NDC 57297-286

ABACAVIR SULFATE, LAMIVUDINE AND ZIDOVUDINE

Abacavir Sulfate, Lamivudine And Zidovudine

ABACAVIR SULFATE, LAMIVUDINE AND ZIDOVUDINE is a Oral Tablet in the Human Prescription Drug category. It is labeled and distributed by Lupin Limited. The primary component is Lamivudine; Zidovudine; Abacavir Sulfate.

Product ID57297-286_24150f6d-980b-4a8f-bf76-6308c091ed56
NDC57297-286
Product TypeHuman Prescription Drug
Proprietary NameABACAVIR SULFATE, LAMIVUDINE AND ZIDOVUDINE
Generic NameAbacavir Sulfate, Lamivudine And Zidovudine
Dosage FormTablet
Route of AdministrationORAL
Marketing Start Date2013-12-17
Marketing CategoryANDA / ANDA
Application NumberANDA202912
Labeler NameLUPIN LIMITED
Substance NameLAMIVUDINE; ZIDOVUDINE; ABACAVIR SULFATE
Active Ingredient Strength150 mg/1; mg/1; mg/1
Pharm ClassesHepatitis 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],Human Immunodeficiency Virus Nucleoside Analog Reverse Transcriptase Inhibitor [EPC],Nucleoside Analog [EXT],Nucleoside Reverse Transcriptase Inhibitors [MoA],Human Immunodeficiency Virus Nucleoside Analog Reverse Transcriptase Inhibitor [EPC],Nucleoside Analog [EXT],Nucleoside Reverse Transcriptase Inhibitors [MoA]
NDC Exclude FlagE
Listing Certified Through2017-12-31

Packaging

NDC 57297-286-02

1 BOTTLE in 1 CARTON (57297-286-02) > 500 TABLET in 1 BOTTLE
Marketing Start Date2013-12-17
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 57297-286-01 [57297028601]

ABACAVIR SULFATE, LAMIVUDINE AND ZIDOVUDINE TABLET
Marketing CategoryANDA
Application NumberANDA202912
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2013-12-17
Inactivation Date2020-01-31

NDC 57297-286-07 [57297028607]

ABACAVIR SULFATE, LAMIVUDINE AND ZIDOVUDINE TABLET
Marketing CategoryANDA
Application NumberANDA202912
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2013-12-17
Inactivation Date2020-01-31

NDC 57297-286-02 [57297028602]

ABACAVIR SULFATE, LAMIVUDINE AND ZIDOVUDINE TABLET
Marketing CategoryANDA
Application NumberANDA202912
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2013-12-17
Inactivation Date2020-01-31

Drug Details

Active Ingredients

IngredientStrength
LAMIVUDINE150 mg/1

OpenFDA Data

SPL SET ID:18dc6cc7-ec64-4730-941c-8a9ad5dcb252
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 307650
  • Pharmacological Class

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

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