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 26 of 108 · 2,146 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
GoodSense Eye Drops Advanced Relief MoisturizerDEXTRAN, POLYETHYLENE GLYCOL 400, POVIDONE, TETRAHYDROZOLINE HCLGeiss, Derstin & Dunn, Inc.9b34de99-13df-201a-e053-2a95a90ae5592025-12-30WarningsExact identifier
unii: B697894SGQ
GoodSense Ultra Lubricant Eye DropsPOLYETHYLENE GLYCOL 400, PROPYLENE GLYCOLGeiss, Destin & Dunn, Inc.9b45ebb5-c43b-c9fb-e053-2a95a90a34112025-12-30WarningsExact identifier
unii: B697894SGQ
Discount Drug Mart Eye Drops Advanced ReliefDEXTRAN 70, POLYETHYLENE GLYCOL 400, POVIDONE, TETRAHYDROZOLINE HYDROCHLORIDEDiscount Drug Mart, Inc.f75c2f84-a28c-5807-e053-6294a90a22952025-12-30WarningsExact identifier
unii: B697894SGQ
Discount Drug Mart Eye Drops Dry Eye ReliefGLYCERIN, HYPROMELLOSE, POLYETHYLENE GLYCOL 400Discount Drug Martf7fd53be-e501-d97f-e053-6394a90ad4092025-12-30WarningsExact identifier
unii: B697894SGQ
Exchange Select Eye Drops Advanced Relief MoisturizerDEXTRAN 70, POLYETHYLENE GLYCOL 400, POVIDONE, TETRAHYDROZOLINE HCLArmy and Air Force Exchange Service9e475240-2df1-9bee-e053-2995a90a8d4b2025-12-30WarningsExact identifier
unii: B697894SGQ
Exchange Select Artificial Tears Lubricant Eye DropsGLYCERIN, HYPROMELLOSE, POLYETHYLENE GLYCOL 400Army and Air Force Exchange Service9e478343-8ae7-823e-e053-2995a90a84ed2025-12-30WarningsExact identifier
unii: B697894SGQ
Family Wellness Advanced Redness Relief Eye DropsPOLYETHYLENE GLYCOL 400, TETRAHYDROZOLINE HCLFamily Dollar Services, Inc.fabec215-a040-3f4e-e053-6394a90ad45f2025-12-30WarningsExact identifier
unii: B697894SGQ
DG Health Advanced Relief Eye DropsDEXTRAN 70, POLYETHYLENE GLYCOL 400, POVIDONE, TETRAHYDROZOLINE HCLDolgencorp LLC9c62f8a3-7cf5-40f9-e053-2a95a90afd862025-12-30WarningsExact identifier
unii: B697894SGQ
Medics Choice Eye Drops AdvancedTETRAHYDROZOLINE HYDROCHLORIDE, POLYETHYLENE GLYCOL 400, DEXTRAN 70, POVIDONEKC Pharmaceuticals, Inc.ab906fd8-265c-4359-a920-d626366e245c2025-12-30WarningsExact identifier
unii: B697894SGQ
Medics Choice Fresh and Soothe Lubricant Eye DropsPOLYETHYLENE GLYCOL 400, PROPYLENE GLYCOLKC Pharmaceuticals, Inc.1f65b91a-4eac-65c2-e063-6394a90a02952025-12-30WarningsExact identifier
unii: B697894SGQ
DG Health Dry Eye ReliefGLYCERIN, HYPROMELLOSE, POLYPROPYLENE GLYCOL 400Dolgencorp LLC9cb20c3b-bf6d-8c7c-e053-2995a90aa4852025-12-30WarningsExact identifier
unii: B697894SGQ
DG Lubricant Eye DropsPOLYETHYLENE GLYCOL 400, PROPYLENE GLYCOLDolgencorp LLC9cb27899-6c36-3c37-e053-2995a90a1d432025-12-30WarningsExact identifier
unii: B697894SGQ
Publix Advanced Relief Eye DropsDEXTRAN 70, POLYETHYLENE GLYCOL 400, POVIDONE, TETRAHYDROZOLINE HYDROCHLORIDEPublix Super Markets, Inc.f7b0c3d6-0324-46c3-e053-6394a90a82412025-12-30WarningsExact identifier
unii: B697894SGQ
Publix High Performance Eye DropsPOLYETHYLENE GLYCOL 400, PROPYLENE GLYCOLPublix Super Markets, Inc.9b402aa8-87cb-3928-e053-2995a90afa3c2025-12-30WarningsExact identifier
unii: B697894SGQ
Health Mart Lubricating TearsPOLYETHYLENE GLYCOL 400, PROPYLENE GLYCOLStrategic Sourcing Services LLCc8be678f-2b4a-4d39-9cb4-910d36d721742025-12-30WarningsExact identifier
unii: B697894SGQ
Core Values Eye Drops Dry Eye ReliefGLYCERIN, HYPROMELLOSE, POLYETHYLENE GLYCOL 400Liberty Procurement Co. Inc.f8285f68-c40c-19a8-e053-6394a90aacad2025-12-30WarningsExact identifier
unii: B697894SGQ
Core Values Eye Drops Advanced ReliefDEXTRAN 70, POLYETHYLENE GLYCOL 400, POVIDONE, TETRAHYDROZOLINE HYDROCHLORIDELiberty Procurement Co., Inc.f76dfeca-4e86-0b5d-e053-6294a90a29b92025-12-30WarningsExact identifier
unii: B697894SGQ
Harris Teeter Eye Drops Artificial TearsGLYCERIN, HYPROMELLOSE, POLYETHYLENE GLYCOL 400Harris Teeter, LLC.f82957d9-c4ad-a914-e053-6294a90aac502025-12-30WarningsExact identifier
unii: B697894SGQ
Best Choice Eye Drops Advanced ReliefDEXTRAN 70, POLYETHYLENE GLYCOL 400, POVIDONE, TETRAHYDROZOLINE HYDROCHLORIDEValu Merchandisers, Co.f7491a17-8035-5a3c-e053-6294a90a615c2025-12-30WarningsExact identifier
unii: B697894SGQ
Winco Advanced Relief Eye DropsDEXTRAN 70, POLYETHYLENE GLYCOL 400, POVIDONE, TETRAHYDROZOLINE HCLWinCo Foods, LLCf10778c8-14fe-4852-8b73-42db502fd2bc2025-12-30WarningsExact identifier
unii: B697894SGQ

Reported adverse events (FAERS/openFDA)#

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