FDA.reportPublic FDA data

Zidovudine

Product NDC
53808-0878
11-digit product format
538080878
Labeler code
53808
Product ID
53808-0878_0602ce68-264c-4b34-b2f0-fb0f623bbde3
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
zidovudine
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
State of Florida DOH Central Pharmacy
Application
ANDA078922
Marketing category
ANDA
Marketing start
2013-01-01
Marketing end
0000-00-00
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
2019-12-31
Current FDA listing
Historical FDA.report record

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
fbdbfbef-2c33-0298-4fef-f6693e670fe1Product name720181210
d07e0b9e-e041-41dc-942a-a2a6601dc221Product name120181029
af19b329-4f44-cd81-491a-fbb7fe7a079fProduct name220151013
e1098f43-eafb-82a0-ef30-575f1d8189b0Product name220150227
9ceb457b-0c09-9326-bbca-f296202d412cProduct name120140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
53808-0878-22020-01-31C16284748780-19d75b9d0-4f30-f424-e053-dadaa90a57ceThese highlights do not include all the information needed to use zidovudine tablets safely and effectively. See full prescribing information for zidovudine tablets. Zidovudine Tablets, USP Initial U.S. Approval: 1987

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
53808-0878-2Zidovudine60 in 1 BLISTER PACKTABLET, FILM COATED601

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
ZIDOVUDINEACTIVE INGREDIENT4B9XT59T7SZIDOVUDINE TABLET, FILM COATED [STATE OF FLORIDA DOH CENTRAL PHARMACY]1
ZIDOVUDINEACTIVE MOIETY4B9XT59T7SZIDOVUDINE TABLET, FILM COATED [STATE OF FLORIDA DOH CENTRAL PHARMACY]1
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UZIDOVUDINE TABLET, FILM COATED [STATE OF FLORIDA DOH CENTRAL PHARMACY]1
HYPROMELLOSESINACTIVE INGREDIENT3NXW29V3WOZIDOVUDINE TABLET, FILM COATED [STATE OF FLORIDA DOH CENTRAL PHARMACY]1
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30ZIDOVUDINE TABLET, FILM COATED [STATE OF FLORIDA DOH CENTRAL PHARMACY]1
POLYETHYLENE GLYCOLSINACTIVE INGREDIENT3WJQ0SDW1AZIDOVUDINE TABLET, FILM COATED [STATE OF FLORIDA DOH CENTRAL PHARMACY]1
SODIUM STARCH GLYCOLATE TYPE A POTATOINACTIVE INGREDIENT5856J3G2A2ZIDOVUDINE TABLET, FILM COATED [STATE OF FLORIDA DOH CENTRAL PHARMACY]1
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPZIDOVUDINE TABLET, FILM COATED [STATE OF FLORIDA DOH CENTRAL PHARMACY]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
53808-0878ZIDOVUDINE TABLET, FILM COATED [STATE OF FLORIDA DOH CENTRAL PHARMACY]1Legacy NDC, 1 package rows20140415_4ccc8192-fc3a-4671-a7ce-5565a7b5aaef.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
199663zidovudine 300 MG Oral TabletPSN4ccc8192-fc3a-4671-a7ce-5565a7b5aaef1
199663zidovudine 300 MG Oral TabletSCD4ccc8192-fc3a-4671-a7ce-5565a7b5aaef1
199663AZT 300 MG Oral TabletSY4ccc8192-fc3a-4671-a7ce-5565a7b5aaef1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionStatus
53808-0878-25380808780260 in 1 BLISTER PACKHistorical