Hydroxyzine Pamoate

Product NDC
70518-3311
11-digit product format
705183311
Labeler code
70518
Product ID
70518-3311_ea4dc439-f085-3f0b-e053-2995a90ae4f6
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Hydroxyzine Pamoate
Dosage form
CAPSULE
Route
ORAL
Labeler
REMEDYREPACK INC.
Application
ANDA088487
Marketing category
ANDA
Marketing start
2021-12-27
Marketing end
0000-00-00
Substance
HYDROXYZINE PAMOATE
Active strength
50 mg/1
Pharmacologic classes
Antihistamine [EPC], Histamine Receptor Antagonists [MoA]
NDC exclude flag
No
Listing certified through
2023-12-31
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 · 5 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct70518-3311DDiscontinued by firm2026-08-03
excluded packagepackage70518-331170518-3311-0DDiscontinued by firm2026-08-03
excluded packagepackage70518-331170518-3311-2DDiscontinued by firm2026-08-03
excluded packagepackage70518-331170518-3311-3DDiscontinued by firm2026-08-03
excluded packagepackage70518-331170518-3311-4DDiscontinued 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 · 29 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 packagepackage70518-3311-0d630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage70518-3311-2d630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage70518-3311-3d630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage70518-3311-4d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26excluded productproductf5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage70518-3311-0f5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage70518-3311-2f5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage70518-3311-3f5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage70518-3311-4f5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage70518-3311-02ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage70518-3311-22ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage70518-3311-0a1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage70518-3311-2a1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage70518-3311-0cfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage70518-3311-2cfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage70518-3311-0cdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage70518-3311-2cdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage70518-3311-0302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage70518-3311-2302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage70518-3311-0ed331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage70518-3311-2ed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage70518-3311-00efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage70518-3311-20efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage70518-3311-0ad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage70518-3311-2ad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage70518-3311-0367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage70518-3311-2367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage70518-3311-0557ba5c1ecfa…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
A088487-001HYDROXYZINE PAMOATEHYDROXYZINE PAMOATEEQ 50MG 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
A088487-001AB

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 UTC2026-02A088487-001HYDROXYZINE PAMOATEEQ 50MG HYDROCHLORIDECAPSULE / ORALAB1984-06-15011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A088487-001HYDROXYZINE PAMOATEEQ 50MG HYDROCHLORIDECAPSULE / ORALAB1984-06-1531067a03dcf5…
2025-08-23 18:47 UTC2025-08A088487-001HYDROXYZINE PAMOATEEQ 50MG HYDROCHLORIDECAPSULE / ORALAB1984-06-156a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A088487-001HYDROXYZINE PAMOATEEQ 50MG HYDROCHLORIDECAPSULE / ORALAB1984-06-15fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A088487-001HYDROXYZINE PAMOATEEQ 50MG HYDROCHLORIDECAPSULE / ORALAB1984-06-15b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A088487-001HYDROXYZINE PAMOATEEQ 50MG HYDROCHLORIDECAPSULE / ORALAB1984-06-1503ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A088487-001HYDROXYZINE PAMOATEEQ 50MG HYDROCHLORIDECAPSULE / ORALAB1984-06-152680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A088487-001HYDROXYZINE PAMOATEEQ 50MG HYDROCHLORIDECAPSULE / ORALAB1984-06-155bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A088487-001HYDROXYZINE PAMOATEEQ 50MG HYDROCHLORIDECAPSULE / ORALAB1984-06-15d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A088487-001HYDROXYZINE PAMOATEEQ 50MG HYDROCHLORIDECAPSULE / ORALAB1984-06-15d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A088487-001HYDROXYZINE PAMOATEEQ 50MG HYDROCHLORIDECAPSULE / ORALAB1984-06-1579d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A088487-001HYDROXYZINE PAMOATEEQ 50MG HYDROCHLORIDECAPSULE / ORALAB1984-06-15301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A088487-001HYDROXYZINE PAMOATEEQ 50MG HYDROCHLORIDECAPSULE / ORALAB1984-06-151e350fbaab3a…
2024-05-31 18:47 UTC2024-05A088487-001HYDROXYZINE PAMOATEEQ 50MG HYDROCHLORIDECAPSULE / ORALAB1984-06-158072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A088487-001HYDROXYZINE PAMOATEEQ 50MG HYDROCHLORIDECAPSULE / ORALAB1984-06-155c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A088487-001HYDROXYZINE PAMOATEEQ 50MG HYDROCHLORIDECAPSULE / ORALAB1984-06-155d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A088487-001HYDROXYZINE PAMOATEEQ 50MG HYDROCHLORIDECAPSULE / ORALAB1984-06-154b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A088487-001HYDROXYZINE PAMOATEEQ 50MG HYDROCHLORIDECAPSULE / ORALAB1984-06-1574a2ff9319b5…
2022-03-09 01:35 UTC2022-03A088487-001HYDROXYZINE PAMOATEEQ 50MG HYDROCHLORIDECAPSULE / ORALAB1984-06-15bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A088487-001HYDROXYZINE PAMOATEEQ 50MG HYDROCHLORIDECAPSULE / ORALAB1984-06-15782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A088487-001HYDROXYZINE PAMOATEEQ 50MG HYDROCHLORIDECAPSULE / ORALAB1984-06-1587673890dc5c…
2021-03-12 10:30 UTC2021-03A088487-001HYDROXYZINE PAMOATEEQ 50MG HYDROCHLORIDECAPSULE / ORALAB1984-06-155aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A088487-001HYDROXYZINE PAMOATEEQ 50MG HYDROCHLORIDECAPSULE / ORALAB1984-06-158869cabd3fbd…
2020-11-12 02:37 UTC2020-11A088487-001HYDROXYZINE PAMOATEEQ 50MG HYDROCHLORIDECAPSULE / ORALAB1984-06-15c0c555d07b60…
2019-12-14 00:12 UTC2019-12A088487-001HYDROXYZINE PAMOATEEQ 50MG HYDROCHLORIDECAPSULE / ORALAB1984-06-153f01610625f2…
2019-09-15 20:21 UTC2019-09A088487-001HYDROXYZINE PAMOATEEQ 50MG HYDROCHLORIDECAPSULE / ORALAB1984-06-15b00525d2431f…
2019-07-19 19:46 UTC2019-07A088487-001HYDROXYZINE PAMOATEEQ 50MG HYDROCHLORIDECAPSULE / ORALAB1984-06-15ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A088487-001HYDROXYZINE PAMOATEEQ 50MG HYDROCHLORIDECAPSULE / ORALAB1984-06-156a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A088487-001HYDROXYZINE PAMOATEEQ 50MG HYDROCHLORIDECAPSULE / ORALAB1984-06-151c564ffb4f44…
2023-12-20 04:57 UTC2023-12A088487-001HYDROXYZINE PAMOATEEQ 50MG HYDROCHLORIDECAPSULE / ORALAB1984-06-15ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A088487-001HYDROXYZINE PAMOATEEQ 50MG HYDROCHLORIDECAPSULE / ORALAB1984-06-15a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A088487-001HYDROXYZINE PAMOATEEQ 50MG HYDROCHLORIDECAPSULE / ORALAB1984-06-159b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A088487-001HYDROXYZINE PAMOATEEQ 50MG HYDROCHLORIDECAPSULE / ORALAB1984-06-15a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A088487-001HYDROXYZINE PAMOATEEQ 50MG HYDROCHLORIDECAPSULE / ORALAB1984-06-153f0d92c62455…
2023-05-13 08:27 UTC2023-05A088487-001HYDROXYZINE PAMOATEEQ 50MG HYDROCHLORIDECAPSULE / ORALAB1984-06-15053a50430f4f…
2023-01-26 05:58 UTC2023-01A088487-001HYDROXYZINE PAMOATEEQ 50MG HYDROCHLORIDECAPSULE / ORALAB1984-06-153bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A088487-001HYDROXYZINE PAMOATEEQ 50MG HYDROCHLORIDECAPSULE / ORALAB1984-06-153a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A088487-001HYDROXYZINE PAMOATEEQ 50MG HYDROCHLORIDECAPSULE / ORALAB1984-06-15f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09A088487-001HYDROXYZINE PAMOATEEQ 50MG HYDROCHLORIDECAPSULE / ORALAB1984-06-15e64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07A088487-001HYDROXYZINE PAMOATEEQ 50MG HYDROCHLORIDECAPSULE / ORALAB1984-06-15cb3db0bc1861…

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 UTC2026-02A088487-001AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A088487-001AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08A088487-001AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A088487-001AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A088487-001AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A088487-001AB103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A088487-001AB12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A088487-001AB15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A088487-001AB1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A088487-001AB1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A088487-001AB179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A088487-001AB1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A088487-001AB11e350fbaab3a…
2024-05-31 18:47 UTC2024-05A088487-001AB18072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A088487-001AB15c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A088487-001AB15d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A088487-001AB14b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A088487-001AB174a2ff9319b5…
2022-03-09 01:35 UTC2022-03A088487-001AB1bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A088487-001AB1782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A088487-001AB187673890dc5c…
2021-03-12 10:30 UTC2021-03A088487-001AB15aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A088487-001AB18869cabd3fbd…
2020-11-12 02:37 UTC2020-11A088487-001AB1c0c555d07b60…
2019-12-14 00:12 UTC2019-12A088487-001AB13f01610625f2…
2019-09-15 20:21 UTC2019-09A088487-001AB1b00525d2431f…
2019-07-19 19:46 UTC2019-07A088487-001AB1ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A088487-001AB16a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A088487-001AB11c564ffb4f44…
2023-12-20 04:57 UTC2023-12A088487-001AB1ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A088487-001AB1a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A088487-001AB19b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A088487-001AB1a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A088487-001AB13f0d92c62455…
2023-05-13 08:27 UTC2023-05A088487-001AB1053a50430f4f…
2023-01-26 05:58 UTC2023-01A088487-001AB13bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A088487-001AB13a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A088487-001AB1f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09A088487-001AB1e64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07A088487-001AB1cb3db0bc1861…

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
70518-3311HYDROXYZINE PAMOATE CAPSULE [REMEDYREPACK INC.]7Legacy NDC20241003_0db57673-7315-448f-8a99-a11ea2c4b237.zip

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 4 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Hydroxyzine PamoateHYDROXYZINE PAMOATENorthwind Health Company, LLCfaf7932b-40ee-8822-e053-6394a90a5e402026-01-01Warnings, Adverse reactionsExact identifier
application applno (ANDA): 088487
application number: ANDA088487
Hydroxyzine PamoateHYDROXYZINE PAMOATEAsclemed USA, Inc.82187031-779e-47bc-943c-eb1a1ef30a7a2025-02-17Warnings, Adverse reactionsExact identifier
application applno (ANDA): 088487
application number: ANDA088487
Hydroxyzine PamoateHYDROXYZINE PAMOATEAmerican Health Packaginge1a7d95c-e6f6-4a89-90b0-002156e90b412024-11-21Warnings, Adverse reactionsExact identifier
application applno (ANDA): 088487
application number: ANDA088487
Hydroxyzine PamoateHYDROXYZINE PAMOATETeva Pharmaceuticals USA, Inc.06068fff-2e79-4721-bcc7-b0938aa20e7a2022-10-01Warnings, Adverse reactionsExact identifier
application applno (ANDA): 088487
application number: ANDA088487

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
70518-3311-070518331100100 POUCH in 1 BOX (70518-3311-0) > 1 CAPSULE in 1 POUCH (70518-3311-1) 100 pouch2021-12-270000-00-00NoNoCurrent
70518-3311-27051833110230 CAPSULE in 1 BLISTER PACK (70518-3311-2) 30 capsule2022-03-210000-00-00NoNoCurrent
70518-3311-37051833110330 CAPSULE in 1 BLISTER PACK (70518-3311-3) 30 capsule2022-08-250000-00-00NoNoCurrent