NDC 0597-0153 – Jardiance
Empagliflozin 25 mg/1 · Tablet, Film Coated · Oral
Product NDC0597-0153
Product details
- Brand name
- Jardiance
- Generic name
- Empagliflozin
- Labeler
- Boehringer Ingelheim Pharmaceuticals, Inc.
- Dosage form
- Tablet, Film Coated
- Route
- Oral
- Marketing category
- NDA · NDA204629
- Marketed since
- August 1, 2014
- Listing expires
- December 31, 2027
- Pharmacologic class
- Sodium-Glucose Cotransporter 2 Inhibitor
Active ingredients
- Empagliflozin 25 mg/1
Package NDC codes (4)
| Package NDC | Description | Since |
|---|---|---|
| 0597-0153-07 sample | 1 BOTTLE in 1 CARTON (0597-0153-07) / 7 TABLET, FILM COATED in 1 BOTTLE | Aug 1, 2014 |
| 0597-0153-30 | 30 TABLET, FILM COATED in 1 BOTTLE (0597-0153-30) | Aug 1, 2014 |
| 0597-0153-37 | 30 BLISTER PACK in 1 CARTON (0597-0153-37) / 1 TABLET, FILM COATED in 1 BLISTER PACK | Aug 1, 2014 |
| 0597-0153-90 | 90 TABLET, FILM COATED in 1 BOTTLE (0597-0153-90) | Aug 1, 2014 |
Recalls mentioning this NDC
- D-0185-2024 Jan 3, 2024 · Class II
CGMP Deviations: Products were exposed to temperatures outside of the products labeled storage conditions. - D-0468-2023 Mar 29, 2023 · Class II
Labeling: Label Mix-up
Other Jardiance products
- 50090-4384 Empagliflozin 25 mg/1 · Tablet, Film Coated · A-S Medication Solutions
- 50090-4492 Empagliflozin 10 mg/1 · Tablet, Film Coated · A-S Medication Solutions
- 50090-6452 Empagliflozin 10 mg/1 · Tablet, Film Coated · A-S Medication Solutions
- 50090-6457 Empagliflozin 25 mg/1 · Tablet, Film Coated · A-S Medication Solutions
- 71610-177 Empagliflozin 25 mg/1 · Tablet, Film Coated · Aphena Pharma Solutions - Tennessee, LLC
- 71610-900 Empagliflozin 10 mg/1 · Tablet, Film Coated · Aphena Pharma Solutions - Tennessee, LLC
- 0597-0152 Empagliflozin 10 mg/1 · Tablet, Film Coated · Boehringer Ingelheim Pharmaceuticals, Inc.
- 55154-0411 Empagliflozin 10 mg/1 · Tablet, Film Coated · Cardinal Health 107, LLC
- 55154-0412 Empagliflozin 25 mg/1 · Tablet, Film Coated · Cardinal Health 107, LLC
- 67296-2324 Empagliflozin 25 mg/1 · Tablet, Film Coated · Redpharm Drug