FDA.reportPublic FDA data

NDC 68084-059-11 - Zafirlukast

This NDC is not currently matched to an FDA NDC product listing in FDA.report, but it is a valid NDC-form code. FDA.report is showing the available DailyMed label context for the product root.

Product NDC
68084-059
Requested NDC
68084-059-11
Package NDCs from labels
68084-059-11, 68084-059-21
Manufacturer
American Health Packaging
Effective date
2024-10-11
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
Zafirlukast - American Health PackagingAmerican Health Packaging2024-10-11HUMAN PRESCRIPTION DRUG LABEL

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
68084-059-11Zafirlukast1 in 1 BLISTER PACKTABLET, FILM COATED17
68084-059-21Zafirlukast30 in 1 BOX, UNIT-DOSETABLET, FILM COATED307

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68084-059ZAFIRLUKAST TABLET, FILM COATED [AMERICAN HEALTH PACKAGING]7Current NDC, Legacy NDC, 2 package rows20241013_a60f39f6-d590-4b00-8751-7f12b7ec5385.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
68084-059-11EA - Each68084-059521084b6-0e46-440c-ba5e-d5a7b81c8ffb12013-07-02
68084-059-21EA - Each68084-0592f4d82bb-242a-4ea7-98ec-f18655362a6212013-07-02

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
ZafirlukastACTIVE INGREDIENTXZ629S5L50ZAFIRLUKAST TABLET, FILM COATED [AMERICAN HEALTH PACKAGING]2
ZafirlukastACTIVE MOIETYXZ629S5L50ZAFIRLUKAST TABLET, FILM COATED [AMERICAN HEALTH PACKAGING]2
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UZAFIRLUKAST TABLET, FILM COATED [AMERICAN HEALTH PACKAGING]2
HYDROXYPROPYL CELLULOSE (TYPE H)INACTIVE INGREDIENTRFW2ET671PZAFIRLUKAST TABLET, FILM COATED [AMERICAN HEALTH PACKAGING]2
HYPROMELLOSESINACTIVE INGREDIENT3NXW29V3WOZAFIRLUKAST TABLET, FILM COATED [AMERICAN HEALTH PACKAGING]2
lactose monohydrateINACTIVE INGREDIENTEWQ57Q8I5XZAFIRLUKAST TABLET, FILM COATED [AMERICAN HEALTH PACKAGING]2
magnesium stearateINACTIVE INGREDIENT70097M6I30ZAFIRLUKAST TABLET, FILM COATED [AMERICAN HEALTH PACKAGING]2
polyethylene glycol 400INACTIVE INGREDIENTB697894SGQZAFIRLUKAST TABLET, FILM COATED [AMERICAN HEALTH PACKAGING]2
SODIUM STARCH GLYCOLATE TYPE A POTATOINACTIVE INGREDIENT5856J3G2A2ZAFIRLUKAST TABLET, FILM COATED [AMERICAN HEALTH PACKAGING]2
titanium dioxideINACTIVE INGREDIENT15FIX9V2JPZAFIRLUKAST TABLET, FILM COATED [AMERICAN HEALTH PACKAGING]2

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 41 of 107 · 2,136 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
PROTECTOR SOLAR NON-TINTED SPF SUNSCREENTITANIUM DIOXIDE, ZINC OXIDEThe Beez Kneez Skin Care & Acne Clinic LLC358195c0-6d28-1ffe-e063-6394a90a60272025-12-12Exact identifier
unii: 15FIX9V2JP
Matte Velvet TintTITANIUM DIOXIDE, ZINC OXIDEBrent Loftis, D.O., Inc., A California Medical Corporation3583f860-664b-2658-e063-6394a90a38572025-12-12Exact identifier
unii: 15FIX9V2JP
SPF LipTITANIUM DIOXIDE, ZINC OXIDEBrent Loftis, D.O., Inc., A California Medical Corporation359297cd-10e2-6ddd-e063-6394a90a4aa02025-12-12Exact identifier
unii: 15FIX9V2JP
Matte Velvet TintTITANIUM DIOXIDE, ZINC OXIDEBrent Loftis, D.O., Inc., A California Medical Corporation359641c5-0e19-f243-e063-6394a90aeebc2025-12-12Exact identifier
unii: 15FIX9V2JP
TINTED MINERAL SUNSCREEN SPF 40TITANIUM DIOXIDE, ZINC OXIDEDERMATOLOGY ARTS35814d5d-fd34-05b3-e063-6294a90aadd12025-12-12Exact identifier
unii: 15FIX9V2JP
Tinted Lip SunscreenTITANIUM DIOXIDE, ZINC OXIDELA HAIR DESIGN36eb4cd3-778c-362f-e063-6294a90a059c2025-12-11Exact identifier
unii: 15FIX9V2JP
Matte FinishTITANIUM DIOXIDE, ZINC OXIDECLEAN BEAUTY BY ANAK LLC37630c6c-f768-7b3e-e063-6394a90af5652025-12-11Exact identifier
unii: 15FIX9V2JP
Mineral Lip SunscreenTITANIUM DIOXIDE, ZINC OXIDEADVANCED AESTHETICS SKIN CARE STUDIO, INC348fcc63-d8e3-90a1-e063-6294a90ade112025-12-11Exact identifier
unii: 15FIX9V2JP
SunscreenTITANIUM DIOXIDE, ZINC OXIDEScottsdale Skin Boutique Aesthetics Pllc34a49563-c74b-2fd1-e063-6394a90a6c562025-12-11Exact identifier
unii: 15FIX9V2JP
Tinted SunscreenTITANIUM DIOXIDE, ZINC OXIDEScottsdale Skin Boutique and Dermatology Pllc34a52011-b781-75cf-e063-6394a90ae0f42025-12-11Exact identifier
unii: 15FIX9V2JP
Tinted SunscreenTITANIUM DIOXIDE, ZINC OXIDEScottsdale Skin Boutique and Dermatology Pllc34a632f5-4458-e335-e063-6394a90a9bcb2025-12-11Exact identifier
unii: 15FIX9V2JP
Matte FinishTITANIUM DIOXIDE, ZINC OXIDECLEAN BEAUTY BY ANAK LLC3761d74c-0137-0c75-e063-6394a90a3c7d2025-12-11Exact identifier
unii: 15FIX9V2JP
Sun Plus Sun Lip ShieldTITANIUM DIOXIDE, ZINC OXIDECLEAN BEAUTY BY ANAK LLC3763a79a-e881-cade-e063-6394a90a49de2025-12-11Exact identifier
unii: 15FIX9V2JP
Tinted Minerals 1point8 ozTITANIUM DIOXIDE, ZINC OXIDESPECKTRA6 LLC374e53c6-307f-f8e5-e063-6394a90a07ef2025-12-11Exact identifier
unii: 15FIX9V2JP
Tinted Minerals 1point8 ozTITANIUM DIOXIDE, ZINC OXIDESPECKTRA6 LLC373e29f1-d665-a3c4-e063-6294a90a403e2025-12-11Exact identifier
unii: 15FIX9V2JP
Defend Tinted Mineral SPF 40TITANIUM DIOXIDE, ZINC OXIDESMOOTH ESTHETICS LLC36eb9fc0-25d7-cfb4-e063-6394a90a2e222025-12-11Exact identifier
unii: 15FIX9V2JP
Sheer Tinted Sunscreen SPF40TITANIUM DIOXIDE, ZINC OXIDESIMPLICITY SKIN, SPA & BOUTIQUE, LLC36ebdb85-ce8a-d7e0-e063-6394a90a22612025-12-11Exact identifier
unii: 15FIX9V2JP
Mineral Lip ProtectionTITANIUM DIOXIDE, ZINC OXIDECOLETTE TOMASI LLC3727b29f-fe51-0b15-e063-6394a90a780b2025-12-11Exact identifier
unii: 15FIX9V2JP
Prevention Acne Safe Facial Mineral Sunscreen TintedTITANIUM DIOXIDE, ZINC OXIDENY BEAUTY PALACE LLC373c291a-7839-8486-e063-6294a90a5af32025-12-11Exact identifier
unii: 15FIX9V2JP
Prevention 2 Acne Safe Facial Mineral Sunscreen Non TintedTITANIUM DIOXIDE, ZINC OXIDENY BEAUTY PALACE LLC373c0ab0-8828-542b-e063-6394a90a86332025-12-11Exact identifier
unii: 15FIX9V2JP

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.