Montelukast Sodium

Product NDC
71335-1599
11-digit product format
713351599
Labeler code
71335
Product ID
71335-1599_a17e3d06-c407-4f96-ab63-57ee7c00fc0f
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Montelukast Sodium
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Bryant Ranch Prepack
Application
ANDA202717
Marketing category
ANDA
Marketing start
2013-04-11
Marketing end
0000-00-00
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
2023-12-31
Current FDA listing
Historical FDA.report record

Related Records

Related UNII Ingredients

UNIIPreferred termRegistry numberMatched term
U1O3J18SFLMONTELUKAST SODIUM151767-02-1MONTELUKAST SODIUM

Packages

Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
71335-1599-17133515990130 TABLET, FILM COATED in 1 BOTTLE (71335-1599-1) 2022-02-140000-00-00NoNoCurrent
71335-1599-2713351599024 TABLET, FILM COATED in 1 BOTTLE (71335-1599-2) 2022-02-140000-00-00NoNoCurrent
71335-1599-3713351599037 TABLET, FILM COATED in 1 BOTTLE (71335-1599-3) 2022-02-140000-00-00NoNoCurrent
71335-1599-47133515990460 TABLET, FILM COATED in 1 BOTTLE (71335-1599-4) 2022-02-140000-00-00NoNoCurrent
71335-1599-57133515990510 TABLET, FILM COATED in 1 BOTTLE (71335-1599-5) 2022-02-140000-00-00NoNoCurrent
71335-1599-67133515990690 TABLET, FILM COATED in 1 BOTTLE (71335-1599-6) 2022-02-140000-00-00NoNoCurrent
71335-1599-771335159907120 TABLET, FILM COATED in 1 BOTTLE (71335-1599-7) 2022-02-140000-00-00NoNoCurrent
71335-1599-87133515990815 TABLET, FILM COATED in 1 BOTTLE (71335-1599-8) 2022-02-140000-00-00NoNoCurrent