Metformin Hydrochloride
- Product NDC
- 59651-548
- 11-digit product format
- 596510548
- Labeler code
- 59651
- Product ID
- 59651-548_9a7792f8-0b47-4a21-94af-0e470c343a9f
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Metformin Hydrochloride
- Dosage form
- TABLET, EXTENDED RELEASE
- Route
- ORAL
- Labeler
- Aurobindo Pharma Limited
- Application
- ANDA079118
- Marketing category
- ANDA
- Marketing start
- 2024-04-15
- 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 | 860975, 860981 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 59651-548-01 | Metformin Hydrochloride | 100 in 1 BOTTLE | TABLET, EXTENDED RELEASE | 100 | | 3 |
| 59651-548-05 | Metformin Hydrochloride | 500 in 1 BOTTLE | TABLET, EXTENDED RELEASE | 500 | | 3 |
| 59651-548-99 | Metformin Hydrochloride | 1000 in 1 BOTTLE | TABLET, EXTENDED RELEASE | 1000 | | 3 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 59651-548 | METFORMIN HYDROCHLORIDE TABLET, EXTENDED RELEASE [AUROBINDO PHARMA LIMITED] | 1 | Current NDC, 3 package rows | 20240423_8d4b8620-5e99-4d12-b4f2-e9967b627b57.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Marketing start | Sample | Exclude flag | Status |
|---|
| 59651-548-01 | 59651054801 | 100 TABLET, EXTENDED RELEASE in 1 BOTTLE (59651-548-01) | 2024-04-15 | No | No | Current |
| 59651-548-05 | 59651054805 | 500 TABLET, EXTENDED RELEASE in 1 BOTTLE (59651-548-05) | 2024-04-15 | No | No | Current |
| 59651-548-25 | 59651054825 | 25000 TABLET, EXTENDED RELEASE in 1 BAG (59651-548-25) | 15-APR-24 | | | Current |
| 59651-548-99 | 59651054899 | 1000 TABLET, EXTENDED RELEASE in 1 BOTTLE (59651-548-99) | 2024-04-15 | No | No | Current |