FDA.reportPublic FDA data

Zidovudine

Product NDC
21695-369
11-digit product format
216950369
Labeler code
21695
Product ID
21695-369_1b34c6ec-ac27-455e-976e-d22cf9d81950
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
ZIDOVUDINE
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Rebel Distributors Corp
Application
ANDA077267
Marketing category
ANDA
Marketing start
2009-07-01
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
E
Listing certified through
2017-12-31
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
21695-369-182019-09-24C16284748780-1934fe258-47a3-48b1-e053-8cdaa90a720aThese highlights do not include all the information needed to use ZIDOVUDINE . See full prescribing information for ZIDOVUDINE. Initial U.S. Approval: 1987

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
21695-369-18Zidovudine18 in 1 BOTTLETABLET, FILM COATED181

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
21695-369-18EA - Each21695-369f3023439-73cb-4a61-afb9-875e394fc6ca12013-02-13

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
ZIDOVUDINEACTIVE INGREDIENT4B9XT59T7SZIDOVUDINE TABLET, FILM COATED [REBEL DISTRIBUTORS CORP]1
ZIDOVUDINEACTIVE MOIETY4B9XT59T7SZIDOVUDINE TABLET, FILM COATED [REBEL DISTRIBUTORS CORP]1
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UZIDOVUDINE TABLET, FILM COATED [REBEL DISTRIBUTORS CORP]1
HYPROMELLOSESINACTIVE INGREDIENT3NXW29V3WOZIDOVUDINE TABLET, FILM COATED [REBEL DISTRIBUTORS CORP]1
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30ZIDOVUDINE TABLET, FILM COATED [REBEL DISTRIBUTORS CORP]1
POLYETHYLENE GLYCOLINACTIVE INGREDIENT3WJQ0SDW1AZIDOVUDINE TABLET, FILM COATED [REBEL DISTRIBUTORS CORP]1
SODIUM STARCH GLYCOLATE TYPE A POTATOINACTIVE INGREDIENT5856J3G2A2ZIDOVUDINE TABLET, FILM COATED [REBEL DISTRIBUTORS CORP]1
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPZIDOVUDINE TABLET, FILM COATED [REBEL DISTRIBUTORS CORP]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
21695-369ZIDOVUDINE TABLET, FILM COATED [REBEL DISTRIBUTORS CORP]1Legacy NDC, 1 package rows20110201_1b34c6ec-ac27-455e-976e-d22cf9d81950.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
199663zidovudine 300 MG Oral TabletPSN1b34c6ec-ac27-455e-976e-d22cf9d819501
199663zidovudine 300 MG Oral TabletSCD1b34c6ec-ac27-455e-976e-d22cf9d819501
199663AZT 300 MG Oral TabletSY1b34c6ec-ac27-455e-976e-d22cf9d819501

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionStatus
21695-369-182169503691818 in 1 BOTTLEHistorical