Metformin HCl
- Product NDC
- 80425-0435
- 11-digit product format
- 804250435
- Labeler code
- 80425
- Product ID
- 80425-0435_22cef642-e37b-a74f-e063-6394a90aef9d
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Metformin HCl
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- Advanced Rx of Tennessee, LLC
- Application
- ANDA090564
- Marketing category
- ANDA
- Marketing start
- 2024-09-03
- Substance
- METFORMIN HYDROCHLORIDE
- Active strength
- 1000 mg/1
- Pharmacologic classes
- Biguanide [EPC], Biguanides [CS]
- NDC exclude flag
- No
- Listing certified through
- 2026-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Metformin HCl
- Listing expiration
- 2026-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| METFORMIN HYDROCHLORIDE | 1000 mg/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | 786Z46389E |
| Rxcui | 861004 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| 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 table| 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 RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Sample | Exclude flag | Status |
|---|
| 80425-0435-1 | 80425043501 | 30 TABLET in 1 BOTTLE (80425-0435-1) | 30 tablet | 2024-09-03 | No | No | Historical |
| 80425-0435-2 | 80425043502 | 60 TABLET in 1 BOTTLE (80425-0435-2) | 60 tablet | 2024-09-03 | No | No | Historical |
| 80425-0435-3 | 80425043503 | 90 TABLET in 1 BOTTLE (80425-0435-3) | 90 tablet | 2024-09-03 | No | No | Historical |
| 80425-0435-4 | 80425043504 | 108 TABLET in 1 BOTTLE (80425-0435-4) | 108 tablet | 2024-09-03 | No | No | Historical |