FDA.reportPublic FDA data

hydroxyzine pamoate

Product NDC
68071-4954
11-digit product format
680714954
Labeler code
68071
Product ID
68071-4954_1b2e33e8-26b5-e5a0-e063-6294a90ae585
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
hydroxyzine pamoate
Dosage form
CAPSULE
Route
ORAL
Labeler
NuCare Pharmaceuticals,Inc.
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
2026-12-31

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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
68071-4954-32023-05-16C16284748780-1ba0f9c33-509c-a910-e053-dadaa90a0b85Rx only
68071-4954-32023-01-30C16284748780-1ba0f9c33-509c-a910-e053-dadaa90a0b85Rx only
68071-4954-32021-02-18C16284748780-1ba0f9c33-509c-a910-e053-dadaa90a0b85Rx only
68071-4954-32021-01-29C16284748780-1ba0f9c33-509c-a910-e053-dadaa90a0b85Rx only

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
68071-4954-3hydroxyzine pamoate30 in 1 BOTTLECAPSULE305
68071-4954-9hydroxyzine pamoate90 in 1 BOTTLECAPSULE905

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68071-4954HYDROXYZINE PAMOATE CAPSULE [NUCARE PHARMACEUTICALS,INC.]5Current NDC, Legacy NDC, 2 package rows20240619_8cb94f1d-1e45-531a-e053-2a95a90a1ba0.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
995253hydrOXYzine pamoate 25 MG Oral CapsulePSN8cb94f1d-1e45-531a-e053-2a95a90a1ba05
995253hydroxyzine pamoate 25 MG Oral CapsuleSCD8cb94f1d-1e45-531a-e053-2a95a90a1ba05

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
68071-4954-36807149540330 CAPSULE in 1 BOTTLE (68071-4954-3) 30 capsule2019-04-230000-00-00NoNoCurrent
68071-4954-96807149540990 CAPSULE in 1 BOTTLE (68071-4954-9) 90 capsule2023-05-24NoNoHistorical