Hydroxyzine Hydrochloride

Product NDC
72789-216
11-digit product format
727890216
Labeler code
72789
Product ID
72789-216_3caab728-dec4-fe78-e063-6294a90a17ec
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Hydroxyzine Hydrochloride
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
PD-Rx Pharmaceuticals, Inc.
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 · 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
2b05bd0e-af57-4e74-92f8-a4311330142fAvailable 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
72789-216-04Hydroxyzine Hydrochloride4 in 1 BOTTLE, PLASTICTABLET, FILM COATED423
72789-216-12Hydroxyzine Hydrochloride12 in 1 BOTTLE, PLASTICTABLET, FILM COATED1223
72789-216-20Hydroxyzine Hydrochloride20 in 1 BOTTLE, PLASTICTABLET, FILM COATED2023
72789-216-30Hydroxyzine Hydrochloride30 in 1 BOTTLE, PLASTICTABLET, FILM COATED3023
72789-216-40Hydroxyzine Hydrochloride40 in 1 BOTTLE, PLASTICTABLET, FILM COATED4023
72789-216-60Hydroxyzine Hydrochloride60 in 1 BOTTLE, PLASTICTABLET, FILM COATED6023
72789-216-90Hydroxyzine Hydrochloride90 in 1 BOTTLE, PLASTICTABLET, FILM COATED9023

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
72789-216-04EA - Each72789-2160e6462b6-bfbd-49b8-be81-4109802e6db412023-09-05
72789-216-12EA - Each72789-2167b4130f2-13fa-4656-b09c-7f3889eb54c412022-03-09
72789-216-20EA - Each72789-2161160369f-75a8-410d-9539-1fc6fef43d3012022-05-04
72789-216-30EA - Each72789-2169f563f96-a88c-4bfd-b948-a38278eb2e3312022-01-06
72789-216-40EA - Each72789-216b4a04e13-2310-470a-8e35-ffc9efad31b312022-01-06
72789-216-60EA - Each72789-216a5845a4b-f224-40fe-8065-04561c8eb26b12022-08-04
72789-216-90EA - Each72789-2169f744cd5-df05-4647-9bd1-ebff7618f3a612022-01-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
72789-216HYDROXYZINE HYDROCHLORIDE TABLET, FILM COATED [PD-RX PHARMACEUTICALS, INC.]22Current NDC, Legacy NDC, 7 package rows20241011_2b05bd0e-af57-4e74-92f8-a4311330142f.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
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
ndc (product): 72789-216
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 TabletPSN2b05bd0e-af57-4e74-92f8-a4311330142f23
995258hydroxyzine hydrochloride 25 MG Oral TabletSCD2b05bd0e-af57-4e74-92f8-a4311330142f23

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
72789-216-04727890216044 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (72789-216-04) 2023-08-17NoNoCurrent
72789-216-127278902161212 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (72789-216-12) 2022-02-140000-00-00NoNoCurrent
72789-216-207278902162020 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (72789-216-20) 2022-03-240000-00-00NoNoCurrent
72789-216-307278902163030 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (72789-216-30) 2021-11-300000-00-00NoNoCurrent
72789-216-407278902164040 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (72789-216-40) 2021-11-180000-00-00NoNoCurrent
72789-216-607278902166060 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (72789-216-60) 2022-06-240000-00-00NoNoCurrent
72789-216-907278902169090 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (72789-216-90) 2021-12-080000-00-00NoNoCurrent