hydroxyzine pamoate

Product NDC
55154-2337
11-digit product format
551542337
Labeler code
55154
Product ID
55154-2337_3a53ce7c-0d75-4dc2-b360-d6312175df45
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
hydroxyzine pamoate
Dosage form
CAPSULE
Route
ORAL
Labeler
Cardinal Health 107, LLC
Application
ANDA201507
Marketing category
ANDA
Marketing start
2013-06-03
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
2027-12-31

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
55154-2337-0hydroxyzine pamoate1 in 1 BLISTER PACKCAPSULE15
55154-2337-0hydroxyzine pamoate10 in 1 BAGCAPSULE105

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
55154-2337HYDROXYZINE PAMOATE CAPSULE [CARDINAL HEALTH 107, LLC]2Current NDC, 2 package rows20240910_6ffb7c82-f780-4527-a7c3-e7d0f7b3b91e.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
995253hydrOXYzine pamoate 25 MG Oral CapsulePSN6ffb7c82-f780-4527-a7c3-e7d0f7b3b91e6
995253hydroxyzine pamoate 25 MG Oral CapsuleSCD6ffb7c82-f780-4527-a7c3-e7d0f7b3b91e6

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
55154-2337-05515423370010 BLISTER PACK in 1 BAG (55154-2337-0) / 1 CAPSULE in 1 BLISTER PACK10 blister pack2013-06-03NoNoCurrent