Accolate

Product NDC
49884-590
11-digit product format
498840590
Labeler code
49884
Product ID
49884-590_1562c939-2d4d-452f-add4-2e24a29464cd
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
zafirlukast
Dosage form
TABLET, COATED
Route
ORAL
Labeler
Par Pharmaceutical, Inc.
Application
NDA020547
Marketing category
NDA
Marketing start
2015-11-01
Marketing end
2023-11-30
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
49884-590-022022-08-25C16284748780-1e4f33bdf-b28e-d8a0-e053-dadaa90a6e4ed31ecca3-23ff-470e-8c91-1bea8a537b3c
49884-590-022022-07-29C16284748780-1e4f33bdf-b28e-d8a0-e053-dadaa90a6e4ed31ecca3-23ff-470e-8c91-1bea8a537b3c

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
49884-590-02EA - Each49884-5904e2797e7-d085-495d-ab0c-732e3e2bfa1d12016-07-19

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
49884-590-024988405900260 TABLET, COATED in 1 BOTTLE (49884-590-02) 2015-11-012023-11-30NoNoCurrent