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 | METFORMIN | REMEDYREPACK INC. | 27f603ec-25e6-4270-a7a3-34a64a76f7ef | 2026-05-01 | Boxed warning, Warnings, Adverse reactions | 786Z46389E |
| Metformin | METFORMIN ER 500 MG | Granules Pharmaceuticals Inc. | 6d6ee6f8-9650-ff4f-e053-2991aa0acf19 | 2026-04-30 | Boxed warning, Warnings, Adverse reactions | 786Z46389E |
| iVIZIA Lubricant Eye Gel | POVIDONE | Thea Pharma Inc. | 1f06ca1a-5270-9a82-e063-6294a90aed64 | 2026-04-29 | Warnings | FZ989GH94E |
| GoodSense Eye Drops Advanced Relief Moisturizer | DEXTRAN, POLYETHYLENE GLYCOL 400, POVIDONE, TETRAHYDROZOLINE HCL | Preferred PHarmaceuticals Inc. | 011473a8-26d5-4661-b3c0-745f9b6aa1d8 | 2026-04-29 | Warnings | FZ989GH94E |
| Metformin | METFORMIN | Ingenus Pharmaceuticals, LLC | 49a0b5c2-ebaf-4c4c-905f-dfd1962ac647 | 2026-04-22 | Boxed warning, Warnings, Adverse reactions | 786Z46389E |
| Metformin Hydrochloride | METFORMIN HYDROCHLORIDE | Granules Pharmaceuticals Inc. | 2387a618-24d8-4813-aa83-9114edb35374 | 2026-04-16 | Boxed warning, Warnings, Adverse reactions | 861007 861010 861004 786Z46389E |
| Metformin Hydrochloride | METFORMIN HYDROCHLORIDE | NCS HealthCare of KY, LLC dba Vangard Labs | 0448c618-2f0d-4ed3-866f-74b413cf902d | 2026-04-16 | Boxed warning, Warnings, Adverse reactions | 861007 861010 861004 786Z46389E |
| Sitagliptin and Metformin Hydrochloride | SITAGLIPTIN AND METFORMIN HYDROCHLORIDE | Apotex Corp. | 950613e2-e959-6b57-e172-251ddc53c64c | 2026-04-14 | Boxed warning, Warnings, Adverse reactions | 786Z46389E |
| Exovisse Preservative-Free Artificial Tears | LUBRICANT EYE GEL DROPS | YD BIO USA, INC. | 4f20191a-9124-2525-e063-6294a90a8428 | 2026-04-10 | Warnings | 3NXW29V3WO |
| DAPAGLIFLOZIN AND METFORMIN HYDROCHLORIDE | DAPAGLIFLOZIN AND METFORMIN HYDROCHLORIDE | Novadoz Pharmaceuticals LLC | 4f890458-be94-4baf-b606-83a097e1e23e | 2026-04-09 | Boxed warning, Warnings, Adverse reactions | 786Z46389E |
| FreshKote Preservative Free Lubricant Eye Drops | POVIDONE, POLYVINYL ALCOHOL | Eyevance Pharmaceuticals | f51c50c3-43ae-4169-9d2b-22b239461dd1 | 2026-04-08 | Warnings | FZ989GH94E |
| Metformin Hydrochloride | METFORMIN HYDROCHLORIDE | Precision Dose, Inc. | 60142fb2-16da-4f54-a542-74f9a70b9c8b | 2026-04-08 | Boxed warning, Warnings, Adverse reactions | 786Z46389E |
| Dapagliflozin and Metformin hydrochloride | DAPAGLIFLOZIN AND METFORMIN HYDROCHLORIDE | Aurobindo Pharma Limited | 513bdf9f-774c-4f7f-935a-54d3885e80a4 | 2026-04-07 | Boxed warning, Warnings, Adverse reactions | 786Z46389E |
| LensMate Preservative-Free Artificial Tears | LUBRICANT EYE DROPS | YD BIO USA, INC. | 4ebacb2b-9b2d-6bc1-e063-6294a90a3426 | 2026-04-05 | Warnings | 3NXW29V3WO |
| Exovisse Preservative-Free Artificial Tears | LUBRICANT EYE GEL DROPS | YD BIO USA, INC. | 4ebc154b-128b-9dde-e063-6294a90ae00e | 2026-04-05 | Warnings | 3NXW29V3WO |
| Crocodile Tears Lubricant Eye Drops | GLYCERIN, HYPROMELLOSE, POLYETHYLENE GLYCOL 400 | Crocodile Tears LLC | 4df29336-ea0c-0484-e063-6294a90a685a | 2026-03-26 | Warnings | 3NXW29V3WO |
| METFORMIN HYDROCHLORIDE | METFORMIN HYDROCHLORIDE | Aphena Pharma Solutions - Tennessee, LLC | 388ee1e0-a0d2-324d-e063-6394a90a1664 | 2026-03-25 | Boxed warning, Warnings, Adverse reactions | 861007 786Z46389E |
| Artificial Tears Lubricant Eye Drops | GLYCERIN, HYPROMELLOSE, POLYETHYLENE GLYCOL 400 | KC Pharmaceuticals, Inc | 4de5c844-85ca-ff9f-e063-6394a90ac12c | 2026-03-25 | Warnings | 3NXW29V3WO |
| dapagliflozin and metformin hydrochloride | DAPAGLIFLOZIN AND METFORMIN HYDROCHLORIDE | Ascend Laboratories, LLC | eadcc3ef-f5c2-4a56-a6aa-12909844144e | 2026-03-18 | Boxed warning, Warnings, Adverse reactions | 786Z46389E |
| Metformin | METFORMIN ER 500 MG | Bryant Ranch Prepack | c047cf64-467a-40f3-be46-a1926b3b8d56 | 2026-03-17 | Warnings, Adverse reactions | 786Z46389E |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.