SINGULAIR

Product NDC
0006-9117
11-digit product format
000069117
Labeler code
0006
Product ID
0006-9117_582e9110-dc03-48f5-a4b8-693cd5cdbf10
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
montelukast sodium
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Merck Sharp & Dohme Corp.
Application
NDA020829
Marketing category
NDA
Marketing start
1998-02-20
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
2022-12-31
Current FDA listing
Historical FDA.report record

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0006-9117-31EA - Each0006-91178b39c3e2-6fc4-4ba0-822c-8ca1de1fec2f12012-07-24
0006-9117-54EA - Each0006-9117dededaa5-6e40-42e6-8f64-68894940a54612012-07-24
0006-9117-80EA - Each0006-9117ff03aa3e-aab4-4b92-8b3d-2ac76882d23212012-07-24

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
0006-9117-310000691173130 TABLET, FILM COATED in 1 BOTTLE (0006-9117-31) 1998-02-200000-00-00NoNoCurrent
0006-9117-540000691175490 TABLET, FILM COATED in 1 BOTTLE (0006-9117-54) 1998-02-200000-00-00NoNoCurrent