FDA.reportPublic FDA data

HYDROXYZINE PAMOATE

Product NDC
72189-315
11-digit product format
721890315
Labeler code
72189
Product ID
72189-315_2c3d02c4-cd10-323b-e063-6394a90accd4
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
HYDROXYZINE PAMOATE
Dosage form
CAPSULE
Route
ORAL
Labeler
DirectRx
Application
ANDA040156
Marketing category
ANDA
Marketing start
2022-01-20
Substance
HYDROXYZINE PAMOATE
Active strength
50 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 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
72189-315-30HYDROXYZINE PAMOATE30 in 1 BOTTLECAPSULE303
72189-315-90HYDROXYZINE PAMOATE90 in 1 BOTTLECAPSULE903

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
72189-315HYDROXYZINE PAMOATE CAPSULE [DIRECTRX]3Current NDC, Legacy NDC, 2 package rows20250122_d60603e7-15c5-7b01-e053-2995a90ad252.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
995278hydrOXYzine pamoate 50 MG Oral CapsulePSNd60603e7-15c5-7b01-e053-2995a90ad2523
995278hydroxyzine pamoate 50 MG Oral CapsuleSCDd60603e7-15c5-7b01-e053-2995a90ad2523
995278hydroxyzine pamoate 50 MG (hydroxyzine pamoate 85.2 MG eqv to hydroxyzine HCl 50 MG) Oral CapsuleSYd60603e7-15c5-7b01-e053-2995a90ad2523

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
72189-315-307218903153030 CAPSULE in 1 BOTTLE (72189-315-30) 30 capsule2022-01-20NoNoCurrent
72189-315-907218903159090 CAPSULE in 1 BOTTLE (72189-315-90) 90 capsule2022-01-200000-00-00NoNoCurrent