METFORMIN HYDROCHLORIDE
- Product NDC
- 65841-039
- 11-digit product format
- 658410039
- Labeler code
- 65841
- Product ID
- 65841-039_d6499cd6-fa2b-4c97-8f96-37ac878f0bac
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- METFORMIN HYDROCHLORIDE
- Dosage form
- TABLET, EXTENDED RELEASE
- Route
- ORAL
- Labeler
- Zydus Lifesciences Limited
- Application
- ANDA077078
- Marketing category
- ANDA
- Marketing start
- 2005-09-28
- Substance
- METFORMIN HYDROCHLORIDE
- Active strength
- 750 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 | 750 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 |
|---|
| 65841-039-01 | METFORMIN HYDROCHLORIDE | 100 in 1 BOTTLE | TABLET, EXTENDED RELEASE | 100 | | 3 |
| 65841-039-05 | METFORMIN HYDROCHLORIDE | 500 in 1 BOTTLE | TABLET, EXTENDED RELEASE | 500 | | 3 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 65841-039 | METFORMIN HYDROCHLORIDE TABLET, EXTENDED RELEASE [ZYDUS LIFESCIENCES LIMITED] | 3 | Current NDC, Legacy NDC, 2 package rows | 20240821_a8a10ea0-7aa6-48ab-aad4-af8895636672.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 65841-039-01 | 65841003901 | 100 TABLET, EXTENDED RELEASE in 1 BOTTLE (65841-039-01) | 2005-09-28 | 0000-00-00 | No | No | Current |
| 65841-039-05 | 65841003905 | 500 TABLET, EXTENDED RELEASE in 1 BOTTLE (65841-039-05) | 2005-09-28 | 0000-00-00 | No | No | Current |