NDC 0904-6523

Abacavir Sulfate

Abacavir Sulfate

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

Product ID0904-6523_1c588af2-3239-4c81-9337-0c3ba5d261f0
NDC0904-6523
Product TypeHuman Prescription Drug
Proprietary NameAbacavir Sulfate
Generic NameAbacavir Sulfate
Dosage FormTablet, Film Coated
Route of AdministrationORAL
Marketing Start Date2012-12-17
Marketing CategoryANDA / ANDA
Application NumberANDA201570
Labeler NameMajor Pharmaceuticals
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 0904-6523-04

30 BLISTER PACK in 1 CARTON (0904-6523-04) > 1 TABLET, FILM COATED in 1 BLISTER PACK
Marketing Start Date2012-12-17
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 0904-6523-06 [00904652306]

Abacavir Sulfate TABLET, FILM COATED
Marketing CategoryANDA
Application NumberANDA201570
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2012-12-17

NDC 0904-6523-04 [00904652304]

Abacavir Sulfate TABLET, FILM COATED
Marketing CategoryANDA
Application NumberANDA201570
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2012-12-17

Drug Details

Active Ingredients

IngredientStrength
ABACAVIR SULFATE300 mg/1

OpenFDA Data

SPL SET ID:35267d2b-9a97-43d6-a7e7-1cb47ea009df
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 242679
  • UPC Code
  • 0309046523048
  • 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 Sulfate" or generic name "Abacavir Sulfate"

    NDCBrand NameGeneric Name
    0378-4105Abacavir Sulfateabacavir sulfate
    0904-6523Abacavir SulfateAbacavir Sulfate
    51079-204Abacavir Sulfateabacavir sulfate
    53808-0627Abacavir Sulfateabacavir sulfate
    60505-3583Abacavir SulfateAbacavir Sulfate
    70518-0640Abacavir SulfateAbacavir Sulfate
    64980-405AbacavirAbacavir Sulfate
    65862-089AbacavirAbacavir Sulfate
    68084-021AbacavirAbacavir Sulfate
    49702-221ZIAGENabacavir sulfate
    49702-222ZIAGENabacavir sulfate
    53808-0811ZIAGENabacavir sulfate

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