FDA.reportPublic FDA data

HYDROXYZINE HYDROCHLORIDE

Product NDC
61919-743
11-digit product format
619190743
Labeler code
61919
Product ID
61919-743_eac3b1b0-6bfc-f549-e053-2a95a90ac25d
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
HYDROXYZINE HYDROCHLORIDE
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
DIRECT RX
Application
ANDA088618
Marketing category
ANDA
Marketing start
2020-06-16
Marketing end
0000-00-00
Substance
HYDROXYZINE DIHYDROCHLORIDE
Active strength
25 mg/1
Pharmacologic classes
Antihistamine [EPC], Histamine Receptor Antagonists [MoA]
NDC exclude flag
No
Listing certified through
2023-12-31
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
61919-743-152025-01-30C16284748780-12cef2736-8dcc-d83d-e063-dadaa90ab31fHYDROXYZINE HCL 25mg
61919-743-302025-01-30C16284748780-12cef2736-8dcc-d83d-e063-dadaa90ab31fHYDROXYZINE HCL 25mg
61919-743-602025-01-30C16284748780-12cef2736-8dcc-d83d-e063-dadaa90ab31fHYDROXYZINE HCL 25mg
61919-743-902025-01-30C16284748780-12cef2736-8dcc-d83d-e063-dadaa90ab31fHYDROXYZINE HCL 25mg

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
61919-743-15HYDROXYZINE HYDROCHLORIDE15 in 1 BOTTLETABLET, FILM COATED1510
61919-743-30HYDROXYZINE HYDROCHLORIDE30 in 1 BOTTLETABLET, FILM COATED3010
61919-743-60HYDROXYZINE HYDROCHLORIDE60 in 1 BOTTLETABLET, FILM COATED6010
61919-743-90HYDROXYZINE HYDROCHLORIDE90 in 1 BOTTLETABLET, FILM COATED9010

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
61919-743HYDROXYZINE HCL TABLET HYDROXYZINE HCL TABLET, FILM COATED HYDROXYZINE HYDROCHLORIDE TABLET, FILM COATED [DIRECT RX]10Legacy NDC, 4 package rows20230414_5cc3aaa6-e18f-a116-e053-2991aa0a1422.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
995258hydrOXYzine HCl 25 MG Oral TabletPSN5cc3aaa6-e18f-a116-e053-2991aa0a142210
995258hydroxyzine hydrochloride 25 MG Oral TabletSCD5cc3aaa6-e18f-a116-e053-2991aa0a142210

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
61919-743-156191907431515 TABLET, FILM COATED in 1 BOTTLE (61919-743-15) 2020-06-160000-00-00NoNoCurrent
61919-743-306191907433030 TABLET, FILM COATED in 1 BOTTLE (61919-743-30) 2020-06-160000-00-00NoNoCurrent
61919-743-606191907436060 TABLET, FILM COATED in 1 BOTTLE (61919-743-60) 2020-06-160000-00-00NoNoCurrent
61919-743-906191907439090 TABLET, FILM COATED in 1 BOTTLE (61919-743-90) 2020-06-160000-00-00NoNoCurrent