hydroxyzine pamoate

Product NDC
82982-032
11-digit product format
829820032
Labeler code
82982
Product ID
82982-032_198cad03-a8c3-a327-e063-6394a90add85
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
hydroxyzine pamoate
Dosage form
CAPSULE
Route
ORAL
Labeler
Pharmasource Meds, LLC
Application
ANDA087479
Marketing category
ANDA
Marketing start
2023-02-27
Marketing end
2026-11-30
Substance
HYDROXYZINE PAMOATE
Active strength
25 mg/1
Pharmacologic classes
Antihistamine [EPC], Histamine Receptor Antagonists [MoA]
NDC exclude flag
No
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
hydroxyzine pamoate

Active Ingredients#

Ingredient, Strength table
IngredientStrength
HYDROXYZINE PAMOATE25 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiM20215MUFR
Rxcui995253

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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
82982-032-30hydroxyzine pamoate30 in 1 BOTTLECAPSULE302

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
82982-032HYDROXYZINE PAMOATE CAPSULE [PHARMASOURCE MEDS, LLC]2Current NDC, 1 package rows20240601_f563aa1a-1e21-49d4-e053-2a95a90a3264.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
995253hydrOXYzine pamoate 25 MG Oral CapsulePSNf563aa1a-1e21-49d4-e053-2a95a90a32642
995253hydroxyzine pamoate 25 MG Oral CapsuleSCDf563aa1a-1e21-49d4-e053-2a95a90a32642

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
82982-032-308298200323030 CAPSULE in 1 BOTTLE (82982-032-30) 30 capsule2023-02-272026-11-30NoNoHistorical