Metformin Hydrochloride
- Product NDC
- 70518-4369
- 11-digit product format
- 705184369
- Labeler code
- 70518
- Product ID
- 70518-4369_3852dad0-7b83-5c22-e063-6294a90aa2aa
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Metformin Hydrochloride
- Dosage form
- TABLET, EXTENDED RELEASE
- Route
- ORAL
- Labeler
- REMEDYREPACK INC.
- Application
- ANDA090692
- Marketing category
- ANDA
- Marketing start
- 2025-06-24
- 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 | 1807894 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 70518-4369-0 | Metformin Hydrochloride | 30 in 1 BOX | TABLET, EXTENDED RELEASE | 30 | | 1 |
| 70518-4369-1 | Metformin Hydrochloride | 1 in 1 POUCH | TABLET, EXTENDED RELEASE | 1 | | 1 |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Sample | Exclude flag | Status |
|---|
| 70518-4369-0 | 70518436900 | 30 POUCH in 1 BOX (70518-4369-0) / 1 TABLET, EXTENDED RELEASE in 1 POUCH (70518-4369-1) | 30 pouch | 2025-06-24 | No | No | Historical |
| 70518-4369-1 | 70518436901 | 1 in 1 POUCH | | | | | Historical |