FDA.reportPublic FDA data

Hydroxyzine Hydrochloride

Product NDC
71335-1047
11-digit product format
713351047
Labeler code
71335
Product ID
71335-1047_cd25e2c5-25ff-46ae-80ef-b01300cd959d
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Hydroxyzine Hydrochloride
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Bryant Ranch Prepack
Application
ANDA040602
Marketing category
ANDA
Marketing start
2015-03-31
Substance
HYDROXYZINE DIHYDROCHLORIDE
Active strength
25 mg/1
Pharmacologic classes
Antihistamine [EPC], Histamine Receptor Antagonists [MoA]
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Hydroxyzine Hydrochloride
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
HYDROXYZINE DIHYDROCHLORIDE25 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii76755771U3
Rxcui995218, 995258

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
57311cfb-679a-da1a-b70c-8757f7fc431aProduct name420250516
594e2c86-3079-4e6e-96c9-48f7a8afc78dProduct name120230718
aa1826f4-97c1-4705-bdf0-3bc7d234e618Product name220190618
75cb12ee-8eb2-4f1a-a332-5743a5d0da41Product name120151110
3ca5f78b-43dc-30fe-8014-55b922af52b3Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
71335-1047-1Hydroxyzine Hydrochloride30 in 1 BOTTLETABLET, FILM COATED303
71335-1047-2Hydroxyzine Hydrochloride60 in 1 BOTTLETABLET, FILM COATED603
71335-1047-3Hydroxyzine Hydrochloride20 in 1 BOTTLETABLET, FILM COATED203
71335-1047-4Hydroxyzine Hydrochloride100 in 1 BOTTLETABLET, FILM COATED1003
71335-1047-5Hydroxyzine Hydrochloride15 in 1 BOTTLETABLET, FILM COATED153
71335-1047-6Hydroxyzine Hydrochloride90 in 1 BOTTLETABLET, FILM COATED903
71335-1047-7Hydroxyzine Hydrochloride19 in 1 BOTTLETABLET, FILM COATED193
71335-1047-8Hydroxyzine Hydrochloride10 in 1 BOTTLETABLET, FILM COATED103

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
71335-1047-1EA - Each71335-10478370088c-395d-4bd9-b60f-98d4e1f8acb512020-09-14
71335-1047-2EA - Each71335-104729c6a12f-9c7c-49ff-a26e-b1651667646812020-09-14
71335-1047-3EA - Each71335-104784de12d2-b907-4602-b3a4-eb01fad09a8a12020-09-14
71335-1047-5EA - Each71335-1047d3b80083-d256-4957-814d-32531233ba0f12020-09-14
71335-1047-6EA - Each71335-1047656c04e4-6010-4889-bdf3-5dc218e4033012020-09-14
71335-1047-8EA - Each71335-104773824a85-3b08-464b-b3b2-cc6306be263b12020-09-14

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71335-1047HYDROXYZINE HYDROCHLORIDE TABLET, FILM COATED [BRYANT RANCH PREPACK]3Current NDC, Legacy NDC, 8 package rows20240410_1c7d31fb-5e3c-456e-be6c-a3baafe60c37.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
995218hydrOXYzine HCl 10 MG Oral TabletPSN1c7d31fb-5e3c-456e-be6c-a3baafe60c373
995258hydrOXYzine HCl 25 MG Oral TabletPSN1c7d31fb-5e3c-456e-be6c-a3baafe60c373
995218hydroxyzine hydrochloride 10 MG Oral TabletSCD1c7d31fb-5e3c-456e-be6c-a3baafe60c373
995258hydroxyzine hydrochloride 25 MG Oral TabletSCD1c7d31fb-5e3c-456e-be6c-a3baafe60c373

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
71335-1047-17133510470130 TABLET, FILM COATED in 1 BOTTLE (71335-1047-1) 2018-12-270000-00-00NoNoCurrent
71335-1047-27133510470260 TABLET, FILM COATED in 1 BOTTLE (71335-1047-2) 2020-03-130000-00-00NoNoCurrent
71335-1047-37133510470320 TABLET, FILM COATED in 1 BOTTLE (71335-1047-3) 2019-06-190000-00-00NoNoCurrent
71335-1047-471335104704100 TABLET, FILM COATED in 1 BOTTLE (71335-1047-4) 2024-04-020000-00-00NoNoCurrent
71335-1047-57133510470515 TABLET, FILM COATED in 1 BOTTLE (71335-1047-5) 2020-02-140000-00-00NoNoCurrent
71335-1047-67133510470690 TABLET, FILM COATED in 1 BOTTLE (71335-1047-6) 2019-10-030000-00-00NoNoCurrent
71335-1047-77133510470719 TABLET, FILM COATED in 1 BOTTLE (71335-1047-7) 2024-04-020000-00-00NoNoCurrent
71335-1047-87133510470810 TABLET, FILM COATED in 1 BOTTLE (71335-1047-8) 2019-02-220000-00-00NoNoCurrent