FDA.reportPublic FDA data

HYDROXYZINE HYDROCHLORIDE

Product NDC
52959-481
11-digit product format
529590481
Labeler code
52959
Product ID
52959-481_5f140045-e8ea-28c2-e053-2991aa0a46cc
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
HYDROXYZINE HYDROCHLORIDE
Dosage form
TABLET
Route
ORAL
Labeler
H.J Harkins Company inc.
Application
ANDA204279
Marketing category
ANDA
Marketing start
2017-01-03
Marketing end
0000-00-00
Substance
HYDROXYZINE HYDROCHLORIDE
Active strength
10 mg/1
Pharmacologic classes
Antihistamine [EPC],Histamine Receptor Antagonists [MoA]
NDC exclude flag
No
Listing certified through
2019-12-31
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
52959-481-062020-01-31C16284748780-19d75b9d0-16ed-f424-e053-dadaa90a57ce5f140045-e8e9-28c2-e053-2991aa0a46cc
52959-481-102020-01-31C16284748780-19d75b9d0-16ed-f424-e053-dadaa90a57ce5f140045-e8e9-28c2-e053-2991aa0a46cc
52959-481-122020-01-31C16284748780-19d75b9d0-16ed-f424-e053-dadaa90a57ce5f140045-e8e9-28c2-e053-2991aa0a46cc
52959-481-152020-01-31C16284748780-19d75b9d0-16ed-f424-e053-dadaa90a57ce5f140045-e8e9-28c2-e053-2991aa0a46cc
52959-481-202020-01-31C16284748780-19d75b9d0-16ed-f424-e053-dadaa90a57ce5f140045-e8e9-28c2-e053-2991aa0a46cc
52959-481-252020-01-31C16284748780-19d75b9d0-16ed-f424-e053-dadaa90a57ce5f140045-e8e9-28c2-e053-2991aa0a46cc
52959-481-302020-01-31C16284748780-19d75b9d0-16ed-f424-e053-dadaa90a57ce5f140045-e8e9-28c2-e053-2991aa0a46cc
52959-481-602020-01-31C16284748780-19d75b9d0-16ed-f424-e053-dadaa90a57ce5f140045-e8e9-28c2-e053-2991aa0a46cc

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
52959-481-06HYDROXYZINE HYDROCHLORIDE6 in 1 CONTAINERTABLET61
52959-481-10HYDROXYZINE HYDROCHLORIDE10 in 1 CONTAINERTABLET101
52959-481-12HYDROXYZINE HYDROCHLORIDE12 in 1 CONTAINERTABLET121
52959-481-15HYDROXYZINE HYDROCHLORIDE15 in 1 CONTAINERTABLET151
52959-481-20HYDROXYZINE HYDROCHLORIDE20 in 1 CONTAINERTABLET201
52959-481-25HYDROXYZINE HYDROCHLORIDE25 in 1 CONTAINERTABLET251
52959-481-30HYDROXYZINE HYDROCHLORIDE30 in 1 CONTAINERTABLET301
52959-481-60HYDROXYZINE HYDROCHLORIDE60 in 1 CONTAINERTABLET601

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
52959-481HYDROXYZINE HYDROCHLORIDE TABLET [H.J HARKINS COMPANY INC.]1Legacy NDC, 8 package rows20171206_5f140045-e8e9-28c2-e053-2991aa0a46cc.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
995218hydrOXYzine HCl 10 MG Oral TabletPSN5f140045-e8e9-28c2-e053-2991aa0a46cc1
995218hydroxyzine hydrochloride 10 MG Oral TabletSCD5f140045-e8e9-28c2-e053-2991aa0a46cc1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionStatus
52959-481-06529590481066 in 1 CONTAINERHistorical
52959-481-105295904811010 in 1 CONTAINERHistorical
52959-481-125295904811212 in 1 CONTAINERHistorical
52959-481-155295904811515 in 1 CONTAINERHistorical
52959-481-205295904812020 in 1 CONTAINERHistorical
52959-481-255295904812525 in 1 CONTAINERHistorical
52959-481-305295904813030 in 1 CONTAINERHistorical
52959-481-605295904816060 in 1 CONTAINERHistorical