Hydroxyzine Pamoate

Product NDC
70934-444
11-digit product format
709340444
Labeler code
70934
Product ID
70934-444_a798f583-d691-728c-e053-2995a90af43a
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Hydroxyzine Pamoate
Dosage form
CAPSULE
Route
ORAL
Labeler
Denton Pharma, Inc. DBA Northwind Pharmaceuticals
Application
ANDA040156
Marketing category
ANDA
Marketing start
2019-09-19
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
2021-12-31
Current FDA listing
Historical FDA.report record

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
57311cfb-679a-da1a-b70c-8757f7fc431aProduct name420250516
aa1826f4-97c1-4705-bdf0-3bc7d234e618Product name220190618
75cb12ee-8eb2-4f1a-a332-5743a5d0da41Product name120151110
3ca5f78b-43dc-30fe-8014-55b922af52b3Product name120140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
70934-444-302022-01-28C16284748780-1d6a99b39-78cb-a426-e053-dadaa90af4c2Hydroxyzine Pamoate Capsules, USP (25 mg and 50 mg) Rx only

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
70934-444-30Hydroxyzine Pamoate30 in 1 BOTTLE, PLASTICCAPSULE301

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
70934-444HYDROXYZINE PAMOATE CAPSULE [DENTON PHARMA, INC. DBA NORTHWIND PHARMACEUTICALS]1Legacy NDC, 1 package rows20200815_a798f583-d690-728c-e053-2995a90af43a.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
995253hydrOXYzine pamoate 25 MG Oral CapsulePSNa798f583-d690-728c-e053-2995a90af43a1
995253hydroxyzine pamoate 25 MG Oral CapsuleSCDa798f583-d690-728c-e053-2995a90af43a1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
70934-444-307093404443030 CAPSULE in 1 BOTTLE, PLASTIC (70934-444-30) 30 capsule2019-09-190000-00-00NoNoCurrent