Dapagliflozin and Metformin Hydrochloride
- Product NDC
- 63304-026
- 11-digit product format
- 633040026
- Labeler code
- 63304
- Product ID
- 63304-026_c086422b-82cd-4a82-90e1-4369dbea7f02
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Dapagliflozin and Metformin Hydrochloride
- Dosage form
- TABLET, FILM COATED, EXTENDED RELEASE
- Route
- ORAL
- Labeler
- Sun Pharmaceutical Industries, Inc.
- Application
- ANDA211491
- Marketing category
- ANDA
- Marketing start
- 2026-04-06
- Substance
- DAPAGLIFLOZIN; METFORMIN HYDROCHLORIDE
- Active strength
- 5; 1000 mg/1; mg/1
- Pharmacologic classes
- Biguanide [EPC], Biguanides [CS], Sodium-Glucose Cotransporter 2 Inhibitor [EPC], Sodium-Glucose Transporter 2 Inhibitors [MoA]
- NDC exclude flag
- No
- Listing certified through
- 2027-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Dapagliflozin and Metformin Hydrochloride
- Listing expiration
- 2027-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| DAPAGLIFLOZIN | 5 mg/1 |
| METFORMIN HYDROCHLORIDE | 1000 mg/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | 786Z46389E, 1ULL0QJ8UC |
| Rxcui | 1593058, 1593068, 1593070 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 63304-026-30 | Dapagliflozin and Metformin Hydrochloride | 30 in 1 BOTTLE | TABLET, FILM COATED, EXTENDED RE | 30 | | 2 |
| 63304-026-54 | Dapagliflozin and Metformin Hydrochloride | 400 in 1 BOTTLE | TABLET, FILM COATED, EXTENDED RE | 400 | | 2 |
| 63304-026-62 | Dapagliflozin and Metformin Hydrochloride | 60 in 1 BOTTLE | TABLET, FILM COATED, EXTENDED RE | 60 | | 2 |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Marketing start | Sample | Exclude flag | Status |
|---|
| 63304-026-30 | 63304002630 | 30 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (63304-026-30) | 2026-04-06 | No | No | Current |
| 63304-026-54 | 63304002654 | 400 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (63304-026-54) | 2026-04-06 | No | No | Current |
| 63304-026-62 | 63304002662 | 60 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (63304-026-62) | 2026-04-06 | No | No | Current |