Home NDC 0378-6106 Zidovudine
Product NDC 0378-6106
11-digit product format 003786106
Labeler code 0378
Product ID 0378-6106_dbd4caa5-9aae-4de9-a0ca-f9e9d4a97a55
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name zidovudine
Dosage form TABLET, FILM COATED
Route ORAL
Labeler Mylan Pharmaceuticals Inc.
Application ANDA078922
Marketing category ANDA
Marketing start 2008-12-19
Marketing end 2020-11-30
Substance ZIDOVUDINE
Active strength 300 mg/1
Pharmacologic classes Human Immunodeficiency Virus Nucleoside Analog Reverse Transcriptase Inhibitor [EPC],Nucleoside Analog [EXT],Nucleoside Reverse Transcriptase Inhibitors [MoA]
NDC exclude flag No
Listing certified through 0000-00-00
Current FDA listing Historical FDA.report record DailyMed Product Concepts# DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded ZIDOVUDINE ACTIVE INGREDIENT 4B9XT59T7S ZIDOVUDINE TABLET, FILM COATED [STATE OF FLORIDA DOH CENTRAL PHARMACY] 1 ZIDOVUDINE ACTIVE MOIETY 4B9XT59T7S ZIDOVUDINE TABLET, FILM COATED [STATE OF FLORIDA DOH CENTRAL PHARMACY] 1 CELLULOSE, MICROCRYSTALLINE INACTIVE INGREDIENT OP1R32D61U ZIDOVUDINE TABLET, FILM COATED [STATE OF FLORIDA DOH CENTRAL PHARMACY] 1 HYPROMELLOSES INACTIVE INGREDIENT 3NXW29V3WO ZIDOVUDINE TABLET, FILM COATED [STATE OF FLORIDA DOH CENTRAL PHARMACY] 1 MAGNESIUM STEARATE INACTIVE INGREDIENT 70097M6I30 ZIDOVUDINE TABLET, FILM COATED [STATE OF FLORIDA DOH CENTRAL PHARMACY] 1 POLYETHYLENE GLYCOLS INACTIVE INGREDIENT 3WJQ0SDW1A ZIDOVUDINE TABLET, FILM COATED [STATE OF FLORIDA DOH CENTRAL PHARMACY] 1 SODIUM STARCH GLYCOLATE TYPE A POTATO INACTIVE INGREDIENT 5856J3G2A2 ZIDOVUDINE TABLET, FILM COATED [STATE OF FLORIDA DOH CENTRAL PHARMACY] 1 TITANIUM DIOXIDE INACTIVE INGREDIENT 15FIX9V2JP ZIDOVUDINE TABLET, FILM COATED [STATE OF FLORIDA DOH CENTRAL PHARMACY] 1
DailyMed RxNorm Mappings#