NDC 68788-7669-01 - 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
68788-7669
Requested NDC
68788-7669-01
Package NDCs from labels
68788-7669-1, 68788-7669-4, 68788-7669-2, 68788-7669-3, 68788-7669-6, 68788-7669-9, 68788-7669-01
Manufacturer
Preferred Pharmaceuticals, Inc.
Effective date
2026-01-13
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
montelukast sodium - Preferred Pharmaceuticals, Inc.Preferred Pharmaceuticals, Inc.2026-01-13HUMAN PRESCRIPTION DRUG LABEL

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
68788-7669-1montelukast sodium10 in 1 BOTTLETABLET, CHEWABLE106
68788-7669-2montelukast sodium20 in 1 BOTTLETABLET, CHEWABLE206
68788-7669-3montelukast sodium30 in 1 BOTTLETABLET, CHEWABLE306
68788-7669-4montelukast sodium14 in 1 BOTTLETABLET, CHEWABLE146
68788-7669-6montelukast sodium60 in 1 BOTTLETABLET, CHEWABLE606
68788-7669-9montelukast sodium90 in 1 BOTTLETABLET, CHEWABLE906

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68788-7669MONTELUKAST SODIUM TABLET, CHEWABLE [PREFERRED PHARMACEUTICALS, INC.]5Current NDC, Legacy NDC, 6 package rows20240724_09b0bc9e-3035-45b4-b61b-4aca70848360.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
68788-7669-1EA - Each68788-7669d130ce6b-a2ca-45d0-a0a8-17e7747895cc12020-05-08
68788-7669-2EA - Each68788-76697464d2ce-011e-4809-8c93-bd9002fb3eb912020-05-08
68788-7669-3EA - Each68788-76697f8181e8-7f69-4d34-a1cb-390fe7cba86b12020-05-08
68788-7669-4EA - Each68788-76696fced204-8cfd-4b4a-9661-6e6b836bf86612020-05-08
68788-7669-6EA - Each68788-766955367211-9966-44f2-a1cb-1b734d89400712020-05-08
68788-7669-9EA - Each68788-766953c0e2ee-c978-4e3c-880d-1dd89588f57012020-05-08

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 3 of 6 · 110 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Artificial Sweetener Detox 6034ARTIFICIAL SWEETENER DETOXProfessional Complementary Health Formulas38f2ae0b-2b1f-4b49-934d-fe1556f84d932026-01-08WarningsExact identifier
unii: Z0H242BBR1
Thio Combination 9306THIO COMBINATIONProfessional Complementary Health Formulas36e84795-bfb4-4483-9a2c-e14131ce1bea2026-01-08WarningsExact identifier
unii: Z0H242BBR1
Third Chakra (Solar Plexus) 7303THIRD CHAKRA (SOLAR PLEXUS)Professional Complementary Health Formulaseea89c37-ab87-4cc7-8dfc-e7f42a580dd92026-01-08WarningsExact identifier
unii: 1K09F3G675
DermagesicPRAMOXINE HCL, ZINC OXIDE, CALAMINELlorens Pharmaceutical International Divisionbbff6b53-29da-45c1-8ccd-3e9df7f250e02025-12-31WarningsExact identifier
unii: 1K09F3G675
BABY ANTI MONKEY BUTT DIAPER RASHZINC OXIDE, CALAMINEClarion Brands, LLCe4424d74-f89c-5943-42e8-bf3a38e686192025-12-23WarningsExact identifier
unii: 1K09F3G675
MONTELUKAST SODIUMMONTELUKAST SODIUMChartwell RX, LLC5cb4298c-10b1-4d6f-95ad-4aad72daf2492025-12-17Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 311759
rxcui: 242438
Montelukast SodiumMONTELUKAST SODIUMAvKAREed2caffa-a75c-1c27-ae30-2d8280eaea7d2025-12-16Warnings, Adverse reactionsExact identifier
rxcui: 311759
rxcui: 242438
Calamine Plus Pramoxine HClCALAMINE PLUS SPRAYKroger Co.6b3e7aac-395f-48cf-9c5e-f7e163724aef2025-11-17WarningsExact identifier
unii: 1K09F3G675
Calamine Plus Pramoxine HClCALAMINE PLUS SPRAYHY-VEE, INC415ecfe9-3145-f23e-e063-6394a90adfd82025-11-17WarningsExact identifier
unii: 1K09F3G675
QR PAINANALGESICMARYHELENE ENTERPRISES INC8f8f53e3-fe31-e7b5-e053-2995a90a710d2025-11-14WarningsExact identifier
unii: 3OWL53L36A
QR PAINANALGESICMARYHELENE ENTERPRISES INC9984a510-30be-4013-e053-2995a90a841e2025-11-14WarningsExact identifier
unii: 3OWL53L36A
Au Kah Chuen FugicalCALAMINE AND DIPHENHYDRAMINE HYDROCHLORIDZhejiang Dingtai Pharmaceutical Co., Ltd5b4add17-6c3d-4093-826a-2edb41c1d1db2025-11-10WarningsExact identifier
unii: 1K09F3G675
FARGELIN HEMORRHOIDALCALAMINE, PETROLATUM AND PHENYLEPHRINE HYDROCHLORIDEMADISON ONE ACME INC6844ad63-512d-496a-9458-011894185b0d2025-11-10WarningsExact identifier
unii: 1K09F3G675
MannitolMANNITOLProPharma Distribution430669d7-9ad1-9a04-e063-6394a90ababb2025-11-07Warnings, Adverse reactionsExact identifier
unii: 3OWL53L36A
Calamine PlusCALAMINE PLUS PRAMOXINE HCLChain Drug Marketing Association Inc1a3f8819-58cf-8923-e063-6394a90a37af2025-11-06WarningsExact identifier
unii: 1K09F3G675
Calamine Plus Pramoxine HClCALAMINE PLUS NO TOUCH SPRAYPremier Brands of America Inc.36481d67-2346-470b-e063-6294a90aae992025-11-03WarningsExact identifier
unii: 1K09F3G675
Calamine PlusCALAMINE PLUS PRAMOXINE HCLAmerisourceBergen Drug Corporationf161e151-4fab-2fbc-e053-2a95a90a54372025-10-30WarningsExact identifier
unii: 1K09F3G675
REMEDY Calazime Skin ProtectantCALAMINE, MENTHOL, WHITE PETROLATUM, ZINC OXIDEMedline Industries, LP1295cfcc-5b61-481b-964b-f53ffd0cb58e2025-10-30WarningsExact identifier
unii: 1K09F3G675
Calamine PlusCALAMINE PLUS PRAMOXINE HCLMeijer Distribution Inc.03c46823-0b1f-4101-e063-6294a90aaf942025-10-30WarningsExact identifier
unii: 1K09F3G675
Sorbitol-MannitolSORBITOL AND MANNITOLICU Medical Inc.5b44e248-4b7b-4777-954a-921c7b3099442025-10-30Warnings, Adverse reactionsExact identifier
unii: 3OWL53L36A

Reported adverse events (FAERS/openFDA)#

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