NDC 65862-335

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 Aurobindo Pharma Limited. The primary component is Abacavir Sulfate; Lamivudine.

Product ID65862-335_1e359fe5-1c90-4bf7-9b09-e3449fa9cbcc
NDC65862-335
Product TypeHuman Prescription Drug
Proprietary NameAbacavir and Lamivudine
Generic NameAbacavir And Lamivudine
Dosage FormTablet, Film Coated
Route of AdministrationORAL
Marketing Start Date2018-11-15
Marketing CategoryANDA / ANDA
Application NumberANDA090159
Labeler NameAurobindo Pharma Limited
Substance NameABACAVIR SULFATE; LAMIVUDINE
Active Ingredient Strength600 mg/1; mg/1
Pharm ClassesHuman 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 Exclude FlagN
Listing Certified Through2022-12-31

Packaging

NDC 65862-335-10

10 BLISTER PACK in 1 CARTON (65862-335-10) > 10 TABLET, FILM COATED in 1 BLISTER PACK
Marketing Start Date2018-11-15
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 65862-335-10 [65862033510]

abacavir and lamivudine TABLET, FILM COATED
Marketing CategoryANDA
Application NumberANDA090159
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2018-11-15

NDC 65862-335-30 [65862033530]

abacavir and lamivudine TABLET, FILM COATED
Marketing CategoryANDA
Application NumberANDA090159
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2018-11-15

Drug Details

Active Ingredients

IngredientStrength
ABACAVIR SULFATE600 mg/1

OpenFDA Data

SPL SET ID:deda1a24-2f51-4601-9881-347f47270940
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 602393
    • UPC Code
  • 0365862335302

    • 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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