FDA.reportPublic FDA data

Hydroxyzine Hydrochloride

Product NDC
71335-3088
11-digit product format
713353088
Labeler code
71335
Product ID
71335-3088_8db62cda-c456-47b3-85bb-b67f777c0a9a
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Hydroxyzine Hydrochloride
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Bryant Ranch Prepack
Application
ANDA087871
Marketing category
ANDA
Marketing start
2021-10-07
Substance
HYDROXYZINE DIHYDROCHLORIDE
Active strength
10 mg/1
Pharmacologic classes
Antihistamine [EPC], Histamine Receptor Antagonists [MoA]
NDC exclude flag
No
Listing certified through
2027-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Hydroxyzine Hydrochloride
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
HYDROXYZINE DIHYDROCHLORIDE10 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii76755771U3
Rxcui995218

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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
71335-3088-1Hydroxyzine Hydrochloride30 in 1 BOTTLETABLET, FILM COATED301
71335-3088-2Hydroxyzine Hydrochloride100 in 1 BOTTLETABLET, FILM COATED1001
71335-3088-3Hydroxyzine Hydrochloride20 in 1 BOTTLETABLET, FILM COATED201
71335-3088-4Hydroxyzine Hydrochloride90 in 1 BOTTLETABLET, FILM COATED901
71335-3088-5Hydroxyzine Hydrochloride15 in 1 BOTTLETABLET, FILM COATED151
71335-3088-6Hydroxyzine Hydrochloride60 in 1 BOTTLETABLET, FILM COATED601
71335-3088-7Hydroxyzine Hydrochloride120 in 1 BOTTLETABLET, FILM COATED1201
71335-3088-8Hydroxyzine Hydrochloride10 in 1 BOTTLETABLET, FILM COATED101

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
995218hydrOXYzine HCl 10 MG Oral TabletPSN56b49e5c-bb8a-46cd-873c-3c743d1653a41
995218hydroxyzine hydrochloride 10 MG Oral TabletSCD56b49e5c-bb8a-46cd-873c-3c743d1653a41

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
71335-3088-17133530880130 TABLET, FILM COATED in 1 BOTTLE (71335-3088-1) 2026-02-17NoNoHistorical
71335-3088-271335308802100 TABLET, FILM COATED in 1 BOTTLE (71335-3088-2) 2026-02-17NoNoHistorical
71335-3088-37133530880320 TABLET, FILM COATED in 1 BOTTLE (71335-3088-3) 2026-02-17NoNoHistorical
71335-3088-47133530880490 TABLET, FILM COATED in 1 BOTTLE (71335-3088-4) 2026-02-17NoNoHistorical
71335-3088-57133530880515 TABLET, FILM COATED in 1 BOTTLE (71335-3088-5) 2026-02-17NoNoHistorical
71335-3088-67133530880660 TABLET, FILM COATED in 1 BOTTLE (71335-3088-6) 2026-02-17NoNoHistorical
71335-3088-771335308807120 TABLET, FILM COATED in 1 BOTTLE (71335-3088-7) 2026-02-17NoNoHistorical
71335-3088-87133530880810 TABLET, FILM COATED in 1 BOTTLE (71335-3088-8) 2026-02-17NoNoHistorical