Metformin Hydrochloride
- Product NDC
- 70518-1951
- 11-digit product format
- 705181951
- Labeler code
- 70518
- Product ID
- 70518-1951_498a95ea-832f-a15d-e063-6394a90a7026
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- METFORMIN HYDROCHLORIDE
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- REMEDYREPACK INC.
- Application
- ANDA203769
- Marketing category
- ANDA
- Marketing start
- 2019-03-12
- Substance
- METFORMIN HYDROCHLORIDE
- Active strength
- 500 mg/1
- Pharmacologic classes
- Biguanide [EPC], Biguanides [CS]
- NDC exclude flag
- No
- Listing certified through
- 2027-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Metformin Hydrochloride
- Listing expiration
- 2027-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| METFORMIN HYDROCHLORIDE | 500 mg/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | 786Z46389E |
| Rxcui | 861007 |
DailyMed Product Concepts#
FDA-Initiated Inactive NDC Indexing#
NDC, Effective, Action table| NDC | Effective | Action | Document | Indexing SPL | Related label |
|---|
| 70518-1951-0 | 2023-03-07 | C162847 | 48780-1 | f386c64a-1044-0266-e053-dadaa90a7c1a | These highlights do not include all the information needed to use METFORMIN HYDROCHLORIDE TABLETS safely and effectively. See full prescribing information for METFORMIN HYDROCHLORIDE TABLETS. METFORMIN HYDROCHLORIDE tablets, for oral use Initial U.S. Approval: 1995 |
| 70518-1951-0 | 2023-03-07 | C162847 | 48780-1 | f386c64a-1044-0266-e053-dadaa90a7c1a | These highlights do not include all the information needed to use METFORMIN HYDROCHLORIDE TABLETS safely and effectively. See full prescribing information for METFORMIN HYDROCHLORIDE TABLETS. METFORMIN HYDROCHLORIDE tablets, for oral use Initial U.S. Approval: 1995 |
| 70518-1951-0 | 2023-03-07 | C162847 | 48780-1 | f386c64a-1044-0266-e053-dadaa90a7c1a | These highlights do not include all the information needed to use METFORMIN HYDROCHLORIDE TABLETS safely and effectively. See full prescribing information for METFORMIN HYDROCHLORIDE TABLETS. METFORMIN HYDROCHLORIDE tablets, for oral use Initial U.S. Approval: 1995 |
| 70518-1951-1 | 2023-03-07 | C162847 | 48780-1 | f386c64a-1044-0266-e053-dadaa90a7c1a | These highlights do not include all the information needed to use METFORMIN HYDROCHLORIDE TABLETS safely and effectively. See full prescribing information for METFORMIN HYDROCHLORIDE TABLETS. METFORMIN HYDROCHLORIDE tablets, for oral use Initial U.S. Approval: 1995 |
| 70518-1951-1 | 2023-03-07 | C162847 | 48780-1 | f386c64a-1044-0266-e053-dadaa90a7c1a | These highlights do not include all the information needed to use METFORMIN HYDROCHLORIDE TABLETS safely and effectively. See full prescribing information for METFORMIN HYDROCHLORIDE TABLETS. METFORMIN HYDROCHLORIDE tablets, for oral use Initial U.S. Approval: 1995 |
| 70518-1951-1 | 2023-03-07 | C162847 | 48780-1 | f386c64a-1044-0266-e053-dadaa90a7c1a | These highlights do not include all the information needed to use METFORMIN HYDROCHLORIDE TABLETS safely and effectively. See full prescribing information for METFORMIN HYDROCHLORIDE TABLETS. METFORMIN HYDROCHLORIDE tablets, for oral use Initial U.S. Approval: 1995 |
| 70518-1951-0 | 2023-01-30 | C162847 | 48780-1 | f386c64a-1044-0266-e053-dadaa90a7c1a | These highlights do not include all the information needed to use METFORMIN HYDROCHLORIDE TABLETS safely and effectively. See full prescribing information for METFORMIN HYDROCHLORIDE TABLETS. METFORMIN HYDROCHLORIDE tablets, for oral use Initial U.S. Approval: 1995 |
| 70518-1951-0 | 2023-01-30 | C162847 | 48780-1 | f386c64a-1044-0266-e053-dadaa90a7c1a | These highlights do not include all the information needed to use METFORMIN HYDROCHLORIDE TABLETS safely and effectively. See full prescribing information for METFORMIN HYDROCHLORIDE TABLETS. METFORMIN HYDROCHLORIDE tablets, for oral use Initial U.S. Approval: 1995 |
| 70518-1951-0 | 2023-01-30 | C162847 | 48780-1 | f386c64a-1044-0266-e053-dadaa90a7c1a | These highlights do not include all the information needed to use METFORMIN HYDROCHLORIDE TABLETS safely and effectively. See full prescribing information for METFORMIN HYDROCHLORIDE TABLETS. METFORMIN HYDROCHLORIDE tablets, for oral use Initial U.S. Approval: 1995 |
| 70518-1951-1 | 2023-01-30 | C162847 | 48780-1 | f386c64a-1044-0266-e053-dadaa90a7c1a | These highlights do not include all the information needed to use METFORMIN HYDROCHLORIDE TABLETS safely and effectively. See full prescribing information for METFORMIN HYDROCHLORIDE TABLETS. METFORMIN HYDROCHLORIDE tablets, for oral use Initial U.S. Approval: 1995 |
| 70518-1951-1 | 2023-01-30 | C162847 | 48780-1 | f386c64a-1044-0266-e053-dadaa90a7c1a | These highlights do not include all the information needed to use METFORMIN HYDROCHLORIDE TABLETS safely and effectively. See full prescribing information for METFORMIN HYDROCHLORIDE TABLETS. METFORMIN HYDROCHLORIDE tablets, for oral use Initial U.S. Approval: 1995 |
| 70518-1951-1 | 2023-01-30 | C162847 | 48780-1 | f386c64a-1044-0266-e053-dadaa90a7c1a | These highlights do not include all the information needed to use METFORMIN HYDROCHLORIDE TABLETS safely and effectively. See full prescribing information for METFORMIN HYDROCHLORIDE TABLETS. METFORMIN HYDROCHLORIDE tablets, for oral use Initial U.S. Approval: 1995 |
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 70518-1951-0 | Metformin Hydrochloride | 28 in 1 BLISTER PACK | TABLET, FILM COATED | 28 | | 11 |
| 70518-1951-1 | Metformin Hydrochloride | 30 in 1 BLISTER PACK | TABLET, FILM COATED | 30 | | 11 |
| 70518-1951-2 | Metformin Hydrochloride | 90 in 1 BOTTLE, PLASTIC | TABLET, FILM COATED | 90 | | 11 |
| 70518-1951-3 | Metformin Hydrochloride | 30 in 1 BLISTER PACK | TABLET, FILM COATED | 30 | | 11 |
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 |
|---|
| 70518-1951-0 | 70518195100 | 28 in 1 BLISTER PACK | | | | | Historical |
| 70518-1951-1 | 70518195101 | 30 TABLET, FILM COATED in 1 BLISTER PACK (70518-1951-1) | 2021-05-04 | 0000-00-00 | No | No | Current |
| 70518-1951-2 | 70518195102 | 90 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (70518-1951-2) | 2025-06-01 | | No | No | Historical |
| 70518-1951-3 | 70518195103 | 30 TABLET, FILM COATED in 1 BLISTER PACK (70518-1951-3) | 2025-10-28 | | No | No | Historical |