FARXIGA
- Product NDC
- 0310-6210
- 11-digit product format
- 003106210
- Labeler code
- 0310
- Product ID
- 0310-6210_10d25358-e717-4294-9ec1-c73b8f45009d
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- DAPAGLIFLOZIN
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- AstraZeneca Pharmaceuticals LP
- Application
- NDA202293
- Marketing category
- NDA
- Marketing start
- 2008-01-14
- Substance
- DAPAGLIFLOZIN PROPANEDIOL
- 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
- FARXIGA
- Listing expiration
- 2027-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| DAPAGLIFLOZIN PROPANEDIOL | 10 mg/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | 887K2391VH |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 0310-6210-30 | FARXIGA | 30 in 1 BOTTLE, PLASTIC | TABLET, FILM COATED | 30 | | 45 |
| 0310-6210-39 | FARXIGA | 3 in 1 CARTON | TABLET, FILM COATED | 3 | | 45 |
| 0310-6210-39 | FARXIGA | 10 in 1 BLISTER PACK | TABLET, FILM COATED | 10 | | 45 |
| 0310-6210-90 | FARXIGA | 90 in 1 BOTTLE, PLASTIC | TABLET, FILM COATED | 90 | | 45 |
| 0310-6210-95 | FARXIGA | 7 in 1 BLISTER PACK | TABLET, FILM COATED | 7 | | 45 |
| 0310-6210-95 | FARXIGA | 1 in 1 CARTON | TABLET, FILM COATED | 1 | | 45 |
DailyMed Socrata Ingredients#
Ingredient, Type, UNII table| Ingredient | Type | UNII | DailyMed label | SPL version | Uploaded |
|---|
| DAPAGLIFLOZIN PROPANEDIOL | ACTIVE INGREDIENT | 887K2391VH | FARXIGA (DAPAGLIFLOZIN) TABLET, FILM COATED [ASTRAZENECA PHARMACEUTICALS LP] | 3 | |
| dapagliflozin | ACTIVE MOIETY | 1ULL0QJ8UC | FARXIGA (DAPAGLIFLOZIN) TABLET, FILM COATED [ASTRAZENECA PHARMACEUTICALS LP] | 3 | |
| anhydrous lactose | INACTIVE INGREDIENT | 3SY5LH9PMK | FARXIGA (DAPAGLIFLOZIN) TABLET, FILM COATED [ASTRAZENECA PHARMACEUTICALS LP] | 3 | |
| cellulose, microcrystalline | INACTIVE INGREDIENT | OP1R32D61U | FARXIGA (DAPAGLIFLOZIN) TABLET, FILM COATED [ASTRAZENECA PHARMACEUTICALS LP] | 3 | |
| crospovidone | INACTIVE INGREDIENT | 68401960MK | FARXIGA (DAPAGLIFLOZIN) TABLET, FILM COATED [ASTRAZENECA PHARMACEUTICALS LP] | 3 | |
| magnesium stearate | INACTIVE INGREDIENT | 70097M6I30 | FARXIGA (DAPAGLIFLOZIN) TABLET, FILM COATED [ASTRAZENECA PHARMACEUTICALS LP] | 3 | |
| silicon dioxide | INACTIVE INGREDIENT | ETJ7Z6XBU4 | FARXIGA (DAPAGLIFLOZIN) TABLET, FILM COATED [ASTRAZENECA PHARMACEUTICALS LP] | 3 | |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 0310-6210 | FARXIGA (DAPAGLIFLOZIN) TABLET, FILM COATED [ASTRAZENECA PHARMACEUTICALS LP] | 43 | Current NDC, Legacy NDC, 6 package rows | 20241031_72ad22ae-efe6-4cd6-a302-98aaee423d69.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 0310-6210-30 | 00310621030 | 30 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (0310-6210-30) | | 2015-01-05 | 0000-00-00 | No | No | Current |
| 0310-6210-39 | 00310621039 | 3 BLISTER PACK in 1 CARTON (0310-6210-39) / 10 TABLET, FILM COATED in 1 BLISTER PACK | 3 blister pack | 2022-12-02 | 0000-00-00 | No | No | Current |
| 0310-6210-90 | 00310621090 | 90 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (0310-6210-90) | | 2024-03-18 | | No | No | Historical |
| 0310-6210-95 | 00310621095 | 1 BLISTER PACK in 1 CARTON (0310-6210-95) / 7 TABLET, FILM COATED in 1 BLISTER PACK | 1 blister pack | 2015-01-05 | 0000-00-00 | Yes | No | Current |