hydroxyzine pamoate

Product NDC
72162-1054
11-digit product format
721621054
Labeler code
72162
Product ID
72162-1054_34f7e946-4993-3dcb-e063-6294a90a7786
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
hydroxyzine pamoate
Dosage form
CAPSULE
Route
ORAL
Labeler
Bryant Ranch Prepack
Application
ANDA087479
Marketing category
ANDA
Marketing start
2025-05-12
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

Additional Listing Data#

Finished product
Yes
Brand name base
hydroxyzine pamoate
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
HYDROXYZINE PAMOATE25 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiM20215MUFR
Rxcui995253

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
57311cfb-679a-da1a-b70c-8757f7fc431aProduct name420250516
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
72162-1054-3hydroxyzine pamoate30 in 1 BOTTLECAPSULE30100

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
72162-1054-3EA - Each72162-10544036c806-84db-4d24-a70d-a52546e0c9fa12025-06-13

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
72162-1054HYDROXYZINE PAMOATE CAPSULE [BRYANT RANCH PREPACK]100Current NDC, 1 package rows20250514_34f7e401-9b2c-7d63-e063-6394a90a1f00.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
995253hydrOXYzine pamoate 25 MG Oral CapsulePSN34f7e401-9b2c-7d63-e063-6394a90a1f00100
995253hydroxyzine pamoate 25 MG Oral CapsuleSCD34f7e401-9b2c-7d63-e063-6394a90a1f00100

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
72162-1054-37216210540330 CAPSULE in 1 BOTTLE (72162-1054-3) 30 capsule2025-05-12NoNoHistorical