Metformin Hydrochloride
- Product NDC
- 51655-566
- 11-digit product format
- 516550566
- Labeler code
- 51655
- Product ID
- 51655-566_494e1ed6-f072-cffd-e063-6394a90a6c30
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Metformin Hydrochloride
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- Northwind Health Company, LLC
- Application
- ANDA090564
- Marketing category
- ANDA
- Marketing start
- 2021-01-27
- 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 |
|---|
| 51655-566-25 | Metformin Hydrochloride | 60 in 1 BOTTLE, PLASTIC | TABLET | 60 | | 3 |
| 51655-566-26 | Metformin Hydrochloride | 90 in 1 BOTTLE, PLASTIC | TABLET | 90 | | 3 |
| 51655-566-52 | Metformin Hydrochloride | 30 in 1 BOTTLE, PLASTIC | TABLET | 30 | | 3 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 51655-566 | METFORMIN HYDROCHLORIDE TABLET [NORTHWIND PHARMACEUTICALS, LLC] | 2 | Current NDC, 3 package rows | 20240725_dae7b1c1-7ff1-883c-e053-2a95a90a1a2b.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 |
|---|
| 51655-566-25 | 51655056625 | 60 TABLET in 1 BOTTLE, PLASTIC (51655-566-25) | 60 tablet | 2021-01-27 | No | No | Historical |
| 51655-566-26 | 51655056626 | 90 TABLET in 1 BOTTLE, PLASTIC (51655-566-26) | 90 tablet | 2022-09-15 | No | No | Historical |
| 51655-566-52 | 51655056652 | 30 TABLET in 1 BOTTLE, PLASTIC (51655-566-52) | 30 tablet | 2022-09-16 | No | No | Historical |