HYDROXYZINE HCL

Product NDC
61919-646
11-digit product format
619190646
Labeler code
61919
Product ID
61919-646_9c9742a4-a21f-3605-e053-2995a90a2989
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
HYDROXYZINE HCL
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
DIRECT RX
Application
ANDA040804
Marketing category
ANDA
Marketing start
2016-02-12
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
61919-646-302023-01-30C16284748780-1f386c64a-45a5-0266-e053-dadaa90a7c1aHYDROXYZINE HCL

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
61919-646-30HYDROXYZINE HCL30 in 1 BOTTLETABLET, FILM COATED302

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
61919-646HYDROXYZINE HCL TABLET, FILM COATED [DIRECT RX]2Legacy NDC, 1 package rows20200130_2bd1350a-5bb5-33c1-e054-00144ff88e88.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
995218hydrOXYzine HCl 10 MG Oral TabletPSN2bd1350a-5bb5-33c1-e054-00144ff88e882
995218hydroxyzine hydrochloride 10 MG Oral TabletSCD2bd1350a-5bb5-33c1-e054-00144ff88e882

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
61919-646-306191906463030 TABLET, FILM COATED in 1 BOTTLE (61919-646-30) 2016-02-120000-00-00NoNoCurrent