Hydroxyzine Pamoate

Product NDC
0615-8420
11-digit product format
006158420
Labeler code
0615
Product ID
0615-8420_b805a16f-99e8-4e22-902a-6eed48d51d4d
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Hydroxyzine Pamoate
Dosage form
CAPSULE
Route
ORAL
Labeler
NCS HealthCare of KY, LLC dba Vangard Labs
Application
ANDA040156
Marketing category
ANDA
Marketing start
1996-06-15
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
Rxcui995253, 995278

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
0615-8420-39Hydroxyzine Pamoate30 in 1 BLISTER PACKCAPSULE301

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0615-8420HYDROXYZINE PAMOATE CAPSULE [NCS HEALTHCARE OF KY, LLC DBA VANGARD LABS]1Current NDC, Legacy NDC, 1 package rows20220212_207d3478-ac7f-485c-b8ca-e9fcebbdcd89.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
995253hydrOXYzine pamoate 25 MG Oral CapsulePSN207d3478-ac7f-485c-b8ca-e9fcebbdcd891
995278hydrOXYzine pamoate 50 MG Oral CapsulePSN207d3478-ac7f-485c-b8ca-e9fcebbdcd891
995253hydroxyzine pamoate 25 MG Oral CapsuleSCD207d3478-ac7f-485c-b8ca-e9fcebbdcd891
995278hydroxyzine pamoate 50 MG Oral CapsuleSCD207d3478-ac7f-485c-b8ca-e9fcebbdcd891
995278hydroxyzine pamoate 50 MG (hydroxyzine pamoate 85.2 MG eqv to hydroxyzine HCl 50 MG) Oral CapsuleSY207d3478-ac7f-485c-b8ca-e9fcebbdcd891

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0615-8420-390061584203930 CAPSULE in 1 BLISTER PACK (0615-8420-39) 30 capsule2022-01-040000-00-00NoNoCurrent