hydroxyzine pamoate

Product NDC
12634-833
11-digit product format
126340833
Labeler code
12634
Product ID
12634-833_27800e43-e197-3eed-e054-00144ff88e88
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
hydroxyzine pamoate
Dosage form
CAPSULE
Route
ORAL
Labeler
Apotheca Inc.
Application
ANDA086183
Marketing category
ANDA
Marketing start
1981-12-14
Marketing end
0000-00-00
Substance
HYDROXYZINE PAMOATE
Active strength
50 mg/1
Pharmacologic classes
Antihistamine [EPC],Histamine Receptor Antagonists [MoA]
NDC exclude flag
No
Listing certified through
2019-12-31
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
12634-833-012020-01-31C16284748780-19d75b9d0-2656-f424-e053-dadaa90a57ceHydrOXYzine Pamoate Capsules USP
12634-833-712020-01-31C16284748780-19d75b9d0-2656-f424-e053-dadaa90a57ceHydrOXYzine Pamoate Capsules USP

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
12634-833-01hydroxyzine pamoate100 in 1 BOTTLECAPSULE1001
12634-833-71hydroxyzine pamoate30 in 1 BOTTLECAPSULE301

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
12634-833HYDROXYZINE PAMOATE CAPSULE [APOTHECA INC.]1Legacy NDC, 2 package rows20151222_27800e43-e196-3eed-e054-00144ff88e88.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
995278hydrOXYzine pamoate 50 MG Oral CapsulePSN27800e43-e196-3eed-e054-00144ff88e881
995278hydroxyzine pamoate 50 MG Oral CapsuleSCD27800e43-e196-3eed-e054-00144ff88e881
995278hydroxyzine pamoate 50 MG (hydroxyzine pamoate 85.2 MG eqv to hydroxyzine HCl 50 MG) Oral CapsuleSY27800e43-e196-3eed-e054-00144ff88e881

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionStatus
12634-833-0112634083301100 in 1 BOTTLEHistorical
12634-833-711263408337130 in 1 BOTTLEHistorical