Sitagliptin and metformin hydrochloride
- Product NDC
- 70771-1870
- 11-digit product format
- 707711870
- Labeler code
- 70771
- Product ID
- 70771-1870_20a7af2d-467c-4f70-880c-49192be5d8b8
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Sitagliptin and Metformin Hydrochloride
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- Zydus Lifesciences Limited
- Application
- NDA216743
- Marketing category
- NDA AUTHORIZED GENERIC
- Marketing start
- 2024-03-14
- Substance
- METFORMIN HYDROCHLORIDE; SITAGLIPTIN
- 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 |
| QFP0P1DV7Z | SITAGLIPTIN | 486460-32-6 | SITAGLIPTIN |
Packages
| Package NDC | 11-digit format | Description | Marketing start | Sample | Exclude flag | Status |
|---|
| 70771-1870-6 | 70771187006 | 60 TABLET, FILM COATED in 1 BOTTLE (70771-1870-6) | 2024-03-14 | No | No | Historical |
| 70771-1870-8 | 70771187008 | 180 TABLET, FILM COATED in 1 BOTTLE (70771-1870-8) | 2024-03-14 | No | No | Historical |