metformin hydrochloride
- Product NDC
- 23155-103
- 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#
Explicit status records from FDA unfinished, excluded, and compounder auxiliary files. Absence of a row is not itself a regulatory status. Browse every current auxiliary row, including rows without a usable NDC. · Browse every captured source and parsed snapshot.
| Dataset | Scope | Product NDC | Package NDC | Code | Status | Reporting period | Source date |
|---|---|---|---|---|---|---|---|
| excluded product | product | 23155-103 | D | Discontinued by firm | 2026-07-31 | ||
| excluded package | package | 23155-103 | 23155-103-01 | D | Discontinued by firm | 2026-07-31 | |
| excluded package | package | 23155-103 | 23155-103-05 | D | Discontinued by firm | 2026-07-31 | |
| excluded package | package | 23155-103 | 23155-103-06 | D | Discontinued by firm | 2026-07-31 | |
| excluded package | package | 23155-103 | 23155-103-09 | D | Discontinued by firm | 2026-07-31 | |
| excluded package | package | 23155-103 | 23155-103-10 | D | Discontinued by firm | 2026-07-31 |
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 |
|---|---|---|---|---|---|---|---|---|---|
| 2026-08-01 22:54:32 | 2026-06 | A090564-001 | METFORMIN HYDROCHLORIDE | 500MG | TABLET / ORAL | AB | 2010-04-22 | a50c72e98297… | |
| 2026-08-01 22:54:32 | 2026-06 | A090564-002 | METFORMIN HYDROCHLORIDE | 850MG | TABLET / ORAL | AB | 2010-04-22 | a50c72e98297… | |
| 2026-08-01 22:54:32 | 2026-06 | A090564-003 | METFORMIN HYDROCHLORIDE | 1GM | TABLET / ORAL | AB | RS | 2010-04-22 | a50c72e98297… |
Observed Orange Book normalized TE history#
| Captured | Edition | Application-product | TE code | Order | Source SHA-256 |
|---|---|---|---|---|---|
| 2026-08-01 22:54:32 | 2026-06 | A090564-001 | AB | 1 | a50c72e98297… |
| 2026-08-01 22:54:32 | 2026-06 | A090564-002 | AB | 1 | a50c72e98297… |
| 2026-08-01 22:54:32 | 2026-06 | A090564-003 | AB | 1 | a50c72e98297… |
openFDA label cross-check#
Cross-check layer: openFDA label JSON enriches search and identifies hydration gaps. The DailyMed Structured Product Label remains the canonical label presentation on FDA.report. Every label matching the complete exact-identifier union is deduplicated and paginated below.
| Brand | Generic | Manufacturer | SPL set ID | Effective date | Available safety fields | Join |
|---|---|---|---|---|---|---|
| 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 |
| Metformin Hydrochloride | METFORMIN HYDROCHLORIDE | REMEDYREPACK INC. | 1e8136e0-cc98-41e4-ad4b-a8fc27fb4daa | 2026-04-03 | Boxed warning, Warnings, Adverse reactions | 090564 ANDA090564 |
| Metformin Hydrochloride | METFORMIN HYDROCHLORIDE | REMEDYREPACK INC. | 59a4ccda-5487-4ac4-9373-0c0fc8b7c88b | 2026-04-03 | Boxed warning, Warnings, Adverse reactions | 090564 ANDA090564 |
| Metformin hydrochloride | METFORMIN HYDROCHLORIDE | Legacy Pharmaceutical Packaging, LLC | b51da8d7-ab4a-4c40-97c9-88bd379366d1 | 2026-03-11 | Boxed warning, Warnings, Adverse reactions | 090564 ANDA090564 |
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#
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 |
|---|---|---|---|---|---|---|---|---|
| 23155-103-01 | 23155010301 | 100 TABLET in 1 BOTTLE (23155-103-01) | 100 tablet | 2010-04-22 | 0000-00-00 | No | No | Current |
| 23155-103-05 | 23155010305 | 500 TABLET in 1 BOTTLE (23155-103-05) | 500 tablet | 2010-04-22 | 0000-00-00 | No | No | Current |
| 23155-103-06 | 23155010306 | 60 TABLET in 1 BOTTLE (23155-103-06) | 60 tablet | 2010-04-22 | 0000-00-00 | No | No | Current |
| 23155-103-09 | 23155010309 | 90 TABLET in 1 BOTTLE (23155-103-09) | 90 tablet | 2019-02-07 | 0000-00-00 | No | No | Current |
| 23155-103-10 | 23155010310 | 1000 TABLET in 1 BOTTLE (23155-103-10) | 1000 tablet | 2010-04-22 | 0000-00-00 | No | No | Current |