ATAZANAVIR

Product NDC
69097-446
11-digit product format
690970446
Labeler code
69097
Product ID
69097-446_39d9f838-5059-4ac4-be71-96280e2cfe2c
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Atazanavir
Dosage form
CAPSULE, GELATIN COATED
Route
ORAL
Labeler
Cipla USA Inc.
Application
ANDA200626
Marketing category
ANDA
Marketing start
2018-09-14
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

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
69097-446-02EA - Each69097-446b6ffd6eb-7b82-4d4c-a83f-ebbb364c217012018-10-11

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
69097-446-026909704460230 CAPSULE, GELATIN COATED in 1 BOTTLE (69097-446-02) 2018-09-140000-00-00NoNoCurrent
69097-446-036909704460360 CAPSULE, GELATIN COATED in 1 BOTTLE (69097-446-03) 2018-09-140000-00-00NoNoCurrent