Zidovudine

Product NDC
65862-107
11-digit product format
658620107
Labeler code
65862
Product ID
65862-107_6da825d2-eacc-4a7d-98dc-7af924a9af92
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Zidovudine
Dosage form
CAPSULE
Route
ORAL
Labeler
Aurobindo Pharma Limited
Application
ANDA078128
Marketing category
ANDA
Marketing start
2006-03-27
Substance
ZIDOVUDINE
Active strength
100 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
ZIDOVUDINE100 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii4B9XT59T7S
Rxcui198352

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
65862-107-01Zidovudine100 in 1 BOTTLECAPSULE10019
65862-107-10Zidovudine10 in 1 BLISTER PACKCAPSULE1019
65862-107-10Zidovudine10 in 1 CARTONCAPSULE1019

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
65862-107-01EA - Each65862-10760db3b9b-89f1-4a78-a5e1-b82ca587294012013-02-13

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
ZIDOVUDINEACTIVE INGREDIENT4B9XT59T7SZIDOVUDINE CAPSULE [AUROBINDO PHARMA LIMITED]9
ZIDOVUDINEACTIVE MOIETY4B9XT59T7SZIDOVUDINE CAPSULE [AUROBINDO PHARMA LIMITED]9
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UZIDOVUDINE CAPSULE [AUROBINDO PHARMA LIMITED]9
FERROSOFERRIC OXIDEINACTIVE INGREDIENTXM0M87F357ZIDOVUDINE CAPSULE [AUROBINDO PHARMA LIMITED]9
GELATININACTIVE INGREDIENT2G86QN327LZIDOVUDINE CAPSULE [AUROBINDO PHARMA LIMITED]9
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30ZIDOVUDINE CAPSULE [AUROBINDO PHARMA LIMITED]9
SHELLACINACTIVE INGREDIENT46N107B71OZIDOVUDINE CAPSULE [AUROBINDO PHARMA LIMITED]9
SODIUM LAURYL SULFATEINACTIVE INGREDIENT368GB5141JZIDOVUDINE CAPSULE [AUROBINDO PHARMA LIMITED]9
SODIUM STARCH GLYCOLATE TYPE A POTATOINACTIVE INGREDIENT5856J3G2A2ZIDOVUDINE CAPSULE [AUROBINDO PHARMA LIMITED]9
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJZIDOVUDINE CAPSULE [AUROBINDO PHARMA LIMITED]9
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPZIDOVUDINE CAPSULE [AUROBINDO PHARMA LIMITED]9

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
65862-107ZIDOVUDINE CAPSULE [AUROBINDO PHARMA LIMITED]19Current NDC, Legacy NDC, 3 package rows20250216_9907acb2-e4a0-46f9-93c0-a8d7b7ce98cf.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
198352zidovudine 100 MG Oral CapsulePSN9907acb2-e4a0-46f9-93c0-a8d7b7ce98cf19
198352zidovudine 100 MG Oral CapsuleSCD9907acb2-e4a0-46f9-93c0-a8d7b7ce98cf19
198352AZT 100 MG Oral CapsuleSY9907acb2-e4a0-46f9-93c0-a8d7b7ce98cf19

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
65862-107-0165862010701100 CAPSULE in 1 BOTTLE (65862-107-01) 100 capsule2006-03-270000-00-00NoNoCurrent
65862-107-106586201071010 BLISTER PACK in 1 CARTON (65862-107-10) / 10 CAPSULE in 1 BLISTER PACK10 blister pack2006-03-270000-00-00NoNoCurrent