MONTELUKAST SODIUM

Product NDC
69844-075
11-digit product format
698440075
Labeler code
69844
Product ID
69844-075_b287c48f-bf1c-4830-ba9a-92c83f468448
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
2022-01-14
Marketing end
0000-00-00
Substance
MONTELUKAST SODIUM
Active strength
5 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

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
69844-075-016984400750130 TABLET, CHEWABLE in 1 BOTTLE (69844-075-01) 2022-01-140000-00-00NoNoCurrent
69844-075-0269844007502100 TABLET, CHEWABLE in 1 BOTTLE (69844-075-02) 2022-01-140000-00-00NoNoCurrent
69844-075-036984400750390 TABLET, CHEWABLE in 1 BOTTLE (69844-075-03) 2022-01-140000-00-00NoNoCurrent