Hydroxyzine Pamoate

Product NDC
70518-3194
11-digit product format
705183194
Labeler code
70518
Product ID
70518-3194_c9c32455-8ae0-9333-e053-2995a90a596b
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Hydroxyzine Pamoate
Dosage form
CAPSULE
Route
ORAL
Labeler
REMEDYREPACK INC.
Application
ANDA040156
Marketing category
ANDA
Marketing start
2021-08-17
Marketing end
0000-00-00
Substance
HYDROXYZINE PAMOATE
Active strength
50 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
M20215MUFRHYDROXYZINE PAMOATE10246-75-0HYDROXYZINE PAMOATE

Packages

Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
70518-3194-07051831940030 CAPSULE in 1 BLISTER PACK (70518-3194-0) 30 capsule2021-08-170000-00-00NoNoCurrent