Metformin Hydrochloride
- Product NDC
- 50090-5246
- 11-digit product format
- 500905246
- Labeler code
- 50090
- Product ID
- 50090-5246_e7a6bb9d-6691-44d9-932f-5d3298191aa4
- 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
- 750 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 | 750 mg/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | 786Z46389E |
| Rxcui | 860981 |
DailyMed Product Concepts#
FDA-Initiated Inactive NDC Indexing#
NDC, Effective, Action table| NDC | Effective | Action | Document | Indexing SPL | Related label |
|---|
| 50090-5246-0 | 2023-02-07 | C162847 | 48780-1 | f386c649-e081-0266-e053-dadaa90a7c1a | These highlights do not include all the information needed to use METFORMIN HYDROCHLORIDE TABLETS and METFORMIN HYDROCHLORIDE EXTENDED-RELEASE TABLETS safely and effectively. See full prescribing information for METFORMIN HYDROCHLORIDE TABLETS and METFORMIN HYDROCHLORIDE EXTENDED-RELEASE TABLETS. METFORMIN HYDROCHLORIDE tablets, for oral use METFORMIN HYDROCHLORIDE extended-release tablets, for oral use Initial U.S. Approval: 1995 |
| 50090-5246-1 | 2023-02-07 | C162847 | 48780-1 | f386c649-e081-0266-e053-dadaa90a7c1a | These highlights do not include all the information needed to use METFORMIN HYDROCHLORIDE TABLETS and METFORMIN HYDROCHLORIDE EXTENDED-RELEASE TABLETS safely and effectively. See full prescribing information for METFORMIN HYDROCHLORIDE TABLETS and METFORMIN HYDROCHLORIDE EXTENDED-RELEASE TABLETS. METFORMIN HYDROCHLORIDE tablets, for oral use METFORMIN HYDROCHLORIDE extended-release tablets, for oral use Initial U.S. Approval: 1995 |
| 50090-5246-0 | 2023-01-30 | C162847 | 48780-1 | f386c649-e081-0266-e053-dadaa90a7c1a | These highlights do not include all the information needed to use METFORMIN HYDROCHLORIDE TABLETS and METFORMIN HYDROCHLORIDE EXTENDED-RELEASE TABLETS safely and effectively. See full prescribing information for METFORMIN HYDROCHLORIDE TABLETS and METFORMIN HYDROCHLORIDE EXTENDED-RELEASE TABLETS. METFORMIN HYDROCHLORIDE tablets, for oral use METFORMIN HYDROCHLORIDE extended-release tablets, for oral use Initial U.S. Approval: 1995 |
| 50090-5246-1 | 2023-01-30 | C162847 | 48780-1 | f386c649-e081-0266-e053-dadaa90a7c1a | These highlights do not include all the information needed to use METFORMIN HYDROCHLORIDE TABLETS and METFORMIN HYDROCHLORIDE EXTENDED-RELEASE TABLETS safely and effectively. See full prescribing information for METFORMIN HYDROCHLORIDE TABLETS and METFORMIN HYDROCHLORIDE EXTENDED-RELEASE TABLETS. METFORMIN HYDROCHLORIDE tablets, for oral use METFORMIN HYDROCHLORIDE extended-release tablets, for oral use Initial U.S. Approval: 1995 |
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 50090-5246-0 | Metformin Hydrochloride | 90 in 1 BOTTLE | TABLET, EXTENDED RELEASE | 90 | | 13 |
| 50090-5246-1 | Metformin Hydrochloride | 60 in 1 BOTTLE | TABLET, EXTENDED RELEASE | 60 | | 13 |
| 50090-5246-2 | Metformin Hydrochloride | 100 in 1 BOTTLE | TABLET, EXTENDED RELEASE | 100 | | 13 |
| 50090-5246-3 | Metformin Hydrochloride | 30 in 1 BOTTLE | TABLET, EXTENDED RELEASE | 30 | | 13 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 50090-5246 | METFORMIN HYDROCHLORIDE TABLET, EXTENDED RELEASE [A-S MEDICATION SOLUTIONS] | 11 | Current NDC, Legacy NDC, 4 package rows | 20230807_056072d8-6228-4914-831d-ee7c0661b742.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 |
|---|
| 50090-5246-0 | 50090524600 | 90 TABLET, EXTENDED RELEASE in 1 BOTTLE (50090-5246-0) | 2020-10-12 | 0000-00-00 | No | No | Current |
| 50090-5246-1 | 50090524601 | 60 TABLET, EXTENDED RELEASE in 1 BOTTLE (50090-5246-1) | 2020-10-12 | 0000-00-00 | No | No | Current |
| 50090-5246-2 | 50090524602 | 100 TABLET, EXTENDED RELEASE in 1 BOTTLE (50090-5246-2) | 2023-03-13 | | No | No | Historical |
| 50090-5246-3 | 50090524603 | 30 TABLET, EXTENDED RELEASE in 1 BOTTLE (50090-5246-3) | 2023-08-04 | | No | No | Historical |