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 |
|---|---|---|---|---|---|---|
| glyburide-metformin hydrochloride | GLYBURIDE-METFORMIN HYDROCHLORIDE | Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc. | b38213bb-d663-4c95-a1b2-96c23ee5be09 | 2026-07-07 | Boxed warning, Warnings, Adverse reactions | 786Z46389E |
| Glyburide and Metformin Hydrochloride | GLYBURIDE AND METFORMIN HYDROCHLORIDE | Rising Pharma Holdings, Inc. | 372af566-d6ec-446f-88db-0b4cc83b577f | 2026-07-03 | Boxed warning, Warnings, Adverse reactions | 786Z46389E |
| Metformin Hydrochloride | METFORMIN HYDROCHLORIDE | Amneal Pharmaceuticals LLC | dc65065b-cba0-46d7-8fb5-3368f3210b4d | 2026-07-01 | Boxed warning, Warnings, Adverse reactions | 786Z46389E |
| Metformin Hydrochloride | METFORMIN HYDROCHLORIDE | Unichem Pharmaceuticals (USA), Inc. | 9eebed09-2562-4d21-b3b3-c06562fe3f99 | 2026-07-01 | Boxed warning, Warnings, Adverse reactions | 786Z46389E |
| Glyburide and Metformin Hydrochloride | GLYBURIDE AND METFORMIN HYDROCHLORIDE | Aurobindo Pharma Limited | 7010b662-8b34-49ce-8e5b-73dee0821a60 | 2026-06-30 | Boxed warning, Warnings, Adverse reactions | 786Z46389E |
| Metformin Hydrochloride | METFORMIN HYDROCHLORIDE | MARKSANS PHARMA LIMITED | d09a2eda-fdd8-44ed-8e2f-ea91ddfd3c68 | 2026-06-29 | Boxed warning, Warnings, Adverse reactions | 786Z46389E |
| Metformin Hydrochloride | METFORMIN HYDROCHLORIDE TABLET | Granules India Ltd | 8cd5555c-f6b2-28d8-e053-2a95a90a5f1e | 2026-06-29 | Boxed warning, Warnings, Adverse reactions | 861007 861010 861004 786Z46389E |
| Glipizide and Metformin Hydrochloride | GLIPIZIDE AND METFORMIN HYDROCHLORIDE | Zydus Pharmaceuticals USA Inc. | 1b18b903-eb52-4d08-b4a5-f984957eb116 | 2026-06-27 | Warnings, Adverse reactions | 786Z46389E |
| Metformin Hydrochloride | METFORMIN HYDROCHLORIDE | Unit Dose Solutions, Inc. | 552ad61d-bafd-478d-e063-6294a90a02f9 | 2026-06-26 | Boxed warning, Warnings, Adverse reactions | 861004 786Z46389E |
| Metformin HCl | METFORMIN HCL | Unit Dose Solutions, Inc. | 552df462-6dcb-e6f2-e063-6294a90aacfe | 2026-06-26 | Warnings, Adverse reactions | 861004 786Z46389E |
| METFORMIN HYDROCHLORIDE | METFORMIN HYDROCHLORIDE | Marlex Pharmaceuticals, Inc. | 3d6f397b-e909-bee9-e063-6294a90aba17 | 2026-06-26 | Boxed warning, Warnings, Adverse reactions | 786Z46389E |
| Glipizide and Metformin HCl | GLIPIZIDE AND METFORMIN HCL | Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc. | 94a7f96e-2ed1-432d-bc6a-5840863816e1 | 2026-06-26 | Boxed warning, Warnings, Adverse reactions | 786Z46389E |
| Metformin Hydrochloride | METFORMIN HYDROCHLORIDE | Viona Pharmaceuticals Inc | 85027e6c-d35b-49eb-a234-dd71aa77aee0 | 2026-06-26 | Boxed warning, Warnings, Adverse reactions | 786Z46389E |
| Metformin Hydrochloride | METFORMIN HYDROCHLORIDE EXTENDED-RELEASE TABLETS | AiPing Pharmaceutical, Inc. | 96c8a89d-99db-24b1-e053-2a95a90ac2b8 | 2026-06-25 | Boxed warning, Warnings, Adverse reactions | 786Z46389E |
| METFORMIN HYDROCHLORIDE | METFORMIN HYDROCHLORIDE | Sun Pharmaceutical Industries, Inc. | 41a8bb80-7b0b-476c-8134-5d161c3239c8 | 2026-06-25 | Boxed warning, Warnings, Adverse reactions | 786Z46389E |
| Metformin Hydrochloride | METFORMIN HYDROCHLORIDE | Aurobindo Pharma Limited | 8d4b8620-5e99-4d12-b4f2-e9967b627b57 | 2026-06-25 | Boxed warning, Warnings, Adverse reactions | 786Z46389E |
| Metformin Hydrochloride | METFORMIN HYDROCHLORIDE | Major Pharmaceuticals | 5e783025-bf6d-465e-bf58-bcd253afad2c | 2026-06-24 | Boxed warning, Warnings, Adverse reactions | 861007 861010 861004 786Z46389E |
| METFORMIN HYDROCHLORIDE | METFORMIN HYDROCHLORIDE | Preferred Pharmaceuticals Inc. | 4182bcf0-1f9a-4f3a-9428-86b5d757954f | 2026-06-22 | Boxed warning, Warnings, Adverse reactions | 861004 786Z46389E |
| Rohto Sun and Sport | HYPROMELLOSE, POVIDONE | The Mentholatum Company | 8bcc8882-b886-4b55-9bc4-d4b92a41358f | 2026-06-19 | Warnings | 3NXW29V3WO FZ989GH94E |
| Rohto Dual Light Relief | HYPROMELLOSE, POVIDONE | The Mentholatum Company | 1b597f83-d7f1-cf93-e063-6394a90a99f7 | 2026-06-19 | Warnings | 3NXW29V3WO FZ989GH94E |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.