Hydroxyzine Pamoate

Product NDC
51655-252
11-digit product format
516550252
Labeler code
51655
Product ID
51655-252_48e6bda3-48ba-5ce2-e063-6394a90a9e15
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Hydroxyzine Pamoate
Dosage form
CAPSULE
Route
ORAL
Labeler
Northwind Health Company, LLC
Application
ANDA088487
Marketing category
ANDA
Marketing start
2023-04-25
Substance
HYDROXYZINE PAMOATE
Active strength
50 mg/1
Pharmacologic classes
Antihistamine [EPC], Histamine Receptor Antagonists [MoA]
NDC exclude flag
No
Listing certified through
2027-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Hydroxyzine Pamoate
Listing expiration
2027-12-31

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
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
51655-252-52Hydroxyzine Pamoate30 in 1 BOTTLE, PLASTICCAPSULE302

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
51655-252HYDROXYZINE PAMOATE CAPSULE [NORTHWIND PHARMACEUTICALS, LLC]1Current NDC, 1 package rows20230707_faf7932b-40ee-8822-e053-6394a90a5e40.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
995278hydrOXYzine pamoate 50 MG Oral CapsulePSNfaf7932b-40ee-8822-e053-6394a90a5e402
995278hydroxyzine pamoate 50 MG Oral CapsuleSCDfaf7932b-40ee-8822-e053-6394a90a5e402
995278hydroxyzine pamoate 50 MG (hydroxyzine pamoate 85.2 MG eqv to hydroxyzine HCl 50 MG) Oral CapsuleSYfaf7932b-40ee-8822-e053-6394a90a5e402

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
51655-252-525165502525230 CAPSULE in 1 BOTTLE, PLASTIC (51655-252-52) 30 capsule2023-04-25NoNoCurrent