Metformin Hydrochloride
- Product NDC
- 70518-3101
- 11-digit product format
- 705183101
- Labeler code
- 70518
- Product ID
- 70518-3101_4e918280-a0c6-19a7-e063-6394a90a48e3
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Metformin Hydrochloride
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- REMEDYREPACK INC.
- Application
- ANDA090564
- Marketing category
- ANDA
- Marketing start
- 2021-05-24
- Substance
- METFORMIN HYDROCHLORIDE
- Active strength
- 1000 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 | 1000 mg/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | 786Z46389E |
| Rxcui | 861004 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 70518-3101-0 | Metformin Hydrochloride | 30 in 1 BLISTER PACK | TABLET | 30 | | 13 |
| 70518-3101-1 | Metformin Hydrochloride | 180 in 1 BOTTLE, PLASTIC | TABLET | 180 | | 13 |
| 70518-3101-2 | Metformin Hydrochloride | 90 in 1 BOTTLE, PLASTIC | TABLET | 90 | | 13 |
| 70518-3101-3 | Metformin Hydrochloride | 30 in 1 BLISTER PACK | TABLET | 30 | | 13 |
| 70518-3101-4 | Metformin Hydrochloride | 30 in 1 BLISTER PACK | TABLET | 30 | | 13 |
| 70518-3101-5 | Metformin Hydrochloride | 60 in 1 BOTTLE, PLASTIC | TABLET | 60 | | 13 |
| 70518-3101-6 | Metformin Hydrochloride | 100 in 1 BOTTLE, PLASTIC | TABLET | 100 | | 13 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 70518-3101 | METFORMIN HYDROCHLORIDE TABLET [REMEDYREPACK INC.] | 11 | Current NDC, Legacy NDC, 7 package rows | 20250426_59a4ccda-5487-4ac4-9373-0c0fc8b7c88b.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 70518-3101-0 | 70518310100 | 30 TABLET in 1 BLISTER PACK (70518-3101-0) | 30 tablet | 2021-05-24 | 0000-00-00 | No | No | Current |
| 70518-3101-1 | 70518310101 | 180 TABLET in 1 BOTTLE, PLASTIC (70518-3101-1) | 180 tablet | 2022-07-26 | 0000-00-00 | No | No | Current |
| 70518-3101-2 | 70518310102 | 90 TABLET in 1 BOTTLE, PLASTIC (70518-3101-2) | 90 tablet | 2022-07-29 | 0000-00-00 | No | No | Current |
| 70518-3101-3 | 70518310103 | 30 in 1 BLISTER PACK | | | | | | Historical |
| 70518-3101-4 | 70518310104 | 30 TABLET in 1 BLISTER PACK (70518-3101-4) | 30 tablet | 2024-03-20 | | No | No | Current |
| 70518-3101-5 | 70518310105 | 60 TABLET in 1 BOTTLE, PLASTIC (70518-3101-5) | 60 tablet | 2024-12-09 | | No | No | Current |
| 70518-3101-6 | 70518310106 | 100 TABLET in 1 BOTTLE, PLASTIC (70518-3101-6) | 100 tablet | 2025-03-19 | | No | No | Current |