Hydroxyzine hydrochloride

Product NDC
55700-829
11-digit product format
557000829
Labeler code
55700
Product ID
55700-829_762bfdc3-3a42-4475-9fab-c199d072e408
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Hydroxyzine hydrochloride
Dosage form
TABLET
Route
ORAL
Labeler
Quality Care Products, LLC
Application
ANDA204279
Marketing category
ANDA
Marketing start
2019-12-13
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
2022-12-31
Current FDA listing
Historical FDA.report record

Related Records

Related UNII Ingredients

UNIIPreferred termRegistry numberMatched term
76755771U3HYDROXYZINE HYDROCHLORIDE2192-20-3HYDROXYZINE HYDROCHLORIDE

Packages

Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
55700-829-305570008293030 TABLET in 1 BOTTLE (55700-829-30) 30 tablet2019-12-130000-00-00NoNoCurrent