Zidovudine

Product NDC
65862-048
11-digit product format
658620048
Labeler code
65862
Product ID
65862-048_19584bb3-e849-4839-961f-c38bb07a4e8c
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Zidovudine
Dosage form
SYRUP
Route
ORAL
Labeler
Aurobindo Pharma Limited
Application
ANDA077268
Marketing category
ANDA
Marketing start
2005-09-19
Substance
ZIDOVUDINE
Active strength
10 mg/mL
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
ZIDOVUDINE10 mg/mL

Harmonized Identifiers#

Field, Values table
FieldValues
Unii4B9XT59T7S
Rxcui756209

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
65862-048-24Zidovudine240 mL in 1 BOTTLESYRUP24022

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
65862-048-24ML - Milliliter65862-0486f5ffd36-8abe-4a16-805b-d0e2f548d3ee12012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
ZIDOVUDINEACTIVE INGREDIENT4B9XT59T7SZIDOVUDINE SYRUP [AUROBINDO PHARMA LIMITED]12
ZIDOVUDINEACTIVE MOIETY4B9XT59T7SZIDOVUDINE SYRUP [AUROBINDO PHARMA LIMITED]12
ANHYDROUS CITRIC ACIDINACTIVE INGREDIENTXF417D3PSLZIDOVUDINE SYRUP [AUROBINDO PHARMA LIMITED]12
GLYCERININACTIVE INGREDIENTPDC6A3C0OXZIDOVUDINE SYRUP [AUROBINDO PHARMA LIMITED]12
SODIUM BENZOATEINACTIVE INGREDIENTOJ245FE5EUZIDOVUDINE SYRUP [AUROBINDO PHARMA LIMITED]12
SUCROSEINACTIVE INGREDIENTC151H8M554ZIDOVUDINE SYRUP [AUROBINDO PHARMA LIMITED]12

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
65862-048ZIDOVUDINE SYRUP [AUROBINDO PHARMA LIMITED]22Current NDC, Legacy NDC, 1 package rows20250216_51abd2ce-6be1-412d-b806-5f24935ac5e3.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
756209zidovudine 10 MG in 1 mL Oral SolutionPSN51abd2ce-6be1-412d-b806-5f24935ac5e322
756209zidovudine 10 MG/ML Oral SolutionSCD51abd2ce-6be1-412d-b806-5f24935ac5e322
756209AZT 10 MG/ML Oral SolutionSY51abd2ce-6be1-412d-b806-5f24935ac5e322
756209zidovudine 10 MG per 1 ML Oral SolutionSY51abd2ce-6be1-412d-b806-5f24935ac5e322

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
65862-048-2465862004824240 mL in 1 BOTTLE (65862-048-24) 240 ml2005-09-190000-00-00NoNoCurrent