FDA.reportPublic FDA data

Zafirlukast

Product NDC
68151-1977
11-digit product format
681511977
Labeler code
68151
Product ID
68151-1977_768cc9a9-f645-4709-94ea-a915850d40d9
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Zafirlukast
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Carilion Materials Management
Application
ANDA090372
Marketing category
ANDA
Marketing start
2010-11-18
Marketing end
0000-00-00
Substance
ZAFIRLUKAST
Active strength
20 mg/1
Pharmacologic classes
Leukotriene Receptor Antagonists [MoA],Cytochrome P450 2C9 Inhibitors [MoA],Leukotriene Receptor Antagonist [EPC]
NDC exclude flag
No
Listing certified through
2020-12-31
Current FDA listing
Historical FDA.report record

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
cd67ec6b-b946-5e4b-659e-3b3f42e68276Product name120140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
68151-1977-62021-01-29C16284748780-1ba0f9c33-2ebf-a910-e053-dadaa90a0b85ZAFIRLUKAST TABLETS

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
68151-1977-6Zafirlukast1 in 1 PACKAGETABLET, FILM COATED14

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
ZafirlukastACTIVE INGREDIENTXZ629S5L50ZAFIRLUKAST TABLET, FILM COATED [CARILION MATERIALS MANAGEMENT]2
ZafirlukastACTIVE MOIETYXZ629S5L50ZAFIRLUKAST TABLET, FILM COATED [CARILION MATERIALS MANAGEMENT]2
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UZAFIRLUKAST TABLET, FILM COATED [CARILION MATERIALS MANAGEMENT]2
HYDROXYPROPYL CELLULOSE (TYPE H)INACTIVE INGREDIENTRFW2ET671PZAFIRLUKAST TABLET, FILM COATED [CARILION MATERIALS MANAGEMENT]2
HYPROMELLOSE 2910 (5 MPA.S)INACTIVE INGREDIENTR75537T0T4ZAFIRLUKAST TABLET, FILM COATED [CARILION MATERIALS MANAGEMENT]2
LACTOSE MONOHYDRATEINACTIVE INGREDIENTEWQ57Q8I5XZAFIRLUKAST TABLET, FILM COATED [CARILION MATERIALS MANAGEMENT]2
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30ZAFIRLUKAST TABLET, FILM COATED [CARILION MATERIALS MANAGEMENT]2
POLYETHYLENE GLYCOL 400INACTIVE INGREDIENTB697894SGQZAFIRLUKAST TABLET, FILM COATED [CARILION MATERIALS MANAGEMENT]2
SODIUM STARCH GLYCOLATE TYPE A POTATOINACTIVE INGREDIENT5856J3G2A2ZAFIRLUKAST TABLET, FILM COATED [CARILION MATERIALS MANAGEMENT]2
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPZAFIRLUKAST TABLET, FILM COATED [CARILION MATERIALS MANAGEMENT]2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68151-1977ZAFIRLUKAST TABLET, FILM COATED [CARILION MATERIALS MANAGEMENT]4Legacy NDC, 1 package rows20190125_fb546f57-cd2f-4cbf-8c54-fbc23d47fe0f.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
199655zafirlukast 20 MG Oral TabletPSNfb546f57-cd2f-4cbf-8c54-fbc23d47fe0f4
199655zafirlukast 20 MG Oral TabletSCDfb546f57-cd2f-4cbf-8c54-fbc23d47fe0f4

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionStatus
68151-1977-6681511977061 in 1 PACKAGEHistorical