Metformin Hydrochloride
- Product NDC
- 50228-446
- 11-digit product format
- 502280446
- Labeler code
- 50228
- Product ID
- 50228-446_2cd1dc49-0219-4df8-8865-96ac77e77334
- 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
- ANDA213334
- Marketing category
- ANDA
- Marketing start
- 2021-04-16
- Substance
- METFORMIN HYDROCHLORIDE
- Active strength
- 1000 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 | 1000 mg/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | 786Z46389E |
| Rxcui | 1807888, 1807915 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 50228-446-05 | Metformin Hydrochloride | 500 in 1 BOTTLE, PLASTIC | TABLET, FILM COATED, EXTENDED RE | 500 | | 2 |
| 50228-446-30 | Metformin Hydrochloride | 30 in 1 BOTTLE, PLASTIC | TABLET, FILM COATED, EXTENDED RE | 30 | | 2 |
| 50228-446-90 | Metformin Hydrochloride | 90 in 1 BOTTLE, PLASTIC | TABLET, FILM COATED, EXTENDED RE | 90 | | 2 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 50228-446 | METFORMIN HYDROCHLORIDE (METFORMIN HYDROCHLORIDE EXTENDED-RELEASE TABLETS) TABLET, FILM COATED, EXTENDED RELEASE [SCIEGEN PHARMACEUTICALS, INC.] | 2 | Current NDC, Legacy NDC, 3 package rows | 20210629_1452fbb1-e591-4a51-9f83-8a8a6a780b52.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 |
|---|
| 50228-446-05 | 50228044605 | 500 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (50228-446-05) | 2021-04-16 | 0000-00-00 | No | No | Current |
| 50228-446-30 | 50228044630 | 30 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (50228-446-30) | 2021-04-16 | 0000-00-00 | No | No | Current |
| 50228-446-90 | 50228044690 | 90 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (50228-446-90) | 2021-04-16 | 0000-00-00 | No | No | Current |