Zidovudine

Product NDC
67046-1613
11-digit product format
670461613
Labeler code
67046
Product ID
67046-1613_48c0ccac-2fe3-0fe2-e063-6294a90a2a9c
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Zidovudine
Dosage form
TABLET
Route
ORAL
Labeler
Coupler LLC
Application
ANDA090092
Marketing category
ANDA
Marketing start
2025-11-13
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
2027-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Zidovudine
Listing expiration
2027-12-31

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
67046-1613-3Zidovudine30 in 1 BLISTER PACKTABLET302

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
199663zidovudine 300 MG Oral TabletPSN437f55b2-f6d9-0065-e063-6294a90ab9292
199663zidovudine 300 MG Oral TabletSCD437f55b2-f6d9-0065-e063-6294a90ab9292
199663AZT 300 MG Oral TabletSY437f55b2-f6d9-0065-e063-6294a90ab9292

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
67046-1613-36704616130330 TABLET in 1 BLISTER PACK (67046-1613-3) 30 tablet2025-11-13NoNoHistorical