FDA.reportPublic FDA data

Hydroxyzine Hydrochloride

Product NDC
71335-1047
Requested package NDC
71335-1047-2
11-digit product format
713351047
Labeler code
71335
Product ID
71335-1047_cd25e2c5-25ff-46ae-80ef-b01300cd959d
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Hydroxyzine Hydrochloride
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Bryant Ranch Prepack
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 · 2 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
995218Internal RxNorm lookup
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
1c7d31fb-5e3c-456e-be6c-a3baafe60c37Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
57311cfb-679a-da1a-b70c-8757f7fc431aProduct name420250516
594e2c86-3079-4e6e-96c9-48f7a8afc78dProduct name120230718
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
71335-1047-1Hydroxyzine Hydrochloride30 in 1 BOTTLETABLET, FILM COATED303
71335-1047-2Hydroxyzine Hydrochloride60 in 1 BOTTLETABLET, FILM COATED603
71335-1047-3Hydroxyzine Hydrochloride20 in 1 BOTTLETABLET, FILM COATED203
71335-1047-4Hydroxyzine Hydrochloride100 in 1 BOTTLETABLET, FILM COATED1003
71335-1047-5Hydroxyzine Hydrochloride15 in 1 BOTTLETABLET, FILM COATED153
71335-1047-6Hydroxyzine Hydrochloride90 in 1 BOTTLETABLET, FILM COATED903
71335-1047-7Hydroxyzine Hydrochloride19 in 1 BOTTLETABLET, FILM COATED193
71335-1047-8Hydroxyzine Hydrochloride10 in 1 BOTTLETABLET, FILM COATED103

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
71335-1047-1EA - Each71335-10478370088c-395d-4bd9-b60f-98d4e1f8acb512020-09-14
71335-1047-2EA - Each71335-104729c6a12f-9c7c-49ff-a26e-b1651667646812020-09-14
71335-1047-3EA - Each71335-104784de12d2-b907-4602-b3a4-eb01fad09a8a12020-09-14
71335-1047-5EA - Each71335-1047d3b80083-d256-4957-814d-32531233ba0f12020-09-14
71335-1047-6EA - Each71335-1047656c04e4-6010-4889-bdf3-5dc218e4033012020-09-14
71335-1047-8EA - Each71335-104773824a85-3b08-464b-b3b2-cc6306be263b12020-09-14

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71335-1047HYDROXYZINE HYDROCHLORIDE TABLET, FILM COATED [BRYANT RANCH PREPACK]3Current NDC, Legacy NDC, 8 package rows20240410_1c7d31fb-5e3c-456e-be6c-a3baafe60c37.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
ndc (package): 71335-1047-2
ndc (product): 71335-1047
ndc11 (package): 71335104702
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
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
995218hydrOXYzine HCl 10 MG Oral TabletPSN1c7d31fb-5e3c-456e-be6c-a3baafe60c373
995258hydrOXYzine HCl 25 MG Oral TabletPSN1c7d31fb-5e3c-456e-be6c-a3baafe60c373
995218hydroxyzine hydrochloride 10 MG Oral TabletSCD1c7d31fb-5e3c-456e-be6c-a3baafe60c373
995258hydroxyzine hydrochloride 25 MG Oral TabletSCD1c7d31fb-5e3c-456e-be6c-a3baafe60c373

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
71335-1047-27133510470260 TABLET, FILM COATED in 1 BOTTLE (71335-1047-2) 2020-03-130000-00-00NoNoCurrent