dapagliflozin and metformin hydrochloride
- Product NDC
- 67877-620
- 11-digit product format
- 678770620
- Labeler code
- 67877
- Product ID
- 67877-620_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
- 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
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 | Marketing start | Sample | Exclude flag | Status |
|---|
| 67877-620-30 | 67877062030 | 30 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (67877-620-30) | 2026-04-06 | No | No | Historical |
| 67877-620-60 | 67877062060 | 60 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (67877-620-60) | 2026-04-06 | No | No | Historical |
| 67877-620-90 | 67877062090 | 90 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (67877-620-90) | 2026-04-06 | No | No | Historical |