hydroxyzine pamoate

Product NDC
50090-0374
11-digit product format
500900374
Labeler code
50090
Product ID
50090-0374_250c944e-fb84-42b2-8eec-7abd1bdf4274
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
hydroxyzine pamoate
Dosage form
CAPSULE
Route
ORAL
Labeler
A-S Medication Solutions
Application
ANDA086183
Marketing category
ANDA
Marketing start
1981-12-14
Marketing end
2026-05-31
Substance
HYDROXYZINE PAMOATE
Active strength
50 mg/1
Pharmacologic classes
Antihistamine [EPC], Histamine Receptor Antagonists [MoA]
NDC exclude flag
No
Current FDA listing
Yes

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#

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
50090-0374-0hydroxyzine pamoate12 in 1 BOTTLECAPSULE1216
50090-0374-1hydroxyzine pamoate20 in 1 BOTTLECAPSULE2016

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
50090-0374-1EA - Each50090-0374e1b16152-2a2d-42e2-b155-c3fc4883738412018-09-05

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50090-0374HYDROXYZINE PAMOATE CAPSULE [A-S MEDICATION SOLUTIONS]16Current NDC, Legacy NDC, 2 package rows20230510_8e58dc4c-4a94-45db-812c-dbce80e02750.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
50090-0374-05009003740012 CAPSULE in 1 BOTTLE (50090-0374-0) 12 capsule2018-12-052026-05-31NoNoCurrent
50090-0374-15009003740120 CAPSULE in 1 BOTTLE (50090-0374-1) 20 capsule2016-06-292026-05-31NoNoCurrent