Metformin Hydrochloride
- Product NDC
- 70518-4163
- 11-digit product format
- 705184163
- Labeler code
- 70518
- Product ID
- 70518-4163_3fb7a539-66c9-490c-e063-6394a90a6701
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Metformin Hydrochloride
- Dosage form
- TABLET, EXTENDED RELEASE
- Route
- ORAL
- Labeler
- REMEDYREPACK INC.
- Application
- ANDA078321
- Marketing category
- ANDA
- Marketing start
- 2024-08-18
- 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#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 70518-4163-0 | Metformin Hydrochloride | 30 in 1 BLISTER PACK | TABLET, EXTENDED RELEASE | 30 | | 3 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 70518-4163 | METFORMIN HYDROCHLORIDE TABLET, EXTENDED RELEASE [REMEDYREPACK INC.] | 2 | Current NDC, 1 package rows | 20250522_c568d49f-c040-4f1e-ad36-77b05ab659c3.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Marketing start | Sample | Exclude flag | Status |
|---|
| 70518-4163-0 | 70518416300 | 30 TABLET, EXTENDED RELEASE in 1 BLISTER PACK (70518-4163-0) | 2024-08-18 | No | No | Historical |