HYDROXYZINE PAMOATE

Product NDC
67296-1387
11-digit product format
672961387
Labeler code
67296
Product ID
67296-1387_a50ee3a9-4c62-e523-e053-2995a90a5320
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
HYDROXYZINE PAMOATE
Dosage form
CAPSULE
Route
ORAL
Labeler
RedPharm Drug, Inc.
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
2021-12-31
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
67296-1387-32022-01-28C16284748780-1d6a99b39-3c64-a426-e053-dadaa90af4c2Hydroxyzine Pamoate 25mg Caps
67296-1387-52022-01-28C16284748780-1d6a99b39-3c64-a426-e053-dadaa90af4c2Hydroxyzine Pamoate 25mg Caps

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
67296-1387-3HYDROXYZINE PAMOATE30 in 1 BOTTLECAPSULE301
67296-1387-5HYDROXYZINE PAMOATE15 in 1 BOTTLECAPSULE151

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
67296-1387HYDROXYZINE PAMOATE CAPSULE [REDPHARM DRUG, INC.]1Legacy NDC, 2 package rows20200508_a50ee238-faef-a1da-e053-2a95a90af965.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
995253hydrOXYzine pamoate 25 MG Oral CapsulePSNa50ee238-faef-a1da-e053-2a95a90af9651
995253hydroxyzine pamoate 25 MG Oral CapsuleSCDa50ee238-faef-a1da-e053-2a95a90af9651

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
67296-1387-36729613870330 CAPSULE in 1 BOTTLE (67296-1387-3) 30 capsule2010-11-170000-00-00NoNoCurrent
67296-1387-56729613870515 CAPSULE in 1 BOTTLE (67296-1387-5) 15 capsule2010-11-170000-00-00NoNoCurrent