metformin hydrochloride
- Product NDC
- 23155-103
- Requested package NDC
- 23155-103-10
- 11-digit product format
- 231550103
- Labeler code
- 23155
- Product ID
- 23155-103_e8946484-cf5a-7448-e053-2995a90a2acc
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- metformin hydrochloride
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- Heritage Pharmaceuticals Inc.
- Application
- ANDA090564
- Marketing category
- ANDA
- Marketing start
- 2010-04-22
- Marketing end
- 0000-00-00
- Substance
- METFORMIN HYDROCHLORIDE
- Active strength
- 850 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 package | package | 23155-103 | 23155-103-10 | D | Discontinued by firm | 2026-08-17 |
Observed NDC auxiliary status history#
This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.
| Captured / source date | Snapshot | Source SHA-256 |
|---|---|---|
| 2025-12-14 17:58 UTC · source 2025-12-05 | d630ba8d3edf… | 732f749b63fb… |
| 2025-08-27 00:01 UTC · source 2025-08-26 | f5e01cc5f278… | a2eaf40c39c3… |
| 2025-04-01 02:39 UTC · source 2025-03-31 | 2ef7874e63bc… | 57b86245f4fa… |
| 2025-03-28 20:22 UTC · source 2025-03-28 | a1b67e2a42f9… | c4cf2c586c0d… |
| 2025-03-22 03:12 UTC · source 2025-03-21 | cfe11265f3b6… | 090c488252e2… |
| 2025-03-10 12:48 UTC · source 2025-03-10 | cdf11ea48f46… | ba0047e9e063… |
| 2025-02-02 03:52 UTC · source 2025-01-31 | 302b2466d912… | e7b80fea0513… |
| 2025-01-20 13:05 UTC · source 2025-01-20 | ed331223b511… | 672a5bd82f5f… |
| 2025-01-11 03:41 UTC · source 2025-01-10 | 0efc9e666f02… | f202fb6c5f17… |
| 2024-11-09 02:27 UTC · source 2024-11-08 | ad56d346431e… | cc804d4bbf1e… |
| 2024-10-04 04:10 UTC · source 2024-10-03 | 367a005e9d99… | 383a685ebd0f… |
| 2024-07-10 04:00 UTC · source 2024-07-09 | 557ba5c1ecfa… | 9c80585c8c6e… |
Orange Book products#
| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|---|---|---|---|---|---|---|
| A090564-001 | METFORMIN HYDROCHLORIDE | METFORMIN HYDROCHLORIDE | 500MG | TABLET / ORAL | AB | 2010-04-22 | |
| A090564-002 | METFORMIN HYDROCHLORIDE | METFORMIN HYDROCHLORIDE | 850MG | TABLET / ORAL | AB | 2010-04-22 | |
| A090564-003 | METFORMIN HYDROCHLORIDE | METFORMIN HYDROCHLORIDE | 1GM | TABLET / ORAL | AB | RS | 2010-04-22 |
Therapeutic equivalence codes#
| Application-product | TE code |
|---|---|
| A090564-001 | AB |
| A090564-002 | AB |
| A090564-003 | 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 |
|---|---|---|---|---|---|---|---|---|---|
| 2026-08-18 06:07:40 | 2026-07 | A090564-001 | METFORMIN HYDROCHLORIDE | 500MG | TABLET / ORAL | AB | 2010-04-22 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | A090564-002 | METFORMIN HYDROCHLORIDE | 850MG | TABLET / ORAL | AB | 2010-04-22 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | A090564-003 | METFORMIN HYDROCHLORIDE | 1GM | TABLET / ORAL | AB | RS | 2010-04-22 | caaa826d4ba7… |
| 2026-02-19 14:30 UTC | 2026-02 | A090564-001 | METFORMIN HYDROCHLORIDE | 500MG | TABLET / ORAL | AB | 2010-04-22 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | A090564-002 | METFORMIN HYDROCHLORIDE | 850MG | TABLET / ORAL | AB | 2010-04-22 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | A090564-003 | METFORMIN HYDROCHLORIDE | 1GM | TABLET / ORAL | AB | RS | 2010-04-22 | 011fe1cb6892… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A090564-001 | METFORMIN HYDROCHLORIDE | 500MG | TABLET / ORAL | AB | 2010-04-22 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A090564-002 | METFORMIN HYDROCHLORIDE | 850MG | TABLET / ORAL | AB | 2010-04-22 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A090564-003 | METFORMIN HYDROCHLORIDE | 1GM | TABLET / ORAL | AB | RS | 2010-04-22 | 31067a03dcf5… |
| 2025-08-23 18:47 UTC | 2025-08 | A090564-001 | METFORMIN HYDROCHLORIDE | 500MG | TABLET / ORAL | AB | 2010-04-22 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | A090564-002 | METFORMIN HYDROCHLORIDE | 850MG | TABLET / ORAL | AB | 2010-04-22 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | A090564-003 | METFORMIN HYDROCHLORIDE | 1GM | TABLET / ORAL | AB | RS | 2010-04-22 | 6a471c1ec25d… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A090564-001 | METFORMIN HYDROCHLORIDE | 500MG | TABLET / ORAL | AB | 2010-04-22 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A090564-002 | METFORMIN HYDROCHLORIDE | 850MG | TABLET / ORAL | AB | 2010-04-22 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A090564-003 | METFORMIN HYDROCHLORIDE | 1GM | TABLET / ORAL | AB | RS | 2010-04-22 | fd3edfee7708… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A090564-001 | METFORMIN HYDROCHLORIDE | 500MG | TABLET / ORAL | AB | 2010-04-22 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A090564-002 | METFORMIN HYDROCHLORIDE | 850MG | TABLET / ORAL | AB | 2010-04-22 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A090564-003 | METFORMIN HYDROCHLORIDE | 1GM | TABLET / ORAL | AB | RS | 2010-04-22 | b8a1b40f171c… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A090564-001 | METFORMIN HYDROCHLORIDE | 500MG | TABLET / ORAL | AB | 2010-04-22 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A090564-002 | METFORMIN HYDROCHLORIDE | 850MG | TABLET / ORAL | AB | 2010-04-22 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A090564-003 | METFORMIN HYDROCHLORIDE | 1GM | TABLET / ORAL | AB | RS | 2010-04-22 | 03ed91905a0d… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A090564-001 | METFORMIN HYDROCHLORIDE | 500MG | TABLET / ORAL | AB | 2010-04-22 | 2680178bc6a6… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A090564-002 | METFORMIN HYDROCHLORIDE | 850MG | TABLET / ORAL | AB | 2010-04-22 | 2680178bc6a6… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A090564-003 | METFORMIN HYDROCHLORIDE | 1GM | TABLET / ORAL | AB | RS | 2010-04-22 | 2680178bc6a6… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A090564-001 | METFORMIN HYDROCHLORIDE | 500MG | TABLET / ORAL | AB | 2010-04-22 | 5bbf6a4d5a75… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A090564-002 | METFORMIN HYDROCHLORIDE | 850MG | TABLET / ORAL | AB | 2010-04-22 | 5bbf6a4d5a75… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A090564-003 | METFORMIN HYDROCHLORIDE | 1GM | TABLET / ORAL | AB | RS | 2010-04-22 | 5bbf6a4d5a75… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A090564-001 | METFORMIN HYDROCHLORIDE | 500MG | TABLET / ORAL | AB | 2010-04-22 | d8e5a09893c0… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A090564-002 | METFORMIN HYDROCHLORIDE | 850MG | TABLET / ORAL | AB | 2010-04-22 | d8e5a09893c0… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A090564-003 | METFORMIN HYDROCHLORIDE | 1GM | TABLET / ORAL | AB | RS | 2010-04-22 | d8e5a09893c0… |
| 2024-10-29 15:01 UTC | 2024-10 | A090564-001 | METFORMIN HYDROCHLORIDE | 500MG | TABLET / ORAL | AB | 2010-04-22 | d06236e962d9… | |
| 2024-10-29 15:01 UTC | 2024-10 | A090564-002 | METFORMIN HYDROCHLORIDE | 850MG | TABLET / ORAL | AB | 2010-04-22 | d06236e962d9… | |
| 2024-10-29 15:01 UTC | 2024-10 | A090564-003 | METFORMIN HYDROCHLORIDE | 1GM | TABLET / ORAL | AB | RS | 2010-04-22 | d06236e962d9… |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A090564-001 | METFORMIN HYDROCHLORIDE | 500MG | TABLET / ORAL | AB | 2010-04-22 | 79d66fd596c7… | |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A090564-002 | METFORMIN HYDROCHLORIDE | 850MG | TABLET / ORAL | AB | 2010-04-22 | 79d66fd596c7… | |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A090564-003 | METFORMIN HYDROCHLORIDE | 1GM | TABLET / ORAL | AB | RS | 2010-04-22 | 79d66fd596c7… |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A090564-001 | METFORMIN HYDROCHLORIDE | 500MG | TABLET / ORAL | AB | 2010-04-22 | 301d65b070ca… | |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A090564-002 | METFORMIN HYDROCHLORIDE | 850MG | TABLET / ORAL | AB | 2010-04-22 | 301d65b070ca… | |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A090564-003 | METFORMIN HYDROCHLORIDE | 1GM | TABLET / ORAL | AB | RS | 2010-04-22 | 301d65b070ca… |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A090564-001 | METFORMIN HYDROCHLORIDE | 500MG | TABLET / ORAL | AB | 2010-04-22 | 1e350fbaab3a… |
Observed Orange Book normalized TE history#
| Captured | Edition | Application-product | TE code | Order | Source SHA-256 |
|---|---|---|---|---|---|
| 2026-08-18 06:07:40 | 2026-07 | A090564-001 | AB | 1 | caaa826d4ba7… |
| 2026-08-18 06:07:40 | 2026-07 | A090564-002 | AB | 1 | caaa826d4ba7… |
| 2026-08-18 06:07:40 | 2026-07 | A090564-003 | AB | 1 | caaa826d4ba7… |
| 2026-02-19 14:30 UTC | 2026-02 | A090564-001 | AB | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | A090564-002 | AB | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | A090564-003 | AB | 1 | 011fe1cb6892… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A090564-001 | AB | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A090564-002 | AB | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A090564-003 | AB | 1 | 31067a03dcf5… |
| 2025-08-23 18:47 UTC | 2025-08 | A090564-001 | AB | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | A090564-002 | AB | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | A090564-003 | AB | 1 | 6a471c1ec25d… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A090564-001 | AB | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A090564-002 | AB | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A090564-003 | AB | 1 | fd3edfee7708… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A090564-001 | AB | 1 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A090564-002 | AB | 1 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A090564-003 | AB | 1 | b8a1b40f171c… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A090564-001 | AB | 1 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A090564-002 | AB | 1 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A090564-003 | AB | 1 | 03ed91905a0d… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A090564-001 | AB | 1 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A090564-002 | AB | 1 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A090564-003 | AB | 1 | 2680178bc6a6… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A090564-001 | AB | 1 | 5bbf6a4d5a75… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A090564-002 | AB | 1 | 5bbf6a4d5a75… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A090564-003 | AB | 1 | 5bbf6a4d5a75… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A090564-001 | AB | 1 | d8e5a09893c0… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A090564-002 | AB | 1 | d8e5a09893c0… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A090564-003 | AB | 1 | d8e5a09893c0… |
| 2024-10-29 15:01 UTC | 2024-10 | A090564-001 | AB | 1 | d06236e962d9… |
| 2024-10-29 15:01 UTC | 2024-10 | A090564-002 | AB | 1 | d06236e962d9… |
| 2024-10-29 15:01 UTC | 2024-10 | A090564-003 | AB | 1 | d06236e962d9… |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A090564-001 | AB | 1 | 79d66fd596c7… |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A090564-002 | AB | 1 | 79d66fd596c7… |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A090564-003 | AB | 1 | 79d66fd596c7… |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A090564-001 | AB | 1 | 301d65b070ca… |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A090564-002 | AB | 1 | 301d65b070ca… |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A090564-003 | AB | 1 | 301d65b070ca… |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A090564-001 | AB | 1 | 1e350fbaab3a… |
DailyMed Product Concepts#
DailyMed Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 23155-103-01 | EA - Each | 23155-103 | e9c32dd1-904d-40a6-8efc-c036bbbb3b0d | 1 | 2012-07-24 |
| 23155-103-05 | EA - Each | 23155-103 | b8b747c0-51a9-44ac-981e-8ab2122bffbb | 1 | 2012-07-24 |
| 23155-103-06 | EA - Each | 23155-103 | 3bfdd38e-71cf-4eae-af25-41519eb7800e | 1 | 2015-12-02 |
| 23155-103-09 | EA - Each | 23155-103 | 64f52abb-73a2-4e6f-b9d7-f84fe2ee215b | 1 | 2019-04-11 |
| 23155-103-10 | EA - Each | 23155-103 | fecba7e8-2e8d-473d-a3a0-caec0ab853b5 | 1 | 2012-07-24 |
DailyMed Socrata Ingredients#
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. | 1e8136e0-cc98-41e4-ad4b-a8fc27fb4daa | 2026-08-04 | Boxed warning, Warnings, Adverse reactions | 090564 ANDA090564 |
| Metformin HCl | METFORMIN HCL | PD-Rx Pharmaceuticals, Inc. | c8e50300-1838-4c51-8d9d-ebbaaf0f3991 | 2026-08-03 | Warnings, Adverse reactions | 090564 ANDA090564 |
| Metformin Hydrochloride | METFORMIN HYDROCHLORIDE | REMEDYREPACK INC. | 59a4ccda-5487-4ac4-9373-0c0fc8b7c88b | 2026-08-03 | Boxed warning, Warnings, Adverse reactions | 090564 ANDA090564 |
| Metformin Hydrochloride | METFORMIN HYDROCHLORIDE | REMEDYREPACK INC. | 30658e19-8e6e-49aa-a007-e414224797c5 | 2026-07-29 | Boxed warning, Warnings, Adverse reactions | 090564 ANDA090564 |
| Metformin Hydrochloride | METFORMIN HYDROCHLORIDE | Cardinal Health 107, LLC | 46cb7e3f-c739-433d-9dbe-427c2d95bef1 | 2026-07-24 | Boxed warning, Warnings, Adverse reactions | 090564 ANDA090564 |
| Metformin Hydrochloride | METFORMIN HYDROCHLORIDE | REMEDYREPACK INC. | 5aa1c86c-f2c8-49b1-8f81-47b11386c5d3 | 2026-07-15 | Boxed warning, Warnings, Adverse reactions | 090564 ANDA090564 |
| Metformin HCl | METFORMIN HCL | PD-Rx Pharmaceuticals, Inc. | fb890205-5d43-41eb-97b2-fb0dcdd3a950 | 2026-07-13 | Warnings, Adverse reactions | 090564 ANDA090564 |
| Metformin Hydrochloride | METFORMIN HYDROCHLORIDE TABLET | Granules India Ltd | 8cd5555c-f6b2-28d8-e053-2a95a90a5f1e | 2026-06-29 | Boxed warning, Warnings, Adverse reactions | 090564 ANDA090564 |
| Metformin HCl | METFORMIN HCL | Unit Dose Solutions, Inc. | 5538e9df-0983-9281-e063-6394a90a9249 | 2026-06-27 | Warnings, Adverse reactions | 090564 ANDA090564 |
| Metformin Hydrochloride | METFORMIN HYDROCHLORIDE | Unit Dose Solutions, Inc. | 552ad61d-bafd-478d-e063-6294a90a02f9 | 2026-06-26 | Boxed warning, Warnings, Adverse reactions | 090564 ANDA090564 |
| Metformin HCl | METFORMIN HCL | Unit Dose Solutions, Inc. | 552df462-6dcb-e6f2-e063-6294a90aacfe | 2026-06-26 | Warnings, Adverse reactions | 090564 ANDA090564 |
| Metformin Hydrochloride | METFORMIN HYDROCHLORIDE | Major Pharmaceuticals | 5e783025-bf6d-465e-bf58-bcd253afad2c | 2026-06-24 | Boxed warning, Warnings, Adverse reactions | 090564 ANDA090564 |
| Metformin Hydrochloride | METFORMIN HYDROCHLORIDE | Preferred Pharmaceuticals Inc. | 62ca8af4-ff91-4bf6-b7c6-895b3b5ce8c3 | 2026-06-19 | Boxed warning, Warnings, Adverse reactions | 090564 ANDA090564 |
| Metformin Hydrochloride | METFORMIN HYDROCHLORIDE | Preferred Pharmaceuticals Inc. | 902d1bc4-3f1f-4a1a-86d7-cf98c56a3684 | 2026-06-19 | Boxed warning, Warnings, Adverse reactions | 090564 ANDA090564 |
| Metformin Hydrochloride | METFORMIN HYDROCHLORIDE | Preferred Pharmaceuticals Inc. | 33550b88-d4bb-4ce6-a7db-07c966f6984f | 2026-06-19 | Boxed warning, Warnings, Adverse reactions | 090564 ANDA090564 |
| Metformin Hydrochloride | METFORMIN HYDROCHLORIDE | Coupler LLC | 53e950f5-c58f-78e3-e063-6294a90a53e9 | 2026-06-10 | Boxed warning, Warnings, Adverse reactions | 090564 ANDA090564 |
| Metformin HCl | METFORMIN HCL | Proficient Rx LP | d2c927eb-12bf-4c7d-9ef5-0036b2dd8c29 | 2026-06-01 | Warnings, Adverse reactions | 090564 ANDA090564 |
| Metformin HCl | METFORMIN HCL | Northwind Health Company, LLC | 13b1e35f-d047-8ddc-e063-6394a90a24dd | 2026-05-14 | Warnings, Adverse reactions | 090564 ANDA090564 |
| Metformin Hydrochloride | METFORMIN HYDROCHLORIDE | Coupler LLC | 51285096-e2ce-0f3c-e063-6394a90a35d4 | 2026-05-06 | Boxed warning, Warnings, Adverse reactions | 090564 ANDA090564 |
| Metformin Hydrochloride | METFORMIN HYDROCHLORIDE | Granules Pharmaceuticals Inc. | 2387a618-24d8-4813-aa83-9114edb35374 | 2026-04-16 | Boxed warning, Warnings, Adverse reactions | 090564 ANDA090564 |
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | DailyMed | SPL version |
|---|---|---|---|---|
| 861004 | metFORMIN HCl 1000 MG Oral Tablet | PSN | bf6b3206-52ce-40d5-bc6d-a265effb7b26 | 15 |
| 861007 | metFORMIN HCl 500 MG Oral Tablet | PSN | bf6b3206-52ce-40d5-bc6d-a265effb7b26 | 15 |
| 861010 | metFORMIN HCl 850 MG Oral Tablet | PSN | bf6b3206-52ce-40d5-bc6d-a265effb7b26 | 15 |
| 861004 | metformin hydrochloride 1000 MG Oral Tablet | SCD | bf6b3206-52ce-40d5-bc6d-a265effb7b26 | 15 |
| 861007 | metformin hydrochloride 500 MG Oral Tablet | SCD | bf6b3206-52ce-40d5-bc6d-a265effb7b26 | 15 |
| 861010 | metformin hydrochloride 850 MG Oral Tablet | SCD | bf6b3206-52ce-40d5-bc6d-a265effb7b26 | 15 |
| 861004 | metformin HCl 1 GM Oral Tablet | SY | bf6b3206-52ce-40d5-bc6d-a265effb7b26 | 15 |
| 861004 | metFORMIN HCl 1000 MG Oral Tablet | PSN | 69517af8-ac74-48e6-add7-1ef22661a8f6 | 5 |
| 861007 | metFORMIN HCl 500 MG Oral Tablet | PSN | 69517af8-ac74-48e6-add7-1ef22661a8f6 | 5 |
| 861010 | metFORMIN HCl 850 MG Oral Tablet | PSN | 69517af8-ac74-48e6-add7-1ef22661a8f6 | 5 |
| 861004 | metformin hydrochloride 1000 MG Oral Tablet | SCD | 69517af8-ac74-48e6-add7-1ef22661a8f6 | 5 |
| 861007 | metformin hydrochloride 500 MG Oral Tablet | SCD | 69517af8-ac74-48e6-add7-1ef22661a8f6 | 5 |
| 861010 | metformin hydrochloride 850 MG Oral Tablet | SCD | 69517af8-ac74-48e6-add7-1ef22661a8f6 | 5 |
| 861004 | metformin HCl 1 GM Oral Tablet | SY | 69517af8-ac74-48e6-add7-1ef22661a8f6 | 5 |
| 861010 | metFORMIN HCl 850 MG Oral Tablet | PSN | 9145db22-ec84-6f79-e053-2a95a90aa826 | 4 |
| 861010 | metformin hydrochloride 850 MG Oral Tablet | SCD | 9145db22-ec84-6f79-e053-2a95a90aa826 | 4 |
| 861004 | metFORMIN HCl 1000 MG Oral Tablet | PSN | 59a485b1-8299-5d02-e053-2a91aa0a42e3 | 3 |
| 861004 | metFORMIN HCl 1000 MG Oral Tablet | PSN | 398c563d-2286-4d11-9004-73fc57230b0c | 3 |
| 861007 | metFORMIN HCl 500 MG Oral Tablet | PSN | 59a485b1-8299-5d02-e053-2a91aa0a42e3 | 3 |
| 861007 | metFORMIN HCl 500 MG Oral Tablet | PSN | 398c563d-2286-4d11-9004-73fc57230b0c | 3 |
| 861010 | metFORMIN HCl 850 MG Oral Tablet | PSN | 59a485b1-8299-5d02-e053-2a91aa0a42e3 | 3 |
| 861010 | metFORMIN HCl 850 MG Oral Tablet | PSN | 9143527d-8877-5021-e053-2995a90abfd5 | 3 |
| 861010 | metFORMIN HCl 850 MG Oral Tablet | PSN | 398c563d-2286-4d11-9004-73fc57230b0c | 3 |
| 861004 | metformin hydrochloride 1000 MG Oral Tablet | SCD | 59a485b1-8299-5d02-e053-2a91aa0a42e3 | 3 |
| 861004 | metformin hydrochloride 1000 MG Oral Tablet | SCD | 398c563d-2286-4d11-9004-73fc57230b0c | 3 |
| 861007 | metformin hydrochloride 500 MG Oral Tablet | SCD | 398c563d-2286-4d11-9004-73fc57230b0c | 3 |
| 861007 | metformin hydrochloride 500 MG Oral Tablet | SCD | 59a485b1-8299-5d02-e053-2a91aa0a42e3 | 3 |
| 861010 | metformin hydrochloride 850 MG Oral Tablet | SCD | 9143527d-8877-5021-e053-2995a90abfd5 | 3 |
| 861010 | metformin hydrochloride 850 MG Oral Tablet | SCD | 59a485b1-8299-5d02-e053-2a91aa0a42e3 | 3 |
| 861010 | metformin hydrochloride 850 MG Oral Tablet | SCD | 398c563d-2286-4d11-9004-73fc57230b0c | 3 |
| 861004 | metformin HCl 1 GM Oral Tablet | SY | 398c563d-2286-4d11-9004-73fc57230b0c | 3 |
| 861004 | metformin HCl 1 GM Oral Tablet | SY | 59a485b1-8299-5d02-e053-2a91aa0a42e3 | 3 |
| 861010 | metFORMIN HCl 850 MG Oral Tablet | PSN | 2b44622c-9501-0ab7-e054-00144ff8d46c | 1 |
| 861010 | metformin hydrochloride 850 MG Oral Tablet | SCD | 2b44622c-9501-0ab7-e054-00144ff8d46c | 1 |
Packages#
| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|---|
| 23155-103-10 | 23155010310 | 1000 TABLET in 1 BOTTLE (23155-103-10) | 1000 tablet | 2010-04-22 | 0000-00-00 | No | No | Current |