FDA.reportPublic FDA data

hydroxyzine pamoate

Product NDC
43063-172
11-digit product format
430630172
Labeler code
43063
Product ID
43063-172_42dede37-3c6b-c199-e063-6294a90a635c
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
hydroxyzine pamoate
Dosage form
CAPSULE
Route
ORAL
Labeler
PD-Rx Pharmaceuticals, Inc.
Application
ANDA087479
Marketing category
ANDA
Marketing start
1981-12-14
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
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
43063-172-04hydroxyzine pamoate4 in 1 BOTTLE, PLASTICCAPSULE433

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
43063-172-01EA - Each43063-172fcb29b42-9c88-4ca7-a7b0-85ded6cc53b612012-07-24
43063-172-04EA - Each43063-17288ebef90-0522-4f15-a971-7c59db56c6d512012-07-24

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
43063-172HYDROXYZINE PAMOATE CAPSULE [PD-RX PHARMACEUTICALS, INC.]31Current NDC, Legacy NDC, 1 package rows20241012_53153595-41b9-4b2d-8b7d-0ffd29fdd1d8.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
995253hydrOXYzine pamoate 25 MG Oral CapsulePSN53153595-41b9-4b2d-8b7d-0ffd29fdd1d833
995253hydroxyzine pamoate 25 MG Oral CapsuleSCD53153595-41b9-4b2d-8b7d-0ffd29fdd1d833

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
43063-172-0143063017201100 CAPSULE in 1 BOTTLE, PLASTIC (43063-172-01) 100 capsule2014-06-280000-00-00NoNoCurrent
43063-172-04430630172044 CAPSULE in 1 BOTTLE, PLASTIC (43063-172-04) 4 capsule2014-06-280000-00-00NoNoCurrent