FDA.reportPublic FDA data

Zafirlukast

Product NDC
55111-626
11-digit product format
551110626
Labeler code
55111
Product ID
55111-626_b5fb9efb-3369-e1f9-384c-bd22e8ecad92
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Zafirlukast
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Dr. Reddys Laboratories Limited
Application
ANDA090372
Marketing category
ANDA
Marketing start
2010-11-18
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, 313758

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
55111-626-01Zafirlukast100 in 1 BOTTLETABLET, FILM COATED1009
55111-626-05Zafirlukast500 in 1 BOTTLETABLET, FILM COATED5009
55111-626-30Zafirlukast30 in 1 BOTTLETABLET, FILM COATED309
55111-626-60Zafirlukast60 in 1 BOTTLETABLET, FILM COATED609
55111-626-78Zafirlukast10 in 1 CARTONTABLET, FILM COATED109
55111-626-79Zafirlukast10 in 1 BLISTER PACKTABLET, FILM COATED109

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
55111-626-60EA - Each55111-62655202dfa-4d7b-48bd-87e5-8d9017647ba512012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
ZafirlukastACTIVE INGREDIENTXZ629S5L50ZAFIRLUKAST TABLET, FILM COATED [DR. REDDYS LABORATORIES LIMITED]4
ZafirlukastACTIVE MOIETYXZ629S5L50ZAFIRLUKAST TABLET, FILM COATED [DR. REDDYS LABORATORIES LIMITED]4
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UZAFIRLUKAST TABLET, FILM COATED [DR. REDDYS LABORATORIES LIMITED]4
hydroxypropyl celluloseINACTIVE INGREDIENTRFW2ET671PZAFIRLUKAST TABLET, FILM COATED [DR. REDDYS LABORATORIES LIMITED]4
HYPROMELLOSE 2910 (5 MPA.S)INACTIVE INGREDIENTR75537T0T4ZAFIRLUKAST TABLET, FILM COATED [DR. REDDYS LABORATORIES LIMITED]4
lactose monohydrateINACTIVE INGREDIENTEWQ57Q8I5XZAFIRLUKAST TABLET, FILM COATED [DR. REDDYS LABORATORIES LIMITED]4
magnesium stearateINACTIVE INGREDIENT70097M6I30ZAFIRLUKAST TABLET, FILM COATED [DR. REDDYS LABORATORIES LIMITED]4
polyethylene glycol 400INACTIVE INGREDIENTB697894SGQZAFIRLUKAST TABLET, FILM COATED [DR. REDDYS LABORATORIES LIMITED]4
SODIUM STARCH GLYCOLATE TYPE A POTATOINACTIVE INGREDIENT5856J3G2A2ZAFIRLUKAST TABLET, FILM COATED [DR. REDDYS LABORATORIES LIMITED]4
titanium dioxideINACTIVE INGREDIENT15FIX9V2JPZAFIRLUKAST TABLET, FILM COATED [DR. REDDYS LABORATORIES LIMITED]4
ZafirlukastACTIVE INGREDIENTXZ629S5L50ZAFIRLUKAST TABLET, FILM COATED [CARILION MATERIALS MANAGEMENT]2
ZafirlukastACTIVE INGREDIENTXZ629S5L50ZAFIRLUKAST TABLET, FILM COATED [AMERICAN HEALTH PACKAGING]2
ZafirlukastACTIVE MOIETYXZ629S5L50ZAFIRLUKAST TABLET, FILM COATED [CARILION MATERIALS MANAGEMENT]2
ZafirlukastACTIVE MOIETYXZ629S5L50ZAFIRLUKAST TABLET, FILM COATED [AMERICAN HEALTH PACKAGING]2
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UZAFIRLUKAST TABLET, FILM COATED [CARILION MATERIALS MANAGEMENT]2
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UZAFIRLUKAST TABLET, FILM COATED [AMERICAN HEALTH PACKAGING]2
HYDROXYPROPYL CELLULOSE (TYPE H)INACTIVE INGREDIENTRFW2ET671PZAFIRLUKAST TABLET, FILM COATED [AMERICAN HEALTH PACKAGING]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
HYPROMELLOSESINACTIVE INGREDIENT3NXW29V3WOZAFIRLUKAST TABLET, FILM COATED [AMERICAN HEALTH PACKAGING]2
lactose monohydrateINACTIVE INGREDIENTEWQ57Q8I5XZAFIRLUKAST TABLET, FILM COATED [AMERICAN HEALTH PACKAGING]2
LACTOSE MONOHYDRATEINACTIVE INGREDIENTEWQ57Q8I5XZAFIRLUKAST TABLET, FILM COATED [CARILION MATERIALS MANAGEMENT]2
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30ZAFIRLUKAST TABLET, FILM COATED [CARILION MATERIALS MANAGEMENT]2
magnesium stearateINACTIVE INGREDIENT70097M6I30ZAFIRLUKAST TABLET, FILM COATED [AMERICAN HEALTH PACKAGING]2
polyethylene glycol 400INACTIVE INGREDIENTB697894SGQZAFIRLUKAST TABLET, FILM COATED [AMERICAN HEALTH PACKAGING]2
POLYETHYLENE GLYCOL 400INACTIVE INGREDIENTB697894SGQZAFIRLUKAST TABLET, FILM COATED [CARILION MATERIALS MANAGEMENT]2
SODIUM STARCH GLYCOLATE TYPE A POTATOINACTIVE INGREDIENT5856J3G2A2ZAFIRLUKAST TABLET, FILM COATED [AMERICAN HEALTH PACKAGING]2
SODIUM STARCH GLYCOLATE TYPE A POTATOINACTIVE INGREDIENT5856J3G2A2ZAFIRLUKAST TABLET, FILM COATED [CARILION MATERIALS MANAGEMENT]2
titanium dioxideINACTIVE INGREDIENT15FIX9V2JPZAFIRLUKAST TABLET, FILM COATED [AMERICAN HEALTH PACKAGING]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
55111-626ZAFIRLUKAST TABLET, FILM COATED [DR. REDDYS LABORATORIES LIMITED]9Current NDC, Legacy NDC, 6 package rows20190312_6ccb96af-2647-9206-5eee-49a825d32488.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
313758zafirlukast 10 MG Oral TabletPSN6ccb96af-2647-9206-5eee-49a825d324889
199655zafirlukast 20 MG Oral TabletPSN6ccb96af-2647-9206-5eee-49a825d324889
313758zafirlukast 10 MG Oral TabletSCD6ccb96af-2647-9206-5eee-49a825d324889
199655zafirlukast 20 MG Oral TabletSCD6ccb96af-2647-9206-5eee-49a825d324889
199655zafirlukast 20 MG Oral TabletPSNa60f39f6-d590-4b00-8751-7f12b7ec53857
199655zafirlukast 20 MG Oral TabletSCDa60f39f6-d590-4b00-8751-7f12b7ec53857
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 formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
55111-626-0155111062601100 TABLET, FILM COATED in 1 BOTTLE (55111-626-01) 2010-11-180000-00-00NoNoCurrent
55111-626-0555111062605500 TABLET, FILM COATED in 1 BOTTLE (55111-626-05) 2010-11-180000-00-00NoNoCurrent
55111-626-305511106263030 TABLET, FILM COATED in 1 BOTTLE (55111-626-30) 2010-11-180000-00-00NoNoCurrent
55111-626-605511106266060 TABLET, FILM COATED in 1 BOTTLE (55111-626-60) 2010-11-180000-00-00NoNoCurrent
55111-626-785511106267810 BLISTER PACK in 1 CARTON (55111-626-78) / 10 TABLET, FILM COATED in 1 BLISTER PACK (55111-626-79) 10 blister pack2010-11-180000-00-00NoNoCurrent
55111-626-795511106267910 in 1 BLISTER PACKHistorical