Hydroxyzine Pamoate

Product NDC
63629-9244
11-digit product format
636299244
Labeler code
63629
Product ID
63629-9244_a522d2fd-1839-4c5c-bbd8-43e95d8913d1
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Hydroxyzine Pamoate
Dosage form
CAPSULE
Route
ORAL
Labeler
Bryant Ranch Prepack
Application
ANDA088488
Marketing category
ANDA
Marketing start
1984-07-01
Substance
HYDROXYZINE PAMOATE
Active strength
100 mg/1
Pharmacologic classes
Antihistamine [EPC], Histamine Receptor Antagonists [MoA]
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Hydroxyzine Pamoate
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
HYDROXYZINE PAMOATE100 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiM20215MUFR
Rxcui995232

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
57311cfb-679a-da1a-b70c-8757f7fc431aProduct name420250516
351abe41-466c-4dd8-840a-0fdb68318bd5Product name120230316
aa1826f4-97c1-4705-bdf0-3bc7d234e618Product name220190618
75cb12ee-8eb2-4f1a-a332-5743a5d0da41Product name120151110
3ca5f78b-43dc-30fe-8014-55b922af52b3Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
63629-9244-1Hydroxyzine Pamoate30 in 1 BOTTLECAPSULE30102

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
63629-9244HYDROXYZINE PAMOATE CAPSULE [BRYANT RANCH PREPACK]102Current NDC, Legacy NDC, 1 package rows20230329_8cf49dda-580a-4263-bd36-f457d0aea922.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
995232hydrOXYzine pamoate 100 MG Oral CapsulePSN8cf49dda-580a-4263-bd36-f457d0aea922102
995232hydroxyzine pamoate 100 MG Oral CapsuleSCD8cf49dda-580a-4263-bd36-f457d0aea922102
995232hydroxyzine hydrochloride 100 MG (hydroxyzine pamoate 170.4 MG) Oral CapsuleSY8cf49dda-580a-4263-bd36-f457d0aea922102

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
63629-9244-16362992440130 CAPSULE in 1 BOTTLE (63629-9244-1) 30 capsule2022-03-210000-00-00NoNoCurrent