FDA.reportPublic FDA data

Hydroxyzine Hydrochloride

Product NDC
42806-161
Requested package NDC
42806-161-10
11-digit product format
428060161
Labeler code
42806
Product ID
42806-161_5e33c30d-cf33-4d61-98ca-eab9aab2ddf3
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Hydroxyzine Hydrochloride
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Epic Pharma, LLC
Application
ANDA040604
Marketing category
ANDA
Marketing start
2015-03-31
Substance
HYDROXYZINE DIHYDROCHLORIDE
Active strength
50 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
A040604-001HYDROXYZINE HYDROCHLORIDEHYDROXYZINE HYDROCHLORIDE50MGTABLET / ORALAB2004-12-28
A040604-002HYDROXYZINE HYDROCHLORIDEHYDROXYZINE HYDROCHLORIDE10MGTABLET / ORALAB2004-12-28
A040604-003HYDROXYZINE HYDROCHLORIDEHYDROXYZINE HYDROCHLORIDE25MGTABLET / ORALAB2004-12-28

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A040604-001AB
A040604-002AB
A040604-003AB

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 22:54:322026-06A040604-001HYDROXYZINE HYDROCHLORIDE50MGTABLET / ORALAB2004-12-28a50c72e98297…
2026-08-01 22:54:322026-06A040604-002HYDROXYZINE HYDROCHLORIDE10MGTABLET / ORALAB2004-12-28a50c72e98297…
2026-08-01 22:54:322026-06A040604-003HYDROXYZINE HYDROCHLORIDE25MGTABLET / ORALAB2004-12-28a50c72e98297…

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-08-01 22:54:322026-06A040604-001AB1a50c72e98297…
2026-08-01 22:54:322026-06A040604-002AB1a50c72e98297…
2026-08-01 22:54:322026-06A040604-003AB1a50c72e98297…

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 · 8 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Hydroxyzine HydrochlorideHYDROXYZINE HYDROCHLORIDEMajor Pharmaceuticals7534a3bb-b4cd-415f-8612-53b37dc6d55f2026-06-15Warnings, Adverse reactionsExact identifier
application applno (ANDA): 040604
application number: ANDA040604
Hydroxyzine HydrochlorideHYDROXYZINE HYDROCHLORIDECardinal Health 107, LLC157fbedc-b65d-455f-adb5-e7554282e0332026-06-03Warnings, Adverse reactionsExact identifier
application applno (ANDA): 040604
application number: ANDA040604
Hydroxyzine HydrochlorideHYDROXYZINE HYDROCHLORIDEPURACAP LABORATORIES LLC DBA BLU PHARMACEUTICALS19fe26a9-eb1a-4c5b-a5e4-65223ee56ad12026-02-02Warnings, Adverse reactionsExact identifier
application applno (ANDA): 040604
application number: ANDA040604
Hydroxyzine HydrochlorideHYDROXYZINE HYDROCHLORIDEBryant Ranch Prepack5ff091be-6e30-4305-a172-769ee45e110b2025-04-02Warnings, Adverse reactionsExact identifier
application applno (ANDA): 040604
application number: ANDA040604
Hydroxyzine HydrochlorideHYDROXYZINE HYDROCHLORIDEEpic Pharma, LLC82b015dc-999c-46a4-bcaa-a4c81a193b682025-01-31Warnings, Adverse reactionsExact identifier
application applno (ANDA): 040604
application number: ANDA040604
ndc (package): 42806-161-10
ndc (product): 42806-161
ndc11 (package): 42806016110
Hydroxyzine HydrochlorideHYDROXYZINE HYDROCHLORIDENuCare Pharmaceuticals,Inc.99995bdb-a35f-7753-e053-2995a90a683c2024-10-15Warnings, Adverse reactionsExact identifier
application applno (ANDA): 040604
application number: ANDA040604
Hydroxyzine HydrochlorideHYDROXYZINE HYDROCHLORIDEBryant Ranch Prepackf6f688d0-cb13-40af-a65f-480c37334e372024-04-03Warnings, Adverse reactionsExact identifier
application applno (ANDA): 040604
application number: ANDA040604
Hydroxyzine HydrochlorideHYDROXYZINE HYDROCHLORIDEProficient Rx LP3edfac5c-a08b-4270-a343-9b2dc10a4a6e2022-11-01Warnings, Adverse reactionsExact identifier
application applno (ANDA): 040604
application number: ANDA040604

Additional Listing Data#

Finished product
Yes
Brand name base
Hydroxyzine Hydrochloride
Listing expiration
2026-12-31

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
82b015dc-999c-46a4-bcaa-a4c81a193b68Available 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
42806-161-01Hydroxyzine Hydrochloride100 in 1 BOTTLETABLET, FILM COATED10012
42806-161-05Hydroxyzine Hydrochloride500 in 1 BOTTLETABLET, FILM COATED50012
42806-161-10Hydroxyzine Hydrochloride1000 in 1 BOTTLETABLET, FILM COATED100012

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
42806-161-01EA - Each42806-1616490746e-bdac-42e6-b69f-c25b91814ad412015-05-05
42806-161-05EA - Each42806-1614d803d47-37d9-4ae6-942c-9df660d0c51712015-05-05
42806-161-10EA - Each42806-1610c526560-a167-4e96-8371-720fb2088e1312015-05-05

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
HYDROXYZINE HYDROCHLORIDEACTIVE INGREDIENT76755771U3HYDROXYZINE HYDROCHLORIDE TABLET, FILM COATED [EPIC PHARMA, LLC]3
HYDROXYZINEACTIVE MOIETY30S50YM8OGHYDROXYZINE HYDROCHLORIDE TABLET, FILM COATED [EPIC PHARMA, LLC]3
CARNAUBA WAXINACTIVE INGREDIENTR12CBM0EIZHYDROXYZINE HYDROCHLORIDE TABLET, FILM COATED [EPIC PHARMA, LLC]3
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UHYDROXYZINE HYDROCHLORIDE TABLET, FILM COATED [EPIC PHARMA, LLC]3
CROSPOVIDONEINACTIVE INGREDIENT68401960MKHYDROXYZINE HYDROCHLORIDE TABLET, FILM COATED [EPIC PHARMA, LLC]3
D&C YELLOW NO. 10INACTIVE INGREDIENT35SW5USQ3GHYDROXYZINE HYDROCHLORIDE TABLET, FILM COATED [EPIC PHARMA, LLC]3
FD&C BLUE NO. 2INACTIVE INGREDIENTL06K8R7DQKHYDROXYZINE HYDROCHLORIDE TABLET, FILM COATED [EPIC PHARMA, LLC]3
FD&C RED NO. 40INACTIVE INGREDIENTWZB9127XOAHYDROXYZINE HYDROCHLORIDE TABLET, FILM COATED [EPIC PHARMA, LLC]3
FD&C YELLOW NO. 6INACTIVE INGREDIENTH77VEI93A8HYDROXYZINE HYDROCHLORIDE TABLET, FILM COATED [EPIC PHARMA, LLC]3
FERRIC OXIDE YELLOWINACTIVE INGREDIENTEX438O2MRTHYDROXYZINE HYDROCHLORIDE TABLET, FILM COATED [EPIC PHARMA, LLC]3
HYPROMELLOSESINACTIVE INGREDIENT3NXW29V3WOHYDROXYZINE HYDROCHLORIDE TABLET, FILM COATED [EPIC PHARMA, LLC]3
LACTOSE MONOHYDRATEINACTIVE INGREDIENTEWQ57Q8I5XHYDROXYZINE HYDROCHLORIDE TABLET, FILM COATED [EPIC PHARMA, LLC]3
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30HYDROXYZINE HYDROCHLORIDE TABLET, FILM COATED [EPIC PHARMA, LLC]3
POLYETHYLENE GLYCOLSINACTIVE INGREDIENT3WJQ0SDW1AHYDROXYZINE HYDROCHLORIDE TABLET, FILM COATED [EPIC PHARMA, LLC]3
POLYVINYL ALCOHOLINACTIVE INGREDIENT532B59J990HYDROXYZINE HYDROCHLORIDE TABLET, FILM COATED [EPIC PHARMA, LLC]3
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4HYDROXYZINE HYDROCHLORIDE TABLET, FILM COATED [EPIC PHARMA, LLC]3
TALCINACTIVE INGREDIENT7SEV7J4R1UHYDROXYZINE HYDROCHLORIDE TABLET, FILM COATED [EPIC PHARMA, LLC]3
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPHYDROXYZINE HYDROCHLORIDE TABLET, FILM COATED [EPIC PHARMA, LLC]3
TRIACETININACTIVE INGREDIENTXHX3C3X673HYDROXYZINE HYDROCHLORIDE TABLET, FILM COATED [EPIC PHARMA, LLC]3

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
42806-161HYDROXYZINE HYDROCHLORIDE TABLET, FILM COATED [EPIC PHARMA, LLC]12Current NDC, Legacy NDC, 3 package rows20250209_82b015dc-999c-46a4-bcaa-a4c81a193b68.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
995281hydrOXYzine HCl 50 MG Oral TabletPSNf6f688d0-cb13-40af-a65f-480c37334e37102
995281hydroxyzine hydrochloride 50 MG Oral TabletSCDf6f688d0-cb13-40af-a65f-480c37334e37102
995281hydrOXYzine HCl 50 MG Oral TabletPSN5ff091be-6e30-4305-a172-769ee45e110b101
995281hydroxyzine hydrochloride 50 MG Oral TabletSCD5ff091be-6e30-4305-a172-769ee45e110b101
995218hydrOXYzine HCl 10 MG Oral TabletPSN82b015dc-999c-46a4-bcaa-a4c81a193b6812
995258hydrOXYzine HCl 25 MG Oral TabletPSN82b015dc-999c-46a4-bcaa-a4c81a193b6812
995281hydrOXYzine HCl 50 MG Oral TabletPSN82b015dc-999c-46a4-bcaa-a4c81a193b6812
995218hydroxyzine hydrochloride 10 MG Oral TabletSCD82b015dc-999c-46a4-bcaa-a4c81a193b6812
995258hydroxyzine hydrochloride 25 MG Oral TabletSCD82b015dc-999c-46a4-bcaa-a4c81a193b6812
995281hydroxyzine hydrochloride 50 MG Oral TabletSCD82b015dc-999c-46a4-bcaa-a4c81a193b6812
995258hydrOXYzine HCl 25 MG Oral TabletPSN7534a3bb-b4cd-415f-8612-53b37dc6d55f10
995281hydrOXYzine HCl 50 MG Oral TabletPSN7534a3bb-b4cd-415f-8612-53b37dc6d55f10
995258hydroxyzine hydrochloride 25 MG Oral TabletSCD7534a3bb-b4cd-415f-8612-53b37dc6d55f10
995281hydroxyzine hydrochloride 50 MG Oral TabletSCD7534a3bb-b4cd-415f-8612-53b37dc6d55f10
995281hydrOXYzine HCl 50 MG Oral TabletPSN3edfac5c-a08b-4270-a343-9b2dc10a4a6e4
995281hydrOXYzine HCl 50 MG Oral TabletPSN99995bdb-a35f-7753-e053-2995a90a683c4
995281hydroxyzine hydrochloride 50 MG Oral TabletSCD99995bdb-a35f-7753-e053-2995a90a683c4
995281hydroxyzine hydrochloride 50 MG Oral TabletSCD3edfac5c-a08b-4270-a343-9b2dc10a4a6e4
995258hydrOXYzine HCl 25 MG Oral TabletPSN8b371b95-7f94-9efe-e053-2a95a90a87b02
995281hydrOXYzine HCl 50 MG Oral TabletPSN8b371b95-7f94-9efe-e053-2a95a90a87b02
995258hydroxyzine hydrochloride 25 MG Oral TabletSCD8b371b95-7f94-9efe-e053-2a95a90a87b02
995281hydroxyzine hydrochloride 50 MG Oral TabletSCD8b371b95-7f94-9efe-e053-2a95a90a87b02
995281hydrOXYzine HCl 50 MG Oral TabletPSN26cca5b1-f0c9-ed54-e063-6394a90a38641
995281hydroxyzine hydrochloride 50 MG Oral TabletSCD26cca5b1-f0c9-ed54-e063-6394a90a38641

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
42806-161-10428060161101000 TABLET, FILM COATED in 1 BOTTLE (42806-161-10) 2015-03-310000-00-00NoNoCurrent