FDA.reportPublic FDA data

Hydroxyzine Hydrochloride

Product NDC
71335-3035
Requested package NDC
71335-3035-1
11-digit product format
713353035
Labeler code
71335
Product ID
71335-3035_73236eaf-d2da-4b4d-aa43-6c38d71a6ca3
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Hydroxyzine Hydrochloride
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Bryant Ranch Prepack
Application
ANDA087871
Marketing category
ANDA
Marketing start
2021-10-07
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 · 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
ndc (package): 71335-3035-1
ndc (product): 71335-3035
ndc11 (package): 71335303501
Hydroxyzine HydrochlorideHYDROXYZINE HYDROCHLORIDEAurobindo Pharma Limited9de2de56-614f-4294-8794-d30758cf5f702026-03-03Warnings, Adverse reactionsExact identifier
application applno (ANDA): 087871
application number: ANDA087871
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 HYDROCHLORIDE25 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
f84e3365-57d2-4904-9275-96600f8d74c7Available 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
71335-3035-1Hydroxyzine Hydrochloride1000 in 1 BOTTLETABLET, FILM COATED1000100

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
71335-3035-1EA - Each71335-3035e8fc8ba2-9fbd-46b1-8530-25dd23fdf46c12026-01-08

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
995258hydrOXYzine HCl 25 MG Oral TabletPSNf84e3365-57d2-4904-9275-96600f8d74c7100
995258hydroxyzine hydrochloride 25 MG Oral TabletSCDf84e3365-57d2-4904-9275-96600f8d74c7100

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
71335-3035-1713353035011000 TABLET, FILM COATED in 1 BOTTLE (71335-3035-1) 2025-12-03NoNoCurrent