NDC 70771-1053

Abacavir and lamivudine

Abacavir And Lamivudine

Abacavir and lamivudine is a Oral Tablet, Film Coated in the Human Prescription Drug category. It is labeled and distributed by Zydus Lifesciences Limited. The primary component is Abacavir Sulfate; Lamivudine.

Product ID70771-1053_1ee80147-458b-4e6b-9dce-d4286b9d1634
NDC70771-1053
Product TypeHuman Prescription Drug
Proprietary NameAbacavir and lamivudine
Generic NameAbacavir And Lamivudine
Dosage FormTablet, Film Coated
Route of AdministrationORAL
Marketing Start Date2019-03-14
Marketing CategoryANDA / ANDA
Application NumberANDA208990
Labeler NameZydus Lifesciences Limited
Substance NameABACAVIR SULFATE; LAMIVUDINE
Active Ingredient Strength600 mg/1; mg/1
Pharm ClassesCytochrome P450 1A1 Inhibitors [MoA], Hepatitis B Virus Nucleoside Analog Reverse Transcriptase Inhibitor [EPC], Human Immunodeficiency Virus Nucleoside Analog Reverse Transcriptase Inhibitor [EPC], Human Immunodeficiency Virus Nucleoside Analog Reverse Transcriptase Inhibitor [EPC], Nucleoside Reverse Transcriptase Inhibitors [MoA], Nucleoside Reverse Transcriptase Inhibitors [MoA]
NDC Exclude FlagN
Listing Certified Through2023-12-31

Packaging

NDC 70771-1053-3

30 TABLET, FILM COATED in 1 BOTTLE (70771-1053-3)
Marketing Start Date2019-03-14
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 70771-1053-3 [70771105303]

Abacavir and lamivudine TABLET, FILM COATED
Marketing CategoryANDA
Application NumberANDA208990
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2019-03-14

NDC 70771-1053-9 [70771105309]

Abacavir and lamivudine TABLET, FILM COATED
Marketing CategoryANDA
Application NumberANDA208990
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2019-03-14

Drug Details

Active Ingredients

IngredientStrength
ABACAVIR SULFATE600 mg/1

OpenFDA Data

SPL SET ID:3709b07b-a37d-4ffb-92fa-5c0dd9b973b7
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 602393

    • Pharmacological Class

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

    NDC Crossover Matching brand name "Abacavir and lamivudine" or generic name "Abacavir And Lamivudine"

    NDCBrand NameGeneric Name
    0093-5382Abacavir and LamivudineAbacavir and Lamivudine
    35573-402Abacavir and LamivudineAbacavir and Lamivudine
    35573-430Abacavir and LamivudineAbacavir and Lamivudine
    42291-115Abacavir and LamivudineAbacavir and Lamivudine
    42385-962Abacavir and LamivudineAbacavir and Lamivudine
    65862-335Abacavir and LamivudineAbacavir and Lamivudine
    65862-900Abacavir and LamivudineAbacavir and Lamivudine
    66993-482Abacavir and Lamivudineabacavir sulfate and lamivudine
    68180-288Abacavir and LamivudineAbacavir and Lamivudine
    69097-362Abacavir and LamivudineAbacavir and lamivudine
    70518-0715Abacavir and LamivudineAbacavir and Lamivudine
    70710-1049Abacavir and lamivudineAbacavir and lamivudine
    70771-1053Abacavir and lamivudineAbacavir and lamivudine
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