NDC 70518-1274

Abacavir

Abacavir

Abacavir is a Oral Tablet, Film Coated in the Human Prescription Drug category. It is labeled and distributed by Remedyrepack Inc.. The primary component is Abacavir Sulfate.

Product ID70518-1274_6f2e76fd-e705-35f2-e053-2a91aa0a2aa6
NDC70518-1274
Product TypeHuman Prescription Drug
Proprietary NameAbacavir
Generic NameAbacavir
Dosage FormTablet, Film Coated
Route of AdministrationORAL
Marketing Start Date2018-06-21
Marketing CategoryANDA / ANDA
Application NumberANDA078119
Labeler NameREMEDYREPACK INC.
Substance NameABACAVIR SULFATE
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 70518-1274-0

30 TABLET, FILM COATED in 1 BLISTER PACK (70518-1274-0)
Marketing Start Date2018-06-21
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 70518-1274-0 [70518127400]

Abacavir TABLET, FILM COATED
Marketing CategoryANDA
Application NumberANDA078119
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2018-06-21

Drug Details

Active Ingredients

IngredientStrength
ABACAVIR SULFATE300 mg/1

OpenFDA Data

SPL SET ID:4dd14728-02b4-4e75-b9c6-227be7816d5b
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 242679
  • Pharmacological Class

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

    NDC Crossover Matching brand name "Abacavir" or generic name "Abacavir"

    NDCBrand NameGeneric Name
    0121-0897AbacavirAbacavir
    0904-6874AbacavirAbacavir
    31722-557AbacavirAbacavir
    31722-562AbacavirAbacavir
    50268-049AbacavirAbacavir
    64380-717AbacavirAbacavir
    64980-405AbacavirAbacavir Sulfate
    65862-073AbacavirAbacavir
    65862-089AbacavirAbacavir Sulfate
    68084-021AbacavirAbacavir Sulfate
    69097-514AbacavirAbacavir
    70518-0559AbacavirAbacavir
    70518-1274AbacavirAbacavir
    72865-167AbacavirAbacavir

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