FDA.reportPublic FDA data

Hydroxyzine Hydrochloride

Product NDC
43063-518
Requested package NDC
43063-518-28
11-digit product format
430630518
Labeler code
43063
Product ID
43063-518_4138e4f8-23cf-c563-e063-6294a90ad9bb
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Hydroxyzine Hydrochloride
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
PD-Rx Pharmaceuticals, Inc.
Application
ANDA040787
Marketing category
ANDA
Marketing start
2012-07-24
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

Source provenance: Browse the complete Orange Book source catalog.

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

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 UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
76755771U3Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
995258Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
24cb9c83-a7e4-4bae-997c-c3a87426f78cAvailable on FDA.report

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
43063-518-06Hydroxyzine Hydrochloride6 in 1 BOTTLE, PLASTICTABLET, FILM COATED623
43063-518-12Hydroxyzine Hydrochloride12 in 1 BOTTLE, PLASTICTABLET, FILM COATED1223
43063-518-20Hydroxyzine Hydrochloride20 in 1 BOTTLE, PLASTICTABLET, FILM COATED2023
43063-518-28Hydroxyzine Hydrochloride28 in 1 BOTTLE, PLASTICTABLET, FILM COATED2823
43063-518-30Hydroxyzine Hydrochloride30 in 1 BOTTLE, PLASTICTABLET, FILM COATED3023
43063-518-40Hydroxyzine Hydrochloride40 in 1 BOTTLE, PLASTICTABLET, FILM COATED4023
43063-518-60Hydroxyzine Hydrochloride60 in 1 BOTTLE, PLASTICTABLET, FILM COATED6023
43063-518-90Hydroxyzine Hydrochloride90 in 1 BOTTLE, PLASTICTABLET, FILM COATED9023

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
43063-518-06EA - Each43063-51817d4802f-3c22-49ee-8c49-840a2bee226e12015-08-04
43063-518-12EA - Each43063-518f6863693-16af-44ba-8bb4-4786a579c5cf12018-06-11
43063-518-20EA - Each43063-518b5abef3c-3cba-4bea-883f-fdcda3591bcf12018-06-11
43063-518-28EA - Each43063-518650886cf-c8a2-4a1f-9804-3f8ab379bd4a12016-01-13
43063-518-30EA - Each43063-518489cd321-1eb4-4ad0-ae62-dcb1c322b49312018-06-11
43063-518-40EA - Each43063-518560370f3-1b04-4db9-8253-c9deb3d8c1d812015-05-05
43063-518-60EA - Each43063-5189767b00a-136b-4dbf-b7f0-074c526fb69412020-02-13
43063-518-90EA - Each43063-5186ffe0b27-45ed-4733-ac72-667c739402a112015-05-05

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
HYDROXYZINE HYDROCHLORIDEACTIVE INGREDIENT76755771U3HYDROXYZINE HYDROCHLORIDE (HYDROXYZINE HYDROCHLORIDE) TABLET, FILM COATED [PD-RX PHARMACEUTICALS, INC.]6
HYDROXYZINEACTIVE MOIETY30S50YM8OGHYDROXYZINE HYDROCHLORIDE (HYDROXYZINE HYDROCHLORIDE) TABLET, FILM COATED [PD-RX PHARMACEUTICALS, INC.]6
CARNAUBA WAXINACTIVE INGREDIENTR12CBM0EIZHYDROXYZINE HYDROCHLORIDE (HYDROXYZINE HYDROCHLORIDE) TABLET, FILM COATED [PD-RX PHARMACEUTICALS, INC.]6
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UHYDROXYZINE HYDROCHLORIDE (HYDROXYZINE HYDROCHLORIDE) TABLET, FILM COATED [PD-RX PHARMACEUTICALS, INC.]6
CROSPOVIDONEINACTIVE INGREDIENT68401960MKHYDROXYZINE HYDROCHLORIDE (HYDROXYZINE HYDROCHLORIDE) TABLET, FILM COATED [PD-RX PHARMACEUTICALS, INC.]6
LACTOSE MONOHYDRATEINACTIVE INGREDIENTEWQ57Q8I5XHYDROXYZINE HYDROCHLORIDE (HYDROXYZINE HYDROCHLORIDE) TABLET, FILM COATED [PD-RX PHARMACEUTICALS, INC.]6
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30HYDROXYZINE HYDROCHLORIDE (HYDROXYZINE HYDROCHLORIDE) TABLET, FILM COATED [PD-RX PHARMACEUTICALS, INC.]6
POLYETHYLENE GLYCOL 3350INACTIVE INGREDIENTG2M7P15E5PHYDROXYZINE HYDROCHLORIDE (HYDROXYZINE HYDROCHLORIDE) TABLET, FILM COATED [PD-RX PHARMACEUTICALS, INC.]6
POLYVINYL ALCOHOLINACTIVE INGREDIENT532B59J990HYDROXYZINE HYDROCHLORIDE (HYDROXYZINE HYDROCHLORIDE) TABLET, FILM COATED [PD-RX PHARMACEUTICALS, INC.]6
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4HYDROXYZINE HYDROCHLORIDE (HYDROXYZINE HYDROCHLORIDE) TABLET, FILM COATED [PD-RX PHARMACEUTICALS, INC.]6
TALCINACTIVE INGREDIENT7SEV7J4R1UHYDROXYZINE HYDROCHLORIDE (HYDROXYZINE HYDROCHLORIDE) TABLET, FILM COATED [PD-RX PHARMACEUTICALS, INC.]6
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPHYDROXYZINE HYDROCHLORIDE (HYDROXYZINE HYDROCHLORIDE) TABLET, FILM COATED [PD-RX PHARMACEUTICALS, INC.]6
WATERINACTIVE INGREDIENT059QF0KO0RHYDROXYZINE HYDROCHLORIDE (HYDROXYZINE HYDROCHLORIDE) TABLET, FILM COATED [PD-RX PHARMACEUTICALS, INC.]6

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
43063-518HYDROXYZINE HYDROCHLORIDE TABLET, FILM COATED [PD-RX PHARMACEUTICALS, INC.]22Current NDC, Legacy NDC, 8 package rows20241013_24cb9c83-a7e4-4bae-997c-c3a87426f78c.zip

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 3 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Hydroxyzine HydrochlorideHYDROXYZINE HYDROCHLORIDEREMEDYREPACK INC.aa9523e0-c95d-4213-b213-96170d8555362026-07-10Warnings, Adverse reactionsExact identifier
application applno (ANDA): 040787
application number: ANDA040787
Hydroxyzine HydrochlorideHYDROXYZINE HYDROCHLORIDEPD-Rx Pharmaceuticals, Inc.1a3e389f-391d-4f37-9e34-ce3c6f5fe8c12025-10-17Warnings, Adverse reactionsExact identifier
application applno (ANDA): 040787
application number: ANDA040787
Hydroxyzine HydrochlorideHYDROXYZINE HYDROCHLORIDEPD-Rx Pharmaceuticals, Inc.24cb9c83-a7e4-4bae-997c-c3a87426f78c2025-10-15Warnings, Adverse reactionsExact identifier
application applno (ANDA): 040787
application number: ANDA040787
ndc (package): 43063-518-28
ndc (product): 43063-518
ndc11 (package): 43063051828

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
995258hydrOXYzine HCl 25 MG Oral TabletPSN24cb9c83-a7e4-4bae-997c-c3a87426f78c23
995258hydroxyzine hydrochloride 25 MG Oral TabletSCD24cb9c83-a7e4-4bae-997c-c3a87426f78c23

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
43063-518-284306305182828 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (43063-518-28) 2012-07-240000-00-00NoNoCurrent