FDA.reportPublic FDA data

Hydroxyzine Hydrochloride

Product NDC
81033-031
11-digit product format
810330031
Labeler code
81033
Product ID
81033-031_4cac7248-0970-077a-e063-6294a90a782d
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Hydroxyzine Hydrochloride
Dosage form
SOLUTION
Route
ORAL
Labeler
Kesin Pharma
Application
ANDA219289
Marketing category
ANDA
Marketing start
2025-07-17
Substance
HYDROXYZINE DIHYDROCHLORIDE
Active strength
10 mg/5mL
Pharmacologic classes
Antihistamine [EPC], Histamine Receptor Antagonists [MoA]
NDC exclude flag
No
Listing certified through
2027-12-31
Current FDA listing
Yes

Source provenance: Browse the complete Orange Book source catalog · source snapshot 42.

Orange Book products#

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

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A219289-001HYDROXYZINE HYDROCHLORIDEHYDROXYZINE HYDROCHLORIDE10MG/5MLSYRUP / ORALAA2025-04-28

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A219289-001AA

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
2026-08-18 06:07:402026-07A219289-001HYDROXYZINE HYDROCHLORIDE10MG/5MLSYRUP / ORALAA2025-04-28caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A219289-001HYDROXYZINE HYDROCHLORIDE10MG/5MLSYRUP / ORALAA2025-04-28011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A219289-001HYDROXYZINE HYDROCHLORIDE10MG/5MLSYRUP / ORALAA2025-04-2831067a03dcf5…
2025-08-23 18:47 UTC2025-08A219289-001HYDROXYZINE HYDROCHLORIDE10MG/5MLSYRUP / ORALAA2025-04-286a471c1ec25d…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A219289-001HYDROXYZINE HYDROCHLORIDE10MG/5MLSYRUP / ORALAA2025-04-28a50c72e98297…

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-08-18 06:07:402026-07A219289-001AA1caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A219289-001AA1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A219289-001AA131067a03dcf5…
2025-08-23 18:47 UTC2025-08A219289-001AA16a471c1ec25d…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A219289-001AA1a50c72e98297…

Additional Listing Data#

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

Active Ingredients#

Ingredient, Strength table
IngredientStrength
HYDROXYZINE DIHYDROCHLORIDE10 mg/5mL

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
995241Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
4b094d1b-97b2-6ca6-e063-6294a90a2437Available 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
81033-031-05Hydroxyzine Hydrochloride5 mL in 1 CUP, UNIT-DOSESOLUTION52
81033-031-12Hydroxyzine Hydrochloride12.5 mL in 1 CUP, UNIT-DOSESOLUTION12.52
81033-031-44Hydroxyzine Hydrochloride40 in 1 CARTONSOLUTION402
81033-031-45Hydroxyzine Hydrochloride40 in 1 CARTONSOLUTION402

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
81033-031-05ML - Milliliter81033-031d792c426-65f3-4a59-bc7c-da089105f7be12026-04-20
81033-031-12ML - Milliliter81033-031d75e6d7f-abba-4225-9f70-bb18b58d6ea312026-04-20
81033-031-44ML - Milliliter81033-031c0a022c7-f081-46f7-81ce-460abec27ed912026-04-20
81033-031-45ML - Milliliter81033-0311f586e30-cc21-4d11-91f3-2897b6cb341812026-04-20

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 · 2 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Hydroxyzine HydrochlorideHYDROXYZINE HYDROCHLORIDEKesin Pharma4b094d1b-97b2-6ca6-e063-6294a90a24372026-03-10Warnings, Adverse reactionsExact identifier
application applno (ANDA): 219289
application number: ANDA219289
ndc (product): 81033-031
Hydroxyzine HydrochlorideHYDROXYZINE HYDROCHLORIDE ORALBionpharma Inc.39f93633-000e-6c3f-e063-6394a90a5a0b2025-07-15Warnings, Adverse reactionsExact identifier
application applno (ANDA): 219289
application number: ANDA219289

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
995241hydrOXYzine HCl 10 MG in 5 mL Oral SolutionPSN4b094d1b-97b2-6ca6-e063-6294a90a24372
995241hydroxyzine hydrochloride 2 MG/ML Oral SolutionSCD4b094d1b-97b2-6ca6-e063-6294a90a24372
995241hydroxyzine hydrochloride 10 MG per 5 ML Oral SolutionSY4b094d1b-97b2-6ca6-e063-6294a90a24372

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
81033-031-05810330031055 mL in 1 CUP, UNIT-DOSE5 mlHistorical
81033-031-128103300311212.5 mL in 1 CUP, UNIT-DOSE12.5 mlHistorical
81033-031-448103300314440 CUP, UNIT-DOSE in 1 CARTON (81033-031-44) / 5 mL in 1 CUP, UNIT-DOSE (81033-031-05) 2026-02-27NoNoCurrent
81033-031-458103300314540 CUP, UNIT-DOSE in 1 CARTON (81033-031-45) / 12.5 mL in 1 CUP, UNIT-DOSE (81033-031-12) 2026-02-27NoNoCurrent