NDC 53808-0878

Zidovudine

Zidovudine

Zidovudine is a Oral Tablet, Film Coated in the Human Prescription Drug category. It is labeled and distributed by State Of Florida Doh Central Pharmacy. The primary component is Zidovudine.

Product ID53808-0878_0602ce68-264c-4b34-b2f0-fb0f623bbde3
NDC53808-0878
Product TypeHuman Prescription Drug
Proprietary NameZidovudine
Generic NameZidovudine
Dosage FormTablet, Film Coated
Route of AdministrationORAL
Marketing Start Date2013-01-01
Marketing CategoryANDA / ANDA
Application NumberANDA078922
Labeler NameState of Florida DOH Central Pharmacy
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 53808-0878-2

60 TABLET, FILM COATED in 1 BLISTER PACK (53808-0878-2)
Marketing Start Date2013-01-01
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 53808-0878-2 [53808087802]

Zidovudine TABLET, FILM COATED
Marketing CategoryANDA
Application NumberANDA078922
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2013-01-01
Inactivation Date2020-01-31

Drug Details

Active Ingredients

IngredientStrength
ZIDOVUDINE300 mg/1

OpenFDA Data

SPL SET ID:4ccc8192-fc3a-4671-a7ce-5565a7b5aaef
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

    © 2024 FDA.report
    This site is not affiliated with or endorsed by the FDA.