NDC 0378-6106

Zidovudine

Zidovudine

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

Product ID0378-6106_dbd4caa5-9aae-4de9-a0ca-f9e9d4a97a55
NDC0378-6106
Product TypeHuman Prescription Drug
Proprietary NameZidovudine
Generic NameZidovudine
Dosage FormTablet, Film Coated
Route of AdministrationORAL
Marketing Start Date2008-12-19
Marketing End Date2020-11-30
Marketing CategoryANDA / ANDA
Application NumberANDA078922
Labeler NameMylan Pharmaceuticals Inc.
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

Packaging

NDC 0378-6106-91

60 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (0378-6106-91)
Marketing Start Date2008-12-19
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 0378-6106-91 [00378610691]

Zidovudine TABLET, FILM COATED
Marketing CategoryANDA
Application NumberANDA078922
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2008-12-19
Marketing End Date2020-11-30

Drug Details

Active Ingredients

IngredientStrength
ZIDOVUDINE300 mg/1

OpenFDA Data

SPL SET ID:cd3f2a72-3f01-49ba-9efe-9f2e6fedbd01
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]
    • 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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