MONTELUKAST SODIUM

Product NDC
69844-041
11-digit product format
698440041
Labeler code
69844
Product ID
69844-041_3c5c6869-860e-48c3-aa92-cc6ff55d45e2
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
MONTELUKAST SODIUM
Dosage form
TABLET
Route
ORAL
Labeler
Graviti Pharmaceuticals Private Limited
Application
ANDA209012
Marketing category
ANDA
Marketing start
2020-04-06
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#

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
69844-041-016984400410130 TABLET in 1 BOTTLE (69844-041-01) 30 tablet2020-04-060000-00-00NoNoCurrent
69844-041-026984400410290 TABLET in 1 BOTTLE (69844-041-02) 90 tablet2020-04-060000-00-00NoNoCurrent