FDA.reportPublic FDA data

hydroxyzine pamoate

Product NDC
68788-8789
11-digit product format
687888789
Labeler code
68788
Product ID
68788-8789_bbbd36cb-bc02-495e-b06f-caede3705f97
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
hydroxyzine pamoate
Dosage form
CAPSULE
Route
ORAL
Labeler
Preferred Pharmaceuticals Inc.
Application
ANDA201507
Marketing category
ANDA
Marketing start
2024-12-16
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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
68788-8789-32026-01-29C16284748780-149896155-a8ff-586f-e063-e6dba90add90Rx only

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
68788-8789-3hydroxyzine pamoate30 in 1 CONTAINERCAPSULE302

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
68788-8789-3EA - Each68788-8789284da930-dd9c-464d-83b2-83f2d7a7b63d12025-02-10

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68788-8789HYDROXYZINE PAMOATE CAPSULE [PREFERRED PHARMACEUTICALS INC.]1Current NDC, 1 package rows20241218_b903f7e1-250d-46d8-a1ec-3f1dabc597f1.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
995278hydrOXYzine pamoate 50 MG Oral CapsulePSNb903f7e1-250d-46d8-a1ec-3f1dabc597f12
995278hydroxyzine pamoate 50 MG Oral CapsuleSCDb903f7e1-250d-46d8-a1ec-3f1dabc597f12
995278hydroxyzine pamoate 50 MG (hydroxyzine pamoate 85.2 MG eqv to hydroxyzine HCl 50 MG) Oral CapsuleSYb903f7e1-250d-46d8-a1ec-3f1dabc597f12

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
68788-8789-36878887890330 CAPSULE in 1 CONTAINER (68788-8789-3) 30 capsule2024-12-16NoNoHistorical