MONTELUKAST SODIUM

Product NDC
69844-039
11-digit product format
698440039
Labeler code
69844
Product ID
69844-039_4d266794-eeb8-4897-a9c1-6d18dfe5548e
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
MONTELUKAST SODIUM
Dosage form
TABLET, CHEWABLE
Route
ORAL
Labeler
Graviti Pharmaceuticals Private Limited
Application
ANDA209011
Marketing category
ANDA
Marketing start
2020-04-06
Marketing end
0000-00-00
Substance
MONTELUKAST SODIUM
Active strength
4 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#

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
69844-039-016984400390130 TABLET, CHEWABLE in 1 BOTTLE (69844-039-01) 2020-04-060000-00-00NoNoCurrent
69844-039-0269844003902100 TABLET, CHEWABLE in 1 BOTTLE (69844-039-02) 2020-04-060000-00-00NoNoCurrent