Hydroxyzine Pamoate

Product NDC
68071-4540
11-digit product format
680714540
Labeler code
68071
Product ID
68071-4540_bbb85d09-b1e0-1792-e053-2a95a90aae21
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Hydroxyzine Pamoate
Dosage form
CAPSULE
Route
ORAL
Labeler
NuCare Pharmaceuticals,Inc.
Application
ANDA088496
Marketing category
ANDA
Marketing start
1984-07-01
Marketing end
0000-00-00
Substance
HYDROXYZINE PAMOATE
Active strength
25 mg/1
Pharmacologic classes
Antihistamine [EPC],Histamine Receptor Antagonists [MoA]
NDC exclude flag
No
Listing certified through
2022-12-31
Current FDA listing
Historical FDA.report record

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
57311cfb-679a-da1a-b70c-8757f7fc431aProduct name420250516
351abe41-466c-4dd8-840a-0fdb68318bd5Product name120230316
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
68071-4540-3Hydroxyzine Pamoate30 in 1 BOTTLECAPSULE304

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68071-4540HYDROXYZINE PAMOATE CAPSULE [NUCARE PHARMACEUTICALS,INC.]4Legacy NDC, 1 package rows20210221_7432df12-384b-7db6-e053-2991aa0a810a.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
995253hydrOXYzine pamoate 25 MG Oral CapsulePSN7432df12-384b-7db6-e053-2991aa0a810a4
995253hydroxyzine pamoate 25 MG Oral CapsuleSCD7432df12-384b-7db6-e053-2991aa0a810a4

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
68071-4540-36807145400330 CAPSULE in 1 BOTTLE (68071-4540-3) 30 capsule2018-08-240000-00-00NoNoCurrent