FDA.reportPublic FDA data

hydroxyzine pamoate

Product NDC
71205-433
11-digit product format
712050433
Labeler code
71205
Product ID
71205-433_8b9b3ddb-0aac-4b68-8079-d31de791c752
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
hydroxyzine pamoate
Dosage form
CAPSULE
Route
ORAL
Labeler
Proficient Rx LP
Application
ANDA201507
Marketing category
ANDA
Marketing start
2013-06-03
Substance
HYDROXYZINE PAMOATE
Active strength
25 mg/1
Pharmacologic classes
Antihistamine [EPC], Histamine Receptor Antagonists [MoA]
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
hydroxyzine pamoate
Listing expiration
2026-12-31

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
71205-433-30hydroxyzine pamoate30 in 1 BOTTLECAPSULE302
71205-433-60hydroxyzine pamoate60 in 1 BOTTLECAPSULE602
71205-433-90hydroxyzine pamoate90 in 1 BOTTLECAPSULE902

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
71205-433-30EA - Each71205-433df25687b-fb81-4630-897c-81926276903212020-05-08

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71205-433HYDROXYZINE PAMOATE CAPSULE [PROFICIENT RX LP]2Current NDC, Legacy NDC, 3 package rows20221111_b7f806ed-da18-41f2-aa0b-bce2336f2756.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
995253hydrOXYzine pamoate 25 MG Oral CapsulePSNb7f806ed-da18-41f2-aa0b-bce2336f27562
995253hydroxyzine pamoate 25 MG Oral CapsuleSCDb7f806ed-da18-41f2-aa0b-bce2336f27562

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
71205-433-307120504333030 CAPSULE in 1 BOTTLE (71205-433-30) 30 capsule2020-03-180000-00-00NoNoCurrent
71205-433-607120504336060 CAPSULE in 1 BOTTLE (71205-433-60) 60 capsule2020-03-180000-00-00NoNoCurrent
71205-433-907120504339090 CAPSULE in 1 BOTTLE (71205-433-90) 90 capsule2020-03-180000-00-00NoNoCurrent