FDA.reportPublic FDA data

HYDROXYZINE HYDROCHLORIDE

Product NDC
80425-0590
11-digit product format
804250590
Labeler code
80425
Product ID
80425-0590_5648abd7-f01a-43fb-e063-6294a90ab817
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
hydroxyzine hydrochloride
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Advanced Rx of Tennessee, LLC
Application
ANDA217652
Marketing category
ANDA
Marketing start
2026-07-10
Substance
HYDROXYZINE DIHYDROCHLORIDE
Active strength
25 mg/1
Pharmacologic classes
Antihistamine [EPC]; Histamine Receptor Antagonists [MoA]
Listing certified through
2027-12-31
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
A217652-001HYDROXYZINE HYDROCHLORIDEHYDROXYZINE HYDROCHLORIDE10MGTABLET / ORALAB2023-08-17
A217652-002HYDROXYZINE HYDROCHLORIDEHYDROXYZINE HYDROCHLORIDE25MGTABLET / ORALAB2023-08-17
A217652-003HYDROXYZINE HYDROCHLORIDEHYDROXYZINE HYDROCHLORIDE50MGTABLET / ORALABRS2023-08-17

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A217652-001AB
A217652-002AB
A217652-003AB

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 22:54:322026-06A217652-001HYDROXYZINE HYDROCHLORIDE10MGTABLET / ORALAB2023-08-17a50c72e98297…
2026-08-01 22:54:322026-06A217652-002HYDROXYZINE HYDROCHLORIDE25MGTABLET / ORALAB2023-08-17a50c72e98297…
2026-08-01 22:54:322026-06A217652-003HYDROXYZINE HYDROCHLORIDE50MGTABLET / ORALABRS2023-08-17a50c72e98297…

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-08-01 22:54:322026-06A217652-001AB1a50c72e98297…
2026-08-01 22:54:322026-06A217652-002AB1a50c72e98297…
2026-08-01 22:54:322026-06A217652-003AB1a50c72e98297…

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 2 · 22 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
HYDROXYZINE HYDROCHLORIDEHYDROXYZINE HYDROCHLORIDESt. Mary's Medical Park Pharmacy30b6f7b3-b620-961a-e063-6394a90a487b2026-07-23Warnings, Adverse reactionsExact identifier
application applno (ANDA): 217652
application number: ANDA217652
HYDROXYZINE HYDROCHLORIDEHYDROXYZINE HYDROCHLORIDEAdvanced Rx of Tennessee, LLC5648abce-f20e-717c-e063-6294a90a88ac2026-07-10Warnings, Adverse reactionsExact identifier
application applno (ANDA): 217652
application number: ANDA217652
ndc (product): 80425-0590
HYDROXYZINE HYDROCHLORIDEHYDROXYZINE HYDROCHLORIDEBryant Ranch Prepack66be7bde-d2bd-4c65-bde9-0fb9f5be093f2026-07-02Warnings, Adverse reactionsExact identifier
application applno (ANDA): 217652
application number: ANDA217652
HYDROXYZINE HYDROCHLORIDEHYDROXYZINE HYDROCHLORIDENuCare Pharmaceuticals, Inc.534a6a49-23df-d65e-e063-6294a90a1a122026-06-02Warnings, Adverse reactionsExact identifier
application applno (ANDA): 217652
application number: ANDA217652
HYDROXYZINE HYDROCHLORIDEHYDROXYZINE HYDROCHLORIDENuCare Pharmaceuticals, Inc.52fb8616-7d4e-9c37-e063-6294a90a11122026-05-29Warnings, Adverse reactionsExact identifier
application applno (ANDA): 217652
application number: ANDA217652
HYDROXYZINE HYDROCHLORIDEHYDROXYZINE HYDROCHLORIDECoupler LLC519e54e0-a613-e7b3-e063-6294a90a44522026-05-12Warnings, Adverse reactionsExact identifier
application applno (ANDA): 217652
application number: ANDA217652
HYDROXYZINE HYDROCHLORIDEHYDROXYZINE HYDROCHLORIDEPreferred Pharmaceuticals Inc.7edd582c-039c-4bdc-bf8a-61eac8a5a9a02026-05-11Warnings, Adverse reactionsExact identifier
application applno (ANDA): 217652
application number: ANDA217652
HYDROXYZINE HYDROCHLORIDEHYDROXYZINE HYDROCHLORIDEProficient Rx LPca843456-0c93-41e8-9bbc-9cd92447f0922026-05-01Warnings, Adverse reactionsExact identifier
application applno (ANDA): 217652
application number: ANDA217652
HYDROXYZINE HYDROCHLORIDEHYDROXYZINE HYDROCHLORIDEREMEDYREPACK INC.f6ad4729-b291-42c4-8483-99385d8043db2026-04-09Warnings, Adverse reactionsExact identifier
application applno (ANDA): 217652
application number: ANDA217652
HYDROXYZINE HYDROCHLORIDEHYDROXYZINE HYDROCHLORIDENuCare Pharmaceuticals, Inc4aa896b1-4fd5-513e-e063-6294a90ab9502026-02-12Warnings, Adverse reactionsExact identifier
application applno (ANDA): 217652
application number: ANDA217652
HYDROXYZINE HYDROCHLORIDEHYDROXYZINE HYDROCHLORIDEA-S Medication Solutionsafa74394-c079-4ad3-b555-270fe0de3d622025-12-02Warnings, Adverse reactionsExact identifier
application applno (ANDA): 217652
application number: ANDA217652
HYDROXYZINE HYDROCHLORIDEHYDROXYZINE HYDROCHLORIDEA-S Medication Solutions69a58bc6-c8a4-48ad-ac77-90fac42e03982025-12-02Warnings, Adverse reactionsExact identifier
application applno (ANDA): 217652
application number: ANDA217652
HYDROXYZINE HYDROCHLORIDEHYDROXYZINE HYDROCHLORIDEA-S Medication Solutionsa8525244-2acb-4e3e-9769-bbc90549a1882025-12-02Warnings, Adverse reactionsExact identifier
application applno (ANDA): 217652
application number: ANDA217652
HYDROXYZINE HYDROCHLORIDEHYDROXYZINE HYDROCHLORIDEA-S Medication Solutions87b79b7c-0398-47dc-858d-62e44a1b02f42025-12-02Warnings, Adverse reactionsExact identifier
application applno (ANDA): 217652
application number: ANDA217652
HYDROXYZINE HYDROCHLORIDEHYDROXYZINE HYDROCHLORIDEA-S Medication Solutionsa9a133e6-efce-4bdb-9335-49c74e57fafe2025-11-01Warnings, Adverse reactionsExact identifier
application applno (ANDA): 217652
application number: ANDA217652
HYDROXYZINE HYDROCHLORIDEHYDROXYZINE HYDROCHLORIDERising Pharma Holdings, Inc.6a1a48ac-8ad5-4363-b298-d9825ae2a4482025-08-14Warnings, Adverse reactionsExact identifier
application applno (ANDA): 217652
application number: ANDA217652
HYDROXYZINE HYDROCHLORIDEHYDROXYZINE HYDROCHLORIDEREMEDYREPACK INC.8f41912e-12ce-4174-a0fb-cfb4888d8d582025-07-16Warnings, Adverse reactionsExact identifier
application applno (ANDA): 217652
application number: ANDA217652
HYDROXYZINE HYDROCHLORIDEHYDROXYZINE HYDROCHLORIDEBryant Ranch Prepack6577589f-1a80-41d8-847a-70c3f38d8dc02025-06-02Warnings, Adverse reactionsExact identifier
application applno (ANDA): 217652
application number: ANDA217652
HYDROXYZINE HYDROCHLORIDEHYDROXYZINE HYDROCHLORIDEPreferred Pharmaceuticals Inc.a35d1fe2-328d-42ff-ba1f-18a7f2f03c882025-05-01Warnings, Adverse reactionsExact identifier
application applno (ANDA): 217652
application number: ANDA217652
Hydroxyzine HCLHYDROXYZINE HCLDirect_rx22049012-733e-6b45-e063-6294a90a670f2024-09-13Warnings, Adverse reactionsExact identifier
application applno (ANDA): 217652
application number: ANDA217652

Additional Listing Data#

Finished product
Yes
Brand name base
HYDROXYZINE HYDROCHLORIDE
Listing expiration
2027-12-31

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
5648abce-f20e-717c-e063-6294a90a88acAvailable on FDA.report

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleStatus
80425-0590-18042505900130 TABLET, FILM COATED in 1 BOTTLE (80425-0590-1)2026-07-100Current
80425-0590-28042505900260 TABLET, FILM COATED in 1 BOTTLE (80425-0590-2)2026-07-100Current
80425-0590-38042505900390 TABLET, FILM COATED in 1 BOTTLE (80425-0590-3)2026-07-100Current