Jardiance
- Product NDC
- 0597-0152
- 11-digit product format
- 005970152
- Labeler code
- 0597
- Product ID
- 0597-0152_09daa78d-f417-436c-a29e-029c015ca6d6
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Empagliflozin
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- Boehringer Ingelheim Pharmaceuticals, Inc.
- Application
- NDA204629
- Marketing category
- NDA
- Marketing start
- 2014-08-01
- Substance
- EMPAGLIFLOZIN
- 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
- Jardiance
- Listing expiration
- 2027-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| EMPAGLIFLOZIN | 10 mg/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | HDC1R2M35U |
| Rxcui | 1545658, 1545664, 1545666, 1545668 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 0597-0152-07 | Jardiance | 7 in 1 BOTTLE | TABLET, FILM COATED | 7 | | 31 |
| 0597-0152-07 | Jardiance | 1 in 1 CARTON | TABLET, FILM COATED | 1 | | 31 |
| 0597-0152-30 | Jardiance | 30 in 1 BOTTLE | TABLET, FILM COATED | 30 | | 31 |
| 0597-0152-37 | Jardiance | 1 in 1 BLISTER PACK | TABLET, FILM COATED | 1 | | 31 |
| 0597-0152-37 | Jardiance | 30 in 1 CARTON | TABLET, FILM COATED | 30 | | 31 |
| 0597-0152-70 | Jardiance | 7 in 1 CARTON | TABLET, FILM COATED | 7 | | 31 |
| 0597-0152-70 | Jardiance | 1 in 1 BLISTER PACK | TABLET, FILM COATED | 1 | | 31 |
| 0597-0152-90 | Jardiance | 90 in 1 BOTTLE | TABLET, FILM COATED | 90 | | 31 |
DailyMed Socrata Ingredients#
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 0597-0152 | JARDIANCE (EMPAGLIFLOZIN) TABLET, FILM COATED [BOEHRINGER INGELHEIM PHARMACEUTICALS, INC.] | 29 | Current NDC, Legacy NDC, 8 package rows | 20250410_faf3dd6a-9cd0-39c2-0d2e-232cb3f67565.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 |
|---|
| 0597-0152-07 | 00597015207 | 1 BOTTLE in 1 CARTON (0597-0152-07) / 7 TABLET, FILM COATED in 1 BOTTLE | 1 bottle | 2014-08-01 | 0000-00-00 | Yes | No | Current |
| 0597-0152-30 | 00597015230 | 30 TABLET, FILM COATED in 1 BOTTLE (0597-0152-30) | | 2014-08-01 | 0000-00-00 | No | No | Current |
| 0597-0152-37 | 00597015237 | 30 BLISTER PACK in 1 CARTON (0597-0152-37) / 1 TABLET, FILM COATED in 1 BLISTER PACK | 30 blister pack | 2014-08-01 | 0000-00-00 | No | No | Current |
| 0597-0152-70 | 00597015270 | 7 BLISTER PACK in 1 CARTON (0597-0152-70) > 1 TABLET, FILM COATED in 1 BLISTER PACK | 7 blister pack | 2014-08-01 | 0000-00-00 | No | No | Current |
| 0597-0152-90 | 00597015290 | 90 TABLET, FILM COATED in 1 BOTTLE (0597-0152-90) | | 2014-08-01 | 0000-00-00 | No | No | Current |