Metformin
- Product NDC
- 70518-4370
- 11-digit product format
- 705184370
- Labeler code
- 70518
- Product ID
- 70518-4370_3cf39c3e-e7c6-c6d6-e063-6294a90aede4
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Metformin ER 500 mg
- Dosage form
- TABLET, EXTENDED RELEASE
- Route
- ORAL
- Labeler
- REMEDYREPACK INC.
- Application
- ANDA209313
- Marketing category
- ANDA
- Marketing start
- 2025-06-24
- 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
- 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 | 860975 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 70518-4370-0 | Metformin | 30 in 1 BLISTER PACK | TABLET, EXTENDED RELEASE | 30 | | 4 |
| 70518-4370-1 | Metformin | 100 in 1 BOX | TABLET, EXTENDED RELEASE | 100 | | 4 |
| 70518-4370-2 | Metformin | 1 in 1 POUCH | TABLET, EXTENDED RELEASE | 1 | | 4 |
| 70518-4370-3 | Metformin | 90 in 1 BOTTLE, PLASTIC | TABLET, EXTENDED RELEASE | 90 | | 4 |
| 70518-4370-4 | Metformin | 180 in 1 BOTTLE, PLASTIC | TABLET, EXTENDED RELEASE | 180 | | 4 |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Sample | Exclude flag | Status |
|---|
| 70518-4370-0 | 70518437000 | 30 TABLET, EXTENDED RELEASE in 1 BLISTER PACK (70518-4370-0) | | 2025-06-24 | No | No | Historical |
| 70518-4370-1 | 70518437001 | 100 POUCH in 1 BOX (70518-4370-1) / 1 TABLET, EXTENDED RELEASE in 1 POUCH (70518-4370-2) | 100 pouch | 2025-06-24 | No | No | Historical |
| 70518-4370-2 | 70518437002 | 1 in 1 POUCH | | | | | Historical |
| 70518-4370-3 | 70518437003 | 90 TABLET, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (70518-4370-3) | | 2025-07-21 | No | No | Historical |
| 70518-4370-4 | 70518437004 | 180 TABLET, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (70518-4370-4) | | 2025-08-22 | No | No | Historical |