Metformin Hydrochloride
- Product NDC
- 51655-649
- 11-digit product format
- 516550649
- Labeler code
- 51655
- Product ID
- 51655-649_4e407b64-f4a1-f0c7-e063-6294a90a18e7
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Metformin Hydrochloride
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- Northwind Health Company, LLC
- Application
- ANDA077095
- Marketing category
- ANDA
- Marketing start
- 2021-04-01
- Substance
- METFORMIN HYDROCHLORIDE
- Active strength
- 1000 mg/1
- Pharmacologic classes
- Biguanide [EPC], Biguanides [CS]
- NDC exclude flag
- No
- Listing certified through
- 2027-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Metformin Hydrochloride
- Listing expiration
- 2027-12-31
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 |
|---|
| 51655-649-25 | Metformin Hydrochloride | 60 in 1 BOTTLE, PLASTIC | TABLET, FILM COATED | 60 | | 4 |
| 51655-649-26 | Metformin Hydrochloride | 90 in 1 BOTTLE, PLASTIC | TABLET, FILM COATED | 90 | | 4 |
| 51655-649-52 | Metformin Hydrochloride | 30 in 1 BOTTLE, PLASTIC | TABLET, FILM COATED | 30 | | 4 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 51655-649 | METFORMIN HYDROCHLORIDE TABLET, FILM COATED [NORTHWIND PHARMACEUTICALS] | 2 | Current NDC, 3 package rows | 20230630_db113f46-6fac-9005-e053-2995a90a017a.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Marketing start | Sample | Exclude flag | Status |
|---|
| 51655-649-25 | 51655064925 | 60 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (51655-649-25) | 2025-07-23 | No | No | Current |
| 51655-649-26 | 51655064926 | 90 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (51655-649-26) | 2023-06-23 | No | No | Current |
| 51655-649-52 | 51655064952 | 30 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (51655-649-52) | 2021-04-01 | No | No | Current |