Metformin Hydrochloride
- Product NDC
- 50228-503
- 11-digit product format
- 502280503
- Labeler code
- 50228
- Product ID
- 50228-503_dabc66fe-9cb1-3e39-e053-2995a90ab45f
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Metformin Hydrochloride Extended-Release Tablets
- Dosage form
- TABLET, FILM COATED, EXTENDED RELEASE
- Route
- ORAL
- Labeler
- ScieGen Pharmaceuticals, Inc.
- Application
- ANDA214629
- Marketing category
- ANDA
- Marketing start
- 2022-02-22
- 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 | 1807894, 1807917 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 50228-503-05 | Metformin Hydrochloride | 500 in 1 BOTTLE, PLASTIC | TABLET, FILM COATED, EXTENDED RE | 500 | | 2 |
| 50228-503-30 | Metformin Hydrochloride | 30 in 1 BOTTLE, PLASTIC | TABLET, FILM COATED, EXTENDED RE | 30 | | 2 |
| 50228-503-60 | Metformin Hydrochloride | 60 in 1 BOTTLE, PLASTIC | TABLET, FILM COATED, EXTENDED RE | 60 | | 2 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 50228-503 | METFORMIN HYDROCHLORIDE (METFORMIN HYDROCHLORIDE EXTENDED-RELEASE TABLETS) TABLET, FILM COATED, EXTENDED RELEASE [SCIEGEN PHARMACEUTICALS, INC.] | 2 | Current NDC, Legacy NDC, 3 package rows | 20220322_16dc4008-7b5e-4c6d-9bc8-8db96be911a1.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 |
|---|
| 50228-503-05 | 50228050305 | 500 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (50228-503-05) | 2022-02-22 | 0000-00-00 | No | No | Current |
| 50228-503-30 | 50228050330 | 30 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (50228-503-30) | 2022-02-22 | 0000-00-00 | No | No | Current |
| 50228-503-60 | 50228050360 | 60 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (50228-503-60) | 2022-02-22 | 0000-00-00 | No | No | Current |