MONTELUKAST SODIUM

Product NDC
68788-7668
11-digit product format
687887668
Labeler code
68788
Product ID
68788-7668_ca32044e-64dd-48aa-88b3-12a65b766f13
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
MONTELUKAST SODIUM
Dosage form
TABLET, CHEWABLE
Route
ORAL
Labeler
Preferred Pharmaceuticals, Inc.
Application
ANDA203328
Marketing category
ANDA
Marketing start
2020-02-28
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
2023-12-31
Current FDA listing
Historical FDA.report record

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
68788-7668-1EA - Each68788-76684c3400c3-6cd3-4d66-aede-77a032d76bfe12020-05-08
68788-7668-2EA - Each68788-76686c60dbac-ffe6-4da3-908b-769280fd2e8f12020-05-08
68788-7668-3EA - Each68788-76686a53f7fa-8219-4c8d-a8a3-0b3bf6da5ecd12020-05-08
68788-7668-4EA - Each68788-7668896bfe0f-60cc-4b1b-b6ad-30fbe66501ae12020-05-08
68788-7668-6EA - Each68788-766863da370b-bd40-415c-9ad8-675bd264ed5e12020-05-08
68788-7668-9EA - Each68788-7668c59491a0-9189-48ea-9c3f-1efc71f5e35812020-05-08

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
68788-7668-16878876680110 TABLET, CHEWABLE in 1 BOTTLE (68788-7668-1) 2020-02-280000-00-00NoNoCurrent
68788-7668-26878876680220 TABLET, CHEWABLE in 1 BOTTLE (68788-7668-2) 2020-02-280000-00-00NoNoCurrent
68788-7668-36878876680330 TABLET, CHEWABLE in 1 BOTTLE (68788-7668-3) 2020-02-280000-00-00NoNoCurrent
68788-7668-46878876680414 TABLET, CHEWABLE in 1 BOTTLE (68788-7668-4) 2020-02-280000-00-00NoNoCurrent
68788-7668-66878876680660 TABLET, CHEWABLE in 1 BOTTLE (68788-7668-6) 2020-02-280000-00-00NoNoCurrent
68788-7668-96878876680990 TABLET, CHEWABLE in 1 BOTTLE (68788-7668-9) 2020-02-280000-00-00NoNoCurrent