Hydroxyzine Pamoate

Product NDC
72189-480
11-digit product format
721890480
Labeler code
72189
Product ID
72189-480_2c4e17dd-fe0a-06e5-e063-6394a90ab19d
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Hydroxyzine Pamoate
Dosage form
CAPSULE
Route
ORAL
Labeler
Direct_Rx
Application
ANDA086183
Marketing category
ANDA
Marketing start
2023-05-30
Substance
HYDROXYZINE PAMOATE
Active strength
50 mg/1
Pharmacologic classes
Antihistamine [EPC], Histamine Receptor Antagonists [MoA]
NDC exclude flag
No
Listing certified through
2026-12-31
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 · 6 matching rows.

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

Captured / source date, Dataset, Scope table
Captured / source dateDatasetScopePackage NDCSnapshotSource SHA-256
2025-01-20 13:05 UTC · source 2025-01-20excluded productproducted331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage72189-480-30ed331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage72189-480-90ed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-10excluded productproduct0efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage72189-480-300efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage72189-480-900efc9e666f02…f202fb6c5f17…

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
A086183-001HYDROXYZINE PAMOATEHYDROXYZINE PAMOATEEQ 50MG HYDROCHLORIDECAPSULE / ORALABApproved before 1982

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A086183-001AB

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 UTC2026-02A086183-001HYDROXYZINE PAMOATEEQ 50MG HYDROCHLORIDECAPSULE / ORALABApproved before 1982011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A086183-001HYDROXYZINE PAMOATEEQ 50MG HYDROCHLORIDECAPSULE / ORALABApproved before 198231067a03dcf5…
2025-08-23 18:47 UTC2025-08A086183-001HYDROXYZINE PAMOATEEQ 50MG HYDROCHLORIDECAPSULE / ORALABApproved before 19826a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A086183-001HYDROXYZINE PAMOATEEQ 50MG HYDROCHLORIDECAPSULE / ORALABApproved before 1982fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A086183-001HYDROXYZINE PAMOATEEQ 50MG HYDROCHLORIDECAPSULE / ORALABApproved before 1982b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A086183-001HYDROXYZINE PAMOATEEQ 50MG HYDROCHLORIDECAPSULE / ORALABApproved before 198203ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A086183-001HYDROXYZINE PAMOATEEQ 50MG HYDROCHLORIDECAPSULE / ORALABApproved before 19822680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A086183-001HYDROXYZINE PAMOATEEQ 50MG HYDROCHLORIDECAPSULE / ORALABApproved before 19825bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A086183-001HYDROXYZINE PAMOATEEQ 50MG HYDROCHLORIDECAPSULE / ORALABApproved before 1982d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A086183-001HYDROXYZINE PAMOATEEQ 50MG HYDROCHLORIDECAPSULE / ORALABApproved before 1982d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A086183-001HYDROXYZINE PAMOATEEQ 50MG HYDROCHLORIDECAPSULE / ORALABApproved before 198279d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A086183-001HYDROXYZINE PAMOATEEQ 50MG HYDROCHLORIDECAPSULE / ORALABRS, Approved before 1982301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A086183-001HYDROXYZINE PAMOATEEQ 50MG HYDROCHLORIDECAPSULE / ORALABRS, Approved before 19821e350fbaab3a…
2024-05-31 18:47 UTC2024-05A086183-001HYDROXYZINE PAMOATEEQ 50MG HYDROCHLORIDECAPSULE / ORALABRS, Approved before 19828072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A086183-001HYDROXYZINE PAMOATEEQ 50MG HYDROCHLORIDECAPSULE / ORALABRS, Approved before 19825c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A086183-001HYDROXYZINE PAMOATEEQ 50MG HYDROCHLORIDECAPSULE / ORALABRS, Approved before 19825d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A086183-001HYDROXYZINE PAMOATEEQ 50MG HYDROCHLORIDECAPSULE / ORALABRS, Approved before 19824b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A086183-001HYDROXYZINE PAMOATEEQ 50MG HYDROCHLORIDECAPSULE / ORALABApproved before 198274a2ff9319b5…
2022-03-09 01:35 UTC2022-03A086183-001HYDROXYZINE PAMOATEEQ 50MG HYDROCHLORIDECAPSULE / ORALABRS, Approved before 1982bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A086183-001HYDROXYZINE PAMOATEEQ 50MG HYDROCHLORIDECAPSULE / ORALABRS, Approved before 1982782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A086183-001HYDROXYZINE PAMOATEEQ 50MG HYDROCHLORIDECAPSULE / ORALABRS, Approved before 198287673890dc5c…
2021-03-12 10:30 UTC2021-03A086183-001HYDROXYZINE PAMOATEEQ 50MG HYDROCHLORIDECAPSULE / ORALABRS, Approved before 19825aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A086183-001HYDROXYZINE PAMOATEEQ 50MG HYDROCHLORIDECAPSULE / ORALABRS, Approved before 19828869cabd3fbd…
2020-11-12 02:37 UTC2020-11A086183-001HYDROXYZINE PAMOATEEQ 50MG HYDROCHLORIDECAPSULE / ORALABRS, Approved before 1982c0c555d07b60…
2019-12-14 00:12 UTC2019-12A086183-001HYDROXYZINE PAMOATEEQ 50MG HYDROCHLORIDECAPSULE / ORALABRS, Approved before 19823f01610625f2…
2019-09-15 20:21 UTC2019-09A086183-001HYDROXYZINE PAMOATEEQ 50MG HYDROCHLORIDECAPSULE / ORALABApproved before 1982b00525d2431f…
2019-07-19 19:46 UTC2019-07A086183-001HYDROXYZINE PAMOATEEQ 50MG HYDROCHLORIDECAPSULE / ORALABApproved before 1982ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A086183-001HYDROXYZINE PAMOATEEQ 50MG HYDROCHLORIDECAPSULE / ORALABRS, Approved before 19826a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A086183-001HYDROXYZINE PAMOATEEQ 50MG HYDROCHLORIDECAPSULE / ORALABRS, Approved before 19821c564ffb4f44…
2023-12-20 04:57 UTC2023-12A086183-001HYDROXYZINE PAMOATEEQ 50MG HYDROCHLORIDECAPSULE / ORALABRS, Approved before 1982ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A086183-001HYDROXYZINE PAMOATEEQ 50MG HYDROCHLORIDECAPSULE / ORALABRS, Approved before 1982a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A086183-001HYDROXYZINE PAMOATEEQ 50MG HYDROCHLORIDECAPSULE / ORALABRS, Approved before 19829b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A086183-001HYDROXYZINE PAMOATEEQ 50MG HYDROCHLORIDECAPSULE / ORALABRS, Approved before 1982a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A086183-001HYDROXYZINE PAMOATEEQ 50MG HYDROCHLORIDECAPSULE / ORALABRS, Approved before 19823f0d92c62455…
2023-05-13 08:27 UTC2023-05A086183-001HYDROXYZINE PAMOATEEQ 50MG HYDROCHLORIDECAPSULE / ORALABRS, Approved before 1982053a50430f4f…
2023-01-26 05:58 UTC2023-01A086183-001HYDROXYZINE PAMOATEEQ 50MG HYDROCHLORIDECAPSULE / ORALABRS, Approved before 19823bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A086183-001HYDROXYZINE PAMOATEEQ 50MG HYDROCHLORIDECAPSULE / ORALABRS, Approved before 19823a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A086183-001HYDROXYZINE PAMOATEEQ 50MG HYDROCHLORIDECAPSULE / ORALABRS, Approved before 1982f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09A086183-001HYDROXYZINE PAMOATEEQ 50MG HYDROCHLORIDECAPSULE / ORALABRS, Approved before 1982e64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07A086183-001HYDROXYZINE PAMOATEEQ 50MG HYDROCHLORIDECAPSULE / ORALABRS, Approved before 1982cb3db0bc1861…

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 UTC2026-02A086183-001AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A086183-001AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08A086183-001AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A086183-001AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A086183-001AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A086183-001AB103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A086183-001AB12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A086183-001AB15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A086183-001AB1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A086183-001AB1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A086183-001AB179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A086183-001AB1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A086183-001AB11e350fbaab3a…
2024-05-31 18:47 UTC2024-05A086183-001AB18072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A086183-001AB15c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A086183-001AB15d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A086183-001AB14b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A086183-001AB174a2ff9319b5…
2022-03-09 01:35 UTC2022-03A086183-001AB1bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A086183-001AB1782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A086183-001AB187673890dc5c…
2021-03-12 10:30 UTC2021-03A086183-001AB15aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A086183-001AB18869cabd3fbd…
2020-11-12 02:37 UTC2020-11A086183-001AB1c0c555d07b60…
2019-12-14 00:12 UTC2019-12A086183-001AB13f01610625f2…
2019-09-15 20:21 UTC2019-09A086183-001AB1b00525d2431f…
2019-07-19 19:46 UTC2019-07A086183-001AB1ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A086183-001AB16a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A086183-001AB11c564ffb4f44…
2023-12-20 04:57 UTC2023-12A086183-001AB1ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A086183-001AB1a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A086183-001AB19b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A086183-001AB1a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A086183-001AB13f0d92c62455…
2023-05-13 08:27 UTC2023-05A086183-001AB1053a50430f4f…
2023-01-26 05:58 UTC2023-01A086183-001AB13bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A086183-001AB13a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A086183-001AB1f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09A086183-001AB1e64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07A086183-001AB1cb3db0bc1861…

Additional Listing Data#

Finished product
Yes
Brand name base
Hydroxyzine Pamoate
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
HYDROXYZINE PAMOATE50 mg/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
M20215MUFRInternal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
995278Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
fcec985f-9ded-6534-e053-6294a90ac76bAvailable 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
72189-480-30Hydroxyzine Pamoate30 in 1 BOTTLECAPSULE304
72189-480-90Hydroxyzine Pamoate90 in 1 BOTTLECAPSULE904

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
72189-480-30EA - Each72189-48060ae71b5-8fed-4de6-a0fe-52c98361b4e912023-06-06
72189-480-90EA - Each72189-4806e6342eb-73ec-4280-9d6e-2a0f0d2edb6612023-08-08

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
72189-480HYDROXYZINE PAMOATE CAPSULE [DIRECT_RX]4Current NDC, 2 package rows20250123_fcec985f-9ded-6534-e053-6294a90ac76b.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 · 9 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Hydroxyzine pamoateHYDROXYZINE PAMOATEUnit Dose Solutions, Inc.55033469-f5c6-5180-e063-6394a90af5eb2026-06-24Warnings, Adverse reactionsExact identifier
application applno (ANDA): 086183
application number: ANDA086183
Hydroxyzine pamoateHYDROXYZINE PAMOATEUnit Dose Solutions, Inc.5505ef8f-0322-b705-e063-6394a90a5c5c2026-06-24Warnings, Adverse reactionsExact identifier
application applno (ANDA): 086183
application number: ANDA086183
Hydroxyzine pamoateHYDROXYZINE PAMOATECoupler LLC509e9a9c-23a3-ade4-e063-6294a90a74032026-04-29Warnings, Adverse reactionsExact identifier
application applno (ANDA): 086183
application number: ANDA086183
Hydroxyzine pamoateHYDROXYZINE PAMOATEREMEDYREPACK INC.0c9101ee-0746-4833-83cf-d0d09e52c0a92026-03-30Warnings, Adverse reactionsExact identifier
application applno (ANDA): 086183
application number: ANDA086183
Hydroxyzine PamoateHYDROXYZINE PAMOATEDirect_Rxfcec985f-9ded-6534-e053-6294a90ac76b2025-01-22Warnings, Adverse reactionsExact identifier
application applno (ANDA): 086183
application number: ANDA086183
ndc (product): 72189-480
Hydroxyzine pamoateHYDROXYZINE PAMOATENuCare Pharmaceuticals,Inc.1136a291-2f2f-c025-e063-6294a90a76d72024-02-12Warnings, Adverse reactionsExact identifier
application applno (ANDA): 086183
application number: ANDA086183
Hydroxyzine pamoateHYDROXYZINE PAMOATEA-S Medication Solutionsdd6b78d3-6052-40d8-8dd3-d9ea2ab47c9b2024-01-21Warnings, Adverse reactionsExact identifier
application applno (ANDA): 086183
application number: ANDA086183
Hydroxyzine pamoateHYDROXYZINE PAMOATEBryant Ranch Prepack8132d8a9-4d74-4c0a-8db2-e08e34c3e7e02023-11-27Warnings, Adverse reactionsExact identifier
application applno (ANDA): 086183
application number: ANDA086183
hydroxyzine pamoateHYDROXYZINE PAMOATESandoz Incc38cfd32-2562-4d6c-8a2e-d9984c16d9eb2022-06-27Warnings, Adverse reactionsExact identifier
application applno (ANDA): 086183
application number: ANDA086183

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
995278hydrOXYzine pamoate 50 MG Oral CapsulePSNfcec985f-9ded-6534-e053-6294a90ac76b4
995278hydroxyzine pamoate 50 MG Oral CapsuleSCDfcec985f-9ded-6534-e053-6294a90ac76b4
995278hydroxyzine pamoate 50 MG (hydroxyzine pamoate 85.2 MG eqv to hydroxyzine HCl 50 MG) Oral CapsuleSYfcec985f-9ded-6534-e053-6294a90ac76b4

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
72189-480-307218904803030 CAPSULE in 1 BOTTLE (72189-480-30) 30 capsule2023-05-30NoNoCurrent
72189-480-907218904809090 CAPSULE in 1 BOTTLE (72189-480-90) 90 capsule2023-05-30NoNoCurrent