hydroxyzine pamoate

Product NDC
63629-8874
11-digit product format
636298874
Labeler code
63629
Product ID
63629-8874_638cf29d-9dc9-4a80-8937-ba3811482f08
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
hydroxyzine pamoate
Dosage form
CAPSULE
Route
ORAL
Labeler
Bryant Ranch Prepack
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
63629-8874-1hydroxyzine pamoate500 in 1 BOTTLECAPSULE500105

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
63629-8874-1EA - Each63629-88749c795b20-7a8c-4e98-bf2b-7e317958618812021-12-08

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
63629-8874HYDROXYZINE PAMOATE CAPSULE [BRYANT RANCH PREPACK]105Current NDC, Legacy NDC, 1 package rows20241218_02616eee-a1a4-4afc-b84e-69fd28755138.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
995253hydrOXYzine pamoate 25 MG Oral CapsulePSN02616eee-a1a4-4afc-b84e-69fd28755138105
995253hydroxyzine pamoate 25 MG Oral CapsuleSCD02616eee-a1a4-4afc-b84e-69fd28755138105

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
63629-8874-163629887401500 CAPSULE in 1 BOTTLE (63629-8874-1) 500 capsule2014-06-270000-00-00NoNoCurrent