DAPAGLIFLOZIN
- Product NDC
- 71921-421
- 11-digit product format
- 719210421
- Labeler code
- 71921
- Product ID
- 71921-421_507fd598-51fe-831a-e063-6394a90accab
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Dapagliflozin
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- Florida Pharmaceutical Products, LLC
- Application
- ANDA211156
- 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 |
|---|
| 71921-421-09 | DAPAGLIFLOZIN | 90 in 1 BOTTLE | TABLET | 90 | | 3 |
| 71921-421-33 | DAPAGLIFLOZIN | 30 in 1 BOTTLE | TABLET | 30 | | 3 |
| 71921-421-50 | DAPAGLIFLOZIN | 500 in 1 BOTTLE | TABLET | 500 | | 3 |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Sample | Exclude flag | Status |
|---|
| 71921-421-09 | 71921042109 | 90 TABLET in 1 BOTTLE (71921-421-09) | 90 tablet | 2026-04-06 | No | No | Current |
| 71921-421-33 | 71921042133 | 30 TABLET in 1 BOTTLE (71921-421-33) | 30 tablet | 2026-04-06 | No | No | Current |
| 71921-421-50 | 71921042150 | 500 TABLET in 1 BOTTLE (71921-421-50) | 500 tablet | 2026-04-06 | No | No | Current |