JARDIANCE
- Product NDC
- 50090-6452
- 11-digit product format
- 500906452
- Labeler code
- 50090
- Product ID
- 50090-6452_46a68ec5-d52b-46dd-920f-38eff4165301
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Empagliflozin
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- A-S Medication Solutions
- 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
- 2026-12-31
- Current FDA listing
- Yes
openFDA Listing Details
- Product ID
- 50090-6452_46a68ec5-d52b-46dd-920f-38eff4165301
- Product type
- HUMAN PRESCRIPTION DRUG
- Finished product
- Yes
- Brand name base
- JARDIANCE
- Generic name
- Empagliflozin
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Marketing start
- 2014-08-01
- Marketing category
- NDA
- Application number
- NDA204629
- Pharmacologic classes
- Sodium-Glucose Cotransporter 2 Inhibitor [EPC]; Sodium-Glucose Transporter 2 Inhibitors [MoA]
- Listing expiration
- 2026-12-31
openFDA Active Ingredients
| Ingredient | Strength |
|---|
| EMPAGLIFLOZIN | 10 mg/1 |
openFDA Harmonized Identifiers
| Field | Values |
|---|
| Unii | HDC1R2M35U |
| Rxcui | 1545658, 1545664 |
| Spl Set Id | 1782b947-4a72-4feb-a488-1469d9af82bd |
| Manufacturer Name | A-S Medication Solutions |
Related UNII Ingredients
| UNII | Preferred term | Registry number | Matched term |
|---|
| HDC1R2M35U | EMPAGLIFLOZIN | 864070-44-0 | EMPAGLIFLOZIN |
Packages
| Package NDC | 11-digit format | Description | Marketing start | Sample | Exclude flag | Status |
|---|
| 50090-6452-0 | 50090645200 | 90 TABLET, FILM COATED in 1 BOTTLE (50090-6452-0) | 2023-04-27 | No | No | Current |
Related DailyMed Labels
| Title | Manufacturer | Effective date | Type | Version |
|---|
| JARDIANCE | A-S Medication Solutions | 2023-05-03 | HUMAN PRESCRIPTION DRUG LABEL | 1 |