Hydroxyzine Pamoate

Product NDC
68071-4915
11-digit product format
680714915
Labeler code
68071
Product ID
68071-4915_1ae22598-d78f-f945-e063-6394a90a97c8
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Hydroxyzine Pamoate
Dosage form
CAPSULE
Route
ORAL
Labeler
NuCare Pharmaceuticals,Inc.
Application
ANDA040156
Marketing category
ANDA
Marketing start
1996-07-15
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

FDA-Initiated Inactive NDC Indexing#

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
68071-4915-3Hydroxyzine Pamoate30 in 1 BOTTLECAPSULE303

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68071-4915HYDROXYZINE PAMOATE CAPSULE [NUCARE PHARMACEUTICALS,INC.]3Current NDC, Legacy NDC, 1 package rows20240627_8a8416f8-18ce-99e6-e053-2995a90a1045.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
995253hydrOXYzine pamoate 25 MG Oral CapsulePSN8a8416f8-18ce-99e6-e053-2995a90a10453
995253hydroxyzine pamoate 25 MG Oral CapsuleSCD8a8416f8-18ce-99e6-e053-2995a90a10453

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
68071-4915-36807149150330 CAPSULE in 1 BOTTLE (68071-4915-3) 30 capsule2019-06-040000-00-00NoNoCurrent