FDA.reportPublic FDA data

Hydroxyzine Pamoate

Product NDC
71335-2187
11-digit product format
713352187
Labeler code
71335
Product ID
71335-2187_c0538532-e7e9-475c-8598-f88bc06b1779
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Hydroxyzine Pamoate
Dosage form
CAPSULE
Route
ORAL
Labeler
Bryant Ranch Prepack
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
71335-2187-1Hydroxyzine Pamoate20 in 1 BOTTLECAPSULE20101
71335-2187-2Hydroxyzine Pamoate30 in 1 BOTTLECAPSULE30101
71335-2187-3Hydroxyzine Pamoate100 in 1 BOTTLECAPSULE100101
71335-2187-4Hydroxyzine Pamoate10 in 1 BOTTLECAPSULE10101
71335-2187-5Hydroxyzine Pamoate15 in 1 BOTTLECAPSULE15101
71335-2187-6Hydroxyzine Pamoate60 in 1 BOTTLECAPSULE60101
71335-2187-7Hydroxyzine Pamoate90 in 1 BOTTLECAPSULE90101
71335-2187-8Hydroxyzine Pamoate120 in 1 BOTTLECAPSULE120101
71335-2187-9Hydroxyzine Pamoate42 in 1 BOTTLECAPSULE42101

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71335-2187HYDROXYZINE PAMOATE CAPSULE [BRYANT RANCH PREPACK]101Current NDC, Legacy NDC, 9 package rows20231026_ea1c7326-52ea-4934-844c-892d868042cf.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
995253hydrOXYzine pamoate 25 MG Oral CapsulePSNea1c7326-52ea-4934-844c-892d868042cf101
995253hydroxyzine pamoate 25 MG Oral CapsuleSCDea1c7326-52ea-4934-844c-892d868042cf101

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
71335-2187-17133521870120 CAPSULE in 1 BOTTLE (71335-2187-1) 20 capsule2022-11-070000-00-00NoNoCurrent
71335-2187-27133521870230 CAPSULE in 1 BOTTLE (71335-2187-2) 30 capsule2022-11-070000-00-00NoNoCurrent
71335-2187-371335218703100 CAPSULE in 1 BOTTLE (71335-2187-3) 100 capsule2022-11-070000-00-00NoNoCurrent
71335-2187-47133521870410 CAPSULE in 1 BOTTLE (71335-2187-4) 10 capsule2022-11-070000-00-00NoNoCurrent
71335-2187-57133521870515 CAPSULE in 1 BOTTLE (71335-2187-5) 15 capsule2022-11-070000-00-00NoNoCurrent
71335-2187-67133521870660 CAPSULE in 1 BOTTLE (71335-2187-6) 60 capsule2022-11-070000-00-00NoNoCurrent
71335-2187-77133521870790 CAPSULE in 1 BOTTLE (71335-2187-7) 90 capsule2022-11-070000-00-00NoNoCurrent
71335-2187-871335218708120 CAPSULE in 1 BOTTLE (71335-2187-8) 120 capsule2022-11-070000-00-00NoNoCurrent
71335-2187-97133521870942 CAPSULE in 1 BOTTLE (71335-2187-9) 42 capsule2022-11-070000-00-00NoNoCurrent