NDC 0597-0182 – Glyxambi
Empagliflozin 10 mg/1; Linagliptin 5 mg/1 · Tablet, Film Coated · Oral
Product NDC0597-0182
Product details
- Brand name
- Glyxambi
- Generic name
- empagliflozin and linagliptin
- Labeler
- Boehringer Ingelheim Pharmaceuticals, Inc.
- Dosage form
- Tablet, Film Coated
- Route
- Oral
- Marketing category
- NDA · NDA206073
- Marketed since
- January 30, 2015
- Listing expires
- December 31, 2027
- Pharmacologic class
- Dipeptidyl Peptidase 4 Inhibitor; Sodium-Glucose Cotransporter 2 Inhibitor
Active ingredients
- Empagliflozin 10 mg/1
- Linagliptin 5 mg/1
Package NDC codes (3)
| Package NDC | Description | Since |
|---|---|---|
| 0597-0182-30 | 30 TABLET, FILM COATED in 1 BOTTLE (0597-0182-30) | Jan 30, 2015 |
| 0597-0182-39 | 30 BLISTER PACK in 1 CARTON (0597-0182-39) / 1 TABLET, FILM COATED in 1 BLISTER PACK | Jan 30, 2015 |
| 0597-0182-90 | 90 TABLET, FILM COATED in 1 BOTTLE (0597-0182-90) | Jan 30, 2015 |
Recalls mentioning this NDC
- D-0455-2021 Jun 2, 2021 · Class II
CGMP Deviations: Intermittent exposure to temperature excursion during storage.
Other Glyxambi products
- 0597-0164 Empagliflozin 25 mg/1; Linagliptin 5 mg/1 · Tablet, Film Coated · Boehringer Ingelheim Pharmaceuticals, Inc.