Hydroxyzine Hydrochloride

Product NDC
70518-2066
11-digit product format
705182066
Labeler code
70518
Product ID
70518-2066_499c7349-9995-6589-e063-6394a90a0e58
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Hydroxyzine Hydrochloride
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
REMEDYREPACK INC.
Application
ANDA088618
Marketing category
ANDA
Marketing start
2019-05-07
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

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 · 18 matching rows.

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

Captured / source date, Dataset, Scope table
Captured / source dateDatasetScopePackage NDCSnapshotSource SHA-256
2025-04-01 02:39 UTC · source 2025-03-31excluded productproduct2ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage70518-2066-02ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28excluded productproducta1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage70518-2066-0a1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21excluded productproductcfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage70518-2066-0cfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10excluded productproductcdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage70518-2066-0cdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31excluded productproduct302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage70518-2066-0302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20excluded productproducted331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage70518-2066-0ed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-10excluded productproduct0efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage70518-2066-00efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08excluded productproductad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage70518-2066-0ad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03excluded productproduct367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage70518-2066-0367a005e9d99…383a685ebd0f…

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.

Product history page 1 of 2 · 41 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-02-19 14:30 UTC2026-02A088618-001HYDROXYZINE HYDROCHLORIDE25MGTABLET / ORALABRLD, RS1986-01-10011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A088618-001HYDROXYZINE HYDROCHLORIDE25MGTABLET / ORALABRLD, RS1986-01-1031067a03dcf5…
2025-08-23 18:47 UTC2025-08A088618-001HYDROXYZINE HYDROCHLORIDE25MGTABLET / ORALABRLD, RS1986-01-106a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A088618-001HYDROXYZINE HYDROCHLORIDE25MGTABLET / ORALABRLD, RS1986-01-10fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A088618-001HYDROXYZINE HYDROCHLORIDE25MGTABLET / ORALABRLD, RS1986-01-10b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A088618-001HYDROXYZINE HYDROCHLORIDE25MGTABLET / ORALABRLD, RS1986-01-1003ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A088618-001HYDROXYZINE HYDROCHLORIDE25MGTABLET / ORALABRLD, RS1986-01-102680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A088618-001HYDROXYZINE HYDROCHLORIDE25MGTABLET / ORALABRLD, RS1986-01-105bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A088618-001HYDROXYZINE HYDROCHLORIDE25MGTABLET / ORALABRLD, RS1986-01-10d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A088618-001HYDROXYZINE HYDROCHLORIDE25MGTABLET / ORALABRLD, RS1986-01-10d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A088618-001HYDROXYZINE HYDROCHLORIDE25MGTABLET / ORALABRLD, RS1986-01-1079d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A088618-001HYDROXYZINE HYDROCHLORIDE25MGTABLET / ORALABRLD, RS1986-01-10301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A088618-001HYDROXYZINE HYDROCHLORIDE25MGTABLET / ORALABRLD, RS1986-01-101e350fbaab3a…
2024-05-31 18:47 UTC2024-05A088618-001HYDROXYZINE HYDROCHLORIDE25MGTABLET / ORALABRLD, RS1986-01-108072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A088618-001HYDROXYZINE HYDROCHLORIDE25MGTABLET / ORALABRLD, RS1986-01-105c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A088618-001HYDROXYZINE HYDROCHLORIDE25MGTABLET / ORALABRLD, RS1986-01-105d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A088618-001HYDROXYZINE HYDROCHLORIDE25MGTABLET / ORALABRLD, RS1986-01-104b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A088618-001HYDROXYZINE HYDROCHLORIDE25MGTABLET / ORALABRS1986-01-1074a2ff9319b5…
2022-03-09 01:35 UTC2022-03A088618-001HYDROXYZINE HYDROCHLORIDE25MGTABLET / ORALABRLD, RS1986-01-10bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A088618-001HYDROXYZINE HYDROCHLORIDE25MGTABLET / ORALABRLD, RS1986-01-10782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A088618-001HYDROXYZINE HYDROCHLORIDE25MGTABLET / ORALABRS1986-01-1087673890dc5c…
2021-03-12 10:30 UTC2021-03A088618-001HYDROXYZINE HYDROCHLORIDE25MGTABLET / ORALABRS1986-01-105aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A088618-001HYDROXYZINE HYDROCHLORIDE25MGTABLET / ORALABRS1986-01-108869cabd3fbd…
2020-11-12 02:37 UTC2020-11A088618-001HYDROXYZINE HYDROCHLORIDE25MGTABLET / ORALABRS1986-01-10c0c555d07b60…
2019-12-14 00:12 UTC2019-12A088618-001HYDROXYZINE HYDROCHLORIDE25MGTABLET / ORALABRS1986-01-103f01610625f2…
2019-09-15 20:21 UTC2019-09A088618-001HYDROXYZINE HYDROCHLORIDE25MGTABLET / ORALABRS1986-01-10b00525d2431f…
2019-07-19 19:46 UTC2019-07A088618-001HYDROXYZINE HYDROCHLORIDE25MGTABLET / ORALABRS1986-01-10ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A088618-001HYDROXYZINE HYDROCHLORIDE25MGTABLET / ORALABRLD, RS1986-01-106a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A088618-001HYDROXYZINE HYDROCHLORIDE25MGTABLET / ORALABRLD, RS1986-01-101c564ffb4f44…
2023-12-20 04:57 UTC2023-12A088618-001HYDROXYZINE HYDROCHLORIDE25MGTABLET / ORALABRLD, RS1986-01-10ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A088618-001HYDROXYZINE HYDROCHLORIDE25MGTABLET / ORALABRLD, RS1986-01-10a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A088618-001HYDROXYZINE HYDROCHLORIDE25MGTABLET / ORALABRLD, RS1986-01-109b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A088618-001HYDROXYZINE HYDROCHLORIDE25MGTABLET / ORALABRLD, RS1986-01-10a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A088618-001HYDROXYZINE HYDROCHLORIDE25MGTABLET / ORALABRLD, RS1986-01-103f0d92c62455…
2023-05-13 08:27 UTC2023-05A088618-001HYDROXYZINE HYDROCHLORIDE25MGTABLET / ORALABRLD, RS1986-01-10053a50430f4f…
2023-01-26 05:58 UTC2023-01A088618-001HYDROXYZINE HYDROCHLORIDE25MGTABLET / ORALABRLD, RS1986-01-103bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A088618-001HYDROXYZINE HYDROCHLORIDE25MGTABLET / ORALABRLD, RS1986-01-103a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A088618-001HYDROXYZINE HYDROCHLORIDE25MGTABLET / ORALABRLD, RS1986-01-10f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09A088618-001HYDROXYZINE HYDROCHLORIDE25MGTABLET / ORALABRLD, RS1986-01-10e64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07A088618-001HYDROXYZINE HYDROCHLORIDE25MGTABLET / ORALABRLD, RS1986-01-10cb3db0bc1861…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 41 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-02-19 14:30 UTC2026-02A088618-001AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A088618-001AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08A088618-001AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A088618-001AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A088618-001AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A088618-001AB103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A088618-001AB12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A088618-001AB15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A088618-001AB1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A088618-001AB1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A088618-001AB179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A088618-001AB1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A088618-001AB11e350fbaab3a…
2024-05-31 18:47 UTC2024-05A088618-001AB18072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A088618-001AB15c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A088618-001AB15d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A088618-001AB14b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A088618-001AB174a2ff9319b5…
2022-03-09 01:35 UTC2022-03A088618-001AB1bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A088618-001AB1782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A088618-001AB187673890dc5c…
2021-03-12 10:30 UTC2021-03A088618-001AB15aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A088618-001AB18869cabd3fbd…
2020-11-12 02:37 UTC2020-11A088618-001AB1c0c555d07b60…
2019-12-14 00:12 UTC2019-12A088618-001AB13f01610625f2…
2019-09-15 20:21 UTC2019-09A088618-001AB1b00525d2431f…
2019-07-19 19:46 UTC2019-07A088618-001AB1ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A088618-001AB16a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A088618-001AB11c564ffb4f44…
2023-12-20 04:57 UTC2023-12A088618-001AB1ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A088618-001AB1a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A088618-001AB19b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A088618-001AB1a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A088618-001AB13f0d92c62455…
2023-05-13 08:27 UTC2023-05A088618-001AB1053a50430f4f…
2023-01-26 05:58 UTC2023-01A088618-001AB13bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A088618-001AB13a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A088618-001AB1f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09A088618-001AB1e64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07A088618-001AB1cb3db0bc1861…

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
6ad55cd1-a284-4c3d-aa90-653704afdb75Available 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
70518-2066-0Hydroxyzine Hydrochloride30 in 1 BLISTER PACKTABLET, FILM COATED3010

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 · 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
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
ndc (product): 70518-2066
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

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
995258hydrOXYzine HCl 25 MG Oral TabletPSN6ad55cd1-a284-4c3d-aa90-653704afdb7510
995258hydroxyzine hydrochloride 25 MG Oral TabletSCD6ad55cd1-a284-4c3d-aa90-653704afdb7510

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
70518-2066-07051820660030 TABLET, FILM COATED in 1 BLISTER PACK (70518-2066-0) 2019-05-07NoNoCurrent