Hydroxyzine Pamoate

Product NDC
53002-6211
11-digit product format
530026211
Labeler code
53002
Product ID
53002-6211_0e79d89f-4422-4c5f-bfa1-fe83c9ac9855
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Hydroxyzine Pamoate
Dosage form
CAPSULE
Route
ORAL
Labeler
RPK Pharmaceuticals, Inc.
Application
ANDA088496
Marketing category
ANDA
Marketing start
1984-07-01
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
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
351abe41-466c-4dd8-840a-0fdb68318bd5Product name120230316
aa1826f4-97c1-4705-bdf0-3bc7d234e618Product name220190618
75cb12ee-8eb2-4f1a-a332-5743a5d0da41Product name120151110
3ca5f78b-43dc-30fe-8014-55b922af52b3Product name120140508

FDA-Initiated Inactive NDC Indexing#

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
53002-6211-1Hydroxyzine Pamoate10 in 1 BOTTLECAPSULE103
53002-6211-2Hydroxyzine Pamoate20 in 1 BOTTLECAPSULE203
53002-6211-3Hydroxyzine Pamoate30 in 1 BOTTLECAPSULE303

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
53002-6211HYDROXYZINE PAMOATE CAPSULE [RPK PHARMACEUTICALS, INC.]3Legacy NDC, 3 package rows20201218_362d0d0c-1977-4b19-ba62-228d910d69f9.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
995253hydrOXYzine pamoate 25 MG Oral CapsulePSN362d0d0c-1977-4b19-ba62-228d910d69f93
995253hydroxyzine pamoate 25 MG Oral CapsuleSCD362d0d0c-1977-4b19-ba62-228d910d69f93

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
53002-6211-15300262110110 CAPSULE in 1 BOTTLE (53002-6211-1) 10 capsule2018-10-010000-00-00NoNoCurrent
53002-6211-25300262110220 CAPSULE in 1 BOTTLE (53002-6211-2) 20 capsule2018-10-010000-00-00NoNoCurrent
53002-6211-35300262110330 CAPSULE in 1 BOTTLE (53002-6211-3) 30 capsule2018-10-010000-00-00NoNoCurrent