Hydroxyzine Hydrochloride

Product NDC
71205-273
11-digit product format
712050273
Labeler code
71205
Product ID
71205-273_7160086d-21ca-4ca0-9aee-1680c2c4d61c
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Hydroxyzine Hydrochloride
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Proficient Rx LP
Application
ANDA040602
Marketing category
ANDA
Marketing start
2015-03-31
Substance
HYDROXYZINE DIHYDROCHLORIDE
Active strength
25 mg/1
Pharmacologic classes
Antihistamine [EPC], Histamine Receptor Antagonists [MoA]
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Related Records

Related UNII Ingredients

UNIIPreferred termRegistry numberMatched term
76755771U3HYDROXYZINE HYDROCHLORIDE2192-20-3Hydroxyzine Hydrochloride

Packages

Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
71205-273-157120502731515 TABLET, FILM COATED in 1 BOTTLE (71205-273-15) 2019-05-01NoNoHistorical
71205-273-207120502732020 TABLET, FILM COATED in 1 BOTTLE (71205-273-20) 2019-05-01NoNoHistorical
71205-273-307120502733030 TABLET, FILM COATED in 1 BOTTLE (71205-273-30) 2019-05-01NoNoHistorical
71205-273-607120502736060 TABLET, FILM COATED in 1 BOTTLE (71205-273-60) 2019-05-01NoNoHistorical
71205-273-907120502739090 TABLET, FILM COATED in 1 BOTTLE (71205-273-90) 2019-05-01NoNoHistorical

Related DailyMed Labels

TitleManufacturerEffective dateTypeVersion
Hydroxyzine Hydrochloride Tablets USP, Film-Coated Rx OnlyProficient Rx LP2022-11-01HUMAN PRESCRIPTION DRUG LABEL3