Montelukast Sodium

Product NDC
70934-202
11-digit product format
709340202
Labeler code
70934
Product ID
70934-202_af603659-27ba-75d4-e053-2995a90a69f0
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Montelukast Sodium
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Denton Pharma, Inc. dba Northwind Pharmaceuticals
Application
ANDA202717
Marketing category
ANDA
Marketing start
2018-12-06
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
2021-12-31
Current FDA listing
Historical FDA.report record

FDA-Initiated Inactive NDC Indexing#

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
70934-202-30EA - Each70934-20256bb08e5-4143-42a1-a311-4cf0877a526712023-01-09
70934-202-90EA - Each70934-20259e23f29-3d2b-4f90-b952-b77937a085e112022-02-07

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
70934-202-307093402023030 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (70934-202-30) 2019-10-080000-00-00NoNoCurrent
70934-202-907093402029090 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (70934-202-90) 2018-12-060000-00-00NoNoCurrent