NDC 35573-402

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 Burel Pharma. The primary component is Abacavir Sulfate; Lamivudine.

Product ID35573-402_3f620fa4-3749-4080-ab3c-92b3f8120de8
NDC35573-402
Product TypeHuman Prescription Drug
Proprietary NameAbacavir and Lamivudine
Generic NameAbacavir And Lamivudine
Dosage FormTablet, Film Coated
Route of AdministrationORAL
Marketing Start Date2017-03-28
Marketing CategoryANDA / ANDA
Application NumberANDA206151
Labeler NameBurel Pharma
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 Through2020-12-31

Packaging

NDC 35573-402-30

1 BOTTLE in 1 CARTON (35573-402-30) > 30 TABLET, FILM COATED in 1 BOTTLE
Marketing Start Date2017-03-28
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 35573-402-30 [35573040230]

Abacavir and Lamivudine TABLET, FILM COATED
Marketing CategoryANDA
Application NumberANDA206151
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2017-03-28

Drug Details

Active Ingredients

IngredientStrength
ABACAVIR SULFATE600 mg/1

OpenFDA Data

SPL SET ID:9d86b3a9-2222-49e4-ba7f-c307a8f7f9f7
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]

    Medicade Reported Pricing

    35573040230 ABACAVIR-LAMIVUDINE 600-300 MG

    Pricing Unit: EA | Drug Type:

    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

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