NDC 53104-0105

zidovudine

Zidovudine

zidovudine is a Oral Syrup in the Human Prescription Drug category. It is labeled and distributed by Cipla Ltd.. The primary component is Zidovudine.

Product ID53104-0105_e94ab1eb-51f3-4cb0-a4de-f3b93d3943b7
NDC53104-0105
Product TypeHuman Prescription Drug
Proprietary Namezidovudine
Generic NameZidovudine
Dosage FormSyrup
Route of AdministrationORAL
Marketing Start Date2008-06-26
Marketing CategoryANDA / ANDA
Application NumberANDA077981
Labeler NameCipla Ltd.
Substance NameZIDOVUDINE
Active Ingredient Strength50 mg/5mL
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 53104-0105-9

240 mL in 1 BOTTLE (53104-0105-9)
Marketing Start Date2008-06-26
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 53104-0105-9 [53104010509]

zidovudine SYRUP
Marketing CategoryANDA
Application NumberANDA077981
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2008-06-26
Inactivation Date2020-01-31

NDC 53104-0105-4 [53104010504]

zidovudine SYRUP
Marketing CategoryANDA
Application NumberANDA077981
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2008-06-26
Marketing End Date2017-04-20

Drug Details

Active Ingredients

IngredientStrength
ZIDOVUDINE50 mg/5mL

OpenFDA Data

SPL SET ID:e62ae0e4-0689-431a-a552-f0711ca68844
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 756209

    • 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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