NDC 51079-204

Abacavir Sulfate

Abacavir Sulfate

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

Product ID51079-204_7b1fe14c-856e-2e18-e053-2a91aa0ae072
NDC51079-204
Product TypeHuman Prescription Drug
Proprietary NameAbacavir Sulfate
Generic NameAbacavir Sulfate
Dosage FormTablet, Film Coated
Route of AdministrationORAL
Marketing Start Date2012-08-01
Marketing CategoryANDA / ANDA
Application NumberANDA091294
Labeler NameMylan Institutional 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 51079-204-06

50 BLISTER PACK in 1 CARTON (51079-204-06) > 1 TABLET, FILM COATED in 1 BLISTER PACK (51079-204-01)
Marketing Start Date2012-08-01
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 51079-204-01 [51079020401]

Abacavir Sulfate TABLET, FILM COATED
Marketing CategoryANDA
Application NumberANDA091294
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2012-08-01

NDC 51079-204-06 [51079020406]

Abacavir Sulfate TABLET, FILM COATED
Marketing CategoryANDA
Application NumberANDA091294
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2012-08-01

Drug Details

Active Ingredients

IngredientStrength
ABACAVIR SULFATE300 mg/1

OpenFDA Data

SPL SET ID:80c1702a-973c-436a-90f8-69b29674dca0
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]

    Medicade Reported Pricing

    51079020406 ABACAVIR 300 MG TABLET

    Pricing Unit: EA | Drug Type:

    51079020401 ABACAVIR 300 MG TABLET

    Pricing Unit: EA | Drug Type:

    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

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