FDA.reportPublic FDA data

NDC 68084-875-11 - Montelukast Sodium

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
68084-875
Requested NDC
68084-875-11
Package NDCs from labels
68084-875-11, 68084-875-01
Manufacturer
American Health Packaging
Effective date
2024-10-31
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
Montelukast Sodium - American Health PackagingAmerican Health Packaging2024-10-31HUMAN PRESCRIPTION DRUG LABEL

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
68084-875-01Montelukast Sodium100 in 1 BOX, UNIT-DOSETABLET, COATED1009
68084-875-11Montelukast Sodium1 in 1 BLISTER PACKTABLET, COATED19

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68084-875MONTELUKAST SODIUM TABLET, COATED [AMERICAN HEALTH PACKAGING]9Current NDC, Legacy NDC, 2 package rows20241102_fb1b2e4e-a840-447b-b943-ad0b6acc32b5.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
68084-875-01EA - Each68084-8759388416b-2643-400d-a996-fb6470a92b2312015-05-05
68084-875-11EA - Each68084-8756a0a3be9-6843-41fb-a42f-b0c26f71033712015-05-05

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
Montelukast SodiumACTIVE INGREDIENTU1O3J18SFLMONTELUKAST SODIUM TABLET, CHEWABLE MONTELUKAST SODIUM TABLET, COATED [AMERICAN HEALTH PACKAGING]1
montelukastACTIVE MOIETYMHM278SD3EMONTELUKAST SODIUM TABLET, CHEWABLE MONTELUKAST SODIUM TABLET, COATED [AMERICAN HEALTH PACKAGING]1
aspartameINACTIVE INGREDIENTZ0H242BBR1MONTELUKAST SODIUM TABLET, CHEWABLE MONTELUKAST SODIUM TABLET, COATED [AMERICAN HEALTH PACKAGING]1
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UMONTELUKAST SODIUM TABLET, CHEWABLE MONTELUKAST SODIUM TABLET, COATED [AMERICAN HEALTH PACKAGING]1
cherryINACTIVE INGREDIENTBUC5I9595WMONTELUKAST SODIUM TABLET, CHEWABLE MONTELUKAST SODIUM TABLET, COATED [AMERICAN HEALTH PACKAGING]1
CROSCARMELLOSE SODIUMINACTIVE INGREDIENTM28OL1HH48MONTELUKAST SODIUM TABLET, CHEWABLE MONTELUKAST SODIUM TABLET, COATED [AMERICAN HEALTH PACKAGING]1
FERRIC OXIDE REDINACTIVE INGREDIENT1K09F3G675MONTELUKAST SODIUM TABLET, CHEWABLE MONTELUKAST SODIUM TABLET, COATED [AMERICAN HEALTH PACKAGING]1
FERRIC OXIDE YELLOWINACTIVE INGREDIENTEX438O2MRTMONTELUKAST SODIUM TABLET, CHEWABLE MONTELUKAST SODIUM TABLET, COATED [AMERICAN HEALTH PACKAGING]1
FERROSOFERRIC OXIDEINACTIVE INGREDIENTXM0M87F357MONTELUKAST SODIUM TABLET, CHEWABLE MONTELUKAST SODIUM TABLET, COATED [AMERICAN HEALTH PACKAGING]1
Hydroxypropyl Cellulose (Type H)INACTIVE INGREDIENTRFW2ET671PMONTELUKAST SODIUM TABLET, CHEWABLE MONTELUKAST SODIUM TABLET, COATED [AMERICAN HEALTH PACKAGING]1
HYPROMELLOSESINACTIVE INGREDIENT3NXW29V3WOMONTELUKAST SODIUM TABLET, CHEWABLE MONTELUKAST SODIUM TABLET, COATED [AMERICAN HEALTH PACKAGING]1
LACTOSE MONOHYDRATEINACTIVE INGREDIENTEWQ57Q8I5XMONTELUKAST SODIUM TABLET, CHEWABLE MONTELUKAST SODIUM TABLET, COATED [AMERICAN HEALTH PACKAGING]1
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30MONTELUKAST SODIUM TABLET, CHEWABLE MONTELUKAST SODIUM TABLET, COATED [AMERICAN HEALTH PACKAGING]1
MANNITOLINACTIVE INGREDIENT3OWL53L36AMONTELUKAST SODIUM TABLET, CHEWABLE MONTELUKAST SODIUM TABLET, COATED [AMERICAN HEALTH PACKAGING]1
POLYETHYLENE GLYCOL 400INACTIVE INGREDIENTB697894SGQMONTELUKAST SODIUM TABLET, CHEWABLE MONTELUKAST SODIUM TABLET, COATED [AMERICAN HEALTH PACKAGING]1
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPMONTELUKAST SODIUM TABLET, CHEWABLE MONTELUKAST SODIUM TABLET, COATED [AMERICAN HEALTH PACKAGING]1

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 2 of 114 · 2,265 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Dr. Shitong Photon Energy Eye Care LiquidTETRAHYDROZOLINE HCL 0.05% HYPROMELLOSE 0.3% DR. SHITONG PHOTON ENERGY EYE CARE LIQUIDWenzhou Yuyuan Pharmaceutical Co., Ltd.58ace434-55ef-17ef-e063-6294a90aa8782026-08-10WarningsExact identifier
unii: 3NXW29V3WO
Journee Firm Riche Broad Spectrum Sunscreen SPF 30TITANIUM DIOXIDE AND ZINC OXIDEMerz North America, Inc.d4d4bfcf-3674-4847-8ad8-1716a8e821ae2026-08-10WarningsExact identifier
unii: 15FIX9V2JP
VEIRFOO Brightening Hydrating Antiwrinkle SunscreenTITANIUM DIOXIDE, OCTINOXATELCM TECHNOLOGY Co., Ltd4cbbf8aa-8910-b7e7-e063-6294a90a4f072026-08-07WarningsExact identifier
unii: 15FIX9V2JP
CalamineFERRIC OXIDE REDThe Kroger Co.9ddcd6ba-1aed-48f8-a91a-54bd6f0d93082026-08-06Warnings, Adverse reactionsExact identifier
unii: 1K09F3G675
EltaMD UV RestoreTITANIUM DIOXIDE, ZINC OXIDE SUNSCREENCP Skin Health Group, Inc37fee381-ce6b-4949-9a4a-778aa839fb842026-08-06WarningsExact identifier
unii: 15FIX9V2JP
Leader Lubricant Eye Drops 30ctPOLYETHYLENE GLYCOL 400, PROPYLENE GLYCOLCARDINAL HEALTH 110, LLC. DBA LEADER8df69f2c-40c4-245c-e053-2a95a90a54062026-08-05WarningsExact identifier
unii: B697894SGQ
MontelukastMONTELUKASTCoupler LLC583a9499-97f0-2ebf-e063-6394a90a35af2026-08-04Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 200224
unii: U1O3J18SFL
Luxe Gloss Hydrating Lip Gloss SPF 35-NAKED HONEYOCTOCRYLENE 8%, OCTISALATE 5%, TITANIUM DIOXIDE 6%, ZINC OXIDE 8%Lale Cosmetics LLC581fb0cd-c55d-d562-e063-6394a90a7f112026-08-03WarningsExact identifier
unii: 15FIX9V2JP
EltaMD UV ActiveZINC OXIDE AND TITANIUM DIOXIDE SUNSCREENCP Skin Health Group, Inc39d16479-d491-4c19-aa11-674461687c7b2026-08-03WarningsExact identifier
unii: 15FIX9V2JP
Continuous Correction CreamTITANIUM DIOXIDEBaxter of California, LLC1cbcc648-f2e1-af60-e063-6294a90ad4bb2026-07-31WarningsExact identifier
unii: 15FIX9V2JP
Cover CremeTITANIUM DIOXIDEBaxter of California31f5e8c4-523f-4596-e063-6294a90a6a122026-07-31WarningsExact identifier
unii: 15FIX9V2JP
Montelukast SodiumMONTELUKAST SODIUMTorrent Pharmaceuticals Limitedda038cf6-cfad-43a4-ab8e-d81d028d60872026-07-28Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 311759
rxcui: 200224
rxcui: 242438
unii: U1O3J18SFL
montelukast sodiumMONTELUKAST SODIUMPreferred Pharmaceuticals Inc.1eeb3123-9e93-4681-8096-800a7c7acf8a2026-07-28Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 200224
unii: U1O3J18SFL
MontelukastMONTELUKASTPreferred Pharmaceuticals, Inc.94642db1-5c75-44c4-92b4-8385b486df822026-07-28Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 200224
unii: U1O3J18SFL
Montelukast SodiumMONTELUKAST SODIUMPreferred Pharmaceuticals Inc.64a3b181-e8d8-4caf-9f1b-e0063d0bd94a2026-07-28Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 200224
unii: U1O3J18SFL
ESIKA COLORFIX POLVOS 32H POLVO COMPACTO FACIAL DE ALTA COBERTURA FPS 15 110-COCTINOXATE, TITANIUM DIOXIDE, ZINC OXIDEBEL STAR S.A.575fb2c3-e332-8a3b-e063-6394a90a9fd92026-07-24WarningsExact identifier
unii: 15FIX9V2JP
True Coast SPF 50 Mineral SunscreenZINC OXIDE 18%, TITANIUM DIOXIDE 6%Foshan Sugar Max Cosmetics CO.,Ltd5379466d-8d14-5fc2-e063-6394a90abd7e2026-07-22WarningsExact identifier
unii: 15FIX9V2JP
CalamineCALAMINE AND ZINC OXIDEMarie's Original Formulas LLC57110309-9a3d-025f-e063-6394a90a015a2026-07-22WarningsExact identifier
unii: 1K09F3G675
Yves Saint Laurent All Hours Foundation Sunscreen Broad Spectrum SPF 30 Luminous Matte FoundationOCTINOXATE AND TITANIUM DIOXIDESICOS ET CIE571f23e9-1126-e32d-e063-6294a90a99512026-07-21WarningsExact identifier
unii: 15FIX9V2JP
MENS SPF50 ALL IN ONE SUNSCREENMENS SPF50 ALL IN ONE SUNSCREENLance (Guangzhou) Biological Technology Co., Ltd.57074480-77fd-cc06-e063-6294a90a28d42026-07-20WarningsExact identifier
unii: 15FIX9V2JP

Reported adverse events (FAERS/openFDA)#

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