Hydroxyzine Pamoate

Product NDC
68788-9696
11-digit product format
687889696
Labeler code
68788
Product ID
68788-9696_6fddf6ea-a5a8-4317-83ff-f83e7f99d323
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Hydroxyzine Pamoate
Dosage form
CAPSULE
Route
ORAL
Labeler
Preferred Pharmaceuticals, Inc.
Application
ANDA088496
Marketing category
ANDA
Marketing start
2013-04-22
Marketing end
0000-00-00
Substance
HYDROXYZINE PAMOATE
Active strength
25 mg/1
Pharmacologic classes
Antihistamine [EPC],Histamine Receptor Antagonists [MoA]
NDC exclude flag
No
Listing certified through
2020-12-31
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 · 7 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct68788-9696DDiscontinued by firm2026-08-17
excluded packagepackage68788-969668788-9696-1DDiscontinued by firm2026-08-17
excluded packagepackage68788-969668788-9696-2DDiscontinued by firm2026-08-17
excluded packagepackage68788-969668788-9696-3DDiscontinued by firm2026-08-17
excluded packagepackage68788-969668788-9696-5DDiscontinued by firm2026-08-17
excluded packagepackage68788-969668788-9696-6DDiscontinued by firm2026-08-17
excluded packagepackage68788-969668788-9696-9DDiscontinued by firm2026-08-17

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 2 · 84 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 packagepackage68788-9696-1d630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage68788-9696-3d630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage68788-9696-9d630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage68788-9696-5d630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage68788-9696-2d630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage68788-9696-6d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26excluded productproductf5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage68788-9696-1f5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage68788-9696-3f5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage68788-9696-9f5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage68788-9696-5f5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage68788-9696-2f5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage68788-9696-6f5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-31excluded productproduct2ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage68788-9696-12ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage68788-9696-32ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage68788-9696-92ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage68788-9696-52ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage68788-9696-22ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage68788-9696-62ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28excluded productproducta1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage68788-9696-1a1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage68788-9696-3a1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage68788-9696-9a1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage68788-9696-5a1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage68788-9696-2a1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage68788-9696-6a1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21excluded productproductcfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage68788-9696-1cfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage68788-9696-3cfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage68788-9696-9cfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage68788-9696-5cfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage68788-9696-2cfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage68788-9696-6cfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10excluded productproductcdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage68788-9696-1cdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage68788-9696-3cdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage68788-9696-9cdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage68788-9696-5cdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage68788-9696-2cdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage68788-9696-6cdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31excluded productproduct302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage68788-9696-1302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage68788-9696-3302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage68788-9696-9302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage68788-9696-5302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage68788-9696-2302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage68788-9696-6302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20excluded productproducted331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage68788-9696-1ed331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage68788-9696-3ed331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage68788-9696-9ed331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage68788-9696-5ed331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage68788-9696-2ed331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage68788-9696-6ed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-10excluded productproduct0efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage68788-9696-10efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage68788-9696-30efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage68788-9696-90efc9e666f02…f202fb6c5f17…

Source provenance: Browse the complete Orange Book source catalog · source snapshot 42.

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
A088496-001HYDROXYZINE PAMOATEHYDROXYZINE PAMOATEEQ 25MG HYDROCHLORIDECAPSULE / ORALAB1984-06-15

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A088496-001AB

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 · 42 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-08-18 06:07:402026-07A088496-001HYDROXYZINE PAMOATEEQ 25MG HYDROCHLORIDECAPSULE / ORALAB1984-06-15caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A088496-001HYDROXYZINE PAMOATEEQ 25MG HYDROCHLORIDECAPSULE / ORALAB1984-06-15011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A088496-001HYDROXYZINE PAMOATEEQ 25MG HYDROCHLORIDECAPSULE / ORALAB1984-06-1531067a03dcf5…
2025-08-23 18:47 UTC2025-08A088496-001HYDROXYZINE PAMOATEEQ 25MG HYDROCHLORIDECAPSULE / ORALAB1984-06-156a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A088496-001HYDROXYZINE PAMOATEEQ 25MG HYDROCHLORIDECAPSULE / ORALAB1984-06-15fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A088496-001HYDROXYZINE PAMOATEEQ 25MG HYDROCHLORIDECAPSULE / ORALAB1984-06-15b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A088496-001HYDROXYZINE PAMOATEEQ 25MG HYDROCHLORIDECAPSULE / ORALAB1984-06-1503ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A088496-001HYDROXYZINE PAMOATEEQ 25MG HYDROCHLORIDECAPSULE / ORALAB1984-06-152680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A088496-001HYDROXYZINE PAMOATEEQ 25MG HYDROCHLORIDECAPSULE / ORALAB1984-06-155bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A088496-001HYDROXYZINE PAMOATEEQ 25MG HYDROCHLORIDECAPSULE / ORALAB1984-06-15d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A088496-001HYDROXYZINE PAMOATEEQ 25MG HYDROCHLORIDECAPSULE / ORALAB1984-06-15d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A088496-001HYDROXYZINE PAMOATEEQ 25MG HYDROCHLORIDECAPSULE / ORALAB1984-06-1579d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A088496-001HYDROXYZINE PAMOATEEQ 25MG HYDROCHLORIDECAPSULE / ORALAB1984-06-15301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A088496-001HYDROXYZINE PAMOATEEQ 25MG HYDROCHLORIDECAPSULE / ORALAB1984-06-151e350fbaab3a…
2024-05-31 18:47 UTC2024-05A088496-001HYDROXYZINE PAMOATEEQ 25MG HYDROCHLORIDECAPSULE / ORALAB1984-06-158072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A088496-001HYDROXYZINE PAMOATEEQ 25MG HYDROCHLORIDECAPSULE / ORALAB1984-06-155c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A088496-001HYDROXYZINE PAMOATEEQ 25MG HYDROCHLORIDECAPSULE / ORALAB1984-06-155d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A088496-001HYDROXYZINE PAMOATEEQ 25MG HYDROCHLORIDECAPSULE / ORALAB1984-06-154b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A088496-001HYDROXYZINE PAMOATEEQ 25MG HYDROCHLORIDECAPSULE / ORALAB1984-06-1574a2ff9319b5…
2022-03-09 01:35 UTC2022-03A088496-001HYDROXYZINE PAMOATEEQ 25MG HYDROCHLORIDECAPSULE / ORALAB1984-06-15bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A088496-001HYDROXYZINE PAMOATEEQ 25MG HYDROCHLORIDECAPSULE / ORALAB1984-06-15782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A088496-001HYDROXYZINE PAMOATEEQ 25MG HYDROCHLORIDECAPSULE / ORALAB1984-06-1587673890dc5c…
2021-03-12 10:30 UTC2021-03A088496-001HYDROXYZINE PAMOATEEQ 25MG HYDROCHLORIDECAPSULE / ORALAB1984-06-155aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A088496-001HYDROXYZINE PAMOATEEQ 25MG HYDROCHLORIDECAPSULE / ORALAB1984-06-158869cabd3fbd…
2020-11-12 02:37 UTC2020-11A088496-001HYDROXYZINE PAMOATEEQ 25MG HYDROCHLORIDECAPSULE / ORALAB1984-06-15c0c555d07b60…
2019-12-14 00:12 UTC2019-12A088496-001HYDROXYZINE PAMOATEEQ 25MG HYDROCHLORIDECAPSULE / ORALAB1984-06-153f01610625f2…
2019-09-15 20:21 UTC2019-09A088496-001HYDROXYZINE PAMOATEEQ 25MG HYDROCHLORIDECAPSULE / ORALAB1984-06-15b00525d2431f…
2019-07-19 19:46 UTC2019-07A088496-001HYDROXYZINE PAMOATEEQ 25MG HYDROCHLORIDECAPSULE / ORALAB1984-06-15ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A088496-001HYDROXYZINE PAMOATEEQ 25MG HYDROCHLORIDECAPSULE / ORALAB1984-06-156a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A088496-001HYDROXYZINE PAMOATEEQ 25MG HYDROCHLORIDECAPSULE / ORALAB1984-06-151c564ffb4f44…
2023-12-20 04:57 UTC2023-12A088496-001HYDROXYZINE PAMOATEEQ 25MG HYDROCHLORIDECAPSULE / ORALAB1984-06-15ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A088496-001HYDROXYZINE PAMOATEEQ 25MG HYDROCHLORIDECAPSULE / ORALAB1984-06-15a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A088496-001HYDROXYZINE PAMOATEEQ 25MG HYDROCHLORIDECAPSULE / ORALAB1984-06-159b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A088496-001HYDROXYZINE PAMOATEEQ 25MG HYDROCHLORIDECAPSULE / ORALAB1984-06-15a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A088496-001HYDROXYZINE PAMOATEEQ 25MG HYDROCHLORIDECAPSULE / ORALAB1984-06-153f0d92c62455…
2023-05-13 08:27 UTC2023-05A088496-001HYDROXYZINE PAMOATEEQ 25MG HYDROCHLORIDECAPSULE / ORALAB1984-06-15053a50430f4f…
2023-01-26 05:58 UTC2023-01A088496-001HYDROXYZINE PAMOATEEQ 25MG HYDROCHLORIDECAPSULE / ORALAB1984-06-153bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A088496-001HYDROXYZINE PAMOATEEQ 25MG HYDROCHLORIDECAPSULE / ORALAB1984-06-153a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A088496-001HYDROXYZINE PAMOATEEQ 25MG HYDROCHLORIDECAPSULE / ORALAB1984-06-15f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09A088496-001HYDROXYZINE PAMOATEEQ 25MG HYDROCHLORIDECAPSULE / ORALAB1984-06-15e64feba35796…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 42 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-08-18 06:07:402026-07A088496-001AB1caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A088496-001AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A088496-001AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08A088496-001AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A088496-001AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A088496-001AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A088496-001AB103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A088496-001AB12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A088496-001AB15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A088496-001AB1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A088496-001AB1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A088496-001AB179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A088496-001AB1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A088496-001AB11e350fbaab3a…
2024-05-31 18:47 UTC2024-05A088496-001AB18072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A088496-001AB15c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A088496-001AB15d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A088496-001AB14b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A088496-001AB174a2ff9319b5…
2022-03-09 01:35 UTC2022-03A088496-001AB1bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A088496-001AB1782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A088496-001AB187673890dc5c…
2021-03-12 10:30 UTC2021-03A088496-001AB15aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A088496-001AB18869cabd3fbd…
2020-11-12 02:37 UTC2020-11A088496-001AB1c0c555d07b60…
2019-12-14 00:12 UTC2019-12A088496-001AB13f01610625f2…
2019-09-15 20:21 UTC2019-09A088496-001AB1b00525d2431f…
2019-07-19 19:46 UTC2019-07A088496-001AB1ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A088496-001AB16a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A088496-001AB11c564ffb4f44…
2023-12-20 04:57 UTC2023-12A088496-001AB1ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A088496-001AB1a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A088496-001AB19b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A088496-001AB1a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A088496-001AB13f0d92c62455…
2023-05-13 08:27 UTC2023-05A088496-001AB1053a50430f4f…
2023-01-26 05:58 UTC2023-01A088496-001AB13bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A088496-001AB13a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A088496-001AB1f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09A088496-001AB1e64feba35796…

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
HYDROXYZINE PAMOATEACTIVE INGREDIENTM20215MUFRHYDROXYZINE PAMOATE CAPSULE [PREFERRED PHARMACEUTICALS, INC.]5
HYDROXYZINEACTIVE MOIETY30S50YM8OGHYDROXYZINE PAMOATE CAPSULE [PREFERRED PHARMACEUTICALS, INC.]5
ALUMINUM OXIDEINACTIVE INGREDIENTLMI26O6933HYDROXYZINE PAMOATE CAPSULE [PREFERRED PHARMACEUTICALS, INC.]5
ANHYDROUS LACTOSEINACTIVE INGREDIENT3SY5LH9PMKHYDROXYZINE PAMOATE CAPSULE [PREFERRED PHARMACEUTICALS, INC.]5
CROSCARMELLOSE SODIUMINACTIVE INGREDIENTM28OL1HH48HYDROXYZINE PAMOATE CAPSULE [PREFERRED PHARMACEUTICALS, INC.]5
D&C RED NO. 28INACTIVE INGREDIENT767IP0Y5NHHYDROXYZINE PAMOATE CAPSULE [PREFERRED PHARMACEUTICALS, INC.]5
D&C YELLOW NO. 10INACTIVE INGREDIENT35SW5USQ3GHYDROXYZINE PAMOATE CAPSULE [PREFERRED PHARMACEUTICALS, INC.]5
FD&C BLUE NO. 1INACTIVE INGREDIENTH3R47K3TBDHYDROXYZINE PAMOATE CAPSULE [PREFERRED PHARMACEUTICALS, INC.]5
FD&C BLUE NO. 2INACTIVE INGREDIENTL06K8R7DQKHYDROXYZINE PAMOATE CAPSULE [PREFERRED PHARMACEUTICALS, INC.]5
FD&C RED NO. 40INACTIVE INGREDIENTWZB9127XOAHYDROXYZINE PAMOATE CAPSULE [PREFERRED PHARMACEUTICALS, INC.]5
FD&C YELLOW NO. 6INACTIVE INGREDIENTH77VEI93A8HYDROXYZINE PAMOATE CAPSULE [PREFERRED PHARMACEUTICALS, INC.]5
FERROSOFERRIC OXIDEINACTIVE INGREDIENTXM0M87F357HYDROXYZINE PAMOATE CAPSULE [PREFERRED PHARMACEUTICALS, INC.]5
GELATININACTIVE INGREDIENT2G86QN327LHYDROXYZINE PAMOATE CAPSULE [PREFERRED PHARMACEUTICALS, INC.]5
INDIGOTINDISULFONATE SODIUMINACTIVE INGREDIENTD3741U8K7LHYDROXYZINE PAMOATE CAPSULE [PREFERRED PHARMACEUTICALS, INC.]5
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30HYDROXYZINE PAMOATE CAPSULE [PREFERRED PHARMACEUTICALS, INC.]5
PROPYLENE GLYCOLINACTIVE INGREDIENT6DC9Q167V3HYDROXYZINE PAMOATE CAPSULE [PREFERRED PHARMACEUTICALS, INC.]5
SHELLACINACTIVE INGREDIENT46N107B71OHYDROXYZINE PAMOATE CAPSULE [PREFERRED PHARMACEUTICALS, INC.]5
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJHYDROXYZINE PAMOATE CAPSULE [PREFERRED PHARMACEUTICALS, INC.]5
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPHYDROXYZINE PAMOATE CAPSULE [PREFERRED PHARMACEUTICALS, INC.]5

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 · 5 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Hydroxyzine PamoateHYDROXYZINE PAMOATEAsclemed USA, Inc.82187031-779e-47bc-943c-eb1a1ef30a7a2025-02-17Warnings, Adverse reactionsExact identifier
application applno (ANDA): 088496
application number: ANDA088496
Hydroxyzine PamoateHYDROXYZINE PAMOATEAmerican Health Packaginge1a7d95c-e6f6-4a89-90b0-002156e90b412024-11-21Warnings, Adverse reactionsExact identifier
application applno (ANDA): 088496
application number: ANDA088496
Hydroxyzine PamoateHYDROXYZINE PAMOATEBryant Ranch Prepackea1c7326-52ea-4934-844c-892d868042cf2023-10-25Warnings, Adverse reactionsExact identifier
application applno (ANDA): 088496
application number: ANDA088496
Hydroxyzine PamoateHYDROXYZINE PAMOATETeva Pharmaceuticals USA, Inc.06068fff-2e79-4721-bcc7-b0938aa20e7a2022-10-01Warnings, Adverse reactionsExact identifier
application applno (ANDA): 088496
application number: ANDA088496
Hydroxyzine PamoateHYDROXYZINE PAMOATEProficient Rx LPb098e287-e489-4cdc-9171-7daf50380c1c2022-06-01Warnings, Adverse reactionsExact identifier
application applno (ANDA): 088496
application number: ANDA088496