Hydroxyzine Pamoate

Product NDC
0185-0613
11-digit product format
001850613
Labeler code
0185
Product ID
0185-0613_d42fe10f-8a8a-4c0c-a148-736e98f757db
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Hydroxyzine Pamoate
Dosage form
CAPSULE
Route
ORAL
Labeler
Eon Labs, Inc.
Application
ANDA087479
Marketing category
ANDA
Marketing start
1981-12-14
Marketing end
2019-04-10
Substance
HYDROXYZINE PAM
Active strength
25 mg/1
Pharmacologic classes
Antihistamine [
NDC exclude flag
No
Listing certified through
0000-00-00
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 · 4 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct0185-0613DDiscontinued by firm2026-08-03
excluded packagepackage0185-06130185-0613-01DDiscontinued by firm2026-08-03
excluded packagepackage0185-06130185-0613-05DDiscontinued by firm2026-08-03
excluded packagepackage0185-06130185-0613-10DDiscontinued by firm2026-08-03

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 · 48 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 packagepackage0185-0613-05d630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage0185-0613-10d630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage0185-0613-01d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26excluded productproductf5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage0185-0613-05f5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage0185-0613-10f5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage0185-0613-01f5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-31excluded productproduct2ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage0185-0613-052ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage0185-0613-102ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage0185-0613-012ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28excluded productproducta1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage0185-0613-05a1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage0185-0613-10a1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage0185-0613-01a1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21excluded productproductcfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage0185-0613-05cfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage0185-0613-10cfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage0185-0613-01cfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10excluded productproductcdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage0185-0613-05cdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage0185-0613-10cdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage0185-0613-01cdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31excluded productproduct302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage0185-0613-05302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage0185-0613-10302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage0185-0613-01302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20excluded productproducted331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage0185-0613-05ed331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage0185-0613-10ed331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage0185-0613-01ed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-10excluded productproduct0efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage0185-0613-050efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage0185-0613-100efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage0185-0613-010efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08excluded productproductad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage0185-0613-05ad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage0185-0613-10ad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage0185-0613-01ad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03excluded productproduct367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage0185-0613-05367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage0185-0613-10367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage0185-0613-01367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-09excluded productproduct557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage0185-0613-05557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage0185-0613-10557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage0185-0613-01557ba5c1ecfa…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…

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
0185-0613-01Hydroxyzine Pamoate100 in 1 BOTTLECAPSULE10036
0185-0613-05Hydroxyzine Pamoate500 in 1 BOTTLECAPSULE50036
0185-0613-10Hydroxyzine Pamoate1000 in 1 BOTTLECAPSULE100036

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0185-0613-01EA - Each0185-06136fc4dca6-123f-4683-86ca-8c1d634055f312012-07-24
0185-0613-05EA - Each0185-06135e212c8d-dfab-4a37-bd65-f222dd1c3d6512012-07-24

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 [NCS HEALTHCARE OF KY, INC DBA VANGARD LABS]10
HYDROXYZINEACTIVE MOIETY30S50YM8OGHYDROXYZINE PAMOATE CAPSULE [NCS HEALTHCARE OF KY, INC DBA VANGARD LABS]10
D&C YELLOW NO. 10INACTIVE INGREDIENT35SW5USQ3GHYDROXYZINE PAMOATE CAPSULE [NCS HEALTHCARE OF KY, INC DBA VANGARD LABS]10
FD&C GREEN NO. 3INACTIVE INGREDIENT3P3ONR6O1SHYDROXYZINE PAMOATE CAPSULE [NCS HEALTHCARE OF KY, INC DBA VANGARD LABS]10
FD&C YELLOW NO. 6INACTIVE INGREDIENTH77VEI93A8HYDROXYZINE PAMOATE CAPSULE [NCS HEALTHCARE OF KY, INC DBA VANGARD LABS]10
GELATININACTIVE INGREDIENT2G86QN327LHYDROXYZINE PAMOATE CAPSULE [NCS HEALTHCARE OF KY, INC DBA VANGARD LABS]10
HYDROXYPROPYL CELLULOSE (TYPE H)INACTIVE INGREDIENTRFW2ET671PHYDROXYZINE PAMOATE CAPSULE [NCS HEALTHCARE OF KY, INC DBA VANGARD LABS]10
LACTOSE MONOHYDRATEINACTIVE INGREDIENTEWQ57Q8I5XHYDROXYZINE PAMOATE CAPSULE [NCS HEALTHCARE OF KY, INC DBA VANGARD LABS]10
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30HYDROXYZINE PAMOATE CAPSULE [NCS HEALTHCARE OF KY, INC DBA VANGARD LABS]10
PROPYLENE GLYCOLINACTIVE INGREDIENT6DC9Q167V3HYDROXYZINE PAMOATE CAPSULE [NCS HEALTHCARE OF KY, INC DBA VANGARD LABS]10
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4HYDROXYZINE PAMOATE CAPSULE [NCS HEALTHCARE OF KY, INC DBA VANGARD LABS]10
SODIUM LAURYL SULFATEINACTIVE INGREDIENT368GB5141JHYDROXYZINE PAMOATE CAPSULE [NCS HEALTHCARE OF KY, INC DBA VANGARD LABS]10
SODIUM STARCH GLYCOLATE TYPE A POTATOINACTIVE INGREDIENT5856J3G2A2HYDROXYZINE PAMOATE CAPSULE [NCS HEALTHCARE OF KY, INC DBA VANGARD LABS]10
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPHYDROXYZINE PAMOATE CAPSULE [NCS HEALTHCARE OF KY, INC DBA VANGARD LABS]10
HYDROXYZINE PAMOATEACTIVE INGREDIENTM20215MUFRHYDROXYZINE PAMOATE CAPSULE [PHYSICIANS TOTAL CARE, INC.]3
HYDROXYZINEACTIVE MOIETY30S50YM8OGHYDROXYZINE PAMOATE CAPSULE [PHYSICIANS TOTAL CARE, INC.]3
D&C YELLOW NO. 10INACTIVE INGREDIENT35SW5USQ3GHYDROXYZINE PAMOATE CAPSULE [PHYSICIANS TOTAL CARE, INC.]3
FD&C GREEN NO. 3INACTIVE INGREDIENT3P3ONR6O1SHYDROXYZINE PAMOATE CAPSULE [PHYSICIANS TOTAL CARE, INC.]3
FD&C YELLOW NO. 6INACTIVE INGREDIENTH77VEI93A8HYDROXYZINE PAMOATE CAPSULE [PHYSICIANS TOTAL CARE, INC.]3
GELATININACTIVE INGREDIENT2G86QN327LHYDROXYZINE PAMOATE CAPSULE [PHYSICIANS TOTAL CARE, INC.]3
HYDROXYPROPYL CELLULOSEINACTIVE INGREDIENTRFW2ET671PHYDROXYZINE PAMOATE CAPSULE [PHYSICIANS TOTAL CARE, INC.]3
LACTOSE MONOHYDRATEINACTIVE INGREDIENTEWQ57Q8I5XHYDROXYZINE PAMOATE CAPSULE [PHYSICIANS TOTAL CARE, INC.]3
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30HYDROXYZINE PAMOATE CAPSULE [PHYSICIANS TOTAL CARE, INC.]3
PROPYLENE GLYCOLINACTIVE INGREDIENT6DC9Q167V3HYDROXYZINE PAMOATE CAPSULE [PHYSICIANS TOTAL CARE, INC.]3
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4HYDROXYZINE PAMOATE CAPSULE [PHYSICIANS TOTAL CARE, INC.]3
SODIUM LAURYL SULFATEINACTIVE INGREDIENT368GB5141JHYDROXYZINE PAMOATE CAPSULE [PHYSICIANS TOTAL CARE, INC.]3
SODIUM STARCH GLYCOLATE TYPE A POTATOINACTIVE INGREDIENT5856J3G2A2HYDROXYZINE PAMOATE CAPSULE [PHYSICIANS TOTAL CARE, INC.]3
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPHYDROXYZINE PAMOATE CAPSULE [PHYSICIANS TOTAL CARE, INC.]3
HYDROXYZINE PAMOATEACTIVE INGREDIENTM20215MUFRHYDROXYZINE PAMOATE CAPSULE [STAT RX USA LLC]1
HYDROXYZINE PAMOATEACTIVE INGREDIENTM20215MUFRHYDROXYZINE PAMOATE CAPSULE [CONTRACT PHARMACY SERVICES-PA]1
HYDROXYZINEACTIVE MOIETY30S50YM8OGHYDROXYZINE PAMOATE CAPSULE [CONTRACT PHARMACY SERVICES-PA]1
HYDROXYZINEACTIVE MOIETY30S50YM8OGHYDROXYZINE PAMOATE CAPSULE [STAT RX USA LLC]1
D&C YELLOW NO. 10INACTIVE INGREDIENT35SW5USQ3GHYDROXYZINE PAMOATE CAPSULE [CONTRACT PHARMACY SERVICES-PA]1
D&C YELLOW NO. 10INACTIVE INGREDIENT35SW5USQ3GHYDROXYZINE PAMOATE CAPSULE [STAT RX USA LLC]1
FD&C BLUE NO. 1INACTIVE INGREDIENTH3R47K3TBDHYDROXYZINE PAMOATE CAPSULE [CONTRACT PHARMACY SERVICES-PA]1
FD&C BLUE NO. 2INACTIVE INGREDIENTL06K8R7DQKHYDROXYZINE PAMOATE CAPSULE [CONTRACT PHARMACY SERVICES-PA]1
FD&C GREEN NO. 3INACTIVE INGREDIENT3P3ONR6O1SHYDROXYZINE PAMOATE CAPSULE [CONTRACT PHARMACY SERVICES-PA]1
FD&C GREEN NO. 3INACTIVE INGREDIENT3P3ONR6O1SHYDROXYZINE PAMOATE CAPSULE [STAT RX USA LLC]1
FD&C RED NO. 40INACTIVE INGREDIENTWZB9127XOAHYDROXYZINE PAMOATE CAPSULE [CONTRACT PHARMACY SERVICES-PA]1
FD&C YELLOW NO. 6INACTIVE INGREDIENTH77VEI93A8HYDROXYZINE PAMOATE CAPSULE [CONTRACT PHARMACY SERVICES-PA]1
FD&C YELLOW NO. 6INACTIVE INGREDIENTH77VEI93A8HYDROXYZINE PAMOATE CAPSULE [STAT RX USA LLC]1
GELATININACTIVE INGREDIENT2G86QN327LHYDROXYZINE PAMOATE CAPSULE [CONTRACT PHARMACY SERVICES-PA]1
GELATININACTIVE INGREDIENT2G86QN327LHYDROXYZINE PAMOATE CAPSULE [STAT RX USA LLC]1
HYDROXYPROPYL CELLULOSEINACTIVE INGREDIENTRFW2ET671PHYDROXYZINE PAMOATE CAPSULE [STAT RX USA LLC]1
LACTOSE MONOHYDRATEINACTIVE INGREDIENTEWQ57Q8I5XHYDROXYZINE PAMOATE CAPSULE [STAT RX USA LLC]1
LACTOSE MONOHYDRATEINACTIVE INGREDIENTEWQ57Q8I5XHYDROXYZINE PAMOATE CAPSULE [CONTRACT PHARMACY SERVICES-PA]1
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30HYDROXYZINE PAMOATE CAPSULE [STAT RX USA LLC]1
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30HYDROXYZINE PAMOATE CAPSULE [CONTRACT PHARMACY SERVICES-PA]1
PROPYLENE GLYCOLINACTIVE INGREDIENT6DC9Q167V3HYDROXYZINE PAMOATE CAPSULE [STAT RX USA LLC]1
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4HYDROXYZINE PAMOATE CAPSULE [STAT RX USA LLC]1
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4HYDROXYZINE PAMOATE CAPSULE [CONTRACT PHARMACY SERVICES-PA]1
SODIUM LAURYL SULFATEINACTIVE INGREDIENT368GB5141JHYDROXYZINE PAMOATE CAPSULE [STAT RX USA LLC]1
SODIUM LAURYL SULFATEINACTIVE INGREDIENT368GB5141JHYDROXYZINE PAMOATE CAPSULE [CONTRACT PHARMACY SERVICES-PA]1
SODIUM STARCH GLYCOLATE TYPE A POTATOINACTIVE INGREDIENT5856J3G2A2HYDROXYZINE PAMOATE CAPSULE [STAT RX USA LLC]1
SODIUM STARCH GLYCOLATE TYPE A POTATOINACTIVE INGREDIENT5856J3G2A2HYDROXYZINE PAMOATE CAPSULE [CONTRACT PHARMACY SERVICES-PA]1
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPHYDROXYZINE PAMOATE CAPSULE [STAT RX USA LLC]1
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPHYDROXYZINE PAMOATE CAPSULE [CONTRACT PHARMACY SERVICES-PA]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0185-0613HYDROXYZINE PAMOATE CAPSULE HYDROXYZINE PAMOATE CAPSULE HYDROXYZINE PAMOATE CAPSULE [SANDOZ INC]36Legacy 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 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 CapsulePSNba04ac99-6321-4431-97e1-e18083d7b1373
995278hydrOXYzine pamoate 50 MG Oral CapsulePSNba04ac99-6321-4431-97e1-e18083d7b1373
995253hydroxyzine pamoate 25 MG Oral CapsuleSCDba04ac99-6321-4431-97e1-e18083d7b1373
995278hydroxyzine pamoate 50 MG Oral CapsuleSCDba04ac99-6321-4431-97e1-e18083d7b1373
995278hydroxyzine pamoate 50 MG (hydroxyzine pamoate 85.2 MG eqv to hydroxyzine HCl 50 MG) Oral CapsuleSYba04ac99-6321-4431-97e1-e18083d7b1373
995253hydrOXYzine pamoate 25 MG Oral CapsulePSNb6a5fb1e-b133-452d-ba97-84c1cca03fc11
995253hydrOXYzine pamoate 25 MG Oral CapsulePSN2bbcabc3-657f-4b2e-a473-774adfeba78e1
995278hydrOXYzine pamoate 50 MG Oral CapsulePSN2bbcabc3-657f-4b2e-a473-774adfeba78e1
995253hydroxyzine pamoate 25 MG Oral CapsuleSCD2bbcabc3-657f-4b2e-a473-774adfeba78e1
995253hydroxyzine pamoate 25 MG Oral CapsuleSCDb6a5fb1e-b133-452d-ba97-84c1cca03fc11
995278hydroxyzine pamoate 50 MG Oral CapsuleSCD2bbcabc3-657f-4b2e-a473-774adfeba78e1
995278hydroxyzine pamoate 50 MG (hydroxyzine pamoate 85.2 MG eqv to hydroxyzine HCl 50 MG) Oral CapsuleSY2bbcabc3-657f-4b2e-a473-774adfeba78e1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionStatus
0185-0613-0100185061301100 in 1 BOTTLEHistorical
0185-0613-0500185061305500 in 1 BOTTLEHistorical
0185-0613-10001850613101000 in 1 BOTTLEHistorical