FARXIGA
- Product NDC
- 70518-4614
- 11-digit product format
- 705184614
- Labeler code
- 70518
- Product ID
- 70518-4614_503414ef-02c7-ce5b-e063-6294a90a5f09
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- DAPAGLIFLOZIN
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- REMEDYREPACK INC.
- Application
- NDA202293
- Marketing category
- NDA
- Marketing start
- 2026-04-23
- Substance
- DAPAGLIFLOZIN PROPANEDIOL
- 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
- FARXIGA
- Listing expiration
- 2027-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| DAPAGLIFLOZIN PROPANEDIOL | 5 mg/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | 887K2391VH |
| Rxcui | 1486981, 1488574 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 70518-4614-0 | FARXIGA | 50 in 1 BOX | TABLET, FILM COATED | 50 | | 1 |
| 70518-4614-1 | FARXIGA | 1 in 1 POUCH | TABLET, FILM COATED | 1 | | 1 |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Sample | Exclude flag | Status |
|---|
| 70518-4614-0 | 70518461400 | 50 POUCH in 1 BOX (70518-4614-0) / 1 TABLET, FILM COATED in 1 POUCH (70518-4614-1) | 50 pouch | 2026-04-23 | No | No | Historical |
| 70518-4614-1 | 70518461401 | 1 in 1 POUCH | | | | | Historical |