HydrOXYzine Hydrochloride

Product NDC
70934-191
11-digit product format
709340191
Labeler code
70934
Product ID
70934-191_b8e22590-9d93-511d-e053-2995a90a73bb
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
HydrOXYzine Hydrochloride
Dosage form
TABLET
Route
ORAL
Labeler
Denton Pharma, Inc. DBA Northwind Pharmaceuticals
Application
ANDA040840
Marketing category
ANDA
Marketing start
2018-11-20
Marketing end
0000-00-00
Substance
HYDROXYZINE HYDROCHLORIDE
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
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
70934-191-202023-01-30C16284748780-1ba0f9c33-1173-a910-e053-dadaa90a0b85Rx Only
70934-191-302023-01-30C16284748780-1ba0f9c33-1173-a910-e053-dadaa90a0b85Rx Only
70934-191-202021-01-31C16284748780-1ba0f9c33-1173-a910-e053-dadaa90a0b85Rx Only
70934-191-302021-01-31C16284748780-1ba0f9c33-1173-a910-e053-dadaa90a0b85Rx Only
70934-191-202021-01-29C16284748780-1ba0f9c33-1173-a910-e053-dadaa90a0b85Rx Only
70934-191-302021-01-29C16284748780-1ba0f9c33-1173-a910-e053-dadaa90a0b85Rx Only

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
70934-191-20HydrOXYzine Hydrochloride20 in 1 BOTTLE, PLASTICTABLET203
70934-191-30HydrOXYzine Hydrochloride30 in 1 BOTTLE, PLASTICTABLET303

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
70934-191HYDROXYZINE HYDROCHLORIDE TABLET [DENTON PHARMA, INC. DBA NORTHWIND PHARMACEUTICALS]3Legacy NDC, 2 package rows20210201_8698bfa7-dbde-c9c8-e053-2991aa0a2196.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
995258hydrOXYzine HCl 25 MG Oral TabletPSN8698bfa7-dbde-c9c8-e053-2991aa0a21963
995258hydroxyzine hydrochloride 25 MG Oral TabletSCD8698bfa7-dbde-c9c8-e053-2991aa0a21963

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
70934-191-207093401912020 TABLET in 1 BOTTLE, PLASTIC (70934-191-20) 20 tablet2019-01-020000-00-00NoNoCurrent
70934-191-307093401913030 TABLET in 1 BOTTLE, PLASTIC (70934-191-30) 30 tablet2018-11-200000-00-00NoNoCurrent