Hydroxyzine Pamoate

Product NDC
71205-483
11-digit product format
712050483
Labeler code
71205
Product ID
71205-483_66af6524-9e2e-41b4-b531-42ff21e350f1
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Hydroxyzine Pamoate
Dosage form
CAPSULE
Route
ORAL
Labeler
Proficient Rx LP
Application
ANDA088496
Marketing category
ANDA
Marketing start
1984-07-01
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
351abe41-466c-4dd8-840a-0fdb68318bd5Product name120230316
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
71205-483-30Hydroxyzine Pamoate30 in 1 BOTTLECAPSULE302
71205-483-60Hydroxyzine Pamoate60 in 1 BOTTLECAPSULE602
71205-483-90Hydroxyzine Pamoate90 in 1 BOTTLECAPSULE902

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71205-483HYDROXYZINE PAMOATE CAPSULE [PROFICIENT RX LP]2Current NDC, Legacy NDC, 3 package rows20220701_b098e287-e489-4cdc-9171-7daf50380c1c.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
995253hydrOXYzine pamoate 25 MG Oral CapsulePSNb098e287-e489-4cdc-9171-7daf50380c1c2
995253hydroxyzine pamoate 25 MG Oral CapsuleSCDb098e287-e489-4cdc-9171-7daf50380c1c2

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
71205-483-307120504833030 CAPSULE in 1 BOTTLE (71205-483-30) 30 capsule2020-10-080000-00-00NoNoCurrent
71205-483-607120504836060 CAPSULE in 1 BOTTLE (71205-483-60) 60 capsule2020-10-080000-00-00NoNoCurrent
71205-483-907120504839090 CAPSULE in 1 BOTTLE (71205-483-90) 90 capsule2020-10-080000-00-00NoNoCurrent