FDA.reportPublic FDA data

Hydroxyzine Hydrochloride

Product NDC
70518-1730
Requested package NDC
70518-1730-6
11-digit product format
705181730
Labeler code
70518
Product ID
70518-1730_4962300f-0bce-8118-e063-6294a90af041
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Hydroxyzine Hydrochloride
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
REMEDYREPACK INC.
Application
ANDA040787
Marketing category
ANDA
Marketing start
2018-12-13
Substance
HYDROXYZINE DIHYDROCHLORIDE
Active strength
25 mg/1
Pharmacologic classes
Antihistamine [EPC], Histamine Receptor Antagonists [MoA]
NDC exclude flag
No
Listing certified through
2027-12-31
Current FDA listing
Yes

Source provenance: Browse the complete Orange Book source catalog.

openFDA label cross-check#

Cross-check layer: openFDA label JSON enriches search and identifies hydration gaps. The DailyMed Structured Product Label remains the canonical label presentation on FDA.report. Every label matching the complete exact-identifier union is deduplicated and paginated 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
ndc (package): 70518-1730-6
ndc (product): 70518-1730
ndc11 (package): 70518173006
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

Additional Listing Data#

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

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
aa9523e0-c95d-4213-b213-96170d855536Available 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
70518-1730-0Hydroxyzine Hydrochloride30 in 1 BOTTLE, PLASTICTABLET, FILM COATED3014
70518-1730-1Hydroxyzine Hydrochloride30 in 1 BLISTER PACKTABLET, FILM COATED3014
70518-1730-2Hydroxyzine Hydrochloride30 in 1 BLISTER PACKTABLET, FILM COATED3014
70518-1730-3Hydroxyzine Hydrochloride30 in 1 BOTTLE, PLASTICTABLET, FILM COATED3014
70518-1730-4Hydroxyzine Hydrochloride15 in 1 BOTTLE, PLASTICTABLET, FILM COATED1514
70518-1730-5Hydroxyzine Hydrochloride30 in 1 BOTTLE, PLASTICTABLET, FILM COATED3014
70518-1730-6Hydroxyzine Hydrochloride90 in 1 BOTTLE, PLASTICTABLET, FILM COATED9014
70518-1730-7Hydroxyzine Hydrochloride60 in 1 BOTTLE, PLASTICTABLET, FILM COATED6014

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
70518-1730HYDROXYZINE HYDROCHLORIDE TABLET, FILM COATED [REMEDYREPACK INC.]10Current NDC, Legacy NDC, 8 package rows20250227_aa9523e0-c95d-4213-b213-96170d855536.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
995258hydrOXYzine HCl 25 MG Oral TabletPSNaa9523e0-c95d-4213-b213-96170d85553614
995258hydroxyzine hydrochloride 25 MG Oral TabletSCDaa9523e0-c95d-4213-b213-96170d85553614

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
70518-1730-67051817300690 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (70518-1730-6) 2025-06-18NoNoCurrent