hydroxyzine pamoate

Product NDC
71205-433
11-digit product format
712050433
Labeler code
71205
Product ID
71205-433_8b9b3ddb-0aac-4b68-8079-d31de791c752
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
hydroxyzine pamoate
Dosage form
CAPSULE
Route
ORAL
Labeler
Proficient Rx LP
Application
ANDA201507
Marketing category
ANDA
Marketing start
2013-06-03
Substance
HYDROXYZINE PAMOATE
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
M20215MUFRHYDROXYZINE PAMOATE10246-75-0HYDROXYZINE PAMOATE

Packages

Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
71205-433-307120504333030 CAPSULE in 1 BOTTLE (71205-433-30) 30 capsule2020-03-18NoNoHistorical
71205-433-607120504336060 CAPSULE in 1 BOTTLE (71205-433-60) 60 capsule2020-03-18NoNoHistorical
71205-433-907120504339090 CAPSULE in 1 BOTTLE (71205-433-90) 90 capsule2020-03-18NoNoHistorical

Related DailyMed Labels

TitleManufacturerEffective dateTypeVersion
Rx onlyProficient Rx LP2022-11-01HUMAN PRESCRIPTION DRUG LABEL2