FDA.reportPublic FDA data

Hydroxyzine pamoate

Product NDC
70518-3232
11-digit product format
705183232
Labeler code
70518
Product ID
70518-3232_4e3cc8ad-a873-32bd-e063-6294a90a2026
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Hydroxyzine Pamoate
Dosage form
CAPSULE
Route
ORAL
Labeler
REMEDYREPACK INC.
Application
ANDA086183
Marketing category
ANDA
Marketing start
2021-10-11
Substance
HYDROXYZINE PAMOATE
Active strength
50 mg/1
Pharmacologic classes
Antihistamine [EPC], Histamine Receptor Antagonists [MoA]
NDC exclude flag
No
Listing certified through
2027-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Hydroxyzine pamoate
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
HYDROXYZINE PAMOATE50 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiM20215MUFR
Rxcui995278

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
70518-3232-0Hydroxyzine pamoate60 in 1 BOTTLE, PLASTICCAPSULE6010
70518-3232-1Hydroxyzine pamoate100 in 1 BOXCAPSULE10010
70518-3232-2Hydroxyzine pamoate1 in 1 POUCHCAPSULE110
70518-3232-3Hydroxyzine pamoate30 in 1 BLISTER PACKCAPSULE3010
70518-3232-4Hydroxyzine pamoate100 in 1 BOXCAPSULE10010
70518-3232-5Hydroxyzine pamoate1 in 1 POUCHCAPSULE110
70518-3232-6Hydroxyzine pamoate21 in 1 BLISTER PACKCAPSULE2110
70518-3232-7Hydroxyzine pamoate30 in 1 BLISTER PACKCAPSULE3010

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
70518-3232HYDROXYZINE PAMOATE CAPSULE [REMEDYREPACK INC.]7Current NDC, Legacy NDC, 8 package rows20250125_0c9101ee-0746-4833-83cf-d0d09e52c0a9.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
995278hydrOXYzine pamoate 50 MG Oral CapsulePSN0c9101ee-0746-4833-83cf-d0d09e52c0a910
995278hydroxyzine pamoate 50 MG Oral CapsuleSCD0c9101ee-0746-4833-83cf-d0d09e52c0a910
995278hydroxyzine pamoate 50 MG (hydroxyzine pamoate 85.2 MG eqv to hydroxyzine HCl 50 MG) Oral CapsuleSY0c9101ee-0746-4833-83cf-d0d09e52c0a910

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
70518-3232-07051832320060 CAPSULE in 1 BOTTLE, PLASTIC (70518-3232-0) 60 capsule2021-10-110000-00-00NoNoCurrent
70518-3232-170518323201100 POUCH in 1 BOX (70518-3232-1) > 1 CAPSULE in 1 POUCH (70518-3232-2) 100 pouch2022-02-030000-00-00NoNoCurrent
70518-3232-2705183232021 in 1 POUCHHistorical
70518-3232-37051832320330 CAPSULE in 1 BLISTER PACK (70518-3232-3) 30 capsule2023-03-31NoNoCurrent
70518-3232-470518323204100 POUCH in 1 BOX (70518-3232-4) / 1 CAPSULE in 1 POUCH (70518-3232-5) 100 pouch2023-12-05NoNoCurrent
70518-3232-5705183232051 in 1 POUCHHistorical
70518-3232-67051832320621 in 1 BLISTER PACKHistorical
70518-3232-77051832320730 CAPSULE in 1 BLISTER PACK (70518-3232-7) 30 capsule2024-06-24NoNoCurrent