Glyxambi
- Product NDC
- 70518-2046
- 11-digit product format
- 705182046
- Labeler code
- 70518
- Product ID
- 70518-2046_b947aa89-b45f-6e4d-e053-2995a90abb38
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- empagliflozin and linagliptin
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- REMEDYREPACK INC.
- Application
- NDA206073
- Marketing category
- NDA
- Marketing start
- 2019-04-29
- Marketing end
- 0000-00-00
- Substance
- EMPAGLIFLOZIN; LINAGLIPTIN
- Active strength
- 10 mg/1; mg/1
- Pharmacologic classes
- Sodium-Glucose Cotransporter 2 Inhibitor [EPC],Sodium-Glucose Transporter 2 Inhibitors [MoA],Dipeptidyl Peptidase 4 Inhibitors [MoA],Dipeptidyl Peptidase 4 Inhibitor [EPC]
- NDC exclude flag
- No
- Listing certified through
- 2022-12-31
- Current FDA listing
- Historical FDA.report record