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 | Redpharm Drug | 58bec665-b648-6baf-e063-6394a90a1cbb | 2026-08-11 | Boxed warning, Warnings, Adverse reactions | 786Z46389E |
| Metformin Hydrochloride | METFORMIN HYDROCHLORIDE | REMEDYREPACK INC. | e22a8545-86a6-439e-a758-29c4d6ed8bfe | 2026-08-11 | Boxed warning, Warnings, Adverse reactions | 786Z46389E |
| JANUMET | SITAGLIPTIN AND METFORMIN HYDROCHLORIDE | Merck Sharp & Dohme LLC | d19c7ed0-ad5c-426e-b2df-722508f97d67 | 2026-08-11 | Boxed warning, Warnings, Adverse reactions | 786Z46389E |
| Synjardy XR | EMPAGLIFLOZIN, METFORMIN HYDROCHLORIDE | Boehringer Ingelheim Pharmaceuticals, Inc. | 8006ba29-ee3a-f852-a9bb-c8ec9b41cf66 | 2026-08-11 | Boxed warning, Warnings, Adverse reactions | 786Z46389E |
| XIGDUO XR | DAPAGLIFLOZIN AND METFORMIN HYDROCHLORIDE | AstraZeneca Pharmaceuticals LP | ac8a0f7b-9f69-4495-abbc-3a47cd75a859 | 2026-08-11 | Boxed warning, Warnings, Adverse reactions | 786Z46389E |
| Dr. Shitong Photon Energy Eye Care Liquid | TETRAHYDROZOLINE HCL 0.05% HYPROMELLOSE 0.3% DR. SHITONG PHOTON ENERGY EYE CARE LIQUID | Wenzhou Yuyuan Pharmaceutical Co., Ltd. | 58ace434-55ef-17ef-e063-6294a90aa878 | 2026-08-10 | Warnings | 3NXW29V3WO |
| Metformin Hydrochloride | METFORMIN HYDROCHLORIDE | Bryant Ranch Prepack | c1bfc7b5-c7e0-4353-b772-05d463c12886 | 2026-08-04 | Boxed warning, Warnings, Adverse reactions | 786Z46389E |
| Metformin Hydrochloride | METFORMIN HYDROCHLORIDE | REMEDYREPACK INC. | 1e8136e0-cc98-41e4-ad4b-a8fc27fb4daa | 2026-08-04 | Boxed warning, Warnings, Adverse reactions | 861010 786Z46389E |
| METFORMIN HYDROCHLORIDE | METFORMIN HYDROCHLORIDE | PD-Rx Pharmaceuticals, Inc. | 4d087f00-580b-4b9d-80d9-f97930153e72 | 2026-08-04 | Boxed warning, Warnings, Adverse reactions | 861007 786Z46389E |
| Metformin Hydrochloride | METFORMIN HYDROCHLORIDE | REMEDYREPACK INC. | 5d8d654a-9bb4-4c87-ab43-c21c4e874708 | 2026-08-04 | Boxed warning, Warnings, Adverse reactions | 861004 786Z46389E |
| Metformin Hydrochloride | METFORMIN HYDROCHLORIDE | NuCare Pharmaceuticals, Inc. | 583f2a2e-a9d7-f266-e063-6294a90ad0ab | 2026-08-04 | Boxed warning, Warnings, Adverse reactions | 861004 786Z46389E |
| Metformin HCl | METFORMIN HCL | PD-Rx Pharmaceuticals, Inc. | c8e50300-1838-4c51-8d9d-ebbaaf0f3991 | 2026-08-03 | Warnings, Adverse reactions | 861007 786Z46389E |
| Metformin Hydrochloride | METFORMIN HYDROCHLORIDE | PD-Rx Pharmaceuticals, Inc. | 1d0b74de-ef4c-4dd2-8019-2ddb409c60b4 | 2026-08-03 | Boxed warning, Warnings, Adverse reactions | 786Z46389E |
| Metformin Hydrochloride | METFORMIN HYDROCHLORIDE | REMEDYREPACK INC. | 59a4ccda-5487-4ac4-9373-0c0fc8b7c88b | 2026-08-03 | Boxed warning, Warnings, Adverse reactions | 861004 786Z46389E |
| METFORMIN HYDROCHLORIDE | METFORMIN HYDROCHLORIDE | PD-Rx Pharmaceuticals, Inc. | f55a245b-a786-4a4a-b11c-c61d48294b01 | 2026-07-31 | Boxed warning, Warnings, Adverse reactions | 786Z46389E |
| Metformin Hydrochloride | METFORMIN HYDROCHLORIDE | PD-Rx Pharmaceuticals, Inc. | 41408f64-d366-403e-9595-464ab25c6f97 | 2026-07-30 | Boxed warning, Warnings, Adverse reactions | 786Z46389E |
| Metformin Hydrochloride | METFORMIN HYDROCHLORIDE | PD-Rx Pharmaceuticals, Inc. | 68d0b1a6-c99e-42cf-afdf-b71ee73c4424 | 2026-07-30 | Boxed warning, Warnings, Adverse reactions | 786Z46389E |
| METFORMIN HYDROCHLORIDE | METFORMIN HYDROCHLORIDE | PD-Rx Pharmaceuticals, Inc. | 9171d369-d35a-40e4-a9ad-26484e66fc5e | 2026-07-29 | Boxed warning, Warnings, Adverse reactions | 786Z46389E |
| Metformin Hydrochloride | METFORMIN HYDROCHLORIDE | REMEDYREPACK INC. | 30658e19-8e6e-49aa-a007-e414224797c5 | 2026-07-29 | Boxed warning, Warnings, Adverse reactions | 861007 786Z46389E |
| Metformin Hydrochloride | METFORMIN HYDROCHLORIDE | REMEDYREPACK INC. | 1503bbe4-0ac5-479b-9900-d38e49236bf0 | 2026-07-28 | Boxed warning, Warnings, Adverse reactions | 786Z46389E |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.