DAPAGLIFLOZIN
- Product NDC
- 70377-023
- 11-digit product format
- 703770023
- Labeler code
- 70377
- Product ID
- 70377-023_5a032c8b-d862-951c-d6ea-67bc0aa135d9
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- DAPAGLIFLOZIN
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- Biocon Pharma Inc.
- Application
- ANDA211470
- Marketing category
- ANDA
- Marketing start
- 2026-05-01
- Substance
- DAPAGLIFLOZIN 2,3-BUTANEDIOL MONOHYDRATE
- 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 2,3-BUTANEDIOL MONOHYDRATE | 5 mg/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | U289305BKG |
| Rxcui | 1488569, 1488574 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 70377-023-11 | DAPAGLIFLOZIN | 30 in 1 BOTTLE, PLASTIC | TABLET, FILM COATED | 30 | | 12 |
| 70377-023-12 | DAPAGLIFLOZIN | 1000 in 1 BOTTLE, PLASTIC | TABLET, FILM COATED | 1000 | | 12 |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Marketing start | Sample | Exclude flag | Status |
|---|
| 70377-023-11 | 70377002311 | 30 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (70377-023-11) | 2026-05-01 | No | No | Current |
| 70377-023-12 | 70377002312 | 1000 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (70377-023-12) | 2026-05-01 | No | No | Current |