FDA.reportPublic FDA data

Hydroxyzine Hydrochloride

Product NDC
55154-2148
Requested package NDC
55154-2148-0
11-digit product format
551542148
Labeler code
55154
Product ID
55154-2148_b4d274ce-d616-4835-80ce-76270524ed36
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Hydroxyzine Hydrochloride
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Cardinal Health 107, LLC
Application
ANDA088618
Marketing category
ANDA
Marketing start
2025-10-22
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 · 1 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A088618-001HYDROXYZINE HYDROCHLORIDEHYDROXYZINE HYDROCHLORIDE25MGTABLET / ORALABRLD, RS1986-01-10

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A088618-001AB

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 22:54:322026-06A088618-001HYDROXYZINE HYDROCHLORIDE25MGTABLET / ORALABRLD, RS1986-01-10a50c72e98297…

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-08-01 22:54:322026-06A088618-001AB1a50c72e98297…

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 HYDROCHLORIDEREMEDYREPACK INC.ca67c061-c743-4ebb-a9d5-ece4880606632026-07-22Warnings, Adverse reactionsExact identifier
application applno (ANDA): 088618
application number: ANDA088618
Hydroxyzine HydrochlorideHYDROXYZINE HYDROCHLORIDECardinal Health 107, LLCb4d274ce-d616-4835-80ce-76270524ed362026-07-20Warnings, Adverse reactionsExact identifier
application applno (ANDA): 088618
application number: ANDA088618
ndc (package): 55154-2148-0
ndc (product): 55154-2148
ndc11 (package): 55154214800
Hydroxyzine HydrochlorideHYDROXYZINE HYDROCHLORIDEAmerican Health Packaging47bda4fe-ddb7-4140-900a-970373cc7acc2026-06-23Warnings, Adverse reactionsExact identifier
application applno (ANDA): 088618
application number: ANDA088618
Hydroxyzine HydrochlorideHYDROXYZINE HYDROCHLORIDESt. Mary's Medical Park Pharmacy1767a886-ec92-39fb-e063-6294a90a12492026-06-03Warnings, Adverse reactionsExact identifier
application applno (ANDA): 088618
application number: ANDA088618
Hydroxyzine HydrochlorideHYDROXYZINE HYDROCHLORIDEREMEDYREPACK INC.6ad55cd1-a284-4c3d-aa90-653704afdb752026-01-30Warnings, Adverse reactionsExact identifier
application applno (ANDA): 088618
application number: ANDA088618
Hydroxyzine HydrochlorideHYDROXYZINE HYDROCHLORIDENorthwind Health Company, LLCdb0dce55-5984-7580-e053-2a95a90a36952026-01-01Warnings, Adverse reactionsExact identifier
application applno (ANDA): 088618
application number: ANDA088618
Hydroxyzine HydrochlorideHYDROXYZINE HYDROCHLORIDEBryant Ranch Prepack93d117dd-e2bf-4daa-abe3-d4fefed3313c2025-09-11Warnings, Adverse reactionsExact identifier
application applno (ANDA): 088618
application number: ANDA088618
Hydroxyzine HydrochlorideHYDROXYZINE HYDROCHLORIDEBryant Ranch Prepack3f90259a-a684-498f-8963-d02eaba2e9db2025-09-08Warnings, Adverse reactionsExact identifier
application applno (ANDA): 088618
application number: ANDA088618
Hydroxyzine HydrochlorideHYDROXYZINE HYDROCHLORIDEPD-Rx Pharmaceuticals, Inc.2b05bd0e-af57-4e74-92f8-a4311330142f2025-08-18Warnings, Adverse reactionsExact identifier
application applno (ANDA): 088618
application number: ANDA088618
Hydroxyzine HydrochlorideHYDROXYZINE HYDROCHLORIDETeva Pharmaceuticals USA, Inc.80309ec1-e5d5-4454-b8ce-67d7e6805e442025-07-31Warnings, Adverse reactionsExact identifier
application applno (ANDA): 088618
application number: ANDA088618
Hydroxyzine HydrochlorideHYDROXYZINE HYDROCHLORIDEProficient Rx LPd79be126-39cd-4dbb-ad88-0e4c18109dda2024-05-01Warnings, Adverse reactionsExact identifier
application applno (ANDA): 088618
application number: ANDA088618

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
b4d274ce-d616-4835-80ce-76270524ed36Available 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
55154-2148-0Hydroxyzine Hydrochloride10 in 1 BAGTABLET, FILM COATED101
55154-2148-0Hydroxyzine Hydrochloride1 in 1 BLISTER PACKTABLET, FILM COATED11

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
995258hydrOXYzine HCl 25 MG Oral TabletPSNb4d274ce-d616-4835-80ce-76270524ed361
995258hydroxyzine hydrochloride 25 MG Oral TabletSCDb4d274ce-d616-4835-80ce-76270524ed361

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
55154-2148-05515421480010 BLISTER PACK in 1 BAG (55154-2148-0) / 1 TABLET, FILM COATED in 1 BLISTER PACK10 blister pack2025-10-22NoNoCurrent