NDC 80425-0435-01 - Metformin HCl
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
- 80425-0435
- Requested NDC
- 80425-0435-01
- Package NDCs from labels
- 80425-0435-4, 80425-0435-3, 80425-0435-2, 80425-0435-1, 80425-0435-01
- Manufacturer
- Advanced Rx of Tennessee, LLC
- Effective date
- 2024-09-23
- Current FDA listing
- Not matched in FDA.report NDC product tables
DailyMed Labels#
| Label | Manufacturer | Effective date | Type |
|---|---|---|---|
| Metformin HCl - Advanced Rx of Tennessee, LLC | Advanced Rx of Tennessee, LLC | 2024-09-23 | HUMAN PRESCRIPTION DRUG LABEL |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 80425-0435-1 | Metformin HCl | 30 in 1 BOTTLE | TABLET | 30 | 2 | |
| 80425-0435-2 | Metformin HCl | 60 in 1 BOTTLE | TABLET | 60 | 2 | |
| 80425-0435-3 | Metformin HCl | 90 in 1 BOTTLE | TABLET | 90 | 2 | |
| 80425-0435-4 | Metformin HCl | 108 in 1 BOTTLE | TABLET | 108 | 2 |
DailyMed Dashboard NDC Coverage#
| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|---|---|---|---|
| 80425-0435 | METFORMIN HCL TABLET [ADVANCED RX OF TENNESSEE, LLC] | 2 | Current NDC, 4 package rows | 20240925_21b76183-af30-e06f-e063-6394a90a9653.zip |
DailyMed Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 80425-0435-1 | EA - Each | 80425-0435 | 142ef345-edd4-4403-af30-0eea6ab7689e | 1 | 2024-10-04 |
| 80425-0435-2 | EA - Each | 80425-0435 | edda272f-5085-4a98-b4a2-99b9952d16a3 | 1 | 2024-10-04 |
| 80425-0435-3 | EA - Each | 80425-0435 | 95109327-8c1d-4a92-b777-91f7bc886928 | 1 | 2024-10-04 |
| 80425-0435-4 | EA - Each | 80425-0435 | 21bd2c02-1c9c-4eb0-be20-8db9785711ac | 1 | 2024-10-04 |
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 TABLET | Granules India Ltd | 8cd5555c-f6b2-28d8-e053-2a95a90a5f1e | 2026-06-29 | Boxed warning, Warnings, Adverse reactions | ANDA090564 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 | ANDA090564 861004 786Z46389E |
| Metformin HCl | METFORMIN HCL | Unit Dose Solutions, Inc. | 552df462-6dcb-e6f2-e063-6294a90aacfe | 2026-06-26 | Warnings, Adverse reactions | ANDA090564 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 | ANDA090564 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 |
| Metformin Hydrochloride | METFORMIN HYDROCHLORIDE | Preferred Pharmaceuticals Inc. | 62ca8af4-ff91-4bf6-b7c6-895b3b5ce8c3 | 2026-06-19 | Boxed warning, Warnings, Adverse reactions | ANDA090564 861004 786Z46389E |
| METFORMIN HYDROCHLORIDE | METFORMIN HYDROCHLORIDE | Preferred Pharmaceuticals Inc. | 14450912-54b5-4fc3-ba65-77ece864b2e7 | 2026-06-19 | Boxed warning, Warnings, Adverse reactions | 861010 786Z46389E |
| Metformin Hydrochloride | METFORMIN HYDROCHLORIDE | Preferred Pharmaceuticals Inc. | 902d1bc4-3f1f-4a1a-86d7-cf98c56a3684 | 2026-06-19 | Boxed warning, Warnings, Adverse reactions | ANDA090564 861010 786Z46389E |
| Metformin Hydrochloride | METFORMIN HYDROCHLORIDE | Preferred Pharmaceuticals Inc. | 33550b88-d4bb-4ce6-a7db-07c966f6984f | 2026-06-19 | Boxed warning, Warnings, Adverse reactions | ANDA090564 861007 786Z46389E |
| Metformin Hydrochloride | METFORMIN HYDROCHLORIDE | Preferred Pharmaceuticals, Inc. | 14238afd-200d-4a05-b731-647c43cecbc3 | 2026-06-18 | Boxed warning, Warnings, Adverse reactions | 786Z46389E |
| METFORMIN HYDROCHLORIDE | METFORMIN HYDROCHLORIDE | REMEDYREPACK INC. | 104b5f5b-cc83-450d-82ec-1fd20c4f7119 | 2026-06-17 | Boxed warning, Warnings, Adverse reactions | 786Z46389E |
| Metformin Hydrochloride | METFORMIN HYDROCHLORIDE | Bryant Ranch Prepack | 11d52559-bfde-4c2a-9602-f18fb3187617 | 2026-06-16 | Boxed warning, Warnings, Adverse reactions | 786Z46389E |
| Metformin | METFORMIN ER 500 MG | Coupler LLC | 54620ea3-da64-c5d7-e063-6394a90ad14a | 2026-06-16 | Boxed warning, Warnings, Adverse reactions | 786Z46389E |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.