hydroxyzine pamoate

Product NDC
33261-858
11-digit product format
332610858
Labeler code
33261
Product ID
33261-858_b0679889-19c0-4615-968d-a108d2482aeb
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
hydroxyzine pamoate
Dosage form
CAPSULE
Route
ORAL
Labeler
Aidarex Pharmaceuticals LLC
Application
ANDA086183
Marketing category
ANDA
Marketing start
1981-12-14
Marketing end
0000-00-00
Substance
HYDROXYZINE PAMOATE
Active strength
50 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#

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
33261-858-02hydroxyzine pamoate120 in 1 BOTTLE, PLASTICCAPSULE1201
33261-858-30hydroxyzine pamoate30 in 1 BOTTLE, PLASTICCAPSULE301
33261-858-60hydroxyzine pamoate60 in 1 BOTTLE, PLASTICCAPSULE601

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
33261-858HYDROXYZINE PAMOATE CAPSULE [AIDAREX PHARMACEUTICALS LLC]1Legacy NDC, 3 package rows20140110_f305fb4a-f78f-49ff-b679-ebe84649f5a6.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
995278hydrOXYzine pamoate 50 MG Oral CapsulePSNf305fb4a-f78f-49ff-b679-ebe84649f5a61
995278hydroxyzine pamoate 50 MG Oral CapsuleSCDf305fb4a-f78f-49ff-b679-ebe84649f5a61
995278hydroxyzine pamoate 50 MG (hydroxyzine pamoate 85.2 MG eqv to hydroxyzine HCl 50 MG) Oral CapsuleSYf305fb4a-f78f-49ff-b679-ebe84649f5a61

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionStatus
33261-858-0233261085802120 in 1 BOTTLE, PLASTICHistorical
33261-858-303326108583030 in 1 BOTTLE, PLASTICHistorical
33261-858-603326108586060 in 1 BOTTLE, PLASTICHistorical