DAPAGLIFLOZIN AND SAXAGLIPTIN
- Product NDC
- 72205-438
- 11-digit product format
- 722050438
- Labeler code
- 72205
- Product ID
- 72205-438_1cfa51fd-8406-404c-b2a8-0fc1068675fb
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- DAPAGLIFLOZIN AND SAXAGLIPTIN
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- Novadoz Pharmaceuticals LLC
- Application
- ANDA211533
- Marketing category
- ANDA
- Marketing start
- 2026-04-06
- Substance
- DAPAGLIFLOZIN; SAXAGLIPTIN HYDROCHLORIDE DIHYDRATE
- Active strength
- 10; 5 mg/1; 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 AND SAXAGLIPTIN
- Listing expiration
- 2027-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| DAPAGLIFLOZIN | 10 mg/1 |
| SAXAGLIPTIN HYDROCHLORIDE DIHYDRATE | 5 mg/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | 1ULL0QJ8UC, 4N19ON48ZN |
| Rxcui | 1925498 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 72205-438-01 | DAPAGLIFLOZIN AND SAXAGLIPTIN | 30 in 1 BOTTLE | TABLET, FILM COATED | 30 | | 1 |
| 72205-438-02 | DAPAGLIFLOZIN AND SAXAGLIPTIN | 90 in 1 BOTTLE | TABLET, FILM COATED | 90 | | 1 |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Marketing start | Sample | Exclude flag | Status |
|---|
| 72205-438-01 | 72205043801 | 30 TABLET, FILM COATED in 1 BOTTLE (72205-438-01) | 2026-04-09 | No | No | Current |
| 72205-438-02 | 72205043802 | 90 TABLET, FILM COATED in 1 BOTTLE (72205-438-02) | 2026-04-09 | No | No | Current |