Atazanavir Sulfate

Product NDC
70518-1365
11-digit product format
705181365
Labeler code
70518
Product ID
70518-1365_e3db42fc-5996-19b0-e053-2995a90acd18
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Atazanavir
Dosage form
CAPSULE
Route
ORAL
Labeler
REMEDYREPACK INC.
Application
ANDA204806
Marketing category
ANDA
Marketing start
2018-08-09
Marketing end
0000-00-00
Substance
ATAZANAVIR SULFATE
Active strength
300 mg/1
Pharmacologic classes
Cytochrome P450 2C8 Inhibitors [MoA], Cytochrome P450 3A Inhibitors [MoA], Cytochrome P450 3A4 Inhibitors [MoA], HIV Protease Inhibitors [MoA], Protease Inhibitor [EPC], UDP Glucuronosyltransferases Inhibitors [MoA], UGT1A1 Inhibitors [MoA]
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 formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
70518-1365-07051813650030 CAPSULE in 1 BLISTER PACK (70518-1365-0) 30 capsule2018-08-090000-00-00NoNoCurrent