Metformin hydrochloride
- Product NDC
- 68071-1419
- 11-digit product format
- 680711419
- Labeler code
- 68071
- Product ID
- 68071-1419_3f67ac3d-1505-3418-e063-6394a90a938f
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Metformin hydrochloride
- Dosage form
- TABLET, EXTENDED RELEASE
- Route
- ORAL
- Labeler
- NuCare Pharmaceuticals, Inc.
- Application
- ANDA201991
- Marketing category
- ANDA
- Marketing start
- 2013-03-01
- 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 hydrochloride
- 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 | 1807917 |
DailyMed Product Concepts#
FDA-Initiated Inactive NDC Indexing#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 68071-1419-2 | Metformin hydrochloride | 20 in 1 BOTTLE | TABLET, EXTENDED RELEASE | 20 | | 3 |
| 68071-1419-3 | Metformin hydrochloride | 30 in 1 BOTTLE | TABLET, EXTENDED RELEASE | 30 | | 3 |
| 68071-1419-6 | Metformin hydrochloride | 60 in 1 BOTTLE | TABLET, EXTENDED RELEASE | 60 | | 3 |
| 68071-1419-8 | Metformin hydrochloride | 180 in 1 BOTTLE | TABLET, EXTENDED RELEASE | 180 | | 3 |
| 68071-1419-9 | Metformin hydrochloride | 90 in 1 BOTTLE | TABLET, EXTENDED RELEASE | 90 | | 3 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 68071-1419 | METFORMIN HYDROCHLORIDE TABLET, EXTENDED RELEASE [NUCARE PHARMACEUTICALS, INC.] | 2 | Current NDC, Legacy NDC, 5 package rows | 20241219_4be72741-4f6d-6689-e054-00144ff8d46c.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Marketing start | Sample | Exclude flag | Status |
|---|
| 68071-1419-2 | 68071141902 | 20 TABLET, EXTENDED RELEASE in 1 BOTTLE (68071-1419-2) | 2017-03-29 | No | No | Current |
| 68071-1419-3 | 68071141903 | 30 TABLET, EXTENDED RELEASE in 1 BOTTLE (68071-1419-3) | 2017-03-29 | No | No | Current |
| 68071-1419-6 | 68071141906 | 60 TABLET, EXTENDED RELEASE in 1 BOTTLE (68071-1419-6) | 2017-03-29 | No | No | Current |
| 68071-1419-8 | 68071141908 | 180 TABLET, EXTENDED RELEASE in 1 BOTTLE (68071-1419-8) | 2017-03-29 | No | No | Current |
| 68071-1419-9 | 68071141909 | 90 TABLET, EXTENDED RELEASE in 1 BOTTLE (68071-1419-9) | 2017-03-29 | No | No | Current |