Hydroxyzine Hydrochloride

Product NDC
55289-912
11-digit product format
552890912
Labeler code
55289
Product ID
55289-912_a6bbfbcf-6f35-0b5f-e053-2a95a90abee1
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Hydroxyzine
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
PD-Rx Pharmaceuticals, Inc.
Application
ANDA040808
Marketing category
ANDA
Marketing start
2007-06-29
Marketing end
0000-00-00
Substance
HYDROXYZINE HYDROCHLORIDE
Active strength
10 mg/1
Pharmacologic classes
Antihistamine [EPC],Histamine Receptor Antagonists [MoA]
NDC exclude flag
No
Listing certified through
2021-12-31
Current FDA listing
Historical FDA.report record

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
55289-912-10EA - Each55289-912d45dd2ea-deae-49a5-a722-bcc633d404b112012-07-24
55289-912-30EA - Each55289-912af87b38d-653e-415f-a2b6-2bd4907b6c4712012-07-24
55289-912-60EA - Each55289-91236ac028e-45c6-46ab-ba5a-cc7598b956fa12012-07-24

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
55289-912-105528909121010 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (55289-912-10) 2012-02-240000-00-00NoNoCurrent
55289-912-305528909123030 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (55289-912-30) 2012-02-240000-00-00NoNoCurrent
55289-912-605528909126060 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (55289-912-60) 2012-02-240000-00-00NoNoCurrent