NDC 80425-0435-02 - 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
- 80425-0435-02
- Package NDCs from labels
- 80425-0435-4, 80425-0435-3, 80425-0435-2, 80425-0435-1, 80425-0435-02
- 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 | 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 | ANDA090564 861007 786Z46389E |
| Metformin Hydrochloride | METFORMIN HYDROCHLORIDE | REMEDYREPACK INC. | 1503bbe4-0ac5-479b-9900-d38e49236bf0 | 2026-07-28 | Boxed warning, Warnings, Adverse reactions | 786Z46389E |
| Metformin Hydrochloride | METFORMIN HYDROCHLORIDE | REMEDYREPACK INC. | e22a8545-86a6-439e-a758-29c4d6ed8bfe | 2026-07-28 | Boxed warning, Warnings, Adverse reactions | 786Z46389E |
| Metformin Hydrochloride | METFORMIN HYDROCHLORIDE | Cardinal Health 107, LLC | 46cb7e3f-c739-433d-9dbe-427c2d95bef1 | 2026-07-24 | Boxed warning, Warnings, Adverse reactions | ANDA090564 861007 786Z46389E |
| Metformin Hydrochloride | METFORMIN HYDROCHLORIDE | Chartwell RX, LLC | 4d3dbf6f-1c8a-4daa-8343-8cd8f64a65cd | 2026-07-20 | Boxed warning, Warnings, Adverse reactions | 861007 861010 861004 786Z46389E |
| Metformin ER 500 mg | METFORMIN ER 500 MG | Granules India Ltd | b857eccf-b9ff-45ba-8241-f47f5caada2a | 2026-07-17 | Boxed warning, Warnings, Adverse reactions | 786Z46389E |
| Metformin Hydrochloride | METFORMIN HYDROCHLORIDE | REMEDYREPACK INC. | 13235d8e-ac3a-45b4-9c5d-9a9012951dfe | 2026-07-16 | Boxed warning, Warnings, Adverse reactions | 861007 786Z46389E |
| Metformin Hydrochloride | METFORMIN HYDROCHLORIDE | REMEDYREPACK INC. | 5aa1c86c-f2c8-49b1-8f81-47b11386c5d3 | 2026-07-15 | Boxed warning, Warnings, Adverse reactions | ANDA090564 861007 786Z46389E |
| Metformin Hydrochloride | METFORMIN HYDROCHLORIDE | Aurobindo Pharma Limited | 4ac6d01a-af26-44e7-ae2e-3618de0080aa | 2026-07-15 | Boxed warning, Warnings, Adverse reactions | 861007 861010 861004 786Z46389E |
| glyburide-metformin hydrochloride | GLYBURIDE-METFORMIN HYDROCHLORIDE | Bryant Ranch Prepack | b5ccf5da-cbe1-4009-ba1c-990050838ee9 | 2026-07-15 | Boxed warning, Warnings, Adverse reactions | 786Z46389E |
| glyburide-metformin hydrochloride | GLYBURIDE-METFORMIN HYDROCHLORIDE | Bryant Ranch Prepack | a086cc29-cb5d-40d0-a57d-8e91f1aa9158 | 2026-07-15 | Boxed warning, Warnings, Adverse reactions | 786Z46389E |
| Metformin HCl | METFORMIN HCL | PD-Rx Pharmaceuticals, Inc. | fb890205-5d43-41eb-97b2-fb0dcdd3a950 | 2026-07-13 | Warnings, Adverse reactions | ANDA090564 861007 786Z46389E |
| JANUMET | SITAGLIPTIN AND METFORMIN HYDROCHLORIDE | A-S Medication Solutions | c603b844-2019-4ef4-8385-7bc3f96a2565 | 2026-07-13 | Boxed warning, Warnings, Adverse reactions | 786Z46389E |
| Metformin Hydrochloride | METFORMIN HYDROCHLORIDE | REMEDYREPACK INC. | d5228e81-9c86-4781-b984-20feaa2ae779 | 2026-07-10 | Boxed warning, Warnings, Adverse reactions | 786Z46389E |
| Metformin Hydrochloride | METFORMIN HYDROCHLORIDE | Advanced Rx of Tennessee, LLC | 5647230e-5bc6-1802-e063-6394a90a2724 | 2026-07-10 | Boxed warning, Warnings, Adverse reactions | 861004 786Z46389E |
| JANUMET | SITAGLIPTIN AND METFORMIN HYDROCHLORIDE | A-S Medication Solutions | b55ee3d9-7f0b-4dd9-9213-fbc69f09f567 | 2026-07-09 | Boxed warning, Warnings, Adverse reactions | 786Z46389E |
| Metformin Hydrochloride | METFORMIN HYDROCHLORIDE | Aurobindo Pharma Limited | fc466c46-abaa-4675-aef2-4b1a1adfd912 | 2026-07-08 | Boxed warning, Warnings, Adverse reactions | 861007 861010 861004 786Z46389E |