Hydroxyzine pamoate

Product NDC
50090-5933
11-digit product format
500905933
Labeler code
50090
Product ID
50090-5933_4ea79965-1fc3-49b1-b22b-4cf4d63e8cab
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Hydroxyzine Pamoate
Dosage form
CAPSULE
Route
ORAL
Labeler
A-S Medication Solutions
Application
ANDA086183
Marketing category
ANDA
Marketing start
1981-12-14
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
50090-5933-1Hydroxyzine pamoate20 in 1 BOTTLECAPSULE201

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
50090-5933-1EA - Each50090-59330a76725e-218d-4bbf-925f-105f4d09dbe812024-02-14

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50090-5933HYDROXYZINE PAMOATE CAPSULE [A-S MEDICATION SOLUTIONS]1Current NDC, 1 package rows20240123_dd6b78d3-6052-40d8-8dd3-d9ea2ab47c9b.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
995278hydrOXYzine pamoate 50 MG Oral CapsulePSNdd6b78d3-6052-40d8-8dd3-d9ea2ab47c9b1
995278hydroxyzine pamoate 50 MG Oral CapsuleSCDdd6b78d3-6052-40d8-8dd3-d9ea2ab47c9b1
995278hydroxyzine pamoate 50 MG (hydroxyzine pamoate 85.2 MG eqv to hydroxyzine HCl 50 MG) Oral CapsuleSYdd6b78d3-6052-40d8-8dd3-d9ea2ab47c9b1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
50090-5933-15009059330120 CAPSULE in 1 BOTTLE (50090-5933-1) 20 capsule2024-01-02NoNoCurrent