hydroxyzine pamoate

Product NDC
68071-2521
11-digit product format
680712521
Labeler code
68071
Product ID
68071-2521_ca8e95c7-b26b-a038-e053-2995a90a87a3
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
Marketing end
0000-00-00
Substance
HYDROXYZINE PAMOATE
Active strength
25 mg/1
Pharmacologic classes
Antihistamine [EPC],Histamine Receptor Antagonists [MoA]
NDC exclude flag
No
Listing certified through
2022-12-31
Current FDA listing
Historical FDA.report record

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
68071-2521-12025-01-30C16284748780-1f386c649-e425-0266-e053-dadaa90a7c1aRx only
68071-2521-12023-07-14C16284748780-1f386c649-e425-0266-e053-dadaa90a7c1aRx only
68071-2521-12023-01-30C16284748780-1f386c649-e425-0266-e053-dadaa90a7c1aRx only

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
68071-2521-1hydroxyzine pamoate100 in 1 CONTAINERCAPSULE1002

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68071-2521HYDROXYZINE PAMOATE CAPSULE [NUCARE PHARMACEUTICALS,INC.]2Legacy NDC, 1 package rows20230715_ca8e86ea-b6b4-6a40-e053-2995a90adf11.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
995253hydrOXYzine pamoate 25 MG Oral CapsulePSNca8e86ea-b6b4-6a40-e053-2995a90adf112
995253hydroxyzine pamoate 25 MG Oral CapsuleSCDca8e86ea-b6b4-6a40-e053-2995a90adf112

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
68071-2521-168071252101100 CAPSULE in 1 CONTAINER (68071-2521-1) 100 capsule2021-08-270000-00-00NoNoCurrent