dapagliflozin and metformin hydrochloride
- Product NDC
- 67877-621
- 11-digit product format
- 678770621
- Labeler code
- 67877
- Product ID
- 67877-621_a54a2b85-619a-4bb8-b3fa-dfe945a9008d
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- dapagliflozin and metformin hydrochloride
- Dosage form
- TABLET, FILM COATED, EXTENDED RELEASE
- Route
- ORAL
- Labeler
- Ascend Laboratories, LLC
- Application
- ANDA211563
- Marketing category
- ANDA
- Marketing start
- 2026-04-06
- Substance
- DAPAGLIFLOZIN; METFORMIN HYDROCHLORIDE
- Active strength
- 10; 500 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
Related UNII Ingredients
| UNII | Preferred term | Registry number | Matched term |
|---|
| 1ULL0QJ8UC | DAPAGLIFLOZIN | 461432-26-8 | DAPAGLIFLOZIN |
| 786Z46389E | METFORMIN HYDROCHLORIDE | 1115-70-4 | METFORMIN HYDROCHLORIDE |
Packages
| Package NDC | 11-digit format | Description | Units | Marketing start | Sample | Exclude flag | Status |
|---|
| 67877-621-05 | 67877062105 | 500 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (67877-621-05) | | 2026-04-06 | No | No | Historical |
| 67877-621-30 | 67877062130 | 30 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (67877-621-30) | | 2026-04-06 | No | No | Historical |
| 67877-621-38 | 67877062138 | 10 BLISTER PACK in 1 CARTON (67877-621-38) / 10 TABLET, FILM COATED, EXTENDED RELEASE in 1 BLISTER PACK | 10 blister pack | 2026-04-06 | No | No | Historical |