METFORMIN HYDROCHLORIDE
- Product NDC
- 51655-559
- 11-digit product format
- 516550559
- Labeler code
- 51655
- Product ID
- 51655-559_4a2aee29-b25b-bc57-e063-6394a90a55f6
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- metformin hydrochloride
- Dosage form
- TABLET, EXTENDED RELEASE
- Route
- ORAL
- Labeler
- Northwind Health Company, LLC
- Application
- ANDA201991
- Marketing category
- ANDA
- Marketing start
- 2023-10-11
- Substance
- METFORMIN HYDROCHLORIDE
- Active strength
- 500 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 | 500 mg/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | 786Z46389E |
| Rxcui | 860975 |
DailyMed Product Concepts#
FDA-Initiated Inactive NDC Indexing#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 51655-559-25 | METFORMIN HYDROCHLORIDE | 60 in 1 BOTTLE, PLASTIC | TABLET, EXTENDED RELEASE | 60 | | 3 |
| 51655-559-26 | METFORMIN HYDROCHLORIDE | 90 in 1 BOTTLE, PLASTIC | TABLET, EXTENDED RELEASE | 90 | | 3 |
| 51655-559-52 | METFORMIN HYDROCHLORIDE | 30 in 1 BOTTLE, PLASTIC | TABLET, EXTENDED RELEASE | 30 | | 3 |
| 51655-559-82 | METFORMIN HYDROCHLORIDE | 120 in 1 BOTTLE, PLASTIC | TABLET, EXTENDED RELEASE | 120 | | 3 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 51655-559 | METFORMIN HYDROCHLORIDE TABLET, EXTENDED RELEASE [NORTHWIND PHARMACEUTICALS, LLC] | 2 | Current NDC, 4 package rows | 20240110_07d8a69f-30d9-7511-e063-6394a90a95ca.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Marketing start | Sample | Exclude flag | Status |
|---|
| 51655-559-25 | 51655055925 | 60 TABLET, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (51655-559-25) | 2023-12-12 | No | No | Current |
| 51655-559-26 | 51655055926 | 90 TABLET, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (51655-559-26) | 2023-10-12 | No | No | Current |
| 51655-559-52 | 51655055952 | 30 TABLET, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (51655-559-52) | 2023-10-25 | No | No | Current |
| 51655-559-82 | 51655055982 | 120 TABLET, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (51655-559-82) | 2023-10-11 | No | No | Current |