FDA.reportPublic FDA data

HydrOXYzine Hydrochloride

Product NDC
71610-686
Requested package NDC
71610-686-53
11-digit product format
716100686
Labeler code
71610
Product ID
71610-686_d26d400a-ed41-4b07-91e3-ff207c4b8381
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
HydrOXYzine Hydrochloride
Dosage form
TABLET
Route
ORAL
Labeler
Aphena Pharma Solutions - Tennessee, LLC
Application
ANDA040840
Marketing category
ANDA
Marketing start
2009-11-11
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
A040840-001HYDROXYZINE HYDROCHLORIDEHYDROXYZINE HYDROCHLORIDE50MGTABLET / ORALAB2008-03-31
A040840-002HYDROXYZINE HYDROCHLORIDEHYDROXYZINE HYDROCHLORIDE10MGTABLET / ORALAB2008-03-31
A040840-003HYDROXYZINE HYDROCHLORIDEHYDROXYZINE HYDROCHLORIDE25MGTABLET / ORALAB2008-03-31

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A040840-001AB
A040840-002AB
A040840-003AB

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 22:54:322026-06A040840-001HYDROXYZINE HYDROCHLORIDE50MGTABLET / ORALAB2008-03-31a50c72e98297…
2026-08-01 22:54:322026-06A040840-002HYDROXYZINE HYDROCHLORIDE10MGTABLET / ORALAB2008-03-31a50c72e98297…
2026-08-01 22:54:322026-06A040840-003HYDROXYZINE HYDROCHLORIDE25MGTABLET / ORALAB2008-03-31a50c72e98297…

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-08-01 22:54:322026-06A040840-001AB1a50c72e98297…
2026-08-01 22:54:322026-06A040840-002AB1a50c72e98297…
2026-08-01 22:54:322026-06A040840-003AB1a50c72e98297…

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 HYDROCHLORIDEA-S Medication Solutions5dea636d-dee6-47d4-b83c-b9f0c0b1b6ca2026-07-24Warnings, Adverse reactionsExact identifier
application applno (ANDA): 040840
application number: ANDA040840
HydrOXYzine HydrochlorideHYDROXYZINE HYDROCHLORIDEA-S Medication Solutionsbe6a2f09-c0f3-44e2-aac3-37e3702b93f02026-07-21Warnings, Adverse reactionsExact identifier
application applno (ANDA): 040840
application number: ANDA040840
HydrOXYzine HydrochlorideHYDROXYZINE HYDROCHLORIDERedpharm Drug4fb58637-dc30-c4dd-e063-6394a90a8bbe2026-04-18Warnings, Adverse reactionsExact identifier
application applno (ANDA): 040840
application number: ANDA040840
HydrOXYzine HydrochlorideHYDROXYZINE HYDROCHLORIDENorthstar RxLLC8e5fce17-936e-46ea-a969-518c952c20912025-12-23Warnings, Adverse reactionsExact identifier
application applno (ANDA): 040840
application number: ANDA040840
HydrOXYzine HydrochlorideHYDROXYZINE HYDROCHLORIDENuCare Pharmaceuticals,Inc.acc99b8f-87f0-eb3a-e053-2995a90aaaed2025-11-20Warnings, Adverse reactionsExact identifier
application applno (ANDA): 040840
application number: ANDA040840
HydrOXYzine HydrochlorideHYDROXYZINE HYDROCHLORIDEA-S Medication Solutions723b810b-46cc-4c45-ae1f-93ca358e007d2025-07-09Warnings, Adverse reactionsExact identifier
application applno (ANDA): 040840
application number: ANDA040840
HydrOXYzine HydrochlorideHYDROXYZINE HYDROCHLORIDEREMEDYREPACK INC.58d99cf6-2319-410b-b8be-de9c304541b62025-06-17Warnings, Adverse reactionsExact identifier
application applno (ANDA): 040840
application number: ANDA040840
HydrOXYzine HydrochlorideHYDROXYZINE HYDROCHLORIDENuCare Pharmaceuticals,Inc.ffd33207-3f35-3486-e053-6394a90ac0ae2025-02-05Warnings, Adverse reactionsExact identifier
application applno (ANDA): 040840
application number: ANDA040840
HydrOXYzine HydrochlorideHYDROXYZINE HYDROCHLORIDEA-S Medication Solutions46266803-0905-4ae2-9d17-dbf4c2a081812023-09-07Warnings, Adverse reactionsExact identifier
application applno (ANDA): 040840
application number: ANDA040840
HydrOXYzine HydrochlorideHYDROXYZINE HYDROCHLORIDEA-S Medication Solutions3d2e63c6-993c-42b9-91a0-616246789a7b2023-09-07Warnings, Adverse reactionsExact identifier
application applno (ANDA): 040840
application number: ANDA040840
HydrOXYzine HydrochlorideHYDROXYZINE HYDROCHLORIDEAphena Pharma Solutions - Tennessee, LLC8e954579-b0f5-4ce3-bade-0b9b972f6f8b2023-01-23Warnings, Adverse reactionsExact identifier
application applno (ANDA): 040840
application number: ANDA040840
ndc (package): 71610-686-53
ndc (product): 71610-686
ndc11 (package): 71610068653

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
8e954579-b0f5-4ce3-bade-0b9b972f6f8bAvailable 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
71610-686-53HydrOXYzine Hydrochloride60 in 1 BOTTLETABLET601
71610-686-60HydrOXYzine Hydrochloride90 in 1 BOTTLETABLET901
71610-686-80HydrOXYzine Hydrochloride180 in 1 BOTTLETABLET1801

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
71610-686-53EA - Each71610-6863366c53a-0385-49c2-8bfb-4ceca520bb3d12023-12-05
71610-686-80EA - Each71610-6866b1ffdc8-aa2d-4f2b-afb8-784e579c80f512024-01-04

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71610-686HYDROXYZINE HYDROCHLORIDE TABLET [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]1Current NDC, 3 package rows20230124_8e954579-b0f5-4ce3-bade-0b9b972f6f8b.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
995258hydrOXYzine HCl 25 MG Oral TabletPSN8e954579-b0f5-4ce3-bade-0b9b972f6f8b1
995258hydroxyzine hydrochloride 25 MG Oral TabletSCD8e954579-b0f5-4ce3-bade-0b9b972f6f8b1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
71610-686-537161006865360 TABLET in 1 BOTTLE (71610-686-53) 60 tablet2023-01-19NoNoCurrent