FDA.reportPublic FDA data

NDC 66993-416-81 - 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
66993-416
Requested NDC
66993-416-81
Package NDCs from labels
66993-416-81, 66993-416-30
Manufacturer
Prasco Laboratories | Merck Sharp & Dohme Corp.
Effective date
2020-04-29
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
Montelukast Sodium - Prasco Laboratories | Merck Sharp & Dohme Corp.Prasco Laboratories | Merck Sharp & Dohme Corp.2020-04-29HUMAN PRESCRIPTION DRUG LABEL

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
66993-416-30EA - Each66993-41684d657ba-11f6-4e70-a4f1-28fdc5683f0112013-09-04
66993-416-81EA - Each66993-416153cea6c-9237-42b6-b2d4-3a821511d8c412013-09-04

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
montelukast sodiumACTIVE INGREDIENTU1O3J18SFLMONTELUKAST SODIUM GRANULE [PRASCO LABORATORIES]5
montelukastACTIVE MOIETYMHM278SD3EMONTELUKAST SODIUM GRANULE [PRASCO LABORATORIES]5
hydroxypropyl cellulose (type h)INACTIVE INGREDIENTRFW2ET671PMONTELUKAST SODIUM GRANULE [PRASCO LABORATORIES]5
magnesium stearateINACTIVE INGREDIENT70097M6I30MONTELUKAST SODIUM GRANULE [PRASCO LABORATORIES]5
mannitolINACTIVE INGREDIENT3OWL53L36AMONTELUKAST SODIUM GRANULE [PRASCO LABORATORIES]5

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 1 of 4 · 68 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
MontelukastMONTELUKASTCoupler LLC583a9499-97f0-2ebf-e063-6394a90a35af2026-08-04Boxed warning, Warnings, Adverse reactionsExact identifier
unii: U1O3J18SFL
Montelukast SodiumMONTELUKAST SODIUMTorrent Pharmaceuticals Limitedda038cf6-cfad-43a4-ab8e-d81d028d60872026-07-28Boxed warning, Warnings, Adverse reactionsExact identifier
unii: U1O3J18SFL
montelukast sodiumMONTELUKAST SODIUMPreferred Pharmaceuticals Inc.1eeb3123-9e93-4681-8096-800a7c7acf8a2026-07-28Boxed warning, Warnings, Adverse reactionsExact identifier
unii: U1O3J18SFL
MontelukastMONTELUKASTPreferred Pharmaceuticals, Inc.94642db1-5c75-44c4-92b4-8385b486df822026-07-28Boxed warning, Warnings, Adverse reactionsExact identifier
unii: U1O3J18SFL
Montelukast SodiumMONTELUKAST SODIUMPreferred Pharmaceuticals Inc.64a3b181-e8d8-4caf-9f1b-e0063d0bd94a2026-07-28Boxed warning, Warnings, Adverse reactionsExact identifier
unii: U1O3J18SFL
Montelukast SodiumMONTELUKAST SODIUMRising Pharma Holdings, Inc.49669ac0-0bb5-4576-bed5-9e85e0d76a442026-05-29Boxed warning, Warnings, Adverse reactionsExact identifier
unii: U1O3J18SFL
MannitolMANNITOLHospira, Inc.8ad3145e-00e7-4412-b9a5-06f00f264f302026-04-21Warnings, Adverse reactionsExact identifier
unii: 3OWL53L36A
MontelukastMONTELUKASTREMEDYREPACK INC.ecaa9b4b-5941-4af5-930c-35e9f3b2b4ba2026-04-03Boxed warning, Warnings, Adverse reactionsExact identifier
unii: U1O3J18SFL
MontelukastMONTELUKASTAvPAKd7870c45-5a8b-8369-e053-2a95a90ae1f32026-01-08Boxed warning, Warnings, Adverse reactionsExact identifier
unii: U1O3J18SFL
Montelukast SodiumMONTELUKAST SODIUMRedpharm Drug2fbdf1be-a37f-879b-e063-6394a90aa20d2025-12-30Boxed warning, Warnings, Adverse reactionsExact identifier
unii: U1O3J18SFL
MONTELUKAST SODIUMMONTELUKAST SODIUMChartwell RX, LLC5cb4298c-10b1-4d6f-95ad-4aad72daf2492025-12-17Boxed warning, Warnings, Adverse reactionsExact identifier
unii: U1O3J18SFL
Montelukast SodiumMONTELUKAST SODIUMAvKAREed2caffa-a75c-1c27-ae30-2d8280eaea7d2025-12-16Warnings, Adverse reactionsExact identifier
unii: U1O3J18SFL
MONTELUKASTMONTELUKAST SODIUMA-S Medication Solutionsda9821f1-536a-416b-9594-210bde0cefaf2025-12-11Boxed warning, Warnings, Adverse reactionsExact identifier
unii: U1O3J18SFL
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
MannitolMANNITOLProPharma Distribution430669d7-9ad1-9a04-e063-6394a90ababb2025-11-07Warnings, Adverse reactionsExact identifier
unii: 3OWL53L36A
Sorbitol-MannitolSORBITOL AND MANNITOLICU Medical Inc.5b44e248-4b7b-4777-954a-921c7b3099442025-10-30Warnings, Adverse reactionsExact identifier
unii: 3OWL53L36A
Montelukast SodiumMONTELUKAST SODIUMAvPAK2f90a573-27fd-cc16-f3d1-8c4d630224a02025-10-29Warnings, Adverse reactionsExact identifier
unii: U1O3J18SFL
MannitolMANNITOLICU Medical Inc.ba7bf864-8a4d-4262-8fd1-00174fa2f9d12025-10-24Warnings, Adverse reactionsExact identifier
unii: 3OWL53L36A
Montelukast SodiumMONTELUKAST SODIUMPD-Rx Pharmaceuticals, Inc.c9ec1996-6a54-4622-b8a6-57dea49f6b352025-10-16Boxed warning, Warnings, Adverse reactionsExact identifier
unii: U1O3J18SFL

Reported adverse events (FAERS/openFDA)#

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