Hydroxyzine Pamoate

Product NDC
10544-556
11-digit product format
105440556
Labeler code
10544
Product ID
10544-556_11aab8b5-dcc9-0d4a-e054-00144ff88e88
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Hydroxyzine Pamoate
Dosage form
CAPSULE
Route
ORAL
Labeler
Blenheim Pharmacal, Inc.
Application
ANDA040156
Marketing category
ANDA
Marketing start
2013-11-11
Marketing end
0000-00-00
Substance
HYDROXYZINE PAMOATE
Active strength
25 mg/1
Pharmacologic classes
Antihistamine [EPC],Histamine Receptor Antagonists [MoA]
NDC exclude flag
E
Listing certified through
2017-12-31
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
10544-556-202020-01-31C16284748780-19d75b9d0-b2d2-f424-e053-dadaa90a57ceHydrOXYzine Pamoate Capsules USP Rx only

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
10544-556-20Hydroxyzine Pamoate20 in 1 BOTTLE, PLASTICCAPSULE201

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
10544-556HYDROXYZINE PAMOATE CAPSULE [BLENHEIM PHARMACAL, INC.]1Legacy NDC, 1 package rows20150320_11aab8b5-dcc8-0d4a-e054-00144ff88e88.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
995253hydrOXYzine pamoate 25 MG Oral CapsulePSN11aab8b5-dcc8-0d4a-e054-00144ff88e881
995253hydroxyzine pamoate 25 MG Oral CapsuleSCD11aab8b5-dcc8-0d4a-e054-00144ff88e881

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionStatus
10544-556-201054405562020 in 1 BOTTLE, PLASTICHistorical