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 99 of 107 · 2,136 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Farmasi CC Color Control Cream SPF 25- 03 MediumTITANIUM DIOXIDEFarmasi US LLC9f203e7f-3bba-4f36-a35a-6d9466e390822023-11-05WarningsExact identifier
unii: 15FIX9V2JP
Farmasi CC Color Control Cream SPF 25- 06 DeepTITANIUM DIOXIDEFarmasi US LLCc28afa3b-9a8d-4e19-bc6b-39cc8428c9f92023-11-05WarningsExact identifier
unii: 15FIX9V2JP
PHARMACA Natural Mineral Sunscreen SPF-50TITANIUM DIOXIDE, ZINC OXIDEPharmaca Integrative Pharmacy, Inc.51e6cd7a-5c9a-4666-9021-ade42eb064cd2023-11-05WarningsExact identifier
unii: 15FIX9V2JP
VERTRA Premium Suncare SPF 30TITANIUM DIOXIDE, ZINC OXIDEEai-Jr286, Inc.720ca725-24ca-4b59-b640-afa9832386922023-11-05WarningsExact identifier
unii: 15FIX9V2JP
FOREVER Transfer-proof 24h foundation High perfection Concentrated floral skincare with sunscreen Broad spectrum SPF 15 1COCTISALATE, TITANIUM DIOXIDEParfums Christian Dior4c9ffd30-4799-475d-94cb-07ce3d5b36602023-11-04WarningsExact identifier
unii: 15FIX9V2JP
Youth 2 Activating BB Cream SPF 30 Light MediumZINC OXIDE, TITANIUM DIOXIDEShaklee Corporatione51e38c9-cc9b-4af3-842d-41d0162f17ff2023-11-03WarningsExact identifier
unii: 15FIX9V2JP
Youth 4 Activating BB Cream SPF 30 DarkZINC OXIDE, TITANIUM DIOXIDEShaklee Corporation63f7f8bd-02f0-4a13-bb1e-298754b24fce2023-11-03WarningsExact identifier
unii: 15FIX9V2JP
Youth 1 Activating BB Cream SPF 30 LightZINC OXIDE, TITANIUM DIOXIDEShaklee Corporationc9e05055-48ea-405d-b1d4-50b263d0dbf92023-11-03WarningsExact identifier
unii: 15FIX9V2JP
CAPTURE DREAMSKIN FRESH and PERFECT CUSHION WITH SUNSCREEN BROAD SPECTRUM SPF 50 020OCTINOXATE,TITANIUM DIOXIDE,ZINC OXIDEParfums Christian Diorfe03fc14-4132-4dab-b013-d490764be0d42023-11-03WarningsExact identifier
unii: 15FIX9V2JP
CAPTURE DREAMSKIN FRESH and PERFECT CUSHION WITH SUNSCREEN BROAD SPECTRUM SPF 50 000OCTINOXATE,TITANIUM DIOXIDE,ZINC OXIDEParfums Christian Dior968cfae7-89b6-4ef3-ab60-1c675b90c1512023-11-03WarningsExact identifier
unii: 15FIX9V2JP
CAPTURE DREAMSKIN FRESH and PERFECT CUSHION WITH SUNSCREEN BROAD SPECTRUM SPF 50 010OCTINOXATE,TITANIUM DIOXIDE,ZINC OXIDEParfums Christian Dior775f4009-9fc2-475b-a141-b4b5e55421802023-11-03WarningsExact identifier
unii: 15FIX9V2JP
CAPTURE DREAMSKIN FRESH and PERFECT CUSHION WITH SUNSCREEN BROAD SPECTRUM SPF 50 030OCTINOXATE,TITANIUM DIOXIDE,ZINC OXIDEParfums Christian Dior189f8767-f463-4c83-8a38-975ce8672b2a2023-11-03WarningsExact identifier
unii: 15FIX9V2JP
FOREVER SKIN VEIL Extreme Wear and Moisturizing Primer Correction, Protection, Illumination With Sunscreen Floral Extract-Enriched Broad Spectrum SPF20OCTISALATE, TITANIUM DIOXIDEParfums Christian Diorc59b4ece-0534-4072-afe8-2142a43c6bb22023-11-03WarningsExact identifier
unii: 15FIX9V2JP
CAPTURE DREAMSKIN FRESH AND PERFECT CUSHION WITH SUNSCREEN BROAD SPECTRUM SPF 50 030OCTINOXATE, TITANIUM DIOXIDE, ZINC OXIDEParfums Christian Diorcdc2a156-5ccd-4d40-98af-c529f0911a9e2023-11-03WarningsExact identifier
unii: 15FIX9V2JP
FOREVER SKIN GLOW 24h Wear Radiant Perfection Skin Caring Foundation With Sunscreen BROAD SPECTRUM SPF 35 Lasting Hydration 2WPOCTINOXATE, TITANIUM DIOXIDEPARFUMS CHRISTIAN DIOR6ee0284e-739d-4aad-9352-9ea9c106efa42023-11-03WarningsExact identifier
unii: 15FIX9V2JP
THE SOF FLUID LONG WEAR FOUNDATION BROAD SPECTRUM SPF 20OCTINOXATE AND TITANIUM DIOXIDEMAX HUBER RESEARCH LAB INC97787725-9175-46a7-8e3a-af5d06e21d7f2023-10-30WarningsExact identifier
unii: 15FIX9V2JP
LA MER THE RADIANT SKINTINT BROAD SPECTRUM SPF 30OCTINOXATE, OCTISALATE, AND TITANIUM DIOXIDEMAX HUBER RESEARCH LAB INCecc942c7-5495-43b1-9ffa-d38be78911522023-10-30WarningsExact identifier
unii: 15FIX9V2JP
Vivier Sheer SPF 30 MineralTITANIUM DIOXIDE, ZINC OXIDEVivier Pharma, Inc.1be5ee36-3566-495c-aae2-4d0d7fc210ed2023-10-27WarningsExact identifier
unii: 15FIX9V2JP
SIMPLE TRUTH MINERAL BASED SPF 50 SUNSCREENTITANIUM DIOXIDE, ZINC OXIDETHE KROGER COMPANYa52872bf-cd0f-06da-e053-2995a90af28d2023-10-26WarningsExact identifier
unii: 15FIX9V2JP
PERFECTIONIST PRO MULTI-DEFENSE UV FLUID BROAD SPRECTRUM SPF 45TITANIUM DIOXIDE AND ZINC OXIDEESTEE LAUDER INCe87c4a76-5f21-4989-a1e0-0b7c6902f2012023-10-26WarningsExact identifier
unii: 15FIX9V2JP

Reported adverse events (FAERS/openFDA)#

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