DAPAGLIFLOZIN
- Product NDC
- 0480-3527
- 11-digit product format
- 004803527
- Labeler code
- 0480
- Product ID
- 0480-3527_64caba8e-fb3b-4238-96f1-9155c22bf021
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- DAPAGLIFLOZIN
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- Teva Pharmaceuticals, Inc.
- Application
- ANDA211541
- Marketing category
- ANDA
- Marketing start
- 2026-04-08
- Substance
- DAPAGLIFLOZIN
- Active strength
- 5 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 | 5 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 |
|---|
| 0480-3527-56 | DAPAGLIFLOZIN | 30 in 1 BOTTLE | TABLET, FILM COATED | 30 | | 5 |
| 0480-3527-98 | DAPAGLIFLOZIN | 90 in 1 BOTTLE | TABLET, FILM COATED | 90 | | 5 |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Marketing start | Sample | Exclude flag | Status |
|---|
| 0480-3527-56 | 00480352756 | 30 TABLET, FILM COATED in 1 BOTTLE (0480-3527-56) | 2026-04-08 | No | No | Current |
| 0480-3527-98 | 00480352798 | 90 TABLET, FILM COATED in 1 BOTTLE (0480-3527-98) | 2026-04-27 | No | No | Current |