HYDROXYZINE PAMOATE

Product NDC
53217-256
11-digit product format
532170256
Labeler code
53217
Product ID
53217-256_0ed87590-3f22-4add-8f48-805b84f8d76e
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
HYDROXYZINE PAMOATE
Dosage form
CAPSULE
Route
ORAL
Labeler
Aidarex Pharmaceuticals LLC
Application
ANDA201507
Marketing category
ANDA
Marketing start
2010-11-17
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
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
53217-256-302020-01-31C16284748780-19d75b9d0-8269-f424-e053-dadaa90a57ceRx only
53217-256-602020-01-31C16284748780-19d75b9d0-8269-f424-e053-dadaa90a57ceRx only

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
53217-256-30HYDROXYZINE PAMOATE30 in 1 BOTTLECAPSULE301
53217-256-60HYDROXYZINE PAMOATE60 in 1 BOTTLECAPSULE601

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
53217-256-30EA - Each53217-256b6d7ed96-2e88-4fff-9e60-e257ce28dbcf12017-04-05
53217-256-60EA - Each53217-256a55dbe19-3e1e-4556-8a50-4d859dbf9e8812017-04-05

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
53217-256HYDROXYZINE PAMOATE CAPSULE [AIDAREX PHARMACEUTICALS LLC]1Legacy NDC, 2 package rows20170309_a852d881-3c34-447e-9ed8-1d547cefb75e.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
995253hydrOXYzine pamoate 25 MG Oral CapsulePSNa852d881-3c34-447e-9ed8-1d547cefb75e1
995253hydroxyzine pamoate 25 MG Oral CapsuleSCDa852d881-3c34-447e-9ed8-1d547cefb75e1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionStatus
53217-256-305321702563030 in 1 BOTTLEHistorical
53217-256-605321702566060 in 1 BOTTLEHistorical