FDA.reportPublic FDA data

Hydroxyzine Hydrochloride

Product NDC
43063-963
11-digit product format
430630963
Labeler code
43063
Product ID
43063-963_415f3642-ef05-3671-e063-6294a90ab7a7
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Hydroxyzine Hydrochloride
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
PD-Rx Pharmaceuticals, Inc.
Application
ANDA040788
Marketing category
ANDA
Marketing start
2012-07-24
Substance
HYDROXYZINE DIHYDROCHLORIDE
Active strength
50 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 DIHYDROCHLORIDE50 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii76755771U3
Rxcui995218, 995258, 995281

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
43063-963-01Hydroxyzine Hydrochloride100 in 1 BOTTLE, PLASTICTABLET, FILM COATED10022
43063-963-95Hydroxyzine Hydrochloride1000 in 1 BOTTLE, PLASTICTABLET, FILM COATED100022

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
43063-963-01EA - Each43063-9639bef9057-04f6-4c1c-a993-80090987c6b412019-05-02
43063-963-95EA - Each43063-963c652084f-bf14-4e9d-9c31-270b94d65a8212019-05-02

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
43063-963HYDROXYZINE HYDROCHLORIDE TABLET, FILM COATED HYDROXYZINE HYDROCHLORIDE TABLET, FILM COATED [PD-RX PHARMACEUTICALS, INC.]21Current NDC, Legacy NDC, 2 package rows20241018_1a3e389f-391d-4f37-9e34-ce3c6f5fe8c1.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
995218hydrOXYzine HCl 10 MG Oral TabletPSN1a3e389f-391d-4f37-9e34-ce3c6f5fe8c122
995258hydrOXYzine HCl 25 MG Oral TabletPSN1a3e389f-391d-4f37-9e34-ce3c6f5fe8c122
995281hydrOXYzine HCl 50 MG Oral TabletPSN1a3e389f-391d-4f37-9e34-ce3c6f5fe8c122
995218hydroxyzine hydrochloride 10 MG Oral TabletSCD1a3e389f-391d-4f37-9e34-ce3c6f5fe8c122
995258hydroxyzine hydrochloride 25 MG Oral TabletSCD1a3e389f-391d-4f37-9e34-ce3c6f5fe8c122
995281hydroxyzine hydrochloride 50 MG Oral TabletSCD1a3e389f-391d-4f37-9e34-ce3c6f5fe8c122

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
43063-963-0143063096301100 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (43063-963-01) 2019-04-010000-00-00NoNoCurrent
43063-963-95430630963951000 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (43063-963-95) 2019-04-010000-00-00NoNoCurrent