FDA.reportPublic FDA data

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 7 of 115 · 2,282 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
blink tearsPOLYETHYLENE GLYCOL 400Bausch & Lomb Incorporatedf1d07347-086f-43b2-aa5f-910764fc666e2026-05-13WarningsExact identifier
unii: B697894SGQ
Even Tone Mineral Sunscreen Broad Spectrum SPF 36 Medium - DarkTITANIUM DIOXIDE AND ZINC OXIDESENT, Inc.aedde765-931f-430e-9fc3-d87bde2b78cd2026-05-12WarningsExact identifier
unii: 15FIX9V2JP
Even Tone Mineral Sunscreen Broad Spectrum SPF 40 Light - MediumTITANIUM DIOXIDE AND ZINC OXIDESENT, Inc.417305d7-d32e-4bc9-8f77-0a42b6bdecf52026-05-12WarningsExact identifier
unii: 15FIX9V2JP
Calamine Plus Pramoxine HClCALAMINE PLUS SPRAYCVS Pharmacydb6f518d-3a0e-43f8-8d19-7382d9b7ff1c2026-05-11WarningsExact identifier
unii: 1K09F3G675
The Perfect Derma Mineral Perfection Broad Spectrum SPF 30TITANIUM DIOXIDE, ZINC OXIDEBella Medical Products LLC518f69fc-fd39-8195-e063-6294a90a3fdd2026-05-11WarningsExact identifier
unii: 15FIX9V2JP
Radical Rescue Morning UVA/UVB Defense Primer Broad Spectrum SPF 30 Universal Tint Mineral SunscreenRADICAL RESCUE SPF 30 MINERAL SUNSCREENProTransit, Inc.38e0139c-bb87-55ba-e063-6294a90a82ee2026-05-11WarningsExact identifier
unii: 15FIX9V2JP
EELHOE SunscreenTITANIUM DIOXIDEShantou Eelhoe Daily Chemical Technology Co., Ltd.5196ccb0-4515-7e40-e063-6394a90a09bd2026-05-11WarningsExact identifier
unii: 15FIX9V2JP
Dior Backstage Glow-Up Skin Tint Tinted Moisturizer SPF 20 5.5N NeutralOCTISALATE, TITANIUM DIOXIDEParfums Christian Diorbb65c8d7-318f-4d52-9d74-ca22ce3896382026-05-07WarningsExact identifier
unii: 15FIX9V2JP
Dior Backstage Glow-Up Skin Tint Tinted Moisturizer SPF 20 4.5N NeutralOCTISALATE, TITANIUM DIOXIDEParfums Christian Dior67b90f00-4c82-40cd-af96-f8dedf95f8af2026-05-06WarningsExact identifier
unii: 15FIX9V2JP
Dior Backstage Glow-Up Skin Tint Tinted Moisturizer SPF 20 4W WarmOCTISALATE, TITANIUM DIOXIDEParfums Christian Dior7a2bd17d-0ea7-4326-9939-a747869c01d22026-05-06WarningsExact identifier
unii: 15FIX9V2JP
Dior Backstage Glow-Up Skin Tint Tinted Moisturizer SPF 20 4N NeutralOCTISALATE, TITANIUM DIOXIDEParfums Christian Diora396c0eb-f91f-4732-9c20-6b25aa0634b72026-05-06WarningsExact identifier
unii: 15FIX9V2JP
Dior Backstage Glow-Up Skin Tint Tinted Moisturizer SPF 20 6N NeutralOCTISALATE, TITANIUM DIOXIDEParfums Christian Dior18b21fba-f6ee-4ac5-a536-096716f51da02026-05-06WarningsExact identifier
unii: 15FIX9V2JP
Dior Backstage Glow-Up Skin Tint Tinted Moisturizer SPF 20 1N NeutralOCTISALATE, TITANIUM DIOXIDEParfums Christian Dior13c34bba-f939-4aa7-9457-9d6025902e062026-05-06WarningsExact identifier
unii: 15FIX9V2JP
Dior Backstage Glow-Up Skin Tint Tinted Moisturizer SPF 20 3CR Cool RosyOCTISALATE, TITANIUM DIOXIDEParfums Christian Diord12905b6-97aa-429a-8800-23856fe31f062026-05-06WarningsExact identifier
unii: 15FIX9V2JP
Dior Backstage Glow-Up Skin Tint Tinted Moisturizer SPF 20 0N NeutralOCTISALATE, TITANIUM DIOXIDEParfums Christian Dior43599d17-81f4-4c6e-b6bd-d1e700b668ee2026-05-06WarningsExact identifier
unii: 15FIX9V2JP
Dior Backstage Glow-Up Skin Tint Tinted Moisturizer SPF 20 0.5N NeutralOCTISALATE, TITANIUM DIOXIDEParfums Christian Dior116f09db-f859-40c5-8857-33503903ee762026-05-06WarningsExact identifier
unii: 15FIX9V2JP
Dior Backstage Glow-Up Skin Tint Tinted Moisturizer SPF 20 2N NeutralOCTISALATE, TITANIUM DIOXIDEParfums Christian Dior480e5bf9-8e24-4335-a434-93255ceb640e2026-05-06WarningsExact identifier
unii: 15FIX9V2JP
Dior Backstage Glow-Up Skin Tint Tinted Moisturizer SPF 20 1.5N NeutralOCTISALATE, TITANIUM DIOXIDEParfums Christian Dior7057feab-20fe-4547-8223-0816904bcfd62026-05-06WarningsExact identifier
unii: 15FIX9V2JP
Dior Backstage Glow-Up Skin Tint Tinted Moisturizer SPF 20 1CR Cool RosyOCTISALATE, TITANIUM DIOXIDEParfums Christian Dior672a804d-ba8e-4c03-91fc-3edc0b12c6272026-05-06WarningsExact identifier
unii: 15FIX9V2JP
Dior Backstage Glow-Up Skin Tint Tinted Moisturizer SPF 20 3.5N NeutralOCTISALATE, TITANIUM DIOXIDEParfums Christian Diorb656394d-a410-4f8c-a632-815a349fb17e2026-05-06WarningsExact identifier
unii: 15FIX9V2JP

Reported adverse events (FAERS/openFDA)#

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