Hydroxyzine Hydrochloride

Product NDC
68084-254
11-digit product format
680840254
Labeler code
68084
Product ID
68084-254_de592900-2fd6-7409-e053-2995a90abb13
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Hydroxyzine Hydrochloride
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
American Health Packaging
Application
ANDA040786
Marketing category
ANDA
Marketing start
2009-01-14
Marketing end
2022-08-31
Substance
HYDROXYZINE DIHYDROCHLORIDE
Active strength
25 mg/1
Pharmacologic classes
Antihistamine [EPC], Histamine Receptor Antagonists [MoA]
NDC exclude flag
No
Listing certified through
0000-00-00
Current FDA listing
Historical FDA.report record

NDC auxiliary status#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

Current NDC status page 1 of 1 · 2 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct68084-254DDiscontinued by firm2026-08-07
excluded packagepackage68084-25468084-254-01DDiscontinued by firm2026-08-07

Observed NDC auxiliary status history#

This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.

Historic NDC status page 1 of 1 · 24 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Dataset, Scope table
Captured / source dateDatasetScopePackage NDCSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-05excluded productproductd630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage68084-254-01d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26excluded productproductf5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage68084-254-01f5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-31excluded productproduct2ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage68084-254-012ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28excluded productproducta1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage68084-254-01a1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21excluded productproductcfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage68084-254-01cfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10excluded productproductcdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage68084-254-01cdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31excluded productproduct302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage68084-254-01302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20excluded productproducted331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage68084-254-01ed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-10excluded productproduct0efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage68084-254-010efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08excluded productproductad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage68084-254-01ad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03excluded productproduct367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage68084-254-01367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-09excluded productproduct557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage68084-254-01557ba5c1ecfa…9c80585c8c6e…

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
A040786-001HYDROXYZINE HYDROCHLORIDEHYDROXYZINE HYDROCHLORIDE10MGTABLET / ORALAB2007-03-20
A040786-002HYDROXYZINE HYDROCHLORIDEHYDROXYZINE HYDROCHLORIDE25MGTABLET / ORALAB2007-03-20
A040786-003HYDROXYZINE HYDROCHLORIDEHYDROXYZINE HYDROCHLORIDE50MGTABLET / ORALAB2007-03-20

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A040786-001AB
A040786-002AB
A040786-003AB

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 4 · 123 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-02-19 14:30 UTC2026-02A040786-001HYDROXYZINE HYDROCHLORIDE10MGTABLET / ORALAB2007-03-20011fe1cb6892…
2026-02-19 14:30 UTC2026-02A040786-002HYDROXYZINE HYDROCHLORIDE25MGTABLET / ORALAB2007-03-20011fe1cb6892…
2026-02-19 14:30 UTC2026-02A040786-003HYDROXYZINE HYDROCHLORIDE50MGTABLET / ORALAB2007-03-20011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A040786-001HYDROXYZINE HYDROCHLORIDE10MGTABLET / ORALAB2007-03-2031067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A040786-002HYDROXYZINE HYDROCHLORIDE25MGTABLET / ORALAB2007-03-2031067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A040786-003HYDROXYZINE HYDROCHLORIDE50MGTABLET / ORALAB2007-03-2031067a03dcf5…
2025-08-23 18:47 UTC2025-08A040786-001HYDROXYZINE HYDROCHLORIDE10MGTABLET / ORALAB2007-03-206a471c1ec25d…
2025-08-23 18:47 UTC2025-08A040786-002HYDROXYZINE HYDROCHLORIDE25MGTABLET / ORALAB2007-03-206a471c1ec25d…
2025-08-23 18:47 UTC2025-08A040786-003HYDROXYZINE HYDROCHLORIDE50MGTABLET / ORALAB2007-03-206a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A040786-001HYDROXYZINE HYDROCHLORIDE10MGTABLET / ORALAB2007-03-20fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A040786-002HYDROXYZINE HYDROCHLORIDE25MGTABLET / ORALAB2007-03-20fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A040786-003HYDROXYZINE HYDROCHLORIDE50MGTABLET / ORALAB2007-03-20fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A040786-001HYDROXYZINE HYDROCHLORIDE10MGTABLET / ORALAB2007-03-20b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A040786-002HYDROXYZINE HYDROCHLORIDE25MGTABLET / ORALAB2007-03-20b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A040786-003HYDROXYZINE HYDROCHLORIDE50MGTABLET / ORALAB2007-03-20b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A040786-001HYDROXYZINE HYDROCHLORIDE10MGTABLET / ORALAB2007-03-2003ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A040786-002HYDROXYZINE HYDROCHLORIDE25MGTABLET / ORALAB2007-03-2003ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A040786-003HYDROXYZINE HYDROCHLORIDE50MGTABLET / ORALAB2007-03-2003ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A040786-001HYDROXYZINE HYDROCHLORIDE10MGTABLET / ORALAB2007-03-202680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A040786-002HYDROXYZINE HYDROCHLORIDE25MGTABLET / ORALAB2007-03-202680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A040786-003HYDROXYZINE HYDROCHLORIDE50MGTABLET / ORALAB2007-03-202680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A040786-001HYDROXYZINE HYDROCHLORIDE10MGTABLET / ORALAB2007-03-205bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A040786-002HYDROXYZINE HYDROCHLORIDE25MGTABLET / ORALAB2007-03-205bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A040786-003HYDROXYZINE HYDROCHLORIDE50MGTABLET / ORALAB2007-03-205bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A040786-001HYDROXYZINE HYDROCHLORIDE10MGTABLET / ORALAB2007-03-20d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A040786-002HYDROXYZINE HYDROCHLORIDE25MGTABLET / ORALAB2007-03-20d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A040786-003HYDROXYZINE HYDROCHLORIDE50MGTABLET / ORALAB2007-03-20d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A040786-001HYDROXYZINE HYDROCHLORIDE10MGTABLET / ORALAB2007-03-20d06236e962d9…
2024-10-29 15:01 UTC2024-10A040786-002HYDROXYZINE HYDROCHLORIDE25MGTABLET / ORALAB2007-03-20d06236e962d9…
2024-10-29 15:01 UTC2024-10A040786-003HYDROXYZINE HYDROCHLORIDE50MGTABLET / ORALAB2007-03-20d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A040786-001HYDROXYZINE HYDROCHLORIDE10MGTABLET / ORALAB2007-03-2079d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A040786-002HYDROXYZINE HYDROCHLORIDE25MGTABLET / ORALAB2007-03-2079d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A040786-003HYDROXYZINE HYDROCHLORIDE50MGTABLET / ORALAB2007-03-2079d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A040786-001HYDROXYZINE HYDROCHLORIDE10MGTABLET / ORALAB2007-03-20301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A040786-002HYDROXYZINE HYDROCHLORIDE25MGTABLET / ORALAB2007-03-20301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A040786-003HYDROXYZINE HYDROCHLORIDE50MGTABLET / ORALAB2007-03-20301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A040786-001HYDROXYZINE HYDROCHLORIDE10MGTABLET / ORALAB2007-03-201e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A040786-002HYDROXYZINE HYDROCHLORIDE25MGTABLET / ORALAB2007-03-201e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A040786-003HYDROXYZINE HYDROCHLORIDE50MGTABLET / ORALAB2007-03-201e350fbaab3a…
2024-05-31 18:47 UTC2024-05A040786-001HYDROXYZINE HYDROCHLORIDE10MGTABLET / ORALAB2007-03-208072bd15b7f6…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 4 · 123 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-02-19 14:30 UTC2026-02A040786-001AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A040786-002AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A040786-003AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A040786-001AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A040786-002AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A040786-003AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08A040786-001AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A040786-002AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A040786-003AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A040786-001AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A040786-002AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A040786-003AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A040786-001AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A040786-002AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A040786-003AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A040786-001AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A040786-002AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A040786-003AB103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A040786-001AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A040786-002AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A040786-003AB12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A040786-001AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A040786-002AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A040786-003AB15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A040786-001AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A040786-002AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A040786-003AB1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A040786-001AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A040786-002AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A040786-003AB1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A040786-001AB179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A040786-002AB179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A040786-003AB179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A040786-001AB1301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A040786-002AB1301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A040786-003AB1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A040786-001AB11e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A040786-002AB11e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A040786-003AB11e350fbaab3a…
2024-05-31 18:47 UTC2024-05A040786-001AB18072bd15b7f6…

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
68084-254-01EA - Each68084-2547f315a27-2fb7-4dab-81f9-50264a92a01112012-07-24
68084-254-11EA - Each68084-254a38f6e60-5bed-4847-941d-9e52230bb44312012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
HYDROXYZINE HYDROCHLORIDEACTIVE INGREDIENT76755771U3HYDROXYZINE HYDROCHLORIDE TABLET, FILM COATED [AMERICAN HEALTH PACKAGING]3
HYDROXYZINEACTIVE MOIETY30S50YM8OGHYDROXYZINE HYDROCHLORIDE TABLET, FILM COATED [AMERICAN HEALTH PACKAGING]3
CARNAUBA WAXINACTIVE INGREDIENTR12CBM0EIZHYDROXYZINE HYDROCHLORIDE TABLET, FILM COATED [AMERICAN HEALTH PACKAGING]3
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UHYDROXYZINE HYDROCHLORIDE TABLET, FILM COATED [AMERICAN HEALTH PACKAGING]3
CROSPOVIDONEINACTIVE INGREDIENT68401960MKHYDROXYZINE HYDROCHLORIDE TABLET, FILM COATED [AMERICAN HEALTH PACKAGING]3
GLYCERYL MONOSTEARATEINACTIVE INGREDIENT230OU9XXE4HYDROXYZINE HYDROCHLORIDE TABLET, FILM COATED [AMERICAN HEALTH PACKAGING]3
LACTOSE MONOHYDRATEINACTIVE INGREDIENTEWQ57Q8I5XHYDROXYZINE HYDROCHLORIDE TABLET, FILM COATED [AMERICAN HEALTH PACKAGING]3
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30HYDROXYZINE HYDROCHLORIDE TABLET, FILM COATED [AMERICAN HEALTH PACKAGING]3
POLYVINYL ALCOHOLINACTIVE INGREDIENT532B59J990HYDROXYZINE HYDROCHLORIDE TABLET, FILM COATED [AMERICAN HEALTH PACKAGING]3
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4HYDROXYZINE HYDROCHLORIDE TABLET, FILM COATED [AMERICAN HEALTH PACKAGING]3
SODIUM LAURYL SULFATEINACTIVE INGREDIENT368GB5141JHYDROXYZINE HYDROCHLORIDE TABLET, FILM COATED [AMERICAN HEALTH PACKAGING]3
TALCINACTIVE INGREDIENT7SEV7J4R1UHYDROXYZINE HYDROCHLORIDE TABLET, FILM COATED [AMERICAN HEALTH PACKAGING]3
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPHYDROXYZINE HYDROCHLORIDE TABLET, FILM COATED [AMERICAN HEALTH PACKAGING]3

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 1 · 5 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Hydroxyzine HydrochlorideHYDROXYZINE HYDROCHLORIDEPD-Rx Pharmaceuticals, Inc.4789b7ae-314c-43c0-ad33-92ff50085f272025-10-17Warnings, Adverse reactionsExact identifier
application applno (ANDA): 040786
application number: ANDA040786
Hydroxyzine HydrochlorideHYDROXYZINE HYDROCHLORIDEPD-Rx Pharmaceuticals, Inc.1a3e389f-391d-4f37-9e34-ce3c6f5fe8c12025-10-17Warnings, Adverse reactionsExact identifier
application applno (ANDA): 040786
application number: ANDA040786
Hydroxyzine HydrochlorideHYDROXYZINE HYDROCHLORIDEPD-Rx Pharmaceuticals, Inc.cc6a12ed-411b-4b0c-8108-58ef7db8da552025-10-15Warnings, Adverse reactionsExact identifier
application applno (ANDA): 040786
application number: ANDA040786
Hydroxyzine HydrochlorideHYDROXYZINE HYDROCHLORIDEBryant Ranch Prepack3f5be725-8ade-4889-b6b1-7d45f54585462024-08-20Warnings, Adverse reactionsExact identifier
application applno (ANDA): 040786
application number: ANDA040786
Hydroxyzine HydrochlorideHYDROXYZINE HYDROCHLORIDEKVK-Tech, Inc.adc4cb73-77c6-48ff-aaf2-b3568d53de1f2023-01-04Warnings, Adverse reactionsExact identifier
application applno (ANDA): 040786
application number: ANDA040786

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
68084-254-0168084025401100 BLISTER PACK in 1 BOX, UNIT-DOSE (68084-254-01) > 1 TABLET, FILM COATED in 1 BLISTER PACK (68084-254-11) 100 blister pack2009-01-140000-00-00NoNoCurrent