FDA.reportPublic FDA data

Hydroxyzine Hydrochloride

Product NDC
70934-233
11-digit product format
709340233
Labeler code
70934
Product ID
70934-233_a563e60a-ca54-88d7-e053-2995a90accc4
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Hydroxyzine Hydrochloride
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Denton Pharma, Inc. DBA Northwind Pharmaceuticals
Application
ANDA088617
Marketing category
ANDA
Marketing start
2019-01-11
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
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
70934-233-152022-01-28C16284748780-1d6a99b39-797a-a426-e053-dadaa90af4c2HydrOXYzine Hydrochloride Tablets USP
70934-233-202022-01-28C16284748780-1d6a99b39-797a-a426-e053-dadaa90af4c2HydrOXYzine Hydrochloride Tablets USP
70934-233-302022-01-28C16284748780-1d6a99b39-797a-a426-e053-dadaa90af4c2HydrOXYzine Hydrochloride Tablets USP

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
70934-233-15Hydroxyzine Hydrochloride15 in 1 BOTTLE, PLASTICTABLET, FILM COATED153
70934-233-20Hydroxyzine Hydrochloride20 in 1 BOTTLE, PLASTICTABLET, FILM COATED203
70934-233-30Hydroxyzine Hydrochloride30 in 1 BOTTLE, PLASTICTABLET, FILM COATED303

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
70934-233HYDROXYZINE HYDROCHLORIDE TABLET, FILM COATED [DENTON PHARMA, INC. DBA NORTHWIND PHARMACEUTICALS]3Legacy NDC, 3 package rows20200821_87c4c82c-ae44-769e-e053-2995a90ab6ff.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
995218hydrOXYzine HCl 10 MG Oral TabletPSN87c4c82c-ae44-769e-e053-2995a90ab6ff3
995218hydroxyzine hydrochloride 10 MG Oral TabletSCD87c4c82c-ae44-769e-e053-2995a90ab6ff3

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
70934-233-157093402331515 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (70934-233-15) 2019-01-110000-00-00NoNoCurrent
70934-233-207093402332020 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (70934-233-20) 2020-04-150000-00-00NoNoCurrent
70934-233-307093402333030 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (70934-233-30) 2019-09-090000-00-00NoNoCurrent