Hydroxyzine Hydrochloride

Product NDC
68788-7464
11-digit product format
687887464
Labeler code
68788
Product ID
68788-7464_b2ddf429-a436-46ac-82d5-67b045aeec8a
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Hydroxyzine Hydrochloride
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Preferred Pharmaceuticals, Inc.
Application
ANDA088618
Marketing category
ANDA
Marketing start
2012-10-09
Marketing end
0000-00-00
Substance
HYDROXYZINE DIHYDROCHLORIDE
Active strength
25 mg/1
Pharmacologic classes
Antihistamine [EPC],Histamine Receptor Antagonists [MoA]
NDC exclude flag
No
Listing certified through
2022-12-31
Current FDA listing
Historical FDA.report record

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
68788-7464-1EA - Each68788-7464df237f9c-0668-4d16-8de3-abd20c887be012020-08-06
68788-7464-2EA - Each68788-7464a11b70f9-9427-4a5a-a400-a623adf7512b12020-08-06
68788-7464-3EA - Each68788-746448a9a494-4542-45e7-8c72-7bff7c25f45712020-08-06
68788-7464-5EA - Each68788-746490dae435-fec9-4486-a959-28cb5ab0340c12020-08-06
68788-7464-6EA - Each68788-74646ce50943-e6c4-4827-9004-f69802d4894612020-08-06
68788-7464-9EA - Each68788-7464275b8083-123f-4135-b185-ea0baa24ab3d12020-08-06

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
68788-7464-168788746401100 TABLET, FILM COATED in 1 BOTTLE (68788-7464-1) 2019-12-270000-00-00NoNoCurrent
68788-7464-26878874640220 TABLET, FILM COATED in 1 BOTTLE (68788-7464-2) 2019-12-270000-00-00NoNoCurrent
68788-7464-36878874640330 TABLET, FILM COATED in 1 BOTTLE (68788-7464-3) 2019-12-270000-00-00NoNoCurrent
68788-7464-56878874640515 TABLET, FILM COATED in 1 BOTTLE (68788-7464-5) 2019-12-270000-00-00NoNoCurrent
68788-7464-66878874640660 TABLET, FILM COATED in 1 BOTTLE (68788-7464-6) 2019-12-270000-00-00NoNoCurrent
68788-7464-96878874640990 TABLET, FILM COATED in 1 BOTTLE (68788-7464-9) 2019-12-270000-00-00NoNoCurrent