NDC 53104-0100

Zidovudine

Zidovudine

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

Product ID53104-0100_412da56b-a627-40fa-a943-900540bdd9ae
NDC53104-0100
Product TypeHuman Prescription Drug
Proprietary NameZidovudine
Generic NameZidovudine
Dosage FormCapsule
Route of AdministrationORAL
Marketing Start Date2007-05-23
Marketing CategoryANDA / ANDA
Application NumberANDA078349
Labeler NameCipla Ltd.
Substance NameZIDOVUDINE
Active Ingredient Strength100 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 53104-0100-6

1000 CAPSULE in 1 BOTTLE (53104-0100-6)
Marketing Start Date2007-05-23
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 53104-0100-9 [53104010009]

Zidovudine CAPSULE
Marketing CategoryANDA
Application NumberANDA078349
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2007-05-23
Marketing End Date2011-10-05

NDC 53104-0100-4 [53104010004]

Zidovudine CAPSULE
Marketing CategoryANDA
Application NumberANDA078349
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2007-05-23
Inactivation Date2020-01-31

NDC 53104-0100-6 [53104010006]

Zidovudine CAPSULE
Marketing CategoryANDA
Application NumberANDA078349
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2007-05-23
Inactivation Date2020-01-31

Drug Details

Active Ingredients

IngredientStrength
ZIDOVUDINE100 mg/1

OpenFDA Data

SPL SET ID:536735fc-566c-4ad4-b83e-602199ff82b4
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 198352

    • 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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