Metformin Hydrochloride
- Product NDC
- 51655-077
- 11-digit product format
- 516550077
- Labeler code
- 51655
- Product ID
- 51655-077_499d3590-c2be-64f0-e063-6294a90a6721
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Metformin Hydrochloride
- Dosage form
- TABLET, EXTENDED RELEASE
- Route
- ORAL
- Labeler
- Northwind Health Company, LLC
- Application
- ANDA206145
- Marketing category
- ANDA
- Marketing start
- 2022-10-05
- Substance
- METFORMIN HYDROCHLORIDE
- Active strength
- 750 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 | 750 mg/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | 786Z46389E |
| Rxcui | 860981 |
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 |
|---|
| 51655-077-26 | Metformin Hydrochloride | 90 in 1 BOTTLE, PLASTIC | TABLET, EXTENDED RELEASE | 90 | | 3 |
| 51655-077-52 | Metformin Hydrochloride | 30 in 1 BOTTLE, PLASTIC | TABLET, EXTENDED RELEASE | 30 | | 3 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 51655-077 | METFORMIN HYDROCHLORIDE TABLET, EXTENDED RELEASE [NORTHWIND PHARMACEUTICALS, LLC] | 2 | Current NDC, 2 package rows | 20230706_f2a27d7a-ade4-421f-e053-2a95a90a01a9.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Marketing start | Sample | Exclude flag | Status |
|---|
| 51655-077-26 | 51655007726 | 90 TABLET, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (51655-077-26) | 2023-05-17 | No | No | Historical |
| 51655-077-52 | 51655007752 | 30 TABLET, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (51655-077-52) | 2022-10-05 | No | No | Historical |