PREZISTA

Product NDC
70518-1483
11-digit product format
705181483
Labeler code
70518
Product ID
70518-1483_e452a5dd-4223-0f44-e053-2a95a90a6b06
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
darunavir
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
REMEDYREPACK INC.
Application
NDA021976
Marketing category
NDA
Marketing start
2018-10-06
Marketing end
0000-00-00
Substance
DARUNAVIR ETHANOLATE
Active strength
800 mg/1
Pharmacologic classes
Cytochrome P450 2D6 Inhibitors [MoA], Cytochrome P450 3A Inhibitors [MoA], HIV Protease Inhibitors [MoA], Protease Inhibitor [EPC]
NDC exclude flag
No
Listing certified through
2023-12-31
Current FDA listing
Historical FDA.report record

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
70518-1483-07051814830030 TABLET, FILM COATED in 1 BLISTER PACK (70518-1483-0) 2018-10-060000-00-00NoNoCurrent