Hydroxyzine Hydrochloride

Product NDC
71335-0935
11-digit product format
713350935
Labeler code
71335
Product ID
71335-0935_8a3da07e-0bfc-4d10-9dd9-11a19486fff7
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Hydroxyzine Hydrochloride
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Bryant Ranch Prepack
Application
ANDA088618
Marketing category
ANDA
Marketing start
2012-10-09
Substance
HYDROXYZINE DIHYDROCHLORIDE
Active strength
25 mg/1
Pharmacologic classes
Antihistamine [EPC], Histamine Receptor Antagonists [MoA]
NDC exclude flag
No
Listing certified through
2026-12-31
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 · 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
2026-12-31

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 · 3 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
995218Internal RxNorm lookup
995258Internal RxNorm lookup
995281Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
93d117dd-e2bf-4daa-abe3-d4fefed3313cAvailable 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
71335-0935-1Hydroxyzine Hydrochloride30 in 1 BOTTLETABLET, FILM COATED3014
71335-0935-2Hydroxyzine Hydrochloride60 in 1 BOTTLETABLET, FILM COATED6014
71335-0935-3Hydroxyzine Hydrochloride20 in 1 BOTTLETABLET, FILM COATED2014
71335-0935-4Hydroxyzine Hydrochloride100 in 1 BOTTLETABLET, FILM COATED10014
71335-0935-5Hydroxyzine Hydrochloride15 in 1 BOTTLETABLET, FILM COATED1514
71335-0935-6Hydroxyzine Hydrochloride90 in 1 BOTTLETABLET, FILM COATED9014
71335-0935-7Hydroxyzine Hydrochloride19 in 1 BOTTLETABLET, FILM COATED1914
71335-0935-8Hydroxyzine Hydrochloride10 in 1 BOTTLETABLET, FILM COATED1014

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
71335-0935-1EA - Each71335-09355095a279-81b2-4244-bbf9-897fa73af91312019-09-05

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71335-0935HYDROXYZINE HYDROCHLORIDE TABLET, FILM COATED [BRYANT RANCH PREPACK]13Current NDC, Legacy NDC, 8 package rows20231130_93d117dd-e2bf-4daa-abe3-d4fefed3313c.zip

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
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
ndc (product): 71335-0935
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
995218hydrOXYzine HCl 10 MG Oral TabletPSN93d117dd-e2bf-4daa-abe3-d4fefed3313c14
995258hydrOXYzine HCl 25 MG Oral TabletPSN93d117dd-e2bf-4daa-abe3-d4fefed3313c14
995281hydrOXYzine HCl 50 MG Oral TabletPSN93d117dd-e2bf-4daa-abe3-d4fefed3313c14
995218hydroxyzine hydrochloride 10 MG Oral TabletSCD93d117dd-e2bf-4daa-abe3-d4fefed3313c14
995258hydroxyzine hydrochloride 25 MG Oral TabletSCD93d117dd-e2bf-4daa-abe3-d4fefed3313c14
995281hydroxyzine hydrochloride 50 MG Oral TabletSCD93d117dd-e2bf-4daa-abe3-d4fefed3313c14

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
71335-0935-17133509350130 TABLET, FILM COATED in 1 BOTTLE (71335-0935-1) 2018-08-280000-00-00NoNoCurrent
71335-0935-27133509350260 TABLET, FILM COATED in 1 BOTTLE (71335-0935-2) 2018-08-280000-00-00NoNoCurrent
71335-0935-37133509350320 TABLET, FILM COATED in 1 BOTTLE (71335-0935-3) 2018-08-280000-00-00NoNoCurrent
71335-0935-471335093504100 TABLET, FILM COATED in 1 BOTTLE (71335-0935-4) 2018-08-280000-00-00NoNoCurrent
71335-0935-57133509350515 TABLET, FILM COATED in 1 BOTTLE (71335-0935-5) 2018-08-280000-00-00NoNoCurrent
71335-0935-67133509350690 TABLET, FILM COATED in 1 BOTTLE (71335-0935-6) 2018-08-280000-00-00NoNoCurrent
71335-0935-77133509350719 TABLET, FILM COATED in 1 BOTTLE (71335-0935-7) 2018-08-280000-00-00NoNoCurrent
71335-0935-87133509350810 TABLET, FILM COATED in 1 BOTTLE (71335-0935-8) 2018-08-280000-00-00NoNoCurrent