NDC 50268-805

Zafirlukast

Zafirlukast

Zafirlukast is a Oral Tablet, Film Coated in the Human Prescription Drug category. It is labeled and distributed by Avpak. The primary component is Zafirlukast.

Product ID50268-805_6e14570e-933d-7f1b-e053-2991aa0aa8a0
NDC50268-805
Product TypeHuman Prescription Drug
Proprietary NameZafirlukast
Generic NameZafirlukast
Dosage FormTablet, Film Coated
Route of AdministrationORAL
Marketing Start Date2017-09-15
Marketing CategoryANDA / ANDA
Application NumberANDA090372
Labeler NameAvPAK
Substance NameZAFIRLUKAST
Active Ingredient Strength20 mg/1
Pharm ClassesLeukotriene Receptor Antagonists [MoA],Cytochrome P450 2C9 Inhibitors [MoA],Leukotriene Receptor Antagonist [EPC]
NDC Exclude FlagN
Listing Certified Through2019-12-31

Packaging

NDC 50268-805-12

20 BLISTER PACK in 1 BOX, UNIT-DOSE (50268-805-12) > 1 TABLET, FILM COATED in 1 BLISTER PACK (50268-805-11)
Marketing Start Date2017-09-15
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 50268-805-12 [50268080512]

Zafirlukast TABLET, FILM COATED
Marketing CategoryANDA
Application NumberANDA090372
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2017-09-15

NDC 50268-805-11 [50268080511]

Zafirlukast TABLET, FILM COATED
Marketing CategoryANDA
Application NumberANDA090372
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2017-09-15

Drug Details

Active Ingredients

IngredientStrength
ZAFIRLUKAST20 mg/1

OpenFDA Data

SPL SET ID:5e52e5ca-0cab-48c3-993e-f737e978a8c1
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 199655
  • Pharmacological Class

    • Leukotriene Receptor Antagonists [MoA]
    • Cytochrome P450 2C9 Inhibitors [MoA]
    • Leukotriene Receptor Antagonist [EPC]

    Medicade Reported Pricing

    50268080512 ZAFIRLUKAST 20 MG TABLET

    Pricing Unit: EA | Drug Type:

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

    NDCBrand NameGeneric Name
    0904-6646Zafirlukastzafirlukast
    16571-654ZafirlukastZafirlukast
    16571-655ZafirlukastZafirlukast Tablets
    31722-007ZafirlukastZafirlukast
    31722-008ZafirlukastZafirlukast
    49884-549Zafirlukastzafirlukast
    49884-554Zafirlukastzafirlukast
    50268-805ZafirlukastZafirlukast
    55111-625ZafirlukastZafirlukast
    55111-626ZafirlukastZafirlukast
    63629-2102Zafirlukastzafirlukast
    64380-187Zafirlukastzafirlukast
    64380-188Zafirlukastzafirlukast
    68084-059ZafirlukastZafirlukast
    68151-1977ZafirlukastZafirlukast
    49884-010ACCOLATEzafirlukast
    49884-011ACCOLATEzafirlukast
    49884-589Accolatezafirlukast
    49884-590Accolatezafirlukast
    53808-0203ACCOLATEZafirlukast
    64380-177ACCOLATEZafirlukast
    64380-178ACCOLATEZafirlukast

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