Dapagliflozin
- Product NDC
- 0781-5990
- 11-digit product format
- 007815990
- Labeler code
- 0781
- Product ID
- 0781-5990_8296f538-4c23-4d6c-be53-8005b83c24b7
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Dapagliflozin
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- Sandoz Inc
- Application
- ANDA211312
- 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 |
|---|
| 0781-5990-01 | Dapagliflozin | 100 in 1 BOTTLE, PLASTIC | TABLET, FILM COATED | 100 | | 1 |
| 0781-5990-05 | Dapagliflozin | 500 in 1 BOTTLE, PLASTIC | TABLET, FILM COATED | 500 | | 1 |
| 0781-5990-10 | Dapagliflozin | 1000 in 1 BOTTLE, PLASTIC | TABLET, FILM COATED | 1000 | | 1 |
| 0781-5990-31 | Dapagliflozin | 30 in 1 BOTTLE, PLASTIC | TABLET, FILM COATED | 30 | | 1 |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Marketing start | Sample | Exclude flag | Status |
|---|
| 0781-5990-01 | 00781599001 | 100 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (0781-5990-01) | 2026-04-06 | No | No | Current |
| 0781-5990-05 | 00781599005 | 500 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (0781-5990-05) | 2026-04-06 | No | No | Current |
| 0781-5990-10 | 00781599010 | 1000 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (0781-5990-10) | 2026-04-06 | No | No | Current |
| 0781-5990-31 | 00781599031 | 30 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (0781-5990-31) | 2026-04-06 | No | No | Current |