hydroxyzine pamoate

Product NDC
71205-558
11-digit product format
712050558
Labeler code
71205
Product ID
71205-558_bff75226-d194-4d64-bcbb-d7d79f5d230e
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
hydroxyzine pamoate
Dosage form
CAPSULE
Route
ORAL
Labeler
Proficient Rx LP
Application
ANDA087479
Marketing category
ANDA
Marketing start
1981-12-14
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
71205-558-307120505583030 CAPSULE in 1 BOTTLE (71205-558-30) 30 capsule2021-05-03NoNoHistorical
71205-558-607120505586060 CAPSULE in 1 BOTTLE (71205-558-60) 60 capsule2021-05-03NoNoHistorical
71205-558-907120505589090 CAPSULE in 1 BOTTLE (71205-558-90) 90 capsule2021-05-03NoNoHistorical

Related DailyMed Labels

TitleManufacturerEffective dateTypeVersion
HydrOXYzine Pamoate Capsules, USPProficient Rx LP2021-05-01HUMAN PRESCRIPTION DRUG LABEL1