Zafirlukast

Product NDC
72162-2361
11-digit product format
721622361
Labeler code
72162
Product ID
72162-2361_50679c31-2161-47a0-a704-13a01760fdbf
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Zafirlukast
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Bryant Ranch Prepack
Application
ANDA212475
Marketing category
ANDA
Marketing start
2020-09-10
Substance
ZAFIRLUKAST
Active strength
20 mg/1
Pharmacologic classes
Cytochrome P450 2C9 Inhibitors [MoA], Leukotriene Receptor Antagonist [EPC], Leukotriene Receptor Antagonists [MoA]
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Zafirlukast
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
ZAFIRLUKAST20 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiXZ629S5L50
Rxcui199655

DailyMed Product Concepts#

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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
72162-2361-6Zafirlukast60 in 1 BOTTLETABLET, FILM COATED60100

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
72162-2361-6EA - Each72162-236187657622-5b89-4fa9-8dae-16dc4bda736412024-08-12

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
72162-2361ZAFIRLUKAST TABLET, FILM COATED [BRYANT RANCH PREPACK]100Current NDC, 1 package rows20240702_d2256673-fe8b-4fba-a73a-a81e24e47cf8.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
199655zafirlukast 20 MG Oral TabletPSNd2256673-fe8b-4fba-a73a-a81e24e47cf8100
199655zafirlukast 20 MG Oral TabletSCDd2256673-fe8b-4fba-a73a-a81e24e47cf8100

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
72162-2361-67216223610660 TABLET, FILM COATED in 1 BOTTLE (72162-2361-6) 2024-06-28NoNoCurrent