JANUMET
- Product NDC
- 50090-5502
- 11-digit product format
- 500905502
- Labeler code
- 50090
- Product ID
- 50090-5502_7511c56d-21ea-4bad-89b9-62329c2e3d75
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- SITAGLIPTIN and METFORMIN HYDROCHLORIDE
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- A-S Medication Solutions
- Application
- NDA022044
- Marketing category
- NDA
- Marketing start
- 2007-03-30
- Substance
- METFORMIN HYDROCHLORIDE; SITAGLIPTIN PHOSPHATE
- Active strength
- 1000; 50 mg/1; mg/1
- Pharmacologic classes
- Biguanide [EPC], Biguanides [CS], Dipeptidyl Peptidase 4 Inhibitor [EPC], Dipeptidyl Peptidase 4 Inhibitors [MoA]
- NDC exclude flag
- No
- Listing certified through
- 2026-12-31
- Current FDA listing
- Yes
Related UNII Ingredients
| UNII | Preferred term | Registry number | Matched term |
|---|
| 786Z46389E | METFORMIN HYDROCHLORIDE | 1115-70-4 | METFORMIN HYDROCHLORIDE |
| TS63EW8X6F | SITAGLIPTIN PHOSPHATE | 654671-77-9 | SITAGLIPTIN PHOSPHATE |
Packages
| Package NDC | 11-digit format | Description | Marketing start | Sample | Exclude flag | Status |
|---|
| 50090-5502-0 | 50090550200 | 60 TABLET, FILM COATED in 1 BOTTLE (50090-5502-0) | 2021-03-31 | No | No | Historical |
| 50090-5502-1 | 50090550201 | 180 TABLET, FILM COATED in 1 BOTTLE (50090-5502-1) | 2023-07-19 | No | No | Historical |
Related DailyMed Labels
| Title | Manufacturer | Effective date | Type | Version |
|---|
| JANUMET | A-S Medication Solutions | 2023-07-20 | HUMAN PRESCRIPTION DRUG LABEL | 9 |