FDA.reportPublic FDA data

Hydroxyzine Hydrochloride

Product NDC
59651-501
Requested package NDC
59651-501-49
11-digit product format
596510501
Labeler code
59651
Product ID
59651-501_86a715f8-fbfb-4d28-a144-27581d6aa1bb
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Hydroxyzine Hydrochloride
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Aurobindo Pharma Limited
Application
ANDA087871
Marketing category
ANDA
Marketing start
2021-10-07
Substance
HYDROXYZINE DIHYDROCHLORIDE
Active strength
50 mg/1
Pharmacologic classes
Antihistamine [EPC], Histamine Receptor Antagonists [MoA]
NDC exclude flag
No
Listing certified through
2027-12-31
Current FDA listing
Yes

NDC auxiliary status#

Explicit status records from FDA unfinished, excluded, and compounder auxiliary files. Absence of a row is not itself a regulatory status. Browse every current auxiliary row, including rows without a usable NDC. · Browse every captured source and parsed snapshot.

Current NDC status page 1 of 1 · 1 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
unfinished packagepackage59651-50159651-501-49UNFINISHEDActive or certified unfinished drug listing2026-08-03

Source provenance: Browse the complete Orange Book source catalog · source snapshot 1.

Orange Book products#

Current product rows page 1 of 1 · 3 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A087871-001HYDROXYZINE HYDROCHLORIDEHYDROXYZINE HYDROCHLORIDE50MGTABLET / ORALAB1982-12-20
A087871-002HYDROXYZINE HYDROCHLORIDEHYDROXYZINE HYDROCHLORIDE10MGTABLET / ORALAB1982-12-20
A087871-003HYDROXYZINE HYDROCHLORIDEHYDROXYZINE HYDROCHLORIDE25MGTABLET / ORALAB1982-12-20

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 3 matching rows.

Application-product, TE code table
Application-productTE code
A087871-001AB
A087871-002AB
A087871-003AB

Observed Orange Book product history#

Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-08-01 22:54:322026-06A087871-001HYDROXYZINE HYDROCHLORIDE50MGTABLET / ORALAB1982-12-20a50c72e98297…
2026-08-01 22:54:322026-06A087871-002HYDROXYZINE HYDROCHLORIDE10MGTABLET / ORALAB1982-12-20a50c72e98297…
2026-08-01 22:54:322026-06A087871-003HYDROXYZINE HYDROCHLORIDE25MGTABLET / ORALAB1982-12-20a50c72e98297…

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-08-01 22:54:322026-06A087871-001AB1a50c72e98297…
2026-08-01 22:54:322026-06A087871-002AB1a50c72e98297…
2026-08-01 22:54:322026-06A087871-003AB1a50c72e98297…

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 · 11 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Hydroxyzine HydrochlorideHYDROXYZINE HYDROCHLORIDEBryant Ranch Prepackf84e3365-57d2-4904-9275-96600f8d74c72026-06-22Warnings, Adverse reactionsExact identifier
application applno (ANDA): 087871
application number: ANDA087871
Hydroxyzine HydrochlorideHYDROXYZINE HYDROCHLORIDEAurobindo Pharma Limited9de2de56-614f-4294-8794-d30758cf5f702026-03-03Warnings, Adverse reactionsExact identifier
application applno (ANDA): 087871
application number: ANDA087871
ndc (product): 59651-501
Hydroxyzine HydrochlorideHYDROXYZINE HYDROCHLORIDEBryant Ranch Prepack56b49e5c-bb8a-46cd-873c-3c743d1653a42026-02-17Warnings, Adverse reactionsExact identifier
application applno (ANDA): 087871
application number: ANDA087871
Hydroxyzine HydrochlorideHYDROXYZINE HYDROCHLORIDEBryant Ranch Prepack3526a66b-2182-4b5a-a7d1-563d75f5335f2025-12-03Warnings, Adverse reactionsExact identifier
application applno (ANDA): 087871
application number: ANDA087871
Hydroxyzine HydrochlorideHYDROXYZINE HYDROCHLORIDEBryant Ranch Prepack9504897e-febc-4293-a2dc-9f79f55ea8212025-12-03Warnings, Adverse reactionsExact identifier
application applno (ANDA): 087871
application number: ANDA087871
Hydroxyzine HydrochlorideHYDROXYZINE HYDROCHLORIDEBryant Ranch Prepackeef36dab-c318-44d2-8583-7bae3bfceee72025-10-13Warnings, Adverse reactionsExact identifier
application applno (ANDA): 087871
application number: ANDA087871
Hydroxyzine HydrochlorideHYDROXYZINE HYDROCHLORIDEAmerican Health Packagingfc148d96-b868-4e45-b7d2-977faf4310492025-09-15Warnings, Adverse reactionsExact identifier
application applno (ANDA): 087871
application number: ANDA087871
Hydroxyzine HydrochlorideHYDROXYZINE HYDROCHLORIDEBryant Ranch Prepacke4e6a91d-f10b-4d85-a526-4c6192ea85dc2025-05-23Warnings, Adverse reactionsExact identifier
application applno (ANDA): 087871
application number: ANDA087871
Hydroxyzine HydrochlorideHYDROXYZINE HYDROCHLORIDEBryant Ranch Prepacka8c83479-f919-49f9-b125-747bd0e3211c2025-05-23Warnings, Adverse reactionsExact identifier
application applno (ANDA): 087871
application number: ANDA087871
Hydroxyzine HydrochlorideHYDROXYZINE HYDROCHLORIDEBryant Ranch Prepack7c959515-a5a9-4d5e-90e9-bd58bc9473302025-05-23Warnings, Adverse reactionsExact identifier
application applno (ANDA): 087871
application number: ANDA087871
Hydroxyzine HydrochlorideHYDROXYZINE HYDROCHLORIDEAdvanced Rx Pharmacy of Tennessee, LLC138ec5c1-bb06-2a82-e063-6394a90ab42b2024-05-17Warnings, Adverse reactionsExact identifier
application applno (ANDA): 087871
application number: ANDA087871

Additional Listing Data#

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

Active Ingredients#

Ingredient, Strength table
IngredientStrength
HYDROXYZINE DIHYDROCHLORIDE50 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 · 3 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
995218Internal RxNorm lookup
995258Internal RxNorm lookup
995281Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
9de2de56-614f-4294-8794-d30758cf5f70Available 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
59651-501-01Hydroxyzine Hydrochloride100 in 1 BOTTLETABLET, FILM COATED1002
59651-501-05Hydroxyzine Hydrochloride500 in 1 BOTTLETABLET, FILM COATED5002
59651-501-99Hydroxyzine Hydrochloride1000 in 1 BOTTLETABLET, FILM COATED10002

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
59651-501-01EA - Each59651-501fcab223d-2a7b-4d19-a1d1-e3a5af200bdd12023-09-05
59651-501-05EA - Each59651-501bb4192a4-6aa4-4e36-bd19-6b5ec22cb47112023-09-05
59651-501-99EA - Each59651-5014556fa62-adb4-4971-963e-104c17292f6c12024-11-05

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
59651-501HYDROXYZINE HYDROCHLORIDE TABLET, FILM COATED [AUROBINDO PHARMA LIMITED]1Current NDC, Legacy NDC, 3 package rows20220811_9de2de56-614f-4294-8794-d30758cf5f70.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
995281hydrOXYzine HCl 50 MG Oral TabletPSN3526a66b-2182-4b5a-a7d1-563d75f5335f100
995281hydrOXYzine HCl 50 MG Oral TabletPSNa8c83479-f919-49f9-b125-747bd0e3211c100
995281hydroxyzine hydrochloride 50 MG Oral TabletSCD3526a66b-2182-4b5a-a7d1-563d75f5335f100
995281hydroxyzine hydrochloride 50 MG Oral TabletSCDa8c83479-f919-49f9-b125-747bd0e3211c100
995281hydrOXYzine HCl 50 MG Oral TabletPSN138ec5c1-bb06-2a82-e063-6394a90ab42b4
995281hydroxyzine hydrochloride 50 MG Oral TabletSCD138ec5c1-bb06-2a82-e063-6394a90ab42b4
995218hydrOXYzine HCl 10 MG Oral TabletPSN9de2de56-614f-4294-8794-d30758cf5f702
995258hydrOXYzine HCl 25 MG Oral TabletPSN9de2de56-614f-4294-8794-d30758cf5f702
995281hydrOXYzine HCl 50 MG Oral TabletPSN9de2de56-614f-4294-8794-d30758cf5f702
995281hydrOXYzine HCl 50 MG Oral TabletPSNfc148d96-b868-4e45-b7d2-977faf4310492
995218hydroxyzine hydrochloride 10 MG Oral TabletSCD9de2de56-614f-4294-8794-d30758cf5f702
995258hydroxyzine hydrochloride 25 MG Oral TabletSCD9de2de56-614f-4294-8794-d30758cf5f702
995281hydroxyzine hydrochloride 50 MG Oral TabletSCD9de2de56-614f-4294-8794-d30758cf5f702
995281hydroxyzine hydrochloride 50 MG Oral TabletSCDfc148d96-b868-4e45-b7d2-977faf4310492

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startStatus
59651-501-49596510501494000 TABLET, FILM COATED in 1 BAG (59651-501-49)07-OCT-21Current