Hydroxyzine Pamoate

Product NDC
67296-1660
11-digit product format
672961660
Labeler code
67296
Product ID
67296-1660_b8df9cca-bae3-58f5-e053-2a95a90af5e4
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Hydroxyzine Pamoate
Dosage form
CAPSULE
Route
ORAL
Labeler
RedPharm Drug, Inc.
Application
ANDA040156
Marketing category
ANDA
Marketing start
2019-01-01
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
2022-12-31
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
67296-1660-32023-01-30C16284748780-1f386c649-e266-0266-e053-dadaa90a7c1aHydroxyzine Pamoate 25mg
67296-1660-72023-01-30C16284748780-1f386c649-e266-0266-e053-dadaa90a7c1aHydroxyzine Pamoate 25mg

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
67296-1660-3Hydroxyzine Pamoate30 in 1 BOTTLECAPSULE304
67296-1660-7Hydroxyzine Pamoate15 in 1 BOTTLECAPSULE154

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
67296-1660HYDROXYZINE PAMOATE CAPSULE [REDPHARM DRUG, INC.]4Legacy NDC, 2 package rows20210115_89175a33-d4a8-c1ef-e053-2a95a90a0fb1.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
995253hydrOXYzine pamoate 25 MG Oral CapsulePSN89175a33-d4a8-c1ef-e053-2a95a90a0fb14
995253hydroxyzine pamoate 25 MG Oral CapsuleSCD89175a33-d4a8-c1ef-e053-2a95a90a0fb14

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
67296-1660-36729616600330 CAPSULE in 1 BOTTLE (67296-1660-3) 30 capsule2019-01-010000-00-00NoNoCurrent
67296-1660-76729616600715 CAPSULE in 1 BOTTLE (67296-1660-7) 15 capsule2019-10-310000-00-00NoNoCurrent