NDC 83301-0010-01 - Metformin Hydrochloride
This NDC is not currently matched to an FDA NDC product listing in FDA.report, but it is a valid NDC-form code. FDA.report is showing the available DailyMed label context for the product root.
- Product NDC
- 83301-0010
- Requested NDC
- 83301-0010-01
- Package NDCs from labels
- 83301-0010-1, 83301-0010-2, 83301-0010-3, 83301-0010-01
- Manufacturer
- Mullan Pharmaceutical Inc. | CSPC Ouyi Pharmaceutical Co., Ltd.
- Effective date
- 2025-10-28
- Current FDA listing
- Not matched in FDA.report NDC product tables
DailyMed Labels#
| Label | Manufacturer | Effective date | Type |
|---|---|---|---|
| Metformin Hydrochloride | Mullan Pharmaceutical Inc. | CSPC Ouyi Pharmaceutical Co., Ltd. | 2025-10-28 | HUMAN PRESCRIPTION DRUG LABEL |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 83301-0010-1 | Metformin Hydrochloride | 100 in 1 BOTTLE | TABLET, COATED | 100 | 6 | |
| 83301-0010-2 | Metformin Hydrochloride | 500 in 1 BOTTLE | TABLET, COATED | 500 | 6 | |
| 83301-0010-3 | Metformin Hydrochloride | 1000 in 1 BOTTLE | TABLET, COATED | 1000 | 6 |
DailyMed Dashboard NDC Coverage#
| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|---|---|---|---|
| 83301-0010 | METFORMIN HYDROCHLORIDE TABLET, COATED [MULLAN PHARMACEUTICAL INC.] | 4 | Current NDC, 3 package rows | 20240324_082b4de9-e452-fe71-e063-6394a90ac863.zip |
DailyMed Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 83301-0010-1 | EA - Each | 83301-0010 | 16a38516-a7c6-4f11-a655-118b462e675b | 1 | 2025-07-08 |
| 83301-0010-2 | EA - Each | 83301-0010 | 307aab11-49de-46b6-830e-891e28249164 | 1 | 2025-07-08 |
| 83301-0010-3 | EA - Each | 83301-0010 | 42878dc7-95f7-406b-9955-4ba3dccd61e3 | 1 | 2025-07-08 |
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 | Oceanside Pharmaceuticals | 74d32a8a-c4c2-4dbb-b376-eea3f8fa64d7 | 2024-11-14 | Boxed warning, Warnings, Adverse reactions | 786Z46389E |
| Metformin | METFORMIN ER 500 MG | Proficient Rx LP | 92855c8d-59be-458b-97f1-2ff11b9bf6b0 | 2024-11-01 | Warnings, Adverse reactions | 786Z46389E |
| Clear Eyes Triple Relief | POLYVINYL ALCOHOL AND POVIDONE AND TETRAHYDROZOLINE HYDROCHLORIDE | Prestige Brands Holdings, Inc. | 1269a1a6-843d-4d08-bb3c-c1f3d2e7080d | 2024-10-25 | Warnings | FZ989GH94E |
| Metformin | METFORMIN ER 750 MG | A-S Medication Solutions | 9e3791fb-9a34-4982-8164-0502fa398b01 | 2024-10-22 | Warnings, Adverse reactions | 786Z46389E |
| Metformin | METFORMIN ER 750 MG | A-S Medication Solutions | 953404a4-0f03-42f1-8136-43238dad11f4 | 2024-10-22 | Warnings, Adverse reactions | 786Z46389E |
| Metformin Hydrochloride | METFORMIN HYDROCHLORIDE | A-S Medication Solutions | c2bbaa0c-5b05-4335-882f-14f1b443edd7 | 2024-10-14 | Boxed warning, Warnings, Adverse reactions | ANDA205096 861007 786Z46389E |
| Metformin Hydrochloride | METFORMIN HYDROCHLORIDE | A-S Medication Solutions | 54ca16e6-1213-4877-8ace-477c764c8e76 | 2024-10-14 | Boxed warning, Warnings, Adverse reactions | ANDA205096 861007 786Z46389E |
| Metformin HCl | METFORMIN HCL | NuCare Pharmaceuticals, Inc. | 242256af-c587-060a-e063-6294a90a68cc | 2024-10-10 | Warnings, Adverse reactions | 861004 786Z46389E |
| Metformin hydrochloride | METFORMIN HYDROCHLORIDE | Aphena Pharma Solutions - Tennessee, LLC | 242538d7-fb79-4df6-e063-6394a90a5b96 | 2024-10-10 | Boxed warning, Warnings, Adverse reactions | 786Z46389E |
| Metformin Hydrochloride | METFORMIN HYDROCHLORIDE | VistaPharm, LLC | e087ce3b-8d7f-43a3-8d20-54513da7617d | 2024-10-10 | Boxed warning, Warnings, Adverse reactions | 786Z46389E |
| Metformin Hydrochloride | METFORMIN HYDROCHLORIDE | American Health Packaging | dd54d30b-9390-4e5a-bf62-fbf18b91e4cd | 2024-10-04 | Boxed warning, Warnings, Adverse reactions | 861007 861010 861004 786Z46389E |
| METFORMIN HYDROCHLORIDE | METFORMIN HYDROCHLORIDE | NuCare Pharmaceuticals,Inc. | 0710e208-5b2c-3c72-e063-6394a90a4dac | 2024-09-26 | Boxed warning, Warnings, Adverse reactions | 861007 786Z46389E |
| Advanced Eye Relief/ Redness Maximum Relief | NAPHAZOLINE HYDROCHLORIDE AND HYPROMELLOSE | Bausch & Lomb Incorporated | 3c11285a-7e86-4b47-b1ee-e7d59858087d | 2024-09-25 | Warnings | 3NXW29V3WO |
| Metformin HCl | METFORMIN HCL | Advanced Rx of Tennessee, LLC | 21b76183-af30-e06f-e063-6394a90a9653 | 2024-09-23 | Warnings, Adverse reactions | 861004 786Z46389E |
| Metformin Hydrochloride | METFORMIN HYDROCHLORIDE | NCS HealthCare of KY, LLC dba Vangard Labs | 23aa0072-365c-4d13-9aa7-ae23f7e00ee4 | 2024-09-18 | Boxed warning, Warnings, Adverse reactions | 861007 861010 861004 786Z46389E |
| Sitagliptin and Metformin Hydrochloride | SITAGLIPTIN AND METFORMIN HYDROCHLORIDE | Zydus Pharmaceuticals USA Inc. | d3a728a0-decb-4340-8ee4-c5e27c13eb19 | 2024-08-31 | Boxed warning, Warnings, Adverse reactions | 786Z46389E |
| Metformin Hydrochloride | METFORMIN HYDROCHLORIDE | Westminster Pharmaceuticals, LLC | 583dac53-65e7-4710-912a-ecd89d07ad03 | 2024-08-30 | Boxed warning, Warnings, Adverse reactions | ANDA205096 861007 861010 861004 786Z46389E |
| Metformin Hydrochloride | METFORMIN HYDROCHLORIDE | Bryant Ranch Prepack | ed6e6f87-ddd7-4c9d-a263-47154d3a9478 | 2024-08-27 | Boxed warning, Warnings, Adverse reactions | 861007 786Z46389E |
| Metformin | METFORMIN ER 500 MG | Bryant Ranch Prepack | 1f823d36-c7a6-4cf8-b6f1-52b7a51c8fc4 | 2024-08-26 | Warnings, Adverse reactions | 786Z46389E |
| Sitagliptin and Metformin Hydrochloride | SITAGLIPTIN AND METFORMIN HYDROCHLORIDE | Zydus Lifesciences Limited | a07fa1d9-7171-4f2a-ab34-f8fa410364a6 | 2024-08-24 | 786Z46389E |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.