NDC 49884-011

ACCOLATE

Zafirlukast

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

Product ID49884-011_47ad879f-77c0-4955-a5a1-783aaa19d59f
NDC49884-011
Product TypeHuman Prescription Drug
Proprietary NameACCOLATE
Generic NameZafirlukast
Dosage FormTablet, Film Coated
Route of AdministrationORAL
Marketing Start Date2015-01-09
Marketing CategoryNDA / NDA
Application NumberNDA020547
Labeler NamePar Pharmaceutical Inc.
Substance NameZAFIRLUKAST
Active Ingredient Strength20 mg/1
Pharm ClassesLeukotriene Rec
NDC Exclude FlagE
Listing Certified Through2017-12-31

Packaging

NDC 49884-011-02

60 TABLET, FILM COATED in 1 BOTTLE (49884-011-02)
Marketing Start Date2015-01-09
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 49884-011-02 [49884001102]

ACCOLATE TABLET, FILM COATED
Marketing CategoryNDA
Application NumberNDA020547
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2015-01-09
Marketing End Date2017-09-30

Drug Details

Active Ingredients

IngredientStrength
ZAFIRLUKAST20 mg/1

OpenFDA Data

SPL SET ID:47ad879f-77c0-4955-a5a1-783aaa19d59f
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 211776
  • 313758
  • 261313
  • 199655
    • UPC Code
  • 0349884011024
  • 0349884010027

    • Pharmacological Class

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

    Medicade Reported Pricing

    49884011710 AMILORIDE HCL 5 MG TABLET

    Pricing Unit: EA | Drug Type:

    49884011701 AMILORIDE HCL 5 MG TABLET

    Pricing Unit: EA | Drug Type:

    49884011309 PROPAFENONE HCL ER 225 MG CAP

    Pricing Unit: EA | Drug Type:

    49884011305 PROPAFENONE HCL ER 225 MG CAP

    Pricing Unit: EA | Drug Type:

    49884011302 PROPAFENONE HCL ER 225 MG CAP

    Pricing Unit: EA | Drug Type:

    49884011174 ALPRAZOLAM ODT 0.5 MG TAB

    Pricing Unit: EA | Drug Type:

    49884011152 ALPRAZOLAM ODT 0.5 MG TAB

    Pricing Unit: EA | Drug Type:

    49884011074 ALPRAZOLAM ODT 0.25 MG TAB

    Pricing Unit: EA | Drug Type:

    49884001102 ACCOLATE 20 MG TABLET

    Pricing Unit: EA | Drug Type:

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

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

    Trademark Results [ACCOLATE]

    Mark Image

    Registration | Serial
    Company
    Trademark
    Application Date
    ACCOLATE
    ACCOLATE
    74671240 2009635 Live/Registered
    PAR PHARMACEUTICAL, INC.
    1995-05-08
    ACCOLATE
    ACCOLATE
    74263467 1835117 Live/Registered
    PAR PHARMACEUTICAL, INC.
    1992-04-07
    ACCOLATE
    ACCOLATE
    73713661 1536041 Dead/Cancelled
    IMPERIAL CHEMICAL INDUSTRIES PLC
    1988-02-26
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