Metformin Hydrochloride
- Product NDC
- 59651-042
- 11-digit product format
- 596510042
- Labeler code
- 59651
- Product ID
- 59651-042_c4935e22-b480-4b12-8d32-9d67f1ed434b
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Metformin Hydrochloride
- Dosage form
- TABLET, EXTENDED RELEASE
- Route
- ORAL
- Labeler
- Aurobindo Pharma Limited
- Application
- ANDA209694
- Marketing category
- ANDA
- Marketing start
- 2024-10-18
- 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 | 1807894, 1807917 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 59651-042-60 | Metformin Hydrochloride | 60 in 1 BOTTLE | TABLET, EXTENDED RELEASE | 60 | | 2 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 59651-042 | METFORMIN HYDROCHLORIDE TABLET, EXTENDED RELEASE [AUROBINDO PHARMA LIMITED] | 1 | Current NDC, 1 package rows | 20241027_ef77c7dd-a65f-4adc-a0d9-a93779b459a0.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Marketing start | Sample | Exclude flag | Status |
|---|
| 59651-042-60 | 59651004260 | 60 TABLET, EXTENDED RELEASE in 1 BOTTLE (59651-042-60) | 2024-10-18 | No | No | Current |