FDA.reportPublic FDA data

Hydroxyzine Hydrochloride

Product NDC
55154-7994
11-digit product format
551547994
Labeler code
55154
Product ID
55154-7994_9db03a3f-e0ed-46b1-948d-667383a6bf61
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Hydroxyzine Hydrochloride
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Cardinal Health 107, LLC
Application
ANDA040604
Marketing category
ANDA
Marketing start
2015-03-31
Marketing end
2026-08-31
Substance
HYDROXYZINE DIHYDROCHLORIDE
Active strength
25 mg/1
Pharmacologic classes
Antihistamine [EPC], Histamine Receptor Antagonists [MoA]
NDC exclude flag
No
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
ndc (product): 55154-7994
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
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

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
157fbedc-b65d-455f-adb5-e7554282e033Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
57311cfb-679a-da1a-b70c-8757f7fc431aProduct name420250516
594e2c86-3079-4e6e-96c9-48f7a8afc78dProduct name120230718
aa1826f4-97c1-4705-bdf0-3bc7d234e618Product name220190618
75cb12ee-8eb2-4f1a-a332-5743a5d0da41Product name120151110
3ca5f78b-43dc-30fe-8014-55b922af52b3Product name120140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
55154-7994-02023-02-21C16284748780-1f386c64a-347b-0266-e053-dadaa90a7c1aHydroxyzine Hydrochloride Tablets USP, Film-Coated Rx Only
55154-7994-02023-02-21C16284748780-1f386c64a-347b-0266-e053-dadaa90a7c1aHydroxyzine Hydrochloride Tablets USP, Film-Coated Rx Only
55154-7994-02023-01-30C16284748780-1f386c64a-347b-0266-e053-dadaa90a7c1aHydroxyzine Hydrochloride Tablets USP, Film-Coated Rx Only
55154-7994-02023-01-30C16284748780-1f386c64a-347b-0266-e053-dadaa90a7c1aHydroxyzine Hydrochloride Tablets USP, Film-Coated Rx Only

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
55154-7994-0Hydroxyzine Hydrochloride1 in 1 BLISTER PACKTABLET, FILM COATED17
55154-7994-0Hydroxyzine Hydrochloride10 in 1 BAGTABLET, FILM COATED107

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
55154-7994HYDROXYZINE HYDROCHLORIDE TABLET, FILM COATED [CARDINAL HEALTH 107, LLC]6Current NDC, Legacy NDC, 2 package rows20250514_157fbedc-b65d-455f-adb5-e7554282e033.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
995258hydrOXYzine HCl 25 MG Oral TabletPSN157fbedc-b65d-455f-adb5-e7554282e0337
995258hydroxyzine hydrochloride 25 MG Oral TabletSCD157fbedc-b65d-455f-adb5-e7554282e0337

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
55154-7994-05515479940010 BLISTER PACK in 1 BAG (55154-7994-0) / 1 TABLET, FILM COATED in 1 BLISTER PACK10 blister pack2015-03-312026-08-31NoNoCurrent