Metformin Hydrochloride
- Product NDC
- 68071-3495
- 11-digit product format
- 680713495
- Labeler code
- 68071
- Product ID
- 68071-3495_1ef48a70-a4ad-28bf-e063-6394a90a9795
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Metformin Hydrochloride
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- NuCare Pharmaceuticals,Inc.
- Application
- ANDA090564
- Marketing category
- ANDA
- Marketing start
- 2019-06-26
- Substance
- METFORMIN HYDROCHLORIDE
- Active strength
- 850 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 | 850 mg/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | 786Z46389E |
| Rxcui | 861010 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 68071-3495-8 | Metformin Hydrochloride | 180 in 1 BOTTLE | TABLET | 180 | | 2 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 68071-3495 | METFORMIN HYDROCHLORIDE TABLET [NUCARE PHARMACEUTICALS,INC.] | 2 | Current NDC, 1 package rows | 20240807_041632fa-9bf4-8d7c-e063-6294a90adefb.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Sample | Exclude flag | Status |
|---|
| 68071-3495-8 | 68071349508 | 180 TABLET in 1 BOTTLE (68071-3495-8) | 180 tablet | 2023-08-29 | No | No | Current |