NDC 0006-0577 – Janumet
Sitagliptin Phosphate 50 mg/1; Metformin Hydrochloride 1000 mg/1 · Tablet, Film Coated · Oral
Product NDC0006-0577
Product details
- Brand name
- Janumet
- Generic name
- SITAGLIPTIN and METFORMIN HYDROCHLORIDE
- Labeler
- Merck Sharp & Dohme LLC
- Dosage form
- Tablet, Film Coated
- Route
- Oral
- Marketing category
- NDA · NDA022044
- Marketed since
- March 30, 2007
- Listing expires
- December 31, 2027
- Pharmacologic class
- Biguanide; Dipeptidyl Peptidase 4 Inhibitor
Active ingredients
- Sitagliptin Phosphate 50 mg/1
- Metformin Hydrochloride 1000 mg/1
Package NDC codes (5)
| Package NDC | Description | Since |
|---|---|---|
| 0006-0577-03 sample | 2 BOTTLE in 1 CARTON (0006-0577-03) / 14 TABLET, FILM COATED in 1 BOTTLE (0006-0577-02) | Mar 30, 2007 |
| 0006-0577-56 sample | 4 POUCH in 1 CARTON (0006-0577-56) / 2 BLISTER PACK in 1 POUCH / 7 TABLET, FILM COATED in 1 BLISTER PACK | Mar 30, 2007 |
| 0006-0577-61 | 60 TABLET, FILM COATED in 1 BOTTLE (0006-0577-61) | Mar 30, 2007 |
| 0006-0577-62 | 180 TABLET, FILM COATED in 1 BOTTLE (0006-0577-62) | Mar 30, 2007 |
| 0006-0577-82 | 1000 TABLET, FILM COATED in 1 BOTTLE (0006-0577-82) | Mar 30, 2007 |
Recalls mentioning this NDC
- D-0746-2022 Apr 13, 2022 · Class II
Presence of foreign substance: Presence of stainless steel particulates in tablets.
Other Janumet products
- 50090-5502 Sitagliptin Phosphate 50 mg/1; Metformin Hydrochloride 1000 mg/1 · Tablet, Film Coated · A-S Medication Solutions
- 50090-5616 Sitagliptin Phosphate 50 mg/1; Metformin Hydrochloride 500 mg/1 · Tablet, Film Coated · A-S Medication Solutions
- 0006-0575 Sitagliptin Phosphate 50 mg/1; Metformin Hydrochloride 500 mg/1 · Tablet, Film Coated · Merck Sharp & Dohme LLC
- 50090-5504 Sitagliptin Phosphate 50 mg/1; Metformin Hydrochloride 1000 mg/1 · Tablet, Film Coated, Extended Release · A-S Medication Solutions
- 0006-0078 Sitagliptin Phosphate 50 mg/1; Metformin Hydrochloride 500 mg/1 · Tablet, Film Coated, Extended Release · Merck Sharp & Dohme LLC
- 0006-0080 Sitagliptin Phosphate 50 mg/1; Metformin Hydrochloride 1000 mg/1 · Tablet, Film Coated, Extended Release · Merck Sharp & Dohme LLC
- 0006-0081 Sitagliptin Phosphate 100 mg/1; Metformin Hydrochloride 1000 mg/1 · Tablet, Film Coated, Extended Release · Merck Sharp & Dohme LLC