Zafirlukast

Product NDC
49884-554
11-digit product format
498840554
Labeler code
49884
Product ID
49884-554_8599c60a-49fc-47f3-b49c-2b089f79b202
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
zafirlukast
Dosage form
TABLET, COATED
Route
ORAL
Labeler
Par Pharmaceutical, Inc.
Application
NDA020547
Marketing category
NDA
Marketing start
2010-11-19
Marketing end
2024-09-30
Substance
ZAFIRLUKAST
Active strength
20 mg/1
Pharmacologic classes
Cytochrome P450 2C9 Inhibitors [MoA], Leukotriene Receptor Antagonist [EPC], Leukotriene Receptor Antagonists [MoA]
NDC exclude flag
No
Listing certified through
0000-00-00
Current FDA listing
Historical FDA.report record

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
49884-554-022022-09-27C16284748780-1e4f33bdf-9c7b-d8a0-e053-dadaa90a6e4e0262e192-94f4-423d-a58e-bb374dc106fe
49884-554-022022-07-29C16284748780-1e4f33bdf-9c7b-d8a0-e053-dadaa90a6e4e0262e192-94f4-423d-a58e-bb374dc106fe

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
49884-554-024988405540260 TABLET, COATED in 1 BOTTLE (49884-554-02) 2010-11-190000-00-00NoNoCurrent