Hydroxyzine Hydrochloride

Product NDC
68084-253
11-digit product format
680840253
Labeler code
68084
Product ID
68084-253_de592900-2fd6-7409-e053-2995a90abb13
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Hydroxyzine Hydrochloride
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
American Health Packaging
Application
ANDA040786
Marketing category
ANDA
Marketing start
2009-01-14
Marketing end
2022-06-30
Substance
HYDROXYZINE DIHYDROCHLORIDE
Active strength
10 mg/1
Pharmacologic classes
Antihistamine [EPC], Histamine Receptor Antagonists [MoA]
NDC exclude flag
No
Listing certified through
0000-00-00
Current FDA listing
Historical FDA.report record

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
68084-253-01EA - Each68084-2534fbb607f-c99b-4399-9db2-992fa6a7c18812012-07-24
68084-253-11EA - Each68084-2537c3ca501-6aac-455d-95e5-5545fd02bf2e12012-07-24

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
68084-253-0168084025301100 BLISTER PACK in 1 BOX, UNIT-DOSE (68084-253-01) > 1 TABLET, FILM COATED in 1 BLISTER PACK (68084-253-11) 100 blister pack2009-01-140000-00-00NoNoCurrent