FDA.reportPublic FDA data

Montelukast Sodium

Product NDC
0904-6808
11-digit product format
009046808
Labeler code
0904
Product ID
0904-6808_4a289de2-d2e7-416d-9168-7f79cbff500b
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Montelukast Sodium
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Major Pharmaceuticals
Application
ANDA202843
Marketing category
ANDA
Marketing start
2014-09-10
Substance
MONTELUKAST SODIUM
Active strength
10 mg/1
Pharmacologic classes
Leukotriene Receptor Antagonist [EPC], Leukotriene Receptor Antagonists [MoA]
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Montelukast Sodium
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
MONTELUKAST SODIUM10 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiU1O3J18SFL
Rxcui200224

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
8d8a355b-240d-8c38-7331-c9e3c1068a33Product name920161220

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0904-6808-06Montelukast Sodium1 in 1 BLISTER PACKTABLET, FILM COATED15
0904-6808-06Montelukast Sodium50 in 1 CARTONTABLET, FILM COATED505
0904-6808-61Montelukast Sodium100 in 1 CARTONTABLET, FILM COATED1005
0904-6808-61Montelukast Sodium1 in 1 BLISTER PACKTABLET, FILM COATED15

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0904-6808-06EA - Each0904-6808e8502b79-06d7-4eaf-9b3b-7b06b76bd63812020-06-05
0904-6808-61EA - Each0904-680895c7ff36-44b4-41a4-a7dd-695d564e45d212019-02-13

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0904-6808MONTELUKAST TABLET, FILM COATED [MAJOR PHARMACEUTICALS]4Current NDC, Legacy NDC, 4 package rows20241003_a4dc63cf-8145-42f4-9437-93b414d2aed4.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
200224montelukast sodium 10 MG Oral TabletPSN9287d2f1-2414-4ee2-aecc-b6b59c6a0a4c6
200224montelukast 10 MG Oral TabletSCD9287d2f1-2414-4ee2-aecc-b6b59c6a0a4c6
200224montelukast 10 MG (as montelukast sodium 10.4 MG) Oral TabletSY9287d2f1-2414-4ee2-aecc-b6b59c6a0a4c6
200224montelukast sodium 10 MG Oral TabletPSNa4dc63cf-8145-42f4-9437-93b414d2aed45
200224montelukast 10 MG Oral TabletSCDa4dc63cf-8145-42f4-9437-93b414d2aed45
200224montelukast 10 MG (as montelukast sodium 10.4 MG) Oral TabletSYa4dc63cf-8145-42f4-9437-93b414d2aed45

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0904-6808-060090468080650 BLISTER PACK in 1 CARTON (0904-6808-06) / 1 TABLET, FILM COATED in 1 BLISTER PACK50 blister pack2014-09-100000-00-00NoNoCurrent
0904-6808-6100904680861100 BLISTER PACK in 1 CARTON (0904-6808-61) / 1 TABLET, FILM COATED in 1 BLISTER PACK100 blister pack2014-09-100000-00-00NoNoCurrent