Hydroxyzine Hydrochloride

Product NDC
63187-605
11-digit product format
631870605
Labeler code
63187
Product ID
63187-605_189b4ff1-8308-4869-8e33-c0bb7c803b45
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Hydroxyzine Hydrochloride
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Proficient Rx LP
Application
ANDA040804
Marketing category
ANDA
Marketing start
2008-06-30
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

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
63187-605-20EA - Each63187-605180a252c-3385-4dfc-bc0e-6cb58477709a12019-03-12

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
63187-605-156318706051515 TABLET, FILM COATED in 1 BOTTLE (63187-605-15) 2018-12-010000-00-00NoNoCurrent
63187-605-206318706052020 TABLET, FILM COATED in 1 BOTTLE (63187-605-20) 2018-12-010000-00-00NoNoCurrent
63187-605-306318706053030 TABLET, FILM COATED in 1 BOTTLE (63187-605-30) 2018-12-010000-00-00NoNoCurrent
63187-605-606318706056060 TABLET, FILM COATED in 1 BOTTLE (63187-605-60) 2018-12-010000-00-00NoNoCurrent
63187-605-906318706059090 TABLET, FILM COATED in 1 BOTTLE (63187-605-90) 2018-12-010000-00-00NoNoCurrent