bbf6a4d5a75… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A078321-002 | AB | 1 | 5bbf6a4d5a75… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A078321-001 | AB1 | 1 | d8e5a09893c0… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A078321-002 | AB | 1 | d8e5a09893c0… |
| 2024-10-29 15:01 UTC | 2024-10 | A078321-001 | AB1 | 1 | d06236e962d9… |
| 2024-10-29 15:01 UTC | 2024-10 | A078321-002 | AB | 1 | d06236e962d9… |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A078321-001 | AB1 | 1 | 79d66fd596c7… |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A078321-002 | AB | 1 | 79d66fd596c7… |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A078321-001 | AB1 | 1 | 301d65b070ca… |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A078321-002 | AB | 1 | 301d65b070ca… |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A078321-001 | AB1 | 1 | 1e350fbaab3a… |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A078321-002 | AB | 1 | 1e350fbaab3a… |
| 2024-05-31 18:47 UTC | 2024-05 | A078321-001 | AB1 | 1 | 8072bd15b7f6… |
| 2024-05-31 18:47 UTC | 2024-05 | A078321-002 | AB | 1 | 8072bd15b7f6… |
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | A078321-001 | AB1 | 1 | 5c6f7cd8ea54… |
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | A078321-002 | AB | 1 | 5c6f7cd8ea54… |
| 2022-04-08 23:34 UTC | 2022-04 | A078321-001 | AB1 | 1 | 5d02ea3f76ae… |
| 2022-04-08 23:34 UTC | 2022-04 | A078321-002 | AB | 1 | 5d02ea3f76ae… |
| 2022-04-04 05:41 UTC | 2022-04 | A078321-001 | AB1 | 1 | 4b0b4de00fa7… |
| 2022-04-04 05:41 UTC | 2022-04 | A078321-002 | AB | 1 | 4b0b4de00fa7… |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.
DailyMed Product Concepts#
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 68788-7205-1 | Metformin Hydrochloride | 100 in 1 BOTTLE | TABLET, EXTENDED RELEASE | 100 | 9 | |
| 68788-7205-3 | Metformin Hydrochloride | 30 in 1 BOTTLE | TABLET, EXTENDED RELEASE | 30 | 9 | |
| 68788-7205-6 | Metformin Hydrochloride | 60 in 1 BOTTLE | TABLET, EXTENDED RELEASE | 60 | 9 | |
| 68788-7205-8 | Metformin Hydrochloride | 120 in 1 BOTTLE | TABLET, EXTENDED RELEASE | 120 | 9 | |
| 68788-7205-9 | Metformin Hydrochloride | 90 in 1 BOTTLE | TABLET, EXTENDED RELEASE | 90 | 9 |
DailyMed Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 68788-7205-1 | EA - Each | 68788-7205 | efeb57ef-aa30-4e32-ac3d-2c6371003aac | 1 | 2024-09-09 |
| 68788-7205-3 | EA - Each | 68788-7205 | 8d188f70-21f9-4133-9f02-0f5e886c79f1 | 1 | 2024-09-09 |
| 68788-7205-6 | EA - Each | 68788-7205 | 40fe8959-c290-4b2e-8b3e-170975a4179d | 1 | 2024-09-09 |
| 68788-7205-8 | EA - Each | 68788-7205 | 9f9c95cc-c41d-43fa-ada2-ec8934368de0 | 1 | 2024-09-09 |
| 68788-7205-9 | EA - Each | 68788-7205 | 14bbe8fb-b9b4-415e-9198-6012f2af4a11 | 1 | 2024-09-09 |
DailyMed Dashboard NDC Coverage#
| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|---|---|---|---|
| 68788-7205 | METFORMIN HYDROCHLORIDE TABLET, EXTENDED RELEASE [PREFERRED PHARMACEUTICALS INC.] | 8 | Legacy NDC, 5 package rows | 20240522_bf918d78-3fb6-4d8d-b42d-538ea10bc3e4.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 | Proficient Rx LP | 6f6118c1-cecc-4d7b-9965-7b114a1ad56b | 2019-10-01 | Boxed warning, Warnings, Adverse reactions | 078321 ANDA078321 |
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | DailyMed | SPL version |
|---|---|---|---|---|
| 860981 | metFORMIN HCl 750 MG 24HR Extended Release Oral Tablet | PSN | bf918d78-3fb6-4d8d-b42d-538ea10bc3e4 | 9 |
| 860981 | 24 HR metformin hydrochloride 750 MG Extended Release Oral Tablet | SCD | bf918d78-3fb6-4d8d-b42d-538ea10bc3e4 | 9 |
| 860981 | metformin HCl 750 MG 24 HR Extended Release Oral Tablet | SY | bf918d78-3fb6-4d8d-b42d-538ea10bc3e4 | 9 |
Packages#
| Package NDC | 11-digit format | Description | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|
| 68788-7205-1 | 68788720501 | 100 TABLET, EXTENDED RELEASE in 1 BOTTLE (68788-7205-1) | 2018-07-23 | 0000-00-00 | No | No | Current |
| 68788-7205-3 | 68788720503 | 30 TABLET, EXTENDED RELEASE in 1 BOTTLE (68788-7205-3) | 2018-07-23 | 0000-00-00 | No | No | Current |
| 68788-7205-6 | 68788720506 | 60 TABLET, EXTENDED RELEASE in 1 BOTTLE (68788-7205-6) | 2018-07-23 | 0000-00-00 | No | No | Current |
| 68788-7205-8 | 68788720508 | 120 TABLET, EXTENDED RELEASE in 1 BOTTLE (68788-7205-8) | 2018-07-23 | 0000-00-00 | No | No | Current |
| 68788-7205-9 | 68788720509 | 90 TABLET, EXTENDED RELEASE in 1 BOTTLE (68788-7205-9) | 2018-07-23 | 0000-00-00 | No | No | Current |