HYDROXYZINE PAMOATE

Product NDC
42495-170
11-digit product format
424950170
Labeler code
42495
Product ID
42495-170_9caaf4e7-9323-4974-b5e0-e9306d6a1b61
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
HYDROXYZINE PAMOATE
Dosage form
CAPSULE
Route
ORAL
Labeler
Westwood Manufacturing
Application
ANDA201507
Marketing category
ANDA
Marketing start
2010-11-17
Marketing end
0000-00-00
Substance
HYDROXYZINE PAMOATE
Active strength
50 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
42495-170-302019-11-27C16284748780-19855e2a2-4911-60a7-e053-dbdaa90a05bdRx only

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
42495-170-30HYDROXYZINE PAMOATE30 in 1 BLISTER PACKCAPSULE302

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
42495-170HYDROXYZINE PAMOATE CAPSULE [WESTWOOD MANUFACTURING]2Legacy NDC, 1 package rows20140826_e97b2b86-bea0-4203-97c8-b27510a524a3.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
995278hydrOXYzine pamoate 50 MG Oral CapsulePSNe97b2b86-bea0-4203-97c8-b27510a524a32
995278hydroxyzine pamoate 50 MG Oral CapsuleSCDe97b2b86-bea0-4203-97c8-b27510a524a32
995278hydroxyzine pamoate 50 MG (hydroxyzine pamoate 85.2 MG eqv to hydroxyzine HCl 50 MG) Oral CapsuleSYe97b2b86-bea0-4203-97c8-b27510a524a32

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionStatus
42495-170-304249501703030 in 1 BLISTER PACKHistorical