hydroxyzine hydrochloride

Product NDC
68462-353
11-digit product format
684620353
Labeler code
68462
Product ID
68462-353_4f2a6947-2cf6-42ce-82b3-59d481ef33fb
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
hydroxyzine hydrochloride
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Glenmark Pharmaceuticals Inc., USA
Application
ANDA040812
Marketing category
ANDA
Marketing start
2015-02-01
Marketing end
0000-00-00
Substance
HYDROXYZINE HYDROCHLORIDE
Active strength
25 mg/1
Pharmacologic classes
Antihistamine [EPC],Histamine Receptor Antagonists [MoA]
NDC exclude flag
No
Listing certified through
2019-12-31
Current FDA listing
Historical FDA.report record

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
68462-353-01EA - Each68462-353ac10df1e-ee8c-4e01-a3fd-eb2b1c314c1412015-03-03
68462-353-05EA - Each68462-3535fd21ee8-3a50-43b6-b7d5-fa10996f1aa412015-03-03