hydroxyzine pamoate

Product NDC
68071-2255
11-digit product format
680712255
Labeler code
68071
Product ID
68071-2255_36c1922f-56d1-9a55-e063-6294a90a5571
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
hydroxyzine pamoate
Dosage form
CAPSULE
Route
ORAL
Labeler
NuCare 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
68071-2255-2hydroxyzine pamoate20 in 1 BOTTLECAPSULE205
68071-2255-3hydroxyzine pamoate30 in 1 BOTTLECAPSULE305
68071-2255-9hydroxyzine pamoate90 in 1 BOTTLECAPSULE905

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68071-2255HYDROXYZINE PAMOATE CAPSULE [NUCARE PHARMACEUTICALS,INC.]4Current NDC, Legacy NDC, 3 package rows20240719_aee7c4a8-10cb-2107-e053-2995a90a90e7.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
995253hydrOXYzine pamoate 25 MG Oral CapsulePSNaee7c4a8-10cb-2107-e053-2995a90a90e75
995253hydroxyzine pamoate 25 MG Oral CapsuleSCDaee7c4a8-10cb-2107-e053-2995a90a90e75

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
68071-2255-26807122550220 CAPSULE in 1 BOTTLE (68071-2255-2) 20 capsule2020-09-090000-00-00NoNoCurrent
68071-2255-36807122550330 CAPSULE in 1 BOTTLE (68071-2255-3) 30 capsule2025-06-04NoNoCurrent
68071-2255-96807122550990 CAPSULE in 1 BOTTLE (68071-2255-9) 90 capsule2020-09-090000-00-00NoNoCurrent