FDA.reportPublic FDA data

Montelukast

Product NDC
50268-556
11-digit product format
502680556
Labeler code
50268
Product ID
50268-556_47e755f4-d852-60b7-e063-6294a90aa1e4
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Montelukast
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
AvPAK
Application
ANDA202843
Marketing category
ANDA
Marketing start
2022-02-08
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
2027-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Montelukast
Listing expiration
2027-12-31

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
50268-556-11Montelukast1 in 1 BLISTER PACKTABLET, FILM COATED14
50268-556-15Montelukast50 in 1 BOXTABLET, FILM COATED504

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
50268-556-11EA - Each50268-556ef42f378-7fbf-4b60-8fcc-65d1ab2b26df12022-03-09
50268-556-15EA - Each50268-556721227fa-5aba-4a45-9fe0-f2c7192a5a6212022-03-09

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50268-556MONTELUKAST TABLET, FILM COATED [AVPAK]3Current NDC, Legacy NDC, 2 package rows20240110_d7870c45-5a8b-8369-e053-2a95a90ae1f3.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
200224montelukast sodium 10 MG Oral TabletPSNd7870c45-5a8b-8369-e053-2a95a90ae1f34
200224montelukast 10 MG Oral TabletSCDd7870c45-5a8b-8369-e053-2a95a90ae1f34
200224montelukast 10 MG (as montelukast sodium 10.4 MG) Oral TabletSYd7870c45-5a8b-8369-e053-2a95a90ae1f34

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
50268-556-11502680556111 in 1 BLISTER PACKHistorical
50268-556-155026805561550 BLISTER PACK in 1 BOX (50268-556-15) / 1 TABLET, FILM COATED in 1 BLISTER PACK (50268-556-11) 50 blister pack2022-02-080000-00-00NoNoCurrent