NDC 53104-0101

Zidovudine

Zidovudine

Zidovudine is a Oral Tablet, Film Coated in the Human Prescription Drug category. It is labeled and distributed by Cipla Ltd.. The primary component is Zidovudine.

Product ID53104-0101_8ead5c26-8bc3-40ea-9739-df8d6738097e
NDC53104-0101
Product TypeHuman Prescription Drug
Proprietary NameZidovudine
Generic NameZidovudine
Dosage FormTablet, Film Coated
Route of AdministrationORAL
Marketing Start Date2010-10-27
Marketing CategoryANDA / ANDA
Application NumberANDA090561
Labeler NameCipla Ltd.
Substance NameZIDOVUDINE
Active Ingredient Strength300 mg/1
Pharm ClassesHuman Immunodeficiency Virus Nucleoside Analog Reverse Transcriptase Inhibitor [EPC],Nucleoside Analog [EXT],Nucleoside Reverse Transcriptase Inhibitors [MoA]
NDC Exclude FlagN
Listing Certified Through2019-12-31

Packaging

NDC 53104-0101-2

60 TABLET, FILM COATED in 1 BOTTLE (53104-0101-2)
Marketing Start Date2010-10-27
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 53104-0101-2 [53104010102]

Zidovudine TABLET, FILM COATED
Marketing CategoryANDA
Application NumberANDA090561
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2010-10-27

NDC 53104-0101-9 [53104010109]

Zidovudine TABLET, FILM COATED
Marketing CategoryANDA
Application NumberANDA090561
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2010-10-27

NDC 53104-0101-6 [53104010106]

Zidovudine TABLET, FILM COATED
Marketing CategoryANDA
Application NumberANDA090561
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2010-10-27

Drug Details

Active Ingredients

IngredientStrength
ZIDOVUDINE300 mg/1

OpenFDA Data

SPL SET ID:29489c0e-e981-4bc0-beaf-05c9a9c55c1f
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 199663

    • Pharmacological Class

    • Human Immunodeficiency Virus Nucleoside Analog Reverse Transcriptase Inhibitor [EPC]
    • Nucleoside Analog [EXT]
    • Nucleoside Reverse Transcriptase Inhibitors [MoA]

    NDC Crossover Matching brand name "Zidovudine" or generic name "Zidovudine"

    NDCBrand NameGeneric Name
    0378-6106Zidovudinezidovudine
    0527-1905ZidovudineZidovudine
    21695-369ZidovudineZIDOVUDINE
    31722-509ZidovudineZidovudine
    52343-044ZidovudineZidovudine
    52343-045ZidovudineZidovudine
    53104-0100Zidovudinezidovudine
    53104-0101ZidovudineZidovudine
    53104-0105zidovudinezidovudine
    53808-0812ZidovudineZIDOVUDINE
    53808-0878Zidovudinezidovudine
    57237-241ZidovudineZidovudine
    65862-024ZidovudineZidovudine
    65862-048ZidovudineZidovudine
    65862-107ZidovudineZidovudine
    70518-1656ZidovudineZidovudine
    49702-211RETROVIRzidovudine
    49702-212RETROVIRzidovudine
    49702-213RETROVIRzidovudine
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