HYDROXYZINE HYDROCHLORIDE

Product NDC
80425-0590
Requested package NDC
80425-0590-1
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]
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 43.

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.

Product history page 1 of 2 · 66 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-09-14 22:38:342026-08A217652-001HYDROXYZINE HYDROCHLORIDE10MGTABLET / ORALAB2023-08-1784e616aacf4f…
2026-09-14 22:38:342026-08A217652-002HYDROXYZINE HYDROCHLORIDE25MGTABLET / ORALAB2023-08-1784e616aacf4f…
2026-09-14 22:38:342026-08A217652-003HYDROXYZINE HYDROCHLORIDE50MGTABLET / ORALABRS2023-08-1784e616aacf4f…
2026-08-18 06:07:402026-07A217652-001HYDROXYZINE HYDROCHLORIDE10MGTABLET / ORALAB2023-08-17caaa826d4ba7…
2026-08-18 06:07:402026-07A217652-002HYDROXYZINE HYDROCHLORIDE25MGTABLET / ORALAB2023-08-17caaa826d4ba7…
2026-08-18 06:07:402026-07A217652-003HYDROXYZINE HYDROCHLORIDE50MGTABLET / ORALABRS2023-08-17caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A217652-001HYDROXYZINE HYDROCHLORIDE10MGTABLET / ORALAB2023-08-17011fe1cb6892…
2026-02-19 14:30 UTC2026-02A217652-002HYDROXYZINE HYDROCHLORIDE25MGTABLET / ORALAB2023-08-17011fe1cb6892…
2026-02-19 14:30 UTC2026-02A217652-003HYDROXYZINE HYDROCHLORIDE50MGTABLET / ORALABRS2023-08-17011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A217652-001HYDROXYZINE HYDROCHLORIDE10MGTABLET / ORALAB2023-08-1731067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A217652-002HYDROXYZINE HYDROCHLORIDE25MGTABLET / ORALAB2023-08-1731067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A217652-003HYDROXYZINE HYDROCHLORIDE50MGTABLET / ORALABRS2023-08-1731067a03dcf5…
2025-08-23 18:47 UTC2025-08A217652-001HYDROXYZINE HYDROCHLORIDE10MGTABLET / ORALAB2023-08-176a471c1ec25d…
2025-08-23 18:47 UTC2025-08A217652-002HYDROXYZINE HYDROCHLORIDE25MGTABLET / ORALAB2023-08-176a471c1ec25d…
2025-08-23 18:47 UTC2025-08A217652-003HYDROXYZINE HYDROCHLORIDE50MGTABLET / ORALABRS2023-08-176a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A217652-001HYDROXYZINE HYDROCHLORIDE10MGTABLET / ORALAB2023-08-17fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A217652-002HYDROXYZINE HYDROCHLORIDE25MGTABLET / ORALAB2023-08-17fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A217652-003HYDROXYZINE HYDROCHLORIDE50MGTABLET / ORALAB2023-08-17fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A217652-001HYDROXYZINE HYDROCHLORIDE10MGTABLET / ORALAB2023-08-17b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A217652-002HYDROXYZINE HYDROCHLORIDE25MGTABLET / ORALAB2023-08-17b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A217652-003HYDROXYZINE HYDROCHLORIDE50MGTABLET / ORALAB2023-08-17b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A217652-001HYDROXYZINE HYDROCHLORIDE10MGTABLET / ORALAB2023-08-1703ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A217652-002HYDROXYZINE HYDROCHLORIDE25MGTABLET / ORALAB2023-08-1703ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A217652-003HYDROXYZINE HYDROCHLORIDE50MGTABLET / ORALAB2023-08-1703ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A217652-001HYDROXYZINE HYDROCHLORIDE10MGTABLET / ORALAB2023-08-172680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A217652-002HYDROXYZINE HYDROCHLORIDE25MGTABLET / ORALAB2023-08-172680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A217652-003HYDROXYZINE HYDROCHLORIDE50MGTABLET / ORALAB2023-08-172680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A217652-001HYDROXYZINE HYDROCHLORIDE10MGTABLET / ORALAB2023-08-175bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A217652-002HYDROXYZINE HYDROCHLORIDE25MGTABLET / ORALAB2023-08-175bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A217652-003HYDROXYZINE HYDROCHLORIDE50MGTABLET / ORALAB2023-08-175bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A217652-001HYDROXYZINE HYDROCHLORIDE10MGTABLET / ORALAB2023-08-17d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A217652-002HYDROXYZINE HYDROCHLORIDE25MGTABLET / ORALAB2023-08-17d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A217652-003HYDROXYZINE HYDROCHLORIDE50MGTABLET / ORALAB2023-08-17d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A217652-001HYDROXYZINE HYDROCHLORIDE10MGTABLET / ORALAB2023-08-17d06236e962d9…
2024-10-29 15:01 UTC2024-10A217652-002HYDROXYZINE HYDROCHLORIDE25MGTABLET / ORALAB2023-08-17d06236e962d9…
2024-10-29 15:01 UTC2024-10A217652-003HYDROXYZINE HYDROCHLORIDE50MGTABLET / ORALAB2023-08-17d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A217652-001HYDROXYZINE HYDROCHLORIDE10MGTABLET / ORALAB2023-08-1779d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A217652-002HYDROXYZINE HYDROCHLORIDE25MGTABLET / ORALAB2023-08-1779d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A217652-003HYDROXYZINE HYDROCHLORIDE50MGTABLET / ORALAB2023-08-1779d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A217652-001HYDROXYZINE HYDROCHLORIDE10MGTABLET / ORALAB2023-08-17301d65b070ca…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 66 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-09-14 22:38:342026-08A217652-001AB184e616aacf4f…
2026-09-14 22:38:342026-08A217652-002AB184e616aacf4f…
2026-09-14 22:38:342026-08A217652-003AB184e616aacf4f…
2026-08-18 06:07:402026-07A217652-001AB1caaa826d4ba7…
2026-08-18 06:07:402026-07A217652-002AB1caaa826d4ba7…
2026-08-18 06:07:402026-07A217652-003AB1caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A217652-001AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A217652-002AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A217652-003AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A217652-001AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A217652-002AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A217652-003AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08A217652-001AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A217652-002AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A217652-003AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A217652-001AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A217652-002AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A217652-003AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A217652-001AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A217652-002AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A217652-003AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A217652-001AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A217652-002AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A217652-003AB103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A217652-001AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A217652-002AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A217652-003AB12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A217652-001AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A217652-002AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A217652-003AB15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A217652-001AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A217652-002AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A217652-003AB1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A217652-001AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A217652-002AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A217652-003AB1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A217652-001AB179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A217652-002AB179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A217652-003AB179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A217652-001AB1301d65b070ca…

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

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

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 2 · 22 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
HYDROXYZINE HYDROCHLORIDEHYDROXYZINE HYDROCHLORIDEREMEDYREPACK INC.8f41912e-12ce-4174-a0fb-cfb4888d8d582026-08-27Warnings, Adverse reactionsExact identifier
application applno (ANDA): 217652
application number: ANDA217652
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 (package): 80425-0590-1
ndc (product): 80425-0590
ndc11 (package): 80425059001
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 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

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
80425-0590-18042505900130 TABLET, FILM COATED in 1 BOTTLE (80425-0590-1) 2026-07-10NoNoCurrent