FDA.reportPublic FDA data

hydroxyzine pamoate

Product NDC
53002-6212
11-digit product format
530026212
Labeler code
53002
Product ID
53002-6212_8ed44aee-e8f7-4c9e-b30a-2d615304832c
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
hydroxyzine pamoate
Dosage form
CAPSULE
Route
ORAL
Labeler
RPK Pharmaceuticals, Inc.
Application
ANDA087479
Marketing category
ANDA
Marketing start
1981-12-14
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
53002-6212-12023-01-30C16284748780-1f386c649-abe9-0266-e053-dadaa90a7c1aHydrOXYzine Pamoate Capsules, USP
53002-6212-22023-01-30C16284748780-1f386c649-abe9-0266-e053-dadaa90a7c1aHydrOXYzine Pamoate Capsules, USP
53002-6212-32023-01-30C16284748780-1f386c649-abe9-0266-e053-dadaa90a7c1aHydrOXYzine Pamoate Capsules, USP
53002-6212-52023-01-30C16284748780-1f386c649-abe9-0266-e053-dadaa90a7c1aHydrOXYzine Pamoate Capsules, USP

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
53002-6212-1hydroxyzine pamoate10 in 1 BOTTLECAPSULE101
53002-6212-2hydroxyzine pamoate20 in 1 BOTTLECAPSULE201
53002-6212-3hydroxyzine pamoate30 in 1 BOTTLECAPSULE301
53002-6212-5hydroxyzine pamoate15 in 1 BOTTLECAPSULE151

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
53002-6212HYDROXYZINE PAMOATE CAPSULE [RPK PHARMACEUTICALS, INC.]1Legacy NDC, 4 package rows20201224_c1ef1319-7cd9-4420-8c33-24d2da38a662.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
995253hydrOXYzine pamoate 25 MG Oral CapsulePSNc1ef1319-7cd9-4420-8c33-24d2da38a6621
995253hydroxyzine pamoate 25 MG Oral CapsuleSCDc1ef1319-7cd9-4420-8c33-24d2da38a6621

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
53002-6212-15300262120110 CAPSULE in 1 BOTTLE (53002-6212-1) 10 capsule2019-01-010000-00-00NoNoCurrent
53002-6212-25300262120220 CAPSULE in 1 BOTTLE (53002-6212-2) 20 capsule2019-01-010000-00-00NoNoCurrent
53002-6212-35300262120330 CAPSULE in 1 BOTTLE (53002-6212-3) 30 capsule2019-01-010000-00-00NoNoCurrent
53002-6212-55300262120515 CAPSULE in 1 BOTTLE (53002-6212-5) 15 capsule2019-01-010000-00-00NoNoCurrent