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 | Aphena Pharma Solutions - Tennessee, LLC | d0bee456-c8cd-46a1-acb3-5313a8cddd30 | 2022-11-03 | Boxed warning, Warnings, Adverse reactions | 861004 786Z46389E |
| Metformin Hydrochloride | METFORMIN HYDROCHLORIDE | Proficient Rx LP | 474e2900-43bf-4ebe-9d29-4a7adb8a9429 | 2022-11-01 | Boxed warning, Warnings, Adverse reactions | 786Z46389E |
| Metformin Hydrochloride | METFORMIN HYDROCHLORIDE | Aphena Pharma Solutions - Tennessee, LLC | 6b8824c0-ece0-4b15-ba71-e893d6d2bfdf | 2022-07-15 | Boxed warning, Warnings, Adverse reactions | 786Z46389E |
| Metformin HCl | METFORMIN HCL | Proficient Rx LP | 53361a39-cb69-483b-a4be-3a4753bf1ba6 | 2022-06-01 | Warnings, Adverse reactions | 861004 786Z46389E |
| METFORMIN HYDROCHLORIDE | METFORMIN HYDROCHLORIDE | Solco Healthcare US, LLC. | 1016cad7-2198-483c-893b-e25fd397a226 | 2022-05-31 | Boxed warning, Warnings, Adverse reactions | 786Z46389E |
| Metformin Hydrochloride | METFORMIN HYDROCHLORIDE | Proficient Rx LP | d51f3618-4166-4925-8994-968a653ebc46 | 2022-05-02 | Boxed warning, Warnings, Adverse reactions | 861007 786Z46389E |
| Metformin Hydrochloride | METFORMIN HYDROCHLORIDE | Proficient Rx LP | d80aa4af-a8ce-4cae-b71c-05e1de829551 | 2022-04-01 | Boxed warning, Warnings, Adverse reactions | 786Z46389E |
| Metformin Hydrochloride | METFORMIN HYDROCHLORIDE | Proficient Rx LP | 5f243894-bda3-4fa9-97e4-209dcb389dee | 2022-04-01 | Boxed warning, Warnings, Adverse reactions | 861004 786Z46389E |
| Metformin Hydrochloride | METFORMIN HYDROCHLORIDE EXTENDED-RELEASE TABLETS | ScieGen Pharmaceuticals, Inc. | 16dc4008-7b5e-4c6d-9bc8-8db96be911a1 | 2022-03-21 | Boxed warning, Warnings, Adverse reactions | 786Z46389E |
| Metformin Hydrochloride | METFORMIN HYDROCHLORIDE | Proficient Rx LP | 738402d6-3700-46b2-a90c-2e8f2c354a39 | 2022-03-01 | Boxed warning, Warnings, Adverse reactions | 861007 861010 861004 786Z46389E |
| Metformin hydrochloride | METFORMIN HYDROCHLORIDE | Aphena Pharma Solutions - Tennessee, LLC | c789254c-be70-4d25-8c6c-b284b01eb513 | 2022-02-22 | Boxed warning, Adverse reactions | 786Z46389E |
| Metformin hydrochloride | METFORMIN HYDROCHLORIDE | Aphena Pharma Solutions - Tennessee, LLC | 5e5fb10b-b874-43c9-9424-9080b9e866c8 | 2022-02-22 | Boxed warning, Adverse reactions | 786Z46389E |
| METFORMIN HYDROCHLORIDE EXTENDED RELEASE | METFORMIN HYDROCHLORIDE | Aphena Pharma Solutions - Tennessee, LLC | 0b843f12-a654-4751-be1f-55e6fce163c9 | 2021-12-08 | Warnings | 786Z46389E |
| Metformin HCl | METFORMIN HCL | Bryant Ranch Prepack | 1f8833f9-1232-4aa7-a0d4-04a9f87dc2f0 | 2021-11-01 | Warnings, Adverse reactions | 861010 786Z46389E |
| Metformin Hydrochloride | METFORMIN HYDROCHLORIDE | Aphena Pharma Solutions - Tennessee, LLC | 1e298db3-439e-4e91-8f9e-01c3cdc4d552 | 2021-08-02 | Boxed warning, Warnings, Adverse reactions | 786Z46389E |
| Metformin Hydrochloride | METFORMIN HYDROCHLORIDE | Aphena Pharma Solutions - Tennessee, LLC | 4d89a4ab-6cdd-4c39-92f9-a137fa27a070 | 2021-07-02 | Boxed warning, Warnings, Adverse reactions | 786Z46389E |
| Metformin Hydrochloride | METFORMIN HYDROCHLORIDE EXTENDED-RELEASE TABLETS | ScieGen Pharmaceuticals, Inc. | 1452fbb1-e591-4a51-9f83-8a8a6a780b52 | 2021-06-28 | Boxed warning, Warnings, Adverse reactions | 786Z46389E |
| METFORMIN HYDROCHLORIDE | METFORMIN HYDROCHLORIDE | Aphena Pharma Solutions - Tennessee, LLC | 439bb230-94d8-4522-ad79-5cce5fad965b | 2021-04-27 | Boxed warning, Warnings, Adverse reactions | 786Z46389E |
| METFORMIN HYDROCHLORIDE | METFORMIN HYDROCHLORIDE | Bryant Ranch Prepack | 9632456f-57c2-444b-9f43-d9ca862681fe | 2021-03-10 | Boxed warning, Warnings, Adverse reactions | 861010 786Z46389E |
| METFORMIN HYDROCHLORIDE | METFORMIN HYDROCHLORIDE | ACI Healthcare USA, Inc. | e18b60f9-721e-4db6-9f61-d3437e18faf2 | 2020-12-26 | Boxed warning, Warnings, Adverse reactions | 861007 861010 861004 786Z46389E |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.