Metformin Hydrochloride
- Product NDC
- 50090-5397
- 11-digit product format
- 500905397
- Labeler code
- 50090
- Product ID
- 50090-5397_d54849ef-363f-43c5-ab89-c491f90fea0d
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Metformin Hydrochloride
- Dosage form
- TABLET, EXTENDED RELEASE
- Route
- ORAL
- Labeler
- A-S Medication Solutions
- Application
- ANDA206145
- Marketing category
- ANDA
- Marketing start
- 2018-10-27
- Substance
- METFORMIN HYDROCHLORIDE
- Active strength
- 500 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 | 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 |
|---|
| 50090-5397-0 | Metformin Hydrochloride | 90 in 1 BOTTLE | TABLET, EXTENDED RELEASE | 90 | | 4 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 50090-5397 | METFORMIN HYDROCHLORIDE TABLET, EXTENDED RELEASE [A-S MEDICATION SOLUTIONS] | 4 | Current NDC, Legacy NDC, 1 package rows | 20230919_d60139c2-fd35-4ab4-af7e-7410481edc2e.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 50090-5397-0 | 50090539700 | 90 TABLET, EXTENDED RELEASE in 1 BOTTLE (50090-5397-0) | 2020-12-02 | 0000-00-00 | No | No | Current |