Hydroxyzine Hydrochloride

Product NDC
43063-435
11-digit product format
430630435
Labeler code
43063
Product ID
43063-435_9e53c225-c846-90d6-e053-2a95a90a9617
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
50 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
43063-435-20EA - Each43063-435c6261757-2f68-455f-9254-78903a4bebb012014-09-03
43063-435-30EA - Each43063-435df3f0f13-be09-40e5-a6f9-65ba114f076512013-03-03