Dapagliflozin
- Product NDC
- 72205-432
- 11-digit product format
- 722050432
- Labeler code
- 72205
- Product ID
- 72205-432_5d0fd8b1-1a08-4c86-86f3-06f7ebf6b211
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Dapagliflozin
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- Novadoz Pharmaceuticals LLC
- Application
- ANDA211478
- Marketing category
- ANDA
- Marketing start
- 2026-04-06
- 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 |
|---|
| 72205-432-01 | Dapagliflozin | 30 in 1 BOTTLE | TABLET, FILM COATED | 30 | | 2 |
| 72205-432-02 | Dapagliflozin | 500 in 1 BOTTLE | TABLET, FILM COATED | 500 | | 2 |
| 72205-432-03 | Dapagliflozin | 90 in 1 BOTTLE | TABLET, FILM COATED | 90 | | 2 |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Marketing start | Sample | Exclude flag | Status |
|---|
| 72205-432-01 | 72205043201 | 30 TABLET, FILM COATED in 1 BOTTLE (72205-432-01) | 2026-04-07 | No | No | Current |
| 72205-432-02 | 72205043202 | 500 TABLET, FILM COATED in 1 BOTTLE (72205-432-02) | 2026-04-07 | No | No | Current |
| 72205-432-03 | 72205043203 | 90 TABLET, FILM COATED in 1 BOTTLE (72205-432-03) | 2026-04-07 | No | No | Current |