Hydroxyzine Pamoate

Product NDC
72189-480
11-digit product format
721890480
Labeler code
72189
Product ID
72189-480_2c4e17dd-fe0a-06e5-e063-6394a90ab19d
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Hydroxyzine Pamoate
Dosage form
CAPSULE
Route
ORAL
Labeler
Direct_Rx
Application
ANDA086183
Marketing category
ANDA
Marketing start
2023-05-30
Substance
HYDROXYZINE PAMOATE
Active strength
50 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 PAMOATE50 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiM20215MUFR
Rxcui995278

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
72189-480-30Hydroxyzine Pamoate30 in 1 BOTTLECAPSULE304
72189-480-90Hydroxyzine Pamoate90 in 1 BOTTLECAPSULE904

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
72189-480-30EA - Each72189-48060ae71b5-8fed-4de6-a0fe-52c98361b4e912023-06-06
72189-480-90EA - Each72189-4806e6342eb-73ec-4280-9d6e-2a0f0d2edb6612023-08-08

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
72189-480HYDROXYZINE PAMOATE CAPSULE [DIRECT_RX]4Current NDC, 2 package rows20250123_fcec985f-9ded-6534-e053-6294a90ac76b.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
995278hydrOXYzine pamoate 50 MG Oral CapsulePSNfcec985f-9ded-6534-e053-6294a90ac76b4
995278hydroxyzine pamoate 50 MG Oral CapsuleSCDfcec985f-9ded-6534-e053-6294a90ac76b4
995278hydroxyzine pamoate 50 MG (hydroxyzine pamoate 85.2 MG eqv to hydroxyzine HCl 50 MG) Oral CapsuleSYfcec985f-9ded-6534-e053-6294a90ac76b4

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
72189-480-307218904803030 CAPSULE in 1 BOTTLE (72189-480-30) 30 capsule2023-05-30NoNoCurrent
72189-480-907218904809090 CAPSULE in 1 BOTTLE (72189-480-90) 90 capsule2023-05-30NoNoCurrent