Metformin Hydrochloride
- Product NDC
- 83301-0010
- 11-digit product format
- 833010010
- Labeler code
- 83301
- Product ID
- 83301-0010_423f5f82-8524-65aa-e063-6294a90a1180
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Metformin Hydrochloride
- Dosage form
- TABLET, COATED
- Route
- ORAL
- Labeler
- Mullan Pharmaceutical Inc.
- Application
- ANDA205096
- Marketing category
- ANDA
- Marketing start
- 2024-01-01
- 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 Hydrochloride
- 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, 861007, 861010 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| 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 table| 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 RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Marketing start | Sample | Exclude flag | Status |
|---|
| 83301-0010-1 | 83301001001 | 100 TABLET, COATED in 1 BOTTLE (83301-0010-1) | 2024-01-01 | No | No | Current |
| 83301-0010-2 | 83301001002 | 500 TABLET, COATED in 1 BOTTLE (83301-0010-2) | 2024-01-01 | No | No | Current |
| 83301-0010-3 | 83301001003 | 1000 TABLET, COATED in 1 BOTTLE (83301-0010-3) | 2024-01-01 | No | No | Current |