Dapagliflozin
- Product NDC
- 70771-1715
- 11-digit product format
- 707711715
- Labeler code
- 70771
- Product ID
- 70771-1715_e0ce1921-cd6e-4663-acd0-ae34bd8222fa
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Dapagliflozin
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- Zydus Lifesciences Limited
- Application
- ANDA211582
- Marketing category
- ANDA
- Marketing start
- 2026-04-06
- Substance
- DAPAGLIFLOZIN
- Active strength
- 10 mg/1
- Pharmacologic classes
- 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
- Listing expiration
- 2027-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| DAPAGLIFLOZIN | 10 mg/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | 1ULL0QJ8UC |
| Rxcui | 1488569, 1488574 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 70771-1715-3 | Dapagliflozin | 30 in 1 BOTTLE | TABLET | 30 | | 6 |
| 70771-1715-9 | Dapagliflozin | 90 in 1 BOTTLE | TABLET | 90 | | 6 |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Sample | Exclude flag | Status |
|---|
| 70771-1715-3 | 70771171503 | 30 TABLET in 1 BOTTLE (70771-1715-3) | 30 tablet | 2026-04-06 | No | No | Historical |
| 70771-1715-9 | 70771171509 | 90 TABLET in 1 BOTTLE (70771-1715-9) | 90 tablet | 2026-04-06 | No | No | Historical |