hydroxyzine pamoate

Product NDC
0185-0674
Requested package NDC
0185-0674-10
11-digit product format
001850674
Labeler code
0185
Product ID
0185-0674_c94e4245-cac4-4d59-b3a3-64a09b67c2e9
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
hydroxyzine pamoate
Dosage form
CAPSULE
Route
ORAL
Labeler
Sandoz Inc
Application
ANDA087479
Marketing category
ANDA
Marketing start
1981-12-14
Substance
HYDROXYZINE PAMOATE
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

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 · 1 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded packagepackage0185-06740185-0674-10DDiscontinued by firm2026-08-10

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 · 12 matching rows.

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

Captured / source date, Snapshot, Source SHA-256 table
Captured / source dateSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-05d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26f5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-312ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28a1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21cfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10cdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20ed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-100efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08ad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-09557ba5c1ecfa…9c80585c8c6e…

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
A087479-001HYDROXYZINE PAMOATEHYDROXYZINE PAMOATEEQ 25MG 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
A087479-001AB

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 UTC2026-02A087479-001HYDROXYZINE PAMOATEEQ 25MG HYDROCHLORIDECAPSULE / ORALABApproved before 1982011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A087479-001HYDROXYZINE PAMOATEEQ 25MG HYDROCHLORIDECAPSULE / ORALABApproved before 198231067a03dcf5…
2025-08-23 18:47 UTC2025-08A087479-001HYDROXYZINE PAMOATEEQ 25MG HYDROCHLORIDECAPSULE / ORALABApproved before 19826a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A087479-001HYDROXYZINE PAMOATEEQ 25MG HYDROCHLORIDECAPSULE / ORALABApproved before 1982fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A087479-001HYDROXYZINE PAMOATEEQ 25MG HYDROCHLORIDECAPSULE / ORALABApproved before 1982b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A087479-001HYDROXYZINE PAMOATEEQ 25MG HYDROCHLORIDECAPSULE / ORALABApproved before 198203ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A087479-001HYDROXYZINE PAMOATEEQ 25MG HYDROCHLORIDECAPSULE / ORALABApproved before 19822680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A087479-001HYDROXYZINE PAMOATEEQ 25MG HYDROCHLORIDECAPSULE / ORALABApproved before 19825bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A087479-001HYDROXYZINE PAMOATEEQ 25MG HYDROCHLORIDECAPSULE / ORALABApproved before 1982d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A087479-001HYDROXYZINE PAMOATEEQ 25MG HYDROCHLORIDECAPSULE / ORALABApproved before 1982d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A087479-001HYDROXYZINE PAMOATEEQ 25MG HYDROCHLORIDECAPSULE / ORALABApproved before 198279d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A087479-001HYDROXYZINE PAMOATEEQ 25MG HYDROCHLORIDECAPSULE / ORALABApproved before 1982301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A087479-001HYDROXYZINE PAMOATEEQ 25MG HYDROCHLORIDECAPSULE / ORALABApproved before 19821e350fbaab3a…
2024-05-31 18:47 UTC2024-05A087479-001HYDROXYZINE PAMOATEEQ 25MG HYDROCHLORIDECAPSULE / ORALABApproved before 19828072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A087479-001HYDROXYZINE PAMOATEEQ 25MG HYDROCHLORIDECAPSULE / ORALABApproved before 19825c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A087479-001HYDROXYZINE PAMOATEEQ 25MG HYDROCHLORIDECAPSULE / ORALABApproved before 19825d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A087479-001HYDROXYZINE PAMOATEEQ 25MG HYDROCHLORIDECAPSULE / ORALABApproved before 19824b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A087479-001HYDROXYZINE PAMOATEEQ 25MG HYDROCHLORIDECAPSULE / ORALABApproved before 198274a2ff9319b5…
2022-03-09 01:35 UTC2022-03A087479-001HYDROXYZINE PAMOATEEQ 25MG HYDROCHLORIDECAPSULE / ORALABApproved before 1982bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A087479-001HYDROXYZINE PAMOATEEQ 25MG HYDROCHLORIDECAPSULE / ORALABApproved before 1982782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A087479-001HYDROXYZINE PAMOATEEQ 25MG HYDROCHLORIDECAPSULE / ORALABApproved before 198287673890dc5c…
2021-03-12 10:30 UTC2021-03A087479-001HYDROXYZINE PAMOATEEQ 25MG HYDROCHLORIDECAPSULE / ORALABApproved before 19825aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A087479-001HYDROXYZINE PAMOATEEQ 25MG HYDROCHLORIDECAPSULE / ORALABApproved before 19828869cabd3fbd…
2020-11-12 02:37 UTC2020-11A087479-001HYDROXYZINE PAMOATEEQ 25MG HYDROCHLORIDECAPSULE / ORALABApproved before 1982c0c555d07b60…
2019-12-14 00:12 UTC2019-12A087479-001HYDROXYZINE PAMOATEEQ 25MG HYDROCHLORIDECAPSULE / ORALABApproved before 19823f01610625f2…
2019-09-15 20:21 UTC2019-09A087479-001HYDROXYZINE PAMOATEEQ 25MG HYDROCHLORIDECAPSULE / ORALABApproved before 1982b00525d2431f…
2019-07-19 19:46 UTC2019-07A087479-001HYDROXYZINE PAMOATEEQ 25MG HYDROCHLORIDECAPSULE / ORALABApproved before 1982ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A087479-001HYDROXYZINE PAMOATEEQ 25MG HYDROCHLORIDECAPSULE / ORALABApproved before 19826a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A087479-001HYDROXYZINE PAMOATEEQ 25MG HYDROCHLORIDECAPSULE / ORALABApproved before 19821c564ffb4f44…
2023-12-20 04:57 UTC2023-12A087479-001HYDROXYZINE PAMOATEEQ 25MG HYDROCHLORIDECAPSULE / ORALABApproved before 1982ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A087479-001HYDROXYZINE PAMOATEEQ 25MG HYDROCHLORIDECAPSULE / ORALABApproved before 1982a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A087479-001HYDROXYZINE PAMOATEEQ 25MG HYDROCHLORIDECAPSULE / ORALABApproved before 19829b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A087479-001HYDROXYZINE PAMOATEEQ 25MG HYDROCHLORIDECAPSULE / ORALABApproved before 1982a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A087479-001HYDROXYZINE PAMOATEEQ 25MG HYDROCHLORIDECAPSULE / ORALABApproved before 19823f0d92c62455…
2023-05-13 08:27 UTC2023-05A087479-001HYDROXYZINE PAMOATEEQ 25MG HYDROCHLORIDECAPSULE / ORALABApproved before 1982053a50430f4f…
2023-01-26 05:58 UTC2023-01A087479-001HYDROXYZINE PAMOATEEQ 25MG HYDROCHLORIDECAPSULE / ORALABApproved before 19823bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A087479-001HYDROXYZINE PAMOATEEQ 25MG HYDROCHLORIDECAPSULE / ORALABApproved before 19823a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A087479-001HYDROXYZINE PAMOATEEQ 25MG HYDROCHLORIDECAPSULE / ORALABApproved before 1982f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09A087479-001HYDROXYZINE PAMOATEEQ 25MG HYDROCHLORIDECAPSULE / ORALABApproved before 1982e64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07A087479-001HYDROXYZINE PAMOATEEQ 25MG HYDROCHLORIDECAPSULE / ORALABApproved 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 UTC2026-02A087479-001AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A087479-001AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08A087479-001AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A087479-001AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A087479-001AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A087479-001AB103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A087479-001AB12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A087479-001AB15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A087479-001AB1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A087479-001AB1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A087479-001AB179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A087479-001AB1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A087479-001AB11e350fbaab3a…
2024-05-31 18:47 UTC2024-05A087479-001AB18072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A087479-001AB15c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A087479-001AB15d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A087479-001AB14b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A087479-001AB174a2ff9319b5…
2022-03-09 01:35 UTC2022-03A087479-001AB1bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A087479-001AB1782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A087479-001AB187673890dc5c…
2021-03-12 10:30 UTC2021-03A087479-001AB15aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A087479-001AB18869cabd3fbd…
2020-11-12 02:37 UTC2020-11A087479-001AB1c0c555d07b60…
2019-12-14 00:12 UTC2019-12A087479-001AB13f01610625f2…
2019-09-15 20:21 UTC2019-09A087479-001AB1b00525d2431f…
2019-07-19 19:46 UTC2019-07A087479-001AB1ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A087479-001AB16a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A087479-001AB11c564ffb4f44…
2023-12-20 04:57 UTC2023-12A087479-001AB1ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A087479-001AB1a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A087479-001AB19b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A087479-001AB1a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A087479-001AB13f0d92c62455…
2023-05-13 08:27 UTC2023-05A087479-001AB1053a50430f4f…
2023-01-26 05:58 UTC2023-01A087479-001AB13bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A087479-001AB13a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A087479-001AB1f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09A087479-001AB1e64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07A087479-001AB1cb3db0bc1861…

Additional Listing Data#

Finished product
Yes
Brand name base
hydroxyzine pamoate
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
HYDROXYZINE PAMOATE25 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 · 2 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
995253Internal RxNorm lookup
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
c38cfd32-2562-4d6c-8a2e-d9984c16d9ebAvailable 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
0185-0674-01hydroxyzine pamoate100 in 1 BOTTLECAPSULE10036
0185-0674-05hydroxyzine pamoate500 in 1 BOTTLECAPSULE50036
0185-0674-10hydroxyzine pamoate1000 in 1 BOTTLECAPSULE100036

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0185-0674-01EA - Each0185-06741e02c508-b69d-4ac8-a7f5-b5da8cb1360912014-09-03
0185-0674-05EA - Each0185-0674f24da135-1693-4b17-ac50-271079d3338b12014-09-03

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
HYDROXYZINE PAMOATEACTIVE INGREDIENTM20215MUFRHYDROXYZINE PAMOATE CAPSULE [EON LABS, INC.]20
HYDROXYZINEACTIVE MOIETY30S50YM8OGHYDROXYZINE PAMOATE CAPSULE [EON LABS, INC.]20
D&C YELLOW NO. 10INACTIVE INGREDIENT35SW5USQ3GHYDROXYZINE PAMOATE CAPSULE [EON LABS, INC.]20
FD&C BLUE NO. 1INACTIVE INGREDIENTH3R47K3TBDHYDROXYZINE PAMOATE CAPSULE [EON LABS, INC.]20
FD&C BLUE NO. 2INACTIVE INGREDIENTL06K8R7DQKHYDROXYZINE PAMOATE CAPSULE [EON LABS, INC.]20
FD&C GREEN NO. 3INACTIVE INGREDIENT3P3ONR6O1SHYDROXYZINE PAMOATE CAPSULE [EON LABS, INC.]20
FD&C RED NO. 40INACTIVE INGREDIENTWZB9127XOAHYDROXYZINE PAMOATE CAPSULE [EON LABS, INC.]20
FD&C YELLOW NO. 6INACTIVE INGREDIENTH77VEI93A8HYDROXYZINE PAMOATE CAPSULE [EON LABS, INC.]20
FERROSOFERRIC OXIDEINACTIVE INGREDIENTXM0M87F357HYDROXYZINE PAMOATE CAPSULE [EON LABS, INC.]20
GELATININACTIVE INGREDIENT2G86QN327LHYDROXYZINE PAMOATE CAPSULE [EON LABS, INC.]20
HYDROXYPROPYL CELLULOSE (TYPE H)INACTIVE INGREDIENTRFW2ET671PHYDROXYZINE PAMOATE CAPSULE [EON LABS, INC.]20
LACTOSE MONOHYDRATEINACTIVE INGREDIENTEWQ57Q8I5XHYDROXYZINE PAMOATE CAPSULE [EON LABS, INC.]20
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30HYDROXYZINE PAMOATE CAPSULE [EON LABS, INC.]20
SHELLACINACTIVE INGREDIENT46N107B71OHYDROXYZINE PAMOATE CAPSULE [EON LABS, INC.]20
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4HYDROXYZINE PAMOATE CAPSULE [EON LABS, INC.]20
SODIUM LAURYL SULFATEINACTIVE INGREDIENT368GB5141JHYDROXYZINE PAMOATE CAPSULE [EON LABS, INC.]20
SODIUM STARCH GLYCOLATE TYPE A POTATOINACTIVE INGREDIENT5856J3G2A2HYDROXYZINE PAMOATE CAPSULE [EON LABS, INC.]20
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPHYDROXYZINE PAMOATE CAPSULE [EON LABS, INC.]20
HYDROXYZINE PAMOATEACTIVE INGREDIENTM20215MUFRHYDROXYZINE PAMOATE CAPSULE [PD-RX PHARMACEUTICALS, INC.]17
HYDROXYZINEACTIVE MOIETY30S50YM8OGHYDROXYZINE PAMOATE CAPSULE [PD-RX PHARMACEUTICALS, INC.]17
D&C YELLOW NO. 10INACTIVE INGREDIENT35SW5USQ3GHYDROXYZINE PAMOATE CAPSULE [PD-RX PHARMACEUTICALS, INC.]17
FD&C GREEN NO. 3INACTIVE INGREDIENT3P3ONR6O1SHYDROXYZINE PAMOATE CAPSULE [PD-RX PHARMACEUTICALS, INC.]17
FD&C YELLOW NO. 6INACTIVE INGREDIENTH77VEI93A8HYDROXYZINE PAMOATE CAPSULE [PD-RX PHARMACEUTICALS, INC.]17
GELATININACTIVE INGREDIENT2G86QN327LHYDROXYZINE PAMOATE CAPSULE [PD-RX PHARMACEUTICALS, INC.]17
HYDROXYPROPYL CELLULOSE (TYPE H)INACTIVE INGREDIENTRFW2ET671PHYDROXYZINE PAMOATE CAPSULE [PD-RX PHARMACEUTICALS, INC.]17
LACTOSE MONOHYDRATEINACTIVE INGREDIENTEWQ57Q8I5XHYDROXYZINE PAMOATE CAPSULE [PD-RX PHARMACEUTICALS, INC.]17
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30HYDROXYZINE PAMOATE CAPSULE [PD-RX PHARMACEUTICALS, INC.]17
PROPYLENE GLYCOLINACTIVE INGREDIENT6DC9Q167V3HYDROXYZINE PAMOATE CAPSULE [PD-RX PHARMACEUTICALS, INC.]17
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4HYDROXYZINE PAMOATE CAPSULE [PD-RX PHARMACEUTICALS, INC.]17
SODIUM LAURYL SULFATEINACTIVE INGREDIENT368GB5141JHYDROXYZINE PAMOATE CAPSULE [PD-RX PHARMACEUTICALS, INC.]17
SODIUM STARCH GLYCOLATE TYPE A POTATOINACTIVE INGREDIENT5856J3G2A2HYDROXYZINE PAMOATE CAPSULE [PD-RX PHARMACEUTICALS, INC.]17
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPHYDROXYZINE PAMOATE CAPSULE [PD-RX PHARMACEUTICALS, INC.]17
HYDROXYZINE PAMOATEACTIVE INGREDIENTM20215MUFRHYDROXYZINE PAMOATE CAPSULE [CLINICAL SOLUTIONS WHOLSESALE]2
HYDROXYZINEACTIVE MOIETY30S50YM8OGHYDROXYZINE PAMOATE CAPSULE [CLINICAL SOLUTIONS WHOLSESALE]2
D&C YELLOW NO. 10INACTIVE INGREDIENT35SW5USQ3GHYDROXYZINE PAMOATE CAPSULE [CLINICAL SOLUTIONS WHOLSESALE]2
FD&C GREEN NO. 3INACTIVE INGREDIENT3P3ONR6O1SHYDROXYZINE PAMOATE CAPSULE [CLINICAL SOLUTIONS WHOLSESALE]2
FD&C YELLOW NO. 6INACTIVE INGREDIENTH77VEI93A8HYDROXYZINE PAMOATE CAPSULE [CLINICAL SOLUTIONS WHOLSESALE]2
GELATININACTIVE INGREDIENT2G86QN327LHYDROXYZINE PAMOATE CAPSULE [CLINICAL SOLUTIONS WHOLSESALE]2
HYDROXYPROPYL CELLULOSE (TYPE H)INACTIVE INGREDIENTRFW2ET671PHYDROXYZINE PAMOATE CAPSULE [CLINICAL SOLUTIONS WHOLSESALE]2
LACTOSE MONOHYDRATEINACTIVE INGREDIENTEWQ57Q8I5XHYDROXYZINE PAMOATE CAPSULE [CLINICAL SOLUTIONS WHOLSESALE]2
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30HYDROXYZINE PAMOATE CAPSULE [CLINICAL SOLUTIONS WHOLSESALE]2
PROPYLENE GLYCOLINACTIVE INGREDIENT6DC9Q167V3HYDROXYZINE PAMOATE CAPSULE [CLINICAL SOLUTIONS WHOLSESALE]2
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4HYDROXYZINE PAMOATE CAPSULE [CLINICAL SOLUTIONS WHOLSESALE]2
SODIUM LAURYL SULFATEINACTIVE INGREDIENT368GB5141JHYDROXYZINE PAMOATE CAPSULE [CLINICAL SOLUTIONS WHOLSESALE]2
SODIUM STARCH GLYCOLATE TYPE A POTATOINACTIVE INGREDIENT5856J3G2A2HYDROXYZINE PAMOATE CAPSULE [CLINICAL SOLUTIONS WHOLSESALE]2
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPHYDROXYZINE PAMOATE CAPSULE [CLINICAL SOLUTIONS WHOLSESALE]2
HYDROXYZINE PAMOATEACTIVE INGREDIENTM20215MUFRHYDROXYZINE PAMOATE CAPSULE [NCS HEALTHCARE OF KY, INC DBA VANGARD LABS]1
HYDROXYZINE PAMOATEACTIVE INGREDIENTM20215MUFRHYDROXYZINE PAMOATE CAPSULE [AMERICAN HEALTH PACKAGING]1
HYDROXYZINEACTIVE MOIETY30S50YM8OGHYDROXYZINE PAMOATE CAPSULE [AMERICAN HEALTH PACKAGING]1
HYDROXYZINEACTIVE MOIETY30S50YM8OGHYDROXYZINE PAMOATE CAPSULE [NCS HEALTHCARE OF KY, INC DBA VANGARD LABS]1
D&C YELLOW NO. 10INACTIVE INGREDIENT35SW5USQ3GHYDROXYZINE PAMOATE CAPSULE [AMERICAN HEALTH PACKAGING]1
D&C YELLOW NO. 10INACTIVE INGREDIENT35SW5USQ3GHYDROXYZINE PAMOATE CAPSULE [NCS HEALTHCARE OF KY, INC DBA VANGARD LABS]1
FD&C BLUE NO. 1INACTIVE INGREDIENTH3R47K3TBDHYDROXYZINE PAMOATE CAPSULE [AMERICAN HEALTH PACKAGING]1
FD&C BLUE NO. 2INACTIVE INGREDIENTL06K8R7DQKHYDROXYZINE PAMOATE CAPSULE [AMERICAN HEALTH PACKAGING]1
FD&C GREEN NO. 3INACTIVE INGREDIENT3P3ONR6O1SHYDROXYZINE PAMOATE CAPSULE [AMERICAN HEALTH PACKAGING]1
FD&C GREEN NO. 3INACTIVE INGREDIENT3P3ONR6O1SHYDROXYZINE PAMOATE CAPSULE [NCS HEALTHCARE OF KY, INC DBA VANGARD LABS]1
FD&C RED NO. 40INACTIVE INGREDIENTWZB9127XOAHYDROXYZINE PAMOATE CAPSULE [AMERICAN HEALTH PACKAGING]1
FD&C YELLOW NO. 6INACTIVE INGREDIENTH77VEI93A8HYDROXYZINE PAMOATE CAPSULE [NCS HEALTHCARE OF KY, INC DBA VANGARD LABS]1
FD&C YELLOW NO. 6INACTIVE INGREDIENTH77VEI93A8HYDROXYZINE PAMOATE CAPSULE [AMERICAN HEALTH PACKAGING]1
FERROSOFERRIC OXIDEINACTIVE INGREDIENTXM0M87F357HYDROXYZINE PAMOATE CAPSULE [AMERICAN HEALTH PACKAGING]1
GELATININACTIVE INGREDIENT2G86QN327LHYDROXYZINE PAMOATE CAPSULE [AMERICAN HEALTH PACKAGING]1
GELATININACTIVE INGREDIENT2G86QN327LHYDROXYZINE PAMOATE CAPSULE [NCS HEALTHCARE OF KY, INC DBA VANGARD LABS]1
HYDROXYPROPYL CELLULOSE (TYPE H)INACTIVE INGREDIENTRFW2ET671PHYDROXYZINE PAMOATE CAPSULE [AMERICAN HEALTH PACKAGING]1
HYDROXYPROPYL CELLULOSE (TYPE H)INACTIVE INGREDIENTRFW2ET671PHYDROXYZINE PAMOATE CAPSULE [NCS HEALTHCARE OF KY, INC DBA VANGARD LABS]1
LACTOSE MONOHYDRATEINACTIVE INGREDIENTEWQ57Q8I5XHYDROXYZINE PAMOATE CAPSULE [AMERICAN HEALTH PACKAGING]1
LACTOSE MONOHYDRATEINACTIVE INGREDIENTEWQ57Q8I5XHYDROXYZINE PAMOATE CAPSULE [NCS HEALTHCARE OF KY, INC DBA VANGARD LABS]1
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30HYDROXYZINE PAMOATE CAPSULE [AMERICAN HEALTH PACKAGING]1
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30HYDROXYZINE PAMOATE CAPSULE [NCS HEALTHCARE OF KY, INC DBA VANGARD LABS]1
SHELLACINACTIVE INGREDIENT46N107B71OHYDROXYZINE PAMOATE CAPSULE [AMERICAN HEALTH PACKAGING]1
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4HYDROXYZINE PAMOATE CAPSULE [AMERICAN HEALTH PACKAGING]1
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4HYDROXYZINE PAMOATE CAPSULE [NCS HEALTHCARE OF KY, INC DBA VANGARD LABS]1
SODIUM LAURYL SULFATEINACTIVE INGREDIENT368GB5141JHYDROXYZINE PAMOATE CAPSULE [AMERICAN HEALTH PACKAGING]1
SODIUM LAURYL SULFATEINACTIVE INGREDIENT368GB5141JHYDROXYZINE PAMOATE CAPSULE [NCS HEALTHCARE OF KY, INC DBA VANGARD LABS]1
SODIUM STARCH GLYCOLATE TYPE A POTATOINACTIVE INGREDIENT5856J3G2A2HYDROXYZINE PAMOATE CAPSULE [AMERICAN HEALTH PACKAGING]1
SODIUM STARCH GLYCOLATE TYPE A POTATOINACTIVE INGREDIENT5856J3G2A2HYDROXYZINE PAMOATE CAPSULE [NCS HEALTHCARE OF KY, INC DBA VANGARD LABS]1
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPHYDROXYZINE PAMOATE CAPSULE [AMERICAN HEALTH PACKAGING]1
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPHYDROXYZINE PAMOATE CAPSULE [NCS HEALTHCARE OF KY, INC DBA VANGARD LABS]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0185-0674HYDROXYZINE PAMOATE CAPSULE HYDROXYZINE PAMOATE CAPSULE HYDROXYZINE PAMOATE CAPSULE [SANDOZ INC]36Current NDC, Legacy NDC, 3 package rows20240320_c38cfd32-2562-4d6c-8a2e-d9984c16d9eb.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 2 · 22 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
hydroxyzine pamoateHYDROXYZINE PAMOATEUnit Dose Solutions, Inc.561d8abe-97e8-5dc7-e063-6294a90a39232026-07-08Warnings, Adverse reactionsExact identifier
application applno (ANDA): 087479
application number: ANDA087479
hydroxyzine pamoateHYDROXYZINE PAMOATEREMEDYREPACK INC.6432d1aa-1e73-469e-835b-43d518963f712026-07-07Warnings, Adverse reactionsExact identifier
application applno (ANDA): 087479
application number: ANDA087479
hydroxyzine pamoateHYDROXYZINE PAMOATEREMEDYREPACK INC.2e59dc14-7e17-4663-bc1f-7ee8e104dbfa2026-06-24Warnings, Adverse reactionsExact identifier
application applno (ANDA): 087479
application number: ANDA087479
hydroxyzine pamoateHYDROXYZINE PAMOATEUnit Dose Solutions, Inc.55012f2c-fa10-2a31-e063-6294a90ae7182026-06-24Warnings, Adverse reactionsExact identifier
application applno (ANDA): 087479
application number: ANDA087479
hydroxyzine pamoateHYDROXYZINE PAMOATECoupler LLC545f0e87-2688-5381-e063-6394a90a72d42026-06-16Warnings, Adverse reactionsExact identifier
application applno (ANDA): 087479
application number: ANDA087479
hydroxyzine pamoateHYDROXYZINE PAMOATEPD-Rx Pharmaceuticals, Inc.98a1c161-5728-4626-a6b0-5414935e4eef2026-03-18Warnings, Adverse reactionsExact identifier
application applno (ANDA): 087479
application number: ANDA087479
Hydroxyzine PamoateHYDROXYZINE PAMOATEDirect_Rx8a7084e0-530c-607b-e053-2a95a90a229c2026-03-05Warnings, Adverse reactionsExact identifier
application applno (ANDA): 087479
application number: ANDA087479
hydroxyzine pamoateHYDROXYZINE PAMOATENorthwind Health Company, LLCf99da162-f224-1c19-e053-6294a90acffb2026-01-01Warnings, Adverse reactionsExact identifier
application applno (ANDA): 087479
application number: ANDA087479
hydroxyzine pamoateHYDROXYZINE PAMOATEPD-Rx Pharmaceuticals, Inc.53153595-41b9-4b2d-8b7d-0ffd29fdd1d82025-11-05Warnings, Adverse reactionsExact identifier
application applno (ANDA): 087479
application number: ANDA087479
hydroxyzine pamoateHYDROXYZINE PAMOATEBryant Ranch Prepack836ec7f1-e739-4b85-bb52-08d5c5ed4c112025-11-04Warnings, Adverse reactionsExact identifier
application applno (ANDA): 087479
application number: ANDA087479
hydroxyzine pamoateHYDROXYZINE PAMOATEBryant Ranch Prepack2a869704-2ad0-4ef6-89e6-0f84c39542b62025-07-29Warnings, Adverse reactionsExact identifier
application applno (ANDA): 087479
application number: ANDA087479
hydroxyzine pamoateHYDROXYZINE PAMOATEPreferred Pharmaceuticals Inc.54af47cd-65c2-4bc9-95cd-7883e56ed0352025-06-27Warnings, Adverse reactionsExact identifier
application applno (ANDA): 087479
application number: ANDA087479
hydroxyzine pamoateHYDROXYZINE PAMOATENuCare Pharmaceuticals,Inc.aee7c4a8-10cb-2107-e053-2995a90a90e72025-06-04Warnings, Adverse reactionsExact identifier
application applno (ANDA): 087479
application number: ANDA087479
hydroxyzine pamoateHYDROXYZINE PAMOATEBryant Ranch Prepack34f7e401-9b2c-7d63-e063-6394a90a1f002025-05-12Warnings, Adverse reactionsExact identifier
application applno (ANDA): 087479
application number: ANDA087479
hydroxyzine pamoateHYDROXYZINE PAMOATEBryant Ranch Prepackf74e4b3e-992c-402d-92b8-258fccb42b642025-02-10Warnings, Adverse reactionsExact identifier
application applno (ANDA): 087479
application number: ANDA087479
hydroxyzine pamoateHYDROXYZINE PAMOATEBryant Ranch Prepack02616eee-a1a4-4afc-b84e-69fd287551382024-12-16Warnings, Adverse reactionsExact identifier
application applno (ANDA): 087479
application number: ANDA087479
hydroxyzine pamoateHYDROXYZINE PAMOATENuCare Pharmaceutcals, Inc.2879c79f-bf2f-0bc9-e063-6394a90a98ae2024-12-04Warnings, Adverse reactionsExact identifier
application applno (ANDA): 087479
application number: ANDA087479
hydroxyzine pamoateHYDROXYZINE PAMOATEBryant Ranch Prepackfac2df9d-d395-4b07-b299-2ed946441b222024-10-04Warnings, Adverse reactionsExact identifier
application applno (ANDA): 087479
application number: ANDA087479
hydroxyzine pamoateHYDROXYZINE PAMOATEPharmasource Meds, LLCf563aa1a-1e21-49d4-e053-2a95a90a32642024-05-28Warnings, Adverse reactionsExact identifier
application applno (ANDA): 087479
application number: ANDA087479
hydroxyzine pamoateHYDROXYZINE PAMOATEAphena Pharma Solutions - Tennessee, LLCc29f005e-ae75-415d-9fd6-591f074dcda52023-11-15Warnings, Adverse reactionsExact identifier
application applno (ANDA): 087479
application number: ANDA087479

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
995253hydrOXYzine pamoate 25 MG Oral CapsulePSNf74e4b3e-992c-402d-92b8-258fccb42b64106
995253hydroxyzine pamoate 25 MG Oral CapsuleSCDf74e4b3e-992c-402d-92b8-258fccb42b64106
995253hydrOXYzine pamoate 25 MG Oral CapsulePSN02616eee-a1a4-4afc-b84e-69fd28755138105
995253hydroxyzine pamoate 25 MG Oral CapsuleSCD02616eee-a1a4-4afc-b84e-69fd28755138105
995253hydrOXYzine pamoate 25 MG Oral CapsulePSNfac2df9d-d395-4b07-b299-2ed946441b22102
995253hydroxyzine pamoate 25 MG Oral CapsuleSCDfac2df9d-d395-4b07-b299-2ed946441b22102
995253hydrOXYzine pamoate 25 MG Oral CapsulePSN2a869704-2ad0-4ef6-89e6-0f84c39542b6100
995253hydrOXYzine pamoate 25 MG Oral CapsulePSN34f7e401-9b2c-7d63-e063-6394a90a1f00100
995253hydrOXYzine pamoate 25 MG Oral CapsulePSN836ec7f1-e739-4b85-bb52-08d5c5ed4c11100
995253hydroxyzine pamoate 25 MG Oral CapsuleSCD34f7e401-9b2c-7d63-e063-6394a90a1f00100
995253hydroxyzine pamoate 25 MG Oral CapsuleSCD2a869704-2ad0-4ef6-89e6-0f84c39542b6100
995253hydroxyzine pamoate 25 MG Oral CapsuleSCD836ec7f1-e739-4b85-bb52-08d5c5ed4c11100
995253hydrOXYzine pamoate 25 MG Oral CapsulePSN98a1c161-5728-4626-a6b0-5414935e4eef43
995253hydroxyzine pamoate 25 MG Oral CapsuleSCD98a1c161-5728-4626-a6b0-5414935e4eef43
995253hydrOXYzine pamoate 25 MG Oral CapsulePSNc38cfd32-2562-4d6c-8a2e-d9984c16d9eb36
995278hydrOXYzine pamoate 50 MG Oral CapsulePSNc38cfd32-2562-4d6c-8a2e-d9984c16d9eb36
995253hydroxyzine pamoate 25 MG Oral CapsuleSCDc38cfd32-2562-4d6c-8a2e-d9984c16d9eb36
995278hydroxyzine pamoate 50 MG Oral CapsuleSCDc38cfd32-2562-4d6c-8a2e-d9984c16d9eb36
995278hydroxyzine pamoate 50 MG (hydroxyzine pamoate 85.2 MG eqv to hydroxyzine HCl 50 MG) Oral CapsuleSYc38cfd32-2562-4d6c-8a2e-d9984c16d9eb36
995253hydrOXYzine pamoate 25 MG Oral CapsulePSN53153595-41b9-4b2d-8b7d-0ffd29fdd1d833
995253hydroxyzine pamoate 25 MG Oral CapsuleSCD53153595-41b9-4b2d-8b7d-0ffd29fdd1d833
995253hydrOXYzine pamoate 25 MG Oral CapsulePSN2e59dc14-7e17-4663-bc1f-7ee8e104dbfa20
995253hydroxyzine pamoate 25 MG Oral CapsuleSCD2e59dc14-7e17-4663-bc1f-7ee8e104dbfa20
995253hydrOXYzine pamoate 25 MG Oral CapsulePSN6432d1aa-1e73-469e-835b-43d518963f7118
995253hydroxyzine pamoate 25 MG Oral CapsuleSCD6432d1aa-1e73-469e-835b-43d518963f7118
995253hydrOXYzine pamoate 25 MG Oral CapsulePSNaee7c4a8-10cb-2107-e053-2995a90a90e75
995253hydrOXYzine pamoate 25 MG Oral CapsulePSN54af47cd-65c2-4bc9-95cd-7883e56ed0355
995253hydrOXYzine pamoate 25 MG Oral CapsulePSN8a7084e0-530c-607b-e053-2a95a90a229c5
995253hydroxyzine pamoate 25 MG Oral CapsuleSCDaee7c4a8-10cb-2107-e053-2995a90a90e75
995253hydroxyzine pamoate 25 MG Oral CapsuleSCD54af47cd-65c2-4bc9-95cd-7883e56ed0355
995253hydroxyzine pamoate 25 MG Oral CapsuleSCD8a7084e0-530c-607b-e053-2a95a90a229c5
995253hydrOXYzine pamoate 25 MG Oral CapsulePSNf99da162-f224-1c19-e053-6294a90acffb3
995253hydroxyzine pamoate 25 MG Oral CapsuleSCDf99da162-f224-1c19-e053-6294a90acffb3
995253hydrOXYzine pamoate 25 MG Oral CapsulePSNc29f005e-ae75-415d-9fd6-591f074dcda52
995253hydrOXYzine pamoate 25 MG Oral CapsulePSNf563aa1a-1e21-49d4-e053-2a95a90a32642
995253hydroxyzine pamoate 25 MG Oral CapsuleSCDc29f005e-ae75-415d-9fd6-591f074dcda52
995253hydroxyzine pamoate 25 MG Oral CapsuleSCDf563aa1a-1e21-49d4-e053-2a95a90a32642
995253hydrOXYzine pamoate 25 MG Oral CapsulePSN2879c79f-bf2f-0bc9-e063-6394a90a98ae1
995253hydrOXYzine pamoate 25 MG Oral CapsulePSNa500445c-0fa4-65ea-e053-2995a90a6c1a1
995253hydrOXYzine pamoate 25 MG Oral CapsulePSNc1ef1319-7cd9-4420-8c33-24d2da38a6621
995253hydrOXYzine pamoate 25 MG Oral CapsulePSNbff75226-d194-4d64-bcbb-d7d79f5d230e1
995253hydroxyzine pamoate 25 MG Oral CapsuleSCDa500445c-0fa4-65ea-e053-2995a90a6c1a1
995253hydroxyzine pamoate 25 MG Oral CapsuleSCD2879c79f-bf2f-0bc9-e063-6394a90a98ae1
995253hydroxyzine pamoate 25 MG Oral CapsuleSCDc1ef1319-7cd9-4420-8c33-24d2da38a6621
995253hydroxyzine pamoate 25 MG Oral CapsuleSCDbff75226-d194-4d64-bcbb-d7d79f5d230e1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0185-0674-10001850674101000 CAPSULE in 1 BOTTLE (0185-0674-10) 1000 capsule2014-06-270000-00-00NoNoCurrent