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 81 of 107 · 2,136 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
SPF30 SUPER SENSITIVE SUNSCREENTITANIUM DIOXIDEORGANIC & SUSTAINABLE BEAUTYd79cf2d9-4923-452a-bb44-67e059ee37ee2024-11-07WarningsExact identifier
unii: 15FIX9V2JP
SPF30 EVERYDAY/YEAR-ROUND SUNSCREENTITANIUM DIOXIDEORGANIC & SUSTAINABLE BEAUTYd4f30d95-4a3f-49ad-817e-faa86fca50182024-11-07WarningsExact identifier
unii: 15FIX9V2JP
SPF30 CALENDULA SUNSCREENTITANIUM DIOXIDEORGANIC & SUSTAINABLE BEAUTY64580be7-868c-40fb-b7b8-840b417b25d32024-11-06WarningsExact identifier
unii: 15FIX9V2JP
KIDS SPF30 SUPER SENSITIVE PLUS C111 SUNSCREENTITANIUM DIOXIDEORGANIC & SUSTAINABLE BEAUTY20ebe264-2f79-4eef-b83d-3f09a3ca28982024-11-06WarningsExact identifier
unii: 15FIX9V2JP
Cream Oil SunscreenZINC OXIDE, TITANIUM DIOXIDE SUNSCREENOwen Biosciences, Inc.b2ccdfea-1c27-42af-b9d8-752e9f91ae872024-11-05WarningsExact identifier
unii: 15FIX9V2JP
AddiclenzBOLDO, CARDUUS MARIANUS, CHELIDONIUM MAJUS, PETROSELINUM SATIVUM, TARAXACUM OFFICINALE, ARSENICUM ALBUM, BISPHENOL A, COBALTUM METALLICUM, CUPRUM METALLICUM, GLYPHOSATE, IODIUM, LYCOPODIUM CLAVATUM, PHOSPHORICUM ACIDUM, SELENIUM METALLICUM, ZINCUM METALLICUM, ASPARTAME, BENZALKONIUM CHLORIDE, FORMALINUM, METHYLENE CHLORIDE, METHYL PARABEN, PROPYL PARABEN, SODIUM BENZOATE, SODIUM CITRATE, TITANIUM DIOXIDE, ZINCUM OXYDATUMDeseret Biologicals, Inc.8a3b75ca-8fec-4318-8a55-8bde0b82637d2024-10-31WarningsExact identifier
unii: 15FIX9V2JP
ZO Skin Health Sunscreen Plus Primer Broad-Spectrum SPF 30TITANIUM DIOXIDE AND ZINC OXIDEZO Skin Health, Inc.9a4f5be1-da04-48b9-897a-57f4a3d9d1ec2024-10-29WarningsExact identifier
unii: 15FIX9V2JP
ZO Skin Health Broad-Spectrum Sunscreen SPF 50TITANIUM DIOXIDE, ZINC OXIDEZO Skin Health, Inc.d817f80b-a998-b67e-e053-2995a90a19712024-10-29WarningsExact identifier
unii: 15FIX9V2JP
Banana Boat Kids Mineral Protection SPF50TITANIUM DIOXIDE,ZINC OXIDEEdgewell Personal Care Brands LLCdc7701b5-0c73-b4df-e053-2a95a90a0f1b2024-10-27WarningsExact identifier
unii: 15FIX9V2JP
Banana Boat Mineral Sensitive SPF 50TITANIUM DIOXIDE, ZINC OXIDEEdgewell Personal Care Brands LLCdc7913d5-58f2-3077-e053-2a95a90a16272024-10-27WarningsExact identifier
unii: 15FIX9V2JP
Banana Boat Mineral Sensitive Face SPF50TITANIUM DIOXIDE, ZINC OXIDEEdgewell Personal Care Brands LLCdc783438-b28f-b7f4-e053-2a95a90a3d652024-10-27WarningsExact identifier
unii: 15FIX9V2JP
Banana Boat Sport Mineral SPF 50TITANIUM DIOXIDE, ZINC OXIDEEdgewell Personal Care Brands LLCdc79790f-e2bc-5414-e053-2a95a90a9e7a2024-10-27WarningsExact identifier
unii: 15FIX9V2JP
TiZO Mineral Stick - Tinted SPF 45TITANIUM DIOXIDE, ZINC OXIDEFallien Cosmeceuticals, LTDfd6d0080-0bef-4e7e-8ca5-b859639efd0c2024-10-25WarningsExact identifier
unii: 15FIX9V2JP
TiZO Mineral Stick Non-Tinted SPF 45TITANIUM DIOXIDE, ZINC OXIDEFallien Cosmeceuticals, LTDe7044f18-992a-4f60-9a2b-f11ed06db09b2024-10-25WarningsExact identifier
unii: 15FIX9V2JP
CoTZ Lip BalmTITANIUM DIOXIDE, ZINC OXIDEFallien Cosmeceuticals, LTD479a7d82-a068-4c2e-b50b-555c40e13e372024-10-25WarningsExact identifier
unii: 15FIX9V2JP
TiZO Mineral Sun Defense SPF 50TITANIUM DIOXIDE, ZINC OXIDEFallien Cosmeceuticals Ltd.e17a8c35-2d49-4c99-b154-ea673c14753e2024-10-25WarningsExact identifier
unii: 15FIX9V2JP
IPKN Moist and Firm Beauty Balm Light MediumTITANIUM DIOXIDEInel Cosmetics Co., Ltd.1af6184e-3dc4-4eb3-8d51-aca7244734512024-10-25WarningsExact identifier
unii: 15FIX9V2JP
IPKN Moist and Firm Beauty Balm LightTITANIUM DIOXIDEInel Cosmetics Co., Ltd.77d77838-aa13-4939-a1a0-50189fbb3fe02024-10-25WarningsExact identifier
unii: 15FIX9V2JP
Positive Light Tinted Moisturizer Broad Spectrum SPF 20 Sunscreen 44NHOMOSALATE, TITANIUM DIOXIDE, ZINC OXIDERare Beauty, LLCcffbb6af-5a04-f58a-e053-2995a90a1ae22024-10-23WarningsExact identifier
unii: 15FIX9V2JP
Banana BoatTITANIUM DIOXIDE, ZINC OXIDEEdgewell Personal Care Brands, LLC441a46f0-ecda-4448-e054-00144ff88e882024-10-23WarningsExact identifier
unii: 15FIX9V2JP

Reported adverse events (FAERS/openFDA)#

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