NDC 68462-727 – Saxagliptin
Saxagliptin Hydrochloride 5 mg/1 · Tablet, Film Coated · Oral
Product NDC68462-727
Product details
- Brand name
- Saxagliptin
- Generic name
- Saxagliptin
- Labeler
- Glenmark Pharmaceuticals Inc., USA
- Dosage form
- Tablet, Film Coated
- Route
- Oral
- Marketing category
- ANDA · ANDA205994
- Marketed since
- July 31, 2023
- Listing expires
- December 31, 2027
- Pharmacologic class
- Dipeptidyl Peptidase 4 Inhibitor
Active ingredients
- Saxagliptin Hydrochloride 5 mg/1
Package NDC codes (4)
| Package NDC | Description | Since |
|---|---|---|
| 68462-727-05 | 500 TABLET, FILM COATED in 1 BOTTLE (68462-727-05) | Jul 31, 2023 |
| 68462-727-14 | 10 BLISTER PACK in 1 CARTON (68462-727-14) / 10 TABLET, FILM COATED in 1 BLISTER PACK | Jul 31, 2023 |
| 68462-727-30 | 30 TABLET, FILM COATED in 1 BOTTLE (68462-727-30) | Jul 31, 2023 |
| 68462-727-90 | 90 TABLET, FILM COATED in 1 BOTTLE (68462-727-90) | Jul 31, 2023 |
Recalls mentioning this NDC
- D-0345-2025 Apr 16, 2025 · Class II
CGMP Deviations - D-0332-2025 Apr 16, 2025 · Class II
CGMP Deviations
Other Saxagliptin products
- 65862-825 Saxagliptin Hydrochloride 2.5 mg/1 · Tablet, Film Coated · Aurobindo Pharma Limited
- 65862-826 Saxagliptin Hydrochloride 5 mg/1 · Tablet, Film Coated · Aurobindo Pharma Limited
- 68462-726 Saxagliptin Hydrochloride 2.5 mg/1 · Tablet, Film Coated · Glenmark Pharmaceuticals Inc., USA
- 0378-4705 Saxagliptin Hydrochloride Dihydrate 2.5 mg/1 · Tablet, Film Coated · Mylan Pharmaceuticals Inc.
- 0378-4706 Saxagliptin Hydrochloride Dihydrate 5 mg/1 · Tablet, Film Coated · Mylan Pharmaceuticals Inc.