NDC 55111-593-79 - 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
55111-593
Requested NDC
55111-593-79
Package NDCs from labels
55111-593-30, 55111-593-90, 55111-593-05, 55111-593-79, 55111-593-78
Manufacturer
Dr.Reddy's Laboratories Limited
Effective date
2022-10-30
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
Montelukast Sodium - Dr.Reddy's Laboratories LimitedDr.Reddy's Laboratories Limited2022-10-30HUMAN PRESCRIPTION DRUG LABEL

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
55111-593-05Montelukast Sodium500 in 1 BOTTLETABLET, CHEWABLE50024
55111-593-30Montelukast Sodium30 in 1 BOTTLETABLET, CHEWABLE3024
55111-593-78Montelukast Sodium10 in 1 CARTONTABLET, CHEWABLE1024
55111-593-79Montelukast Sodium10 in 1 BLISTER PACKTABLET, CHEWABLE1024
55111-593-90Montelukast Sodium90 in 1 BOTTLETABLET, CHEWABLE9024

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
55111-593MONTELUKAST SODIUM TABLET, COATED MONTELUKAST SODIUM TABLET, CHEWABLE [DR.REDDY'S LABORATORIES LIMITED]24Current NDC, Legacy NDC, 5 package rows20221217_3d4451a9-d73d-b9de-68ec-853bfeff6e4b.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
55111-593-30EA - Each55111-593f6f6d721-76db-40a4-b18e-05ad609cf91f12013-02-13
55111-593-90EA - Each55111-593b301e076-786b-4e27-81f0-b017278be3bc12013-02-13

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
Montelukast SodiumACTIVE INGREDIENTU1O3J18SFLMONTELUKAST SODIUM TABLET, COATED MONTELUKAST SODIUM TABLET, CHEWABLE [DR.REDDY'S LABORATORIES LIMITED]17
montelukastACTIVE MOIETYMHM278SD3EMONTELUKAST SODIUM TABLET, COATED MONTELUKAST SODIUM TABLET, CHEWABLE [DR.REDDY'S LABORATORIES LIMITED]17
aspartameINACTIVE INGREDIENTZ0H242BBR1MONTELUKAST SODIUM TABLET, COATED MONTELUKAST SODIUM TABLET, CHEWABLE [DR.REDDY'S LABORATORIES LIMITED]17
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UMONTELUKAST SODIUM TABLET, COATED MONTELUKAST SODIUM TABLET, CHEWABLE [DR.REDDY'S LABORATORIES LIMITED]17
cherryINACTIVE INGREDIENTBUC5I9595WMONTELUKAST SODIUM TABLET, COATED MONTELUKAST SODIUM TABLET, CHEWABLE [DR.REDDY'S LABORATORIES LIMITED]17
CROSCARMELLOSE SODIUMINACTIVE INGREDIENTM28OL1HH48MONTELUKAST SODIUM TABLET, COATED MONTELUKAST SODIUM TABLET, CHEWABLE [DR.REDDY'S LABORATORIES LIMITED]17
FERRIC OXIDE REDINACTIVE INGREDIENT1K09F3G675MONTELUKAST SODIUM TABLET, COATED MONTELUKAST SODIUM TABLET, CHEWABLE [DR.REDDY'S LABORATORIES LIMITED]17
FERRIC OXIDE YELLOWINACTIVE INGREDIENTEX438O2MRTMONTELUKAST SODIUM TABLET, COATED MONTELUKAST SODIUM TABLET, CHEWABLE [DR.REDDY'S LABORATORIES LIMITED]17
FERROSOFERRIC OXIDEINACTIVE INGREDIENTXM0M87F357MONTELUKAST SODIUM TABLET, COATED MONTELUKAST SODIUM TABLET, CHEWABLE [DR.REDDY'S LABORATORIES LIMITED]17
Hydroxypropyl Cellulose (Type H)INACTIVE INGREDIENTRFW2ET671PMONTELUKAST SODIUM TABLET, COATED MONTELUKAST SODIUM TABLET, CHEWABLE [DR.REDDY'S LABORATORIES LIMITED]17
HYPROMELLOSESINACTIVE INGREDIENT3NXW29V3WOMONTELUKAST SODIUM TABLET, COATED MONTELUKAST SODIUM TABLET, CHEWABLE [DR.REDDY'S LABORATORIES LIMITED]17
LACTOSE MONOHYDRATEINACTIVE INGREDIENTEWQ57Q8I5XMONTELUKAST SODIUM TABLET, COATED MONTELUKAST SODIUM TABLET, CHEWABLE [DR.REDDY'S LABORATORIES LIMITED]17
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30MONTELUKAST SODIUM TABLET, COATED MONTELUKAST SODIUM TABLET, CHEWABLE [DR.REDDY'S LABORATORIES LIMITED]17
MANNITOLINACTIVE INGREDIENT3OWL53L36AMONTELUKAST SODIUM TABLET, COATED MONTELUKAST SODIUM TABLET, CHEWABLE [DR.REDDY'S LABORATORIES LIMITED]17
POLYETHYLENE GLYCOL 400INACTIVE INGREDIENTB697894SGQMONTELUKAST SODIUM TABLET, COATED MONTELUKAST SODIUM TABLET, CHEWABLE [DR.REDDY'S LABORATORIES LIMITED]17
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPMONTELUKAST SODIUM TABLET, COATED MONTELUKAST SODIUM TABLET, CHEWABLE [DR.REDDY'S LABORATORIES LIMITED]17

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 4 of 115 · 2,282 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Coral Isle SPF 50 Mineral SunscreenTITANIUM DIOXIDE, ZINC OXIDERocky Mountain5515f562-62d9-c6ee-e063-6294a90a9ea62026-06-25WarningsExact identifier
unii: 15FIX9V2JP
Delicate Beige Perfecting Makeup Broad Spectrum SPF 25OCTINOXATE, TITANIUM DIOXIDEMerle Norman Cosmetics, Inc551928b4-74bb-3f6c-e063-6294a90a6b832026-06-25WarningsExact identifier
unii: 15FIX9V2JP
Alabaster Beige Perfecting Makeup Broad Spectrum SPF 25OCTINOXATE, TITANIUM DIOXIDEMerle Norman Cosmetics, Inc5519290c-b040-6a37-e063-6394a90a8a1d2026-06-25WarningsExact identifier
unii: 15FIX9V2JP
Soft Bisque Perfecting Makeup Broad Spectrum SPF 25OCTINOXATE, TITANIUM DIOXIDEMerle Norman Cosmetics, Inc551ab7d1-dd2f-c6d8-e063-6394a90aff652026-06-25WarningsExact identifier
unii: 15FIX9V2JP
Alabaster Perfecting Makeup Broad Spectrum SPF 25OCTINOXATE, TITANIUM DIOXIDEMerle Norman Cosmetics, Inc551b8c21-3afc-c804-e063-6294a90a51562026-06-25WarningsExact identifier
unii: 15FIX9V2JP
Bare Perfecting Makeup Broad Spectrum SPF 25OCTINOXATE, TITANIUM DIOXIDEMerle Norman Cosmetics, Inc552f20b2-9a2e-70f3-e063-6394a90a93372026-06-25WarningsExact identifier
unii: 15FIX9V2JP
CalaSootheCALAMINE, MENTHOL, AND ZINC OXIDEDynarex Corporation54f12005-acfe-4821-e063-6394a90ac3042026-06-24WarningsExact identifier
unii: 1K09F3G675
BROAD SPECTRUM SPF 50 UNIVERSAL TINTED SUNSCREENTITANIUM DIOXIDEShantou Woodsleep Biotechnology Co., Ltd.54fc80b7-8f6c-e2be-e063-6394a90a4b592026-06-24WarningsExact identifier
unii: 15FIX9V2JP
Cerave Developed with Dermatologists Hydrating Sunscreen SPF 30 Body Lightweight, non-greasy feel 3 essential ceramides Mineral SunscreenTITANIUM DIOXIDE AND ZINC OXIDEL'Oreal USA Products Inc54ecaea7-dafe-9694-e063-6394a90ae3b52026-06-23WarningsExact identifier
unii: 15FIX9V2JP
RYDEEN UV CLEARSUNSCREENGuangzhou Oupeng Cosmetics Co., Ltd.548000cd-1655-aeb3-e063-6294a90ad0042026-06-22WarningsExact identifier
unii: 15FIX9V2JP
Good Instincts Proper Sunscreen SPF 50ZINC OXIDE, TITANIUM DIOXIDEInhabit Brands, Inc82d2af99-7c42-4ce5-94e0-b2ac60b8db1b2026-06-22WarningsExact identifier
unii: 15FIX9V2JP
ESPOIR BE VELVET COVER CUSHIONHOMOSALATE, TITANIUM DIOXIDEESPOIR Corporation54ce2420-4ac0-eb51-e063-6294a90a2de92026-06-21WarningsExact identifier
unii: 15FIX9V2JP
BABIES KIDSSUN PROTECTIONMINERAL SUNSCREENPANERGYTEK USA INC3a554118-b71d-a844-e063-6294a90a699f2026-06-20WarningsExact identifier
unii: 15FIX9V2JP
Rohto Sun and SportHYPROMELLOSE, POVIDONEThe Mentholatum Company8bcc8882-b886-4b55-9bc4-d4b92a41358f2026-06-19WarningsExact identifier
unii: 3NXW29V3WO
Rohto Dual Light ReliefHYPROMELLOSE, POVIDONEThe Mentholatum Company1b597f83-d7f1-cf93-e063-6394a90a99f72026-06-19WarningsExact identifier
unii: 3NXW29V3WO
Creamy Beige Perfecting Makeup Broad Spectrum SPF 25OCTINOXATE, TITANIUM DIOXIDEMerle Norman Cosmetics, Inc548b7c90-ef97-38ab-e063-6394a90ac6092026-06-18WarningsExact identifier
unii: 15FIX9V2JP
GlowBiotics Tinted Sunscreen SPF 30ZINC OXIDERum Brands, LLC544dba29-4785-4ab6-e063-6394a90a17b32026-06-16WarningsExact identifier
unii: 15FIX9V2JP
Societe Prime and DefendZINC OXIDE SUNSCREENSociete Clinical Skincare5439bd31-5ee1-9bca-e063-6394a90a748c2026-06-16WarningsExact identifier
unii: 15FIX9V2JP
Societe CoverShield Tinted SPFZINC OXIDESociete Clinical Skincare545efbc4-82d4-f126-e063-6294a90a97102026-06-16WarningsExact identifier
unii: 15FIX9V2JP
Shield by HEALTHY SKIN LAB MD SUNSCREENTITANIUM DIOXIDE, ZINC OXIDEHEALTHY SKIN LAB LIMITED6838b754-9915-48ff-af35-5338dbd06ac42026-06-15WarningsExact identifier
unii: 15FIX9V2JP

Reported adverse events (FAERS/openFDA)#

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