FDA.reportPublic FDA data

Hydroxyzine Hydrochloride

Product NDC
71610-735
Requested package NDC
71610-735-60
11-digit product format
716100735
Labeler code
71610
Product ID
71610-735_e5dbdb97-f222-43f5-b261-8e91950377e4
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Hydroxyzine Hydrochloride
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Aphena Pharma Solutions - Tennessee, LLC
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

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
d618157e-f43f-4b31-ba5b-8a13a94885bcAvailable 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
71610-735-30Hydroxyzine Hydrochloride30 in 1 BOTTLETABLET, FILM COATED302
71610-735-53Hydroxyzine Hydrochloride60 in 1 BOTTLETABLET, FILM COATED602
71610-735-60Hydroxyzine Hydrochloride90 in 1 BOTTLETABLET, FILM COATED902
71610-735-70Hydroxyzine Hydrochloride120 in 1 BOTTLETABLET, FILM COATED1202
71610-735-80Hydroxyzine Hydrochloride180 in 1 BOTTLETABLET, FILM COATED1802

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71610-735HYDROXYZINE HYDROCHLORIDE TABLET, FILM COATED [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]2Current NDC, 5 package rows20230919_d618157e-f43f-4b31-ba5b-8a13a94885bc.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 · 10 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Hydroxyzine HydrochlorideHYDROXYZINE HYDROCHLORIDEBryant Ranch Prepackd03fdfd0-5dbd-40fe-a6e3-082a47751c2c2025-03-31Warnings, Adverse reactionsExact identifier
application applno (ANDA): 040602
application number: ANDA040602
Hydroxyzine HydrochlorideHYDROXYZINE HYDROCHLORIDENuCare Pharmaceuticals,Inc.79f38cc2-f72f-3f30-e053-2991aa0ac5402024-09-25Warnings, Adverse reactionsExact identifier
application applno (ANDA): 040602
application number: ANDA040602
Hydroxyzine HydrochlorideHYDROXYZINE HYDROCHLORIDEA-S Medication Solutionsc59f24b5-0527-423a-ab14-db1ba1f7763f2024-04-16Warnings, Adverse reactionsExact identifier
application applno (ANDA): 040602
application number: ANDA040602
Hydroxyzine HydrochlorideHYDROXYZINE HYDROCHLORIDEBryant Ranch Prepack1c7d31fb-5e3c-456e-be6c-a3baafe60c372024-04-02Warnings, Adverse reactionsExact identifier
application applno (ANDA): 040602
application number: ANDA040602
Hydroxyzine HydrochlorideHYDROXYZINE HYDROCHLORIDEA-S Medication Solutionsc2bce6a4-9feb-4816-a6d8-151e8ef3314d2024-03-11Warnings, Adverse reactionsExact identifier
application applno (ANDA): 040602
application number: ANDA040602
Hydroxyzine HydrochlorideHYDROXYZINE HYDROCHLORIDEA-S Medication Solutionse83de74d-b2e0-45c5-b072-170a96216d3a2024-01-04Warnings, Adverse reactionsExact identifier
application applno (ANDA): 040602
application number: ANDA040602
Hydroxyzine HydrochlorideHYDROXYZINE HYDROCHLORIDEAphena Pharma Solutions - Tennessee, LLCd618157e-f43f-4b31-ba5b-8a13a94885bc2023-09-18Warnings, Adverse reactionsExact identifier
application applno (ANDA): 040602
application number: ANDA040602
ndc (package): 71610-735-60
ndc (product): 71610-735
ndc11 (package): 71610073560
Hydroxyzine HydrochlorideHYDROXYZINE HYDROCHLORIDEA-S Medication Solutions49ee4ecf-b2c0-4301-89da-111e4d8531682023-09-11Warnings, Adverse reactionsExact identifier
application applno (ANDA): 040602
application number: ANDA040602
Hydroxyzine HydrochlorideHYDROXYZINE HYDROCHLORIDEA-S Medication Solutions3d5d3ebf-e57e-4ed1-be97-d4b299fb738d2023-09-07Warnings, Adverse reactionsExact identifier
application applno (ANDA): 040602
application number: ANDA040602
Hydroxyzine HydrochlorideHYDROXYZINE HYDROCHLORIDEProficient Rx LPdaefb617-209a-428b-9567-adc5880fa65c2022-11-01Warnings, Adverse reactionsExact identifier
application applno (ANDA): 040602
application number: ANDA040602

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
995258hydrOXYzine HCl 25 MG Oral TabletPSNd618157e-f43f-4b31-ba5b-8a13a94885bc2
995258hydroxyzine hydrochloride 25 MG Oral TabletSCDd618157e-f43f-4b31-ba5b-8a13a94885bc2

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
71610-735-607161007356090 TABLET, FILM COATED in 1 BOTTLE (71610-735-60) 2023-09-14NoNoCurrent