PREZCOBIX
- Product NDC
- 70518-0714
- 11-digit product format
- 705180714
- Labeler code
- 70518
- Product ID
- 70518-0714_8bc81904-01e2-a108-e053-2995a90ad60f
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- DARUNAVIR ETHANOLATE and COBICISTAT
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- REMEDYREPACK INC.
- Application
- NDA205395
- Marketing category
- NDA
- Marketing start
- 2017-08-28
- Marketing end
- 0000-00-00
- Substance
- DARUNAVIR ETHANOLATE; COBICISTAT
- Active strength
- 800 mg/1; mg/1
- Pharmacologic classes
- HIV Protease Inhibitors [MoA],Protease Inhibitor [EPC],Cytochrome P450 3A Inhibitors [MoA],Cytochrome P450 2D6 Inhibitors [MoA],Cytochrome P450 3A Inhibitors [MoA],Cytochrome P450 3A Inhibitor [EPC],P-Glycoprotein Inhibitors [MoA],Cytochrome P450 2D6 Inhibitors [MoA],Organic Anion Transporting Polypeptide 1B1 Inhibitors [MoA],Organic Anion Transporting Polypeptide 1B3 Inhibitors [MoA],Breast Cancer Resistance Protein Inhibitors [MoA]
- NDC exclude flag
- No
- Listing certified through
- 2020-12-31
- Current FDA listing
- Historical FDA.report record