NDC 0597-0275 – Jentadueto XR
Linagliptin 5 mg/1; Metformin Hydrochloride 1000 mg/1 · Tablet, Film Coated, Extended Release · Oral
Product NDC0597-0275
Product details
- Brand name
- Jentadueto XR
- Generic name
- Linagliptin and metformin hydrochloride
- Labeler
- Boehringer Ingelheim Pharmaceuticals, Inc.
- Dosage form
- Tablet, Film Coated, Extended Release
- Route
- Oral
- Marketing category
- NDA · NDA208026
- Marketed since
- May 27, 2016
- Listing expires
- December 31, 2027
- Pharmacologic class
- Biguanide; Dipeptidyl Peptidase 4 Inhibitor
Active ingredients
- Linagliptin 5 mg/1
- Metformin Hydrochloride 1000 mg/1
Package NDC codes (2)
| Package NDC | Description | Since |
|---|---|---|
| 0597-0275-33 | 30 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (0597-0275-33) | May 27, 2016 |
| 0597-0275-81 | 90 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (0597-0275-81) | May 27, 2016 |
Recalls mentioning this NDC
- D-0457-2021 Jun 2, 2021 · Class II
CGMP Deviations: Intermittent exposure to temperature excursion during storage.
Other Jentadueto XR products
- 0597-0270 Linagliptin 2.5 mg/1; Metformin Hydrochloride 1000 mg/1 · Tablet, Film Coated, Extended Release · Boehringer Ingelheim Pharmaceuticals, Inc.