Zidovudine

Product NDC
65862-024
11-digit product format
658620024
Labeler code
65862
Product ID
65862-024_0f90ebc4-1e78-420b-a2cb-0dc715bdb853
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Zidovudine
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Aurobindo Pharma Limited
Application
ANDA077267
Marketing category
ANDA
Marketing start
2005-09-19
Substance
ZIDOVUDINE
Active strength
300 mg/1
Pharmacologic classes
Human Immunodeficiency Virus Nucleoside Analog Reverse Transcriptase Inhibitor [EPC], Nucleoside Reverse Transcriptase Inhibitors [MoA]
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Zidovudine
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
ZIDOVUDINE300 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii4B9XT59T7S
Rxcui199663

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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
65862-024-10Zidovudine6 in 1 CARTONTABLET, FILM COATED622
65862-024-10Zidovudine10 in 1 BLISTER PACKTABLET, FILM COATED1022
65862-024-60Zidovudine60 in 1 BOTTLETABLET, FILM COATED6022

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
65862-024-60EA - Each65862-0245548246d-79f0-4311-a6d2-93141d89bb5212012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
ZIDOVUDINEACTIVE INGREDIENT4B9XT59T7SZIDOVUDINE TABLET, FILM COATED [AUROBINDO PHARMA LIMITED]13
ZIDOVUDINEACTIVE MOIETY4B9XT59T7SZIDOVUDINE TABLET, FILM COATED [AUROBINDO PHARMA LIMITED]13
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UZIDOVUDINE TABLET, FILM COATED [AUROBINDO PHARMA LIMITED]13
HYPROMELLOSE 2910 (5 MPA.S)INACTIVE INGREDIENTR75537T0T4ZIDOVUDINE TABLET, FILM COATED [AUROBINDO PHARMA LIMITED]13
HYPROMELLOSE 2910 (6 MPA.S)INACTIVE INGREDIENT0WZ8WG20P6ZIDOVUDINE TABLET, FILM COATED [AUROBINDO PHARMA LIMITED]13
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30ZIDOVUDINE TABLET, FILM COATED [AUROBINDO PHARMA LIMITED]13
POLYETHYLENE GLYCOL 400INACTIVE INGREDIENTB697894SGQZIDOVUDINE TABLET, FILM COATED [AUROBINDO PHARMA LIMITED]13
SODIUM STARCH GLYCOLATE TYPE A POTATOINACTIVE INGREDIENT5856J3G2A2ZIDOVUDINE TABLET, FILM COATED [AUROBINDO PHARMA LIMITED]13
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPZIDOVUDINE TABLET, FILM COATED [AUROBINDO PHARMA LIMITED]13
ZIDOVUDINEACTIVE INGREDIENT4B9XT59T7SZIDOVUDINE TABLET, FILM COATED [REBEL DISTRIBUTORS CORP]1
ZIDOVUDINEACTIVE INGREDIENT4B9XT59T7SZIDOVUDINE TABLET, FILM COATED [STATE OF FLORIDA DOH CENTRAL PHARMACY]1
ZIDOVUDINEACTIVE MOIETY4B9XT59T7SZIDOVUDINE TABLET, FILM COATED [STATE OF FLORIDA DOH CENTRAL PHARMACY]1
ZIDOVUDINEACTIVE MOIETY4B9XT59T7SZIDOVUDINE TABLET, FILM COATED [REBEL DISTRIBUTORS CORP]1
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UZIDOVUDINE TABLET, FILM COATED [REBEL DISTRIBUTORS CORP]1
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UZIDOVUDINE TABLET, FILM COATED [STATE OF FLORIDA DOH CENTRAL PHARMACY]1
HYPROMELLOSEINACTIVE INGREDIENT3NXW29V3WOZIDOVUDINE TABLET, FILM COATED [STATE OF FLORIDA DOH CENTRAL PHARMACY]1
HYPROMELLOSESINACTIVE INGREDIENT3NXW29V3WOZIDOVUDINE TABLET, FILM COATED [REBEL DISTRIBUTORS CORP]1
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30ZIDOVUDINE TABLET, FILM COATED [STATE OF FLORIDA DOH CENTRAL PHARMACY]1
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30ZIDOVUDINE TABLET, FILM COATED [REBEL DISTRIBUTORS CORP]1
POLYETHYLENE GLYCOLINACTIVE INGREDIENT3WJQ0SDW1AZIDOVUDINE TABLET, FILM COATED [STATE OF FLORIDA DOH CENTRAL PHARMACY]1
POLYETHYLENE GLYCOLINACTIVE INGREDIENT3WJQ0SDW1AZIDOVUDINE TABLET, FILM COATED [REBEL DISTRIBUTORS CORP]1
SODIUM STARCH GLYCOLATE TYPE A POTATOINACTIVE INGREDIENT5856J3G2A2ZIDOVUDINE TABLET, FILM COATED [STATE OF FLORIDA DOH CENTRAL PHARMACY]1
SODIUM STARCH GLYCOLATE TYPE A POTATOINACTIVE INGREDIENT5856J3G2A2ZIDOVUDINE TABLET, FILM COATED [REBEL DISTRIBUTORS CORP]1
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPZIDOVUDINE TABLET, FILM COATED [STATE OF FLORIDA DOH CENTRAL PHARMACY]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
65862-024ZIDOVUDINE TABLET, FILM COATED [AUROBINDO PHARMA LIMITED]22Current NDC, Legacy NDC, 3 package rows20240130_e7c8ddef-005d-4f1c-8c1a-ea84044ab4d4.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
199663zidovudine 300 MG Oral TabletPSNe7c8ddef-005d-4f1c-8c1a-ea84044ab4d422
199663zidovudine 300 MG Oral TabletSCDe7c8ddef-005d-4f1c-8c1a-ea84044ab4d422
199663AZT 300 MG Oral TabletSYe7c8ddef-005d-4f1c-8c1a-ea84044ab4d422
199663zidovudine 300 MG Oral TabletPSN9a2c643d-5c5f-4427-804d-8b0eb97971574
199663zidovudine 300 MG Oral TabletSCD9a2c643d-5c5f-4427-804d-8b0eb97971574
199663AZT 300 MG Oral TabletSY9a2c643d-5c5f-4427-804d-8b0eb97971574
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 formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
65862-024-10658620024106 BLISTER PACK in 1 CARTON (65862-024-10) / 10 TABLET, FILM COATED in 1 BLISTER PACK6 blister pack2005-09-190000-00-00NoNoCurrent
65862-024-606586200246060 TABLET, FILM COATED in 1 BOTTLE (65862-024-60) 2005-09-190000-00-00NoNoCurrent