Hydroxyzine pamoate

Product NDC
68788-8111
11-digit product format
687888111
Labeler code
68788
Product ID
68788-8111_8385df31-2367-410d-87b9-595bf10fb44a
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Hydroxyzine Pamoate
Dosage form
CAPSULE
Route
ORAL
Labeler
Preferred Pharmaceuticals Inc.
Application
ANDA086183
Marketing category
ANDA
Marketing start
2021-12-03
Marketing end
0000-00-00
Substance
HYDROXYZINE PAMOATE
Active strength
50 mg/1
Pharmacologic classes
Antihistamine [EPC], Histamine Receptor Antagonists [MoA]
NDC exclude flag
No
Listing certified through
2023-12-31
Current FDA listing
Historical FDA.report record

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
68788-8111-3Hydroxyzine pamoate500 in 1 BOTTLECAPSULE5004

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
68788-8111-3EA - Each68788-81117f74655f-8f20-414c-aa20-d79e2996770812022-01-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68788-8111HYDROXYZINE PAMOATE CAPSULE [PREFERRED PHARMACEUTICALS INC.]4Legacy NDC, 1 package rows20240524_1030e6b6-7688-4756-b54b-925801656977.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
995278hydrOXYzine pamoate 50 MG Oral CapsulePSN1030e6b6-7688-4756-b54b-9258016569774
995278hydroxyzine pamoate 50 MG Oral CapsuleSCD1030e6b6-7688-4756-b54b-9258016569774
995278hydroxyzine pamoate 50 MG (hydroxyzine pamoate 85.2 MG eqv to hydroxyzine HCl 50 MG) Oral CapsuleSY1030e6b6-7688-4756-b54b-9258016569774

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
68788-8111-368788811103500 CAPSULE in 1 BOTTLE (68788-8111-3) 500 capsule2021-12-030000-00-00NoNoCurrent