Hydroxyzine

Product NDC
0904-0358
11-digit product format
009040358
Labeler code
0904
Product ID
0904-0358_8c97b943-1051-4d87-84f5-8b0cc0602ffd
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Hydroxyzine Hydrochloride
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Major Pharmaceuticals
Application
ANDA040787
Marketing category
ANDA
Marketing start
2007-03-20
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
2020-12-31
Current FDA listing
Historical FDA.report record

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
0904-0358-4000904035840500 TABLET, FILM COATED in 1 BOTTLE (0904-0358-40) 2007-03-200000-00-00NoNoCurrent
0904-0358-80009040358801000 TABLET, FILM COATED in 1 BOTTLE (0904-0358-80) 2007-03-200000-00-00NoNoCurrent