Hydroxyzine Pamoate

Product NDC
53808-0431
11-digit product format
538080431
Labeler code
53808
Product ID
53808-0431_4a569fe7-e80a-4e04-8b9c-52eb65ed4b96
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
HYDROXYZINE PAMOATE
Dosage form
CAPSULE
Route
ORAL
Labeler
State of Florida DOH Central Pharmacy
Application
ANDA088488
Marketing category
ANDA
Marketing start
2009-07-01
Marketing end
0000-00-00
Substance
HYDROXYZINE PAMOATE
Active strength
100 mg/1
Pharmacologic classes
Antihistamine [EPC],Histamine Receptor Antagonists [MoA]
NDC exclude flag
E
Listing certified through
2017-12-31
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 productproduct53808-0431IInactivated by FDA2026-08-03
excluded packagepackage53808-043153808-0431-1IInactivated by FDA2026-08-03

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 · 44 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 packagepackage53808-0431-1d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26excluded productproductf5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage53808-0431-1f5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-31excluded productproduct2ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage53808-0431-12ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28excluded productproducta1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage53808-0431-1a1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21excluded productproductcfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage53808-0431-1cfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10excluded productproductcdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage53808-0431-1cdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31excluded productproduct302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage53808-0431-1302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20excluded productproducted331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage53808-0431-1ed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-10excluded productproduct0efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage53808-0431-10efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08excluded productproductad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage53808-0431-1ad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03excluded productproduct367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage53808-0431-1367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-09excluded productproduct557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage53808-0431-1557ba5c1ecfa…9c80585c8c6e…
2024-05-28 21:12 UTC · source 2024-05-28excluded productproduct8af77b9d5b6f…d9bbb34c5368…
2024-05-28 21:12 UTC · source 2024-05-28excluded packagepackage53808-0431-18af77b9d5b6f…d9bbb34c5368…
2024-05-15 03:39 UTC · source 2024-05-14excluded productproduct834df4deac94…adcc014656a3…
2024-05-15 03:39 UTC · source 2024-05-14excluded packagepackage53808-0431-1834df4deac94…adcc014656a3…
2024-03-11 06:39 UTC · source 2024-03-08excluded productproduct1332a3947898…d4bfe170f9cd…
2024-03-11 06:39 UTC · source 2024-03-08excluded packagepackage53808-0431-11332a3947898…d4bfe170f9cd…
2022-08-30 03:57 UTC · source 2022-08-29excluded productproductfb8cb913e6d1…eb8c232b6be0…
2022-08-30 03:57 UTC · source 2022-08-29excluded packagepackage53808-0431-1fb8cb913e6d1…eb8c232b6be0…
2022-04-09 23:13 UTC · source 2022-04-08excluded productproduct86f5da6cb304…a595104c45d7…
2022-04-09 23:13 UTC · source 2022-04-08excluded packagepackage53808-0431-186f5da6cb304…a595104c45d7…
2022-04-04 05:40 UTC · source 2022-04-01excluded productproductbd6a592717d7…303034d00443…
2022-04-04 05:40 UTC · source 2022-04-01excluded packagepackage53808-0431-1bd6a592717d7…303034d00443…
2021-12-27 23:28 UTC · source 2021-12-27excluded productproduct8dfbde2a14a4…c9ff85d89658…
2021-12-27 23:28 UTC · source 2021-12-27excluded packagepackage53808-0431-18dfbde2a14a4…c9ff85d89658…
2020-12-18 03:04 UTC · source 2020-12-17excluded productproducte2bbac7714bc…27bdfed8d636…
2020-12-18 03:04 UTC · source 2020-12-17excluded packagepackage53808-0431-1e2bbac7714bc…27bdfed8d636…
2020-06-10 20:45 UTC · source 2020-06-10excluded productproduct9bebd1f3094a…5416666fcb17…
2020-06-10 20:45 UTC · source 2020-06-10excluded packagepackage53808-0431-19bebd1f3094a…5416666fcb17…
2019-12-08 06:16 UTC · source 2019-12-05excluded productproduct110d247fa046…a55b01930146…
2019-12-08 06:16 UTC · source 2019-12-05excluded packagepackage53808-0431-1110d247fa046…a55b01930146…

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
A088488-001HYDROXYZINE PAMOATEHYDROXYZINE PAMOATEEQ 100MG HYDROCHLORIDECAPSULE / ORAL1984-06-15

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 UTC2026-02A088488-001HYDROXYZINE PAMOATEEQ 100MG HYDROCHLORIDECAPSULE / ORAL1984-06-15011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A088488-001HYDROXYZINE PAMOATEEQ 100MG HYDROCHLORIDECAPSULE / ORAL1984-06-1531067a03dcf5…
2025-08-23 18:47 UTC2025-08A088488-001HYDROXYZINE PAMOATEEQ 100MG HYDROCHLORIDECAPSULE / ORAL1984-06-156a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A088488-001HYDROXYZINE PAMOATEEQ 100MG HYDROCHLORIDECAPSULE / ORAL1984-06-15fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A088488-001HYDROXYZINE PAMOATEEQ 100MG HYDROCHLORIDECAPSULE / ORAL1984-06-15b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A088488-001HYDROXYZINE PAMOATEEQ 100MG HYDROCHLORIDECAPSULE / ORAL1984-06-1503ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A088488-001HYDROXYZINE PAMOATEEQ 100MG HYDROCHLORIDECAPSULE / ORAL1984-06-152680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A088488-001HYDROXYZINE PAMOATEEQ 100MG HYDROCHLORIDECAPSULE / ORAL1984-06-155bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A088488-001HYDROXYZINE PAMOATEEQ 100MG HYDROCHLORIDECAPSULE / ORAL1984-06-15d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A088488-001HYDROXYZINE PAMOATEEQ 100MG HYDROCHLORIDECAPSULE / ORAL1984-06-15d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A088488-001HYDROXYZINE PAMOATEEQ 100MG HYDROCHLORIDECAPSULE / ORAL1984-06-1579d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A088488-001HYDROXYZINE PAMOATEEQ 100MG HYDROCHLORIDECAPSULE / ORAL1984-06-15301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A088488-001HYDROXYZINE PAMOATEEQ 100MG HYDROCHLORIDECAPSULE / ORAL1984-06-151e350fbaab3a…
2024-05-31 18:47 UTC2024-05A088488-001HYDROXYZINE PAMOATEEQ 100MG HYDROCHLORIDECAPSULE / ORAL1984-06-158072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A088488-001HYDROXYZINE PAMOATEEQ 100MG HYDROCHLORIDECAPSULE / ORAL1984-06-155c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A088488-001HYDROXYZINE PAMOATEEQ 100MG HYDROCHLORIDECAPSULE / ORAL1984-06-155d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A088488-001HYDROXYZINE PAMOATEEQ 100MG HYDROCHLORIDECAPSULE / ORAL1984-06-154b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A088488-001HYDROXYZINE PAMOATEEQ 100MG HYDROCHLORIDECAPSULE / ORAL1984-06-1574a2ff9319b5…
2022-03-09 01:35 UTC2022-03A088488-001HYDROXYZINE PAMOATEEQ 100MG HYDROCHLORIDECAPSULE / ORAL1984-06-15bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A088488-001HYDROXYZINE PAMOATEEQ 100MG HYDROCHLORIDECAPSULE / ORAL1984-06-15782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A088488-001HYDROXYZINE PAMOATEEQ 100MG HYDROCHLORIDECAPSULE / ORAL1984-06-1587673890dc5c…
2021-03-12 10:30 UTC2021-03A088488-001HYDROXYZINE PAMOATEEQ 100MG HYDROCHLORIDECAPSULE / ORAL1984-06-155aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A088488-001HYDROXYZINE PAMOATEEQ 100MG HYDROCHLORIDECAPSULE / ORAL1984-06-158869cabd3fbd…
2020-11-12 02:37 UTC2020-11A088488-001HYDROXYZINE PAMOATEEQ 100MG HYDROCHLORIDECAPSULE / ORAL1984-06-15c0c555d07b60…
2019-12-14 00:12 UTC2019-12A088488-001HYDROXYZINE PAMOATEEQ 100MG HYDROCHLORIDECAPSULE / ORAL1984-06-153f01610625f2…
2019-09-15 20:21 UTC2019-09A088488-001HYDROXYZINE PAMOATEEQ 100MG HYDROCHLORIDECAPSULE / ORAL1984-06-15b00525d2431f…
2019-07-19 19:46 UTC2019-07A088488-001HYDROXYZINE PAMOATEEQ 100MG HYDROCHLORIDECAPSULE / ORAL1984-06-15ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A088488-001HYDROXYZINE PAMOATEEQ 100MG HYDROCHLORIDECAPSULE / ORAL1984-06-156a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A088488-001HYDROXYZINE PAMOATEEQ 100MG HYDROCHLORIDECAPSULE / ORAL1984-06-151c564ffb4f44…
2023-12-20 04:57 UTC2023-12A088488-001HYDROXYZINE PAMOATEEQ 100MG HYDROCHLORIDECAPSULE / ORAL1984-06-15ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A088488-001HYDROXYZINE PAMOATEEQ 100MG HYDROCHLORIDECAPSULE / ORAL1984-06-15a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A088488-001HYDROXYZINE PAMOATEEQ 100MG HYDROCHLORIDECAPSULE / ORAL1984-06-159b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A088488-001HYDROXYZINE PAMOATEEQ 100MG HYDROCHLORIDECAPSULE / ORAL1984-06-15a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A088488-001HYDROXYZINE PAMOATEEQ 100MG HYDROCHLORIDECAPSULE / ORAL1984-06-153f0d92c62455…
2023-05-13 08:27 UTC2023-05A088488-001HYDROXYZINE PAMOATEEQ 100MG HYDROCHLORIDECAPSULE / ORAL1984-06-15053a50430f4f…
2023-01-26 05:58 UTC2023-01A088488-001HYDROXYZINE PAMOATEEQ 100MG HYDROCHLORIDECAPSULE / ORAL1984-06-153bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A088488-001HYDROXYZINE PAMOATEEQ 100MG HYDROCHLORIDECAPSULE / ORAL1984-06-153a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A088488-001HYDROXYZINE PAMOATEEQ 100MG HYDROCHLORIDECAPSULE / ORAL1984-06-15f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09A088488-001HYDROXYZINE PAMOATEEQ 100MG HYDROCHLORIDECAPSULE / ORAL1984-06-15e64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07A088488-001HYDROXYZINE PAMOATEEQ 100MG HYDROCHLORIDECAPSULE / ORAL1984-06-15cb3db0bc1861…

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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
53808-0431-12021-01-29C16284748780-1956f9ecf-d3cb-621f-e053-dbdaa90a74adHYDROXYZINE PAMOATE CAPSULES, USP
53808-0431-12019-10-21C16284748780-1956f9ecf-d3cb-621f-e053-dbdaa90a74adHYDROXYZINE PAMOATE CAPSULES, USP

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
53808-0431-1Hydroxyzine Pamoate30 in 1 BLISTER PACKCAPSULE301

DailyMed Socrata Ingredients#

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
53808-0431HYDROXYZINE PAMOATE CAPSULE [STATE OF FLORIDA DOH CENTRAL PHARMACY]1Legacy NDC, 1 package rows20100611_b1836032-29b4-43ae-a110-14ac2f9f1d3e.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 · 4 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Hydroxyzine PamoateHYDROXYZINE PAMOATEREMEDYREPACK INC.a21df116-501f-4818-ad10-ccfa7b03d7ad2026-02-11Warnings, Adverse reactionsExact identifier
application applno (ANDA): 088488
application number: ANDA088488
Hydroxyzine PamoateHYDROXYZINE PAMOATEAsclemed USA, Inc.82187031-779e-47bc-943c-eb1a1ef30a7a2025-02-17Warnings, Adverse reactionsExact identifier
application applno (ANDA): 088488
application number: ANDA088488
Hydroxyzine PamoateHYDROXYZINE PAMOATEBryant Ranch Prepack8cf49dda-580a-4263-bd36-f457d0aea9222023-03-28Warnings, Adverse reactionsExact identifier
application applno (ANDA): 088488
application number: ANDA088488
Hydroxyzine PamoateHYDROXYZINE PAMOATETeva Pharmaceuticals USA, Inc.06068fff-2e79-4721-bcc7-b0938aa20e7a2022-10-01Warnings, Adverse reactionsExact identifier
application applno (ANDA): 088488
application number: ANDA088488

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
995232hydrOXYzine pamoate 100 MG Oral CapsulePSNb1836032-29b4-43ae-a110-14ac2f9f1d3e1
995253hydrOXYzine pamoate 25 MG Oral CapsulePSNb1836032-29b4-43ae-a110-14ac2f9f1d3e1
995278hydrOXYzine pamoate 50 MG Oral CapsulePSNb1836032-29b4-43ae-a110-14ac2f9f1d3e1
995232hydroxyzine pamoate 100 MG Oral CapsuleSCDb1836032-29b4-43ae-a110-14ac2f9f1d3e1
995253hydroxyzine pamoate 25 MG Oral CapsuleSCDb1836032-29b4-43ae-a110-14ac2f9f1d3e1
995278hydroxyzine pamoate 50 MG Oral CapsuleSCDb1836032-29b4-43ae-a110-14ac2f9f1d3e1
995232hydroxyzine hydrochloride 100 MG (hydroxyzine pamoate 170.4 MG) Oral CapsuleSYb1836032-29b4-43ae-a110-14ac2f9f1d3e1
995278hydroxyzine pamoate 50 MG (hydroxyzine pamoate 85.2 MG eqv to hydroxyzine HCl 50 MG) Oral CapsuleSYb1836032-29b4-43ae-a110-14ac2f9f1d3e1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionStatus
53808-0431-15380804310130 in 1 BLISTER PACKHistorical