HYDROXYZINE PAMOATE

Product NDC
64980-169
11-digit product format
649800169
Labeler code
64980
Product ID
64980-169_6491d5b0-7f1b-4ac0-8791-308401000e4d
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
HYDROXYZINE PAMOATE
Dosage form
CAPSULE
Route
ORAL
Labeler
Rising Pharmaceuticals Inc.
Application
ANDA201507
Marketing category
ANDA
Marketing start
2010-11-17
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
2019-12-31
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 · 3 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct64980-169DDiscontinued by firm2026-08-03
excluded packagepackage64980-16964980-169-01DDiscontinued by firm2026-08-03
excluded packagepackage64980-16964980-169-05DDiscontinued 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 2 · 63 matching rows.

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

Captured / source date, Dataset, Scope table
Captured / source dateDatasetScopePackage NDCCodeStatusSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-05excluded productproductDDiscontinued by firmd630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage64980-169-05DDiscontinued by firmd630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage64980-169-01DDiscontinued by firmd630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26excluded productproductDDiscontinued by firmf5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage64980-169-05DDiscontinued by firmf5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage64980-169-01DDiscontinued by firmf5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-31excluded productproductIInactivated by FDA2ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage64980-169-01IInactivated by FDA2ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage64980-169-05IInactivated by FDA2ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28excluded productproductIInactivated by FDAa1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage64980-169-01IInactivated by FDAa1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage64980-169-05IInactivated by FDAa1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21excluded productproductIInactivated by FDAcfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage64980-169-01IInactivated by FDAcfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage64980-169-05IInactivated by FDAcfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10excluded productproductIInactivated by FDAcdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage64980-169-01IInactivated by FDAcdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage64980-169-05IInactivated by FDAcdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31excluded productproductIInactivated by FDA302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage64980-169-01IInactivated by FDA302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage64980-169-05IInactivated by FDA302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20excluded productproductIInactivated by FDAed331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage64980-169-01IInactivated by FDAed331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage64980-169-05IInactivated by FDAed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-10excluded productproductIInactivated by FDA0efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage64980-169-01IInactivated by FDA0efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage64980-169-05IInactivated by FDA0efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08excluded productproductIInactivated by FDAad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage64980-169-01IInactivated by FDAad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage64980-169-05IInactivated by FDAad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03excluded productproductIInactivated by FDA367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage64980-169-01IInactivated by FDA367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage64980-169-05IInactivated by FDA367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-09excluded productproductIInactivated by FDA557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage64980-169-01IInactivated by FDA557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage64980-169-05IInactivated by FDA557ba5c1ecfa…9c80585c8c6e…
2024-05-28 21:12 UTC · source 2024-05-28excluded productproductIInactivated by FDA8af77b9d5b6f…d9bbb34c5368…
2024-05-28 21:12 UTC · source 2024-05-28excluded packagepackage64980-169-01IInactivated by FDA8af77b9d5b6f…d9bbb34c5368…
2024-05-28 21:12 UTC · source 2024-05-28excluded packagepackage64980-169-05IInactivated by FDA8af77b9d5b6f…d9bbb34c5368…
2024-05-15 03:39 UTC · source 2024-05-14excluded productproductIInactivated by FDA834df4deac94…adcc014656a3…
2024-05-15 03:39 UTC · source 2024-05-14excluded packagepackage64980-169-01IInactivated by FDA834df4deac94…adcc014656a3…
2024-05-15 03:39 UTC · source 2024-05-14excluded packagepackage64980-169-05IInactivated by FDA834df4deac94…adcc014656a3…
2024-03-11 06:39 UTC · source 2024-03-08excluded productproductIInactivated by FDA1332a3947898…d4bfe170f9cd…
2024-03-11 06:39 UTC · source 2024-03-08excluded packagepackage64980-169-01IInactivated by FDA1332a3947898…d4bfe170f9cd…
2024-03-11 06:39 UTC · source 2024-03-08excluded packagepackage64980-169-05IInactivated by FDA1332a3947898…d4bfe170f9cd…
2022-08-30 03:57 UTC · source 2022-08-29excluded productproductIInactivated by FDAfb8cb913e6d1…eb8c232b6be0…
2022-08-30 03:57 UTC · source 2022-08-29excluded packagepackage64980-169-01IInactivated by FDAfb8cb913e6d1…eb8c232b6be0…
2022-08-30 03:57 UTC · source 2022-08-29excluded packagepackage64980-169-05IInactivated by FDAfb8cb913e6d1…eb8c232b6be0…
2022-04-09 23:13 UTC · source 2022-04-08excluded productproductIInactivated by FDA86f5da6cb304…a595104c45d7…
2022-04-09 23:13 UTC · source 2022-04-08excluded packagepackage64980-169-01IInactivated by FDA86f5da6cb304…a595104c45d7…
2022-04-09 23:13 UTC · source 2022-04-08excluded packagepackage64980-169-05IInactivated by FDA86f5da6cb304…a595104c45d7…
2022-04-04 05:40 UTC · source 2022-04-01excluded productproductIInactivated by FDAbd6a592717d7…303034d00443…
2022-04-04 05:40 UTC · source 2022-04-01excluded packagepackage64980-169-01IInactivated by FDAbd6a592717d7…303034d00443…
2022-04-04 05:40 UTC · source 2022-04-01excluded packagepackage64980-169-05IInactivated by FDAbd6a592717d7…303034d00443…
2021-12-27 23:28 UTC · source 2021-12-27excluded productproductIInactivated by FDA8dfbde2a14a4…c9ff85d89658…
2021-12-27 23:28 UTC · source 2021-12-27excluded packagepackage64980-169-01IInactivated by FDA8dfbde2a14a4…c9ff85d89658…
2021-12-27 23:28 UTC · source 2021-12-27excluded packagepackage64980-169-05IInactivated by FDA8dfbde2a14a4…c9ff85d89658…
2020-12-18 03:04 UTC · source 2020-12-17excluded productproductIInactivated by FDAe2bbac7714bc…27bdfed8d636…
2020-12-18 03:04 UTC · source 2020-12-17excluded packagepackage64980-169-01IInactivated by FDAe2bbac7714bc…27bdfed8d636…
2020-12-18 03:04 UTC · source 2020-12-17excluded packagepackage64980-169-05IInactivated by FDAe2bbac7714bc…27bdfed8d636…

Source provenance: Browse the complete Orange Book source catalog · source snapshot 1.

Orange Book products#

Current product rows page 1 of 1 · 2 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A201507-001HYDROXYZINE PAMOATEHYDROXYZINE PAMOATEEQ 25MG HYDROCHLORIDECAPSULE / ORALAB2013-06-03
A201507-002HYDROXYZINE PAMOATEHYDROXYZINE PAMOATEEQ 50MG HYDROCHLORIDECAPSULE / ORALABRS2013-06-03

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 2 matching rows.

Application-product, TE code table
Application-productTE code
A201507-001AB
A201507-002AB

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 3 · 82 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-02-19 14:30 UTC2026-02A201507-001HYDROXYZINE PAMOATEEQ 25MG HYDROCHLORIDECAPSULE / ORALAB2013-06-03011fe1cb6892…
2026-02-19 14:30 UTC2026-02A201507-002HYDROXYZINE PAMOATEEQ 50MG HYDROCHLORIDECAPSULE / ORALABRS2013-06-03011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A201507-001HYDROXYZINE PAMOATEEQ 25MG HYDROCHLORIDECAPSULE / ORALAB2013-06-0331067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A201507-002HYDROXYZINE PAMOATEEQ 50MG HYDROCHLORIDECAPSULE / ORALABRS2013-06-0331067a03dcf5…
2025-08-23 18:47 UTC2025-08A201507-001HYDROXYZINE PAMOATEEQ 25MG HYDROCHLORIDECAPSULE / ORALAB2013-06-036a471c1ec25d…
2025-08-23 18:47 UTC2025-08A201507-002HYDROXYZINE PAMOATEEQ 50MG HYDROCHLORIDECAPSULE / ORALABRS2013-06-036a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A201507-001HYDROXYZINE PAMOATEEQ 25MG HYDROCHLORIDECAPSULE / ORALAB2013-06-03fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A201507-002HYDROXYZINE PAMOATEEQ 50MG HYDROCHLORIDECAPSULE / ORALABRS2013-06-03fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A201507-001HYDROXYZINE PAMOATEEQ 25MG HYDROCHLORIDECAPSULE / ORALAB2013-06-03b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A201507-002HYDROXYZINE PAMOATEEQ 50MG HYDROCHLORIDECAPSULE / ORALABRS2013-06-03b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A201507-001HYDROXYZINE PAMOATEEQ 25MG HYDROCHLORIDECAPSULE / ORALAB2013-06-0303ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A201507-002HYDROXYZINE PAMOATEEQ 50MG HYDROCHLORIDECAPSULE / ORALABRS2013-06-0303ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A201507-001HYDROXYZINE PAMOATEEQ 25MG HYDROCHLORIDECAPSULE / ORALAB2013-06-032680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A201507-002HYDROXYZINE PAMOATEEQ 50MG HYDROCHLORIDECAPSULE / ORALABRS2013-06-032680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A201507-001HYDROXYZINE PAMOATEEQ 25MG HYDROCHLORIDECAPSULE / ORALAB2013-06-035bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A201507-002HYDROXYZINE PAMOATEEQ 50MG HYDROCHLORIDECAPSULE / ORALABRS2013-06-035bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A201507-001HYDROXYZINE PAMOATEEQ 25MG HYDROCHLORIDECAPSULE / ORALAB2013-06-03d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A201507-002HYDROXYZINE PAMOATEEQ 50MG HYDROCHLORIDECAPSULE / ORALABRS2013-06-03d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A201507-001HYDROXYZINE PAMOATEEQ 25MG HYDROCHLORIDECAPSULE / ORALAB2013-06-03d06236e962d9…
2024-10-29 15:01 UTC2024-10A201507-002HYDROXYZINE PAMOATEEQ 50MG HYDROCHLORIDECAPSULE / ORALABRS2013-06-03d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A201507-001HYDROXYZINE PAMOATEEQ 25MG HYDROCHLORIDECAPSULE / ORALAB2013-06-0379d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A201507-002HYDROXYZINE PAMOATEEQ 50MG HYDROCHLORIDECAPSULE / ORALABRS2013-06-0379d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A201507-001HYDROXYZINE PAMOATEEQ 25MG HYDROCHLORIDECAPSULE / ORALAB2013-06-03301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A201507-002HYDROXYZINE PAMOATEEQ 50MG HYDROCHLORIDECAPSULE / ORALAB2013-06-03301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A201507-001HYDROXYZINE PAMOATEEQ 25MG HYDROCHLORIDECAPSULE / ORALAB2013-06-031e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A201507-002HYDROXYZINE PAMOATEEQ 50MG HYDROCHLORIDECAPSULE / ORALAB2013-06-031e350fbaab3a…
2024-05-31 18:47 UTC2024-05A201507-001HYDROXYZINE PAMOATEEQ 25MG HYDROCHLORIDECAPSULE / ORALAB2013-06-038072bd15b7f6…
2024-05-31 18:47 UTC2024-05A201507-002HYDROXYZINE PAMOATEEQ 50MG HYDROCHLORIDECAPSULE / ORALAB2013-06-038072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A201507-001HYDROXYZINE PAMOATEEQ 25MG HYDROCHLORIDECAPSULE / ORALBX2013-06-035c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A201507-002HYDROXYZINE PAMOATEEQ 50MG HYDROCHLORIDECAPSULE / ORALBX2013-06-035c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A201507-001HYDROXYZINE PAMOATEEQ 25MG HYDROCHLORIDECAPSULE / ORALBX2013-06-035d02ea3f76ae…
2022-04-08 23:34 UTC2022-04A201507-002HYDROXYZINE PAMOATEEQ 50MG HYDROCHLORIDECAPSULE / ORALBX2013-06-035d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A201507-001HYDROXYZINE PAMOATEEQ 25MG HYDROCHLORIDECAPSULE / ORALBX2013-06-034b0b4de00fa7…
2022-04-04 05:41 UTC2022-04A201507-002HYDROXYZINE PAMOATEEQ 50MG HYDROCHLORIDECAPSULE / ORALBX2013-06-034b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A201507-001HYDROXYZINE PAMOATEEQ 25MG HYDROCHLORIDECAPSULE / ORALAB2013-06-0374a2ff9319b5…
2019-12-13 00:20 UTC2019-12A201507-002HYDROXYZINE PAMOATEEQ 50MG HYDROCHLORIDECAPSULE / ORALAB2013-06-0374a2ff9319b5…
2022-03-09 01:35 UTC2022-03A201507-001HYDROXYZINE PAMOATEEQ 25MG HYDROCHLORIDECAPSULE / ORALBX2013-06-03bb7c543d1eb4…
2022-03-09 01:35 UTC2022-03A201507-002HYDROXYZINE PAMOATEEQ 50MG HYDROCHLORIDECAPSULE / ORALBX2013-06-03bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A201507-001HYDROXYZINE PAMOATEEQ 25MG HYDROCHLORIDECAPSULE / ORALBX2013-06-03782e0a99824c…
2021-12-28 21:50 UTC2021-12A201507-002HYDROXYZINE PAMOATEEQ 50MG HYDROCHLORIDECAPSULE / ORALBX2013-06-03782e0a99824c…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 3 · 82 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-02-19 14:30 UTC2026-02A201507-001AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A201507-002AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A201507-001AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A201507-002AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08A201507-001AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A201507-002AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A201507-001AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A201507-002AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A201507-001AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A201507-002AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A201507-001AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A201507-002AB103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A201507-001AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A201507-002AB12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A201507-001AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A201507-002AB15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A201507-001AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A201507-002AB1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A201507-001AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A201507-002AB1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A201507-001AB179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A201507-002AB179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A201507-001AB1301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A201507-002AB1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A201507-001AB11e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A201507-002AB11e350fbaab3a…
2024-05-31 18:47 UTC2024-05A201507-001AB18072bd15b7f6…
2024-05-31 18:47 UTC2024-05A201507-002AB18072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A201507-001BX15c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A201507-002BX15c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A201507-001BX15d02ea3f76ae…
2022-04-08 23:34 UTC2022-04A201507-002BX15d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A201507-001BX14b0b4de00fa7…
2022-04-04 05:41 UTC2022-04A201507-002BX14b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A201507-001AB174a2ff9319b5…
2019-12-13 00:20 UTC2019-12A201507-002AB174a2ff9319b5…
2022-03-09 01:35 UTC2022-03A201507-001BX1bb7c543d1eb4…
2022-03-09 01:35 UTC2022-03A201507-002BX1bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A201507-001BX1782e0a99824c…
2021-12-28 21:50 UTC2021-12A201507-002BX1782e0a99824c…

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

FDA-Initiated Inactive NDC Indexing#

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
64980-169-01EA - Each64980-169478b0198-aff8-46da-b748-de8fdc5efe1012013-11-04
64980-169-05EA - Each64980-1698ab2670d-f753-4ccf-919c-81f654efa62212013-11-04

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
HYDROXYZINE PAMOATEACTIVE INGREDIENTM20215MUFRHYDROXYZINE PAMOATE CAPSULE [RISING PHARMACEUTICALS INC.]10
HYDROXYZINEACTIVE MOIETY30S50YM8OGHYDROXYZINE PAMOATE CAPSULE [RISING PHARMACEUTICALS INC.]10
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UHYDROXYZINE PAMOATE CAPSULE [RISING PHARMACEUTICALS INC.]10
D&C YELLOW NO. 10INACTIVE INGREDIENT35SW5USQ3GHYDROXYZINE PAMOATE CAPSULE [RISING PHARMACEUTICALS INC.]10
FD&C BLUE NO. 1INACTIVE INGREDIENTH3R47K3TBDHYDROXYZINE PAMOATE CAPSULE [RISING PHARMACEUTICALS INC.]10
FD&C RED NO. 40INACTIVE INGREDIENTWZB9127XOAHYDROXYZINE PAMOATE CAPSULE [RISING PHARMACEUTICALS INC.]10
FD&C YELLOW NO. 6INACTIVE INGREDIENTH77VEI93A8HYDROXYZINE PAMOATE CAPSULE [RISING PHARMACEUTICALS INC.]10
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30HYDROXYZINE PAMOATE CAPSULE [RISING PHARMACEUTICALS INC.]10
SODIUM LAURYL SULFATEINACTIVE INGREDIENT368GB5141JHYDROXYZINE PAMOATE CAPSULE [RISING PHARMACEUTICALS INC.]10
SODIUM STARCH GLYCOLATE TYPE A POTATOINACTIVE INGREDIENT5856J3G2A2HYDROXYZINE PAMOATE CAPSULE [RISING PHARMACEUTICALS INC.]10
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJHYDROXYZINE PAMOATE CAPSULE [RISING PHARMACEUTICALS INC.]10
HYDROXYZINE PAMOATEACTIVE INGREDIENTM20215MUFRHYDROXYZINE PAMOATE CAPSULE [TYA PHARMACEUTICALS]4
HYDROXYZINEACTIVE MOIETY30S50YM8OGHYDROXYZINE PAMOATE CAPSULE [TYA PHARMACEUTICALS]4
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UHYDROXYZINE PAMOATE CAPSULE [TYA PHARMACEUTICALS]4
D&C YELLOW NO. 10INACTIVE INGREDIENT35SW5USQ3GHYDROXYZINE PAMOATE CAPSULE [TYA PHARMACEUTICALS]4
FD&C BLUE NO. 1INACTIVE INGREDIENTH3R47K3TBDHYDROXYZINE PAMOATE CAPSULE [TYA PHARMACEUTICALS]4
FD&C RED NO. 40INACTIVE INGREDIENTWZB9127XOAHYDROXYZINE PAMOATE CAPSULE [TYA PHARMACEUTICALS]4
FD&C YELLOW NO. 6INACTIVE INGREDIENTH77VEI93A8HYDROXYZINE PAMOATE CAPSULE [TYA PHARMACEUTICALS]4
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30HYDROXYZINE PAMOATE CAPSULE [TYA PHARMACEUTICALS]4
SODIUM LAURYL SULFATEINACTIVE INGREDIENT368GB5141JHYDROXYZINE PAMOATE CAPSULE [TYA PHARMACEUTICALS]4
SODIUM STARCH GLYCOLATE TYPE A POTATOINACTIVE INGREDIENT5856J3G2A2HYDROXYZINE PAMOATE CAPSULE [TYA PHARMACEUTICALS]4
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJHYDROXYZINE PAMOATE CAPSULE [TYA PHARMACEUTICALS]4
HYDROXYZINE PAMOATEACTIVE INGREDIENTM20215MUFRHYDROXYZINE PAMOATE CAPSULE [PREFERRED PHARMACEUTICALS, INC.]3
HYDROXYZINE PAMOATEACTIVE INGREDIENTM20215MUFRHYDROXYZINE PAMOATE CAPSULE [STATE OF FLORIDA DOH CENTRAL PHARMACY]3
HYDROXYZINEACTIVE MOIETY30S50YM8OGHYDROXYZINE PAMOATE CAPSULE [PREFERRED PHARMACEUTICALS, INC.]3
HYDROXYZINEACTIVE MOIETY30S50YM8OGHYDROXYZINE PAMOATE CAPSULE [STATE OF FLORIDA DOH CENTRAL PHARMACY]3
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UHYDROXYZINE PAMOATE CAPSULE [PREFERRED PHARMACEUTICALS, INC.]3
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UHYDROXYZINE PAMOATE CAPSULE [STATE OF FLORIDA DOH CENTRAL PHARMACY]3
D&C YELLOW NO. 10INACTIVE INGREDIENT35SW5USQ3GHYDROXYZINE PAMOATE CAPSULE [PREFERRED PHARMACEUTICALS, INC.]3
D&C YELLOW NO. 10INACTIVE INGREDIENT35SW5USQ3GHYDROXYZINE PAMOATE CAPSULE [STATE OF FLORIDA DOH CENTRAL PHARMACY]3
FD&C BLUE NO. 1INACTIVE INGREDIENTH3R47K3TBDHYDROXYZINE PAMOATE CAPSULE [PREFERRED PHARMACEUTICALS, INC.]3
FD&C BLUE NO. 1INACTIVE INGREDIENTH3R47K3TBDHYDROXYZINE PAMOATE CAPSULE [STATE OF FLORIDA DOH CENTRAL PHARMACY]3
FD&C RED NO. 40INACTIVE INGREDIENTWZB9127XOAHYDROXYZINE PAMOATE CAPSULE [PREFERRED PHARMACEUTICALS, INC.]3
FD&C RED NO. 40INACTIVE INGREDIENTWZB9127XOAHYDROXYZINE PAMOATE CAPSULE [STATE OF FLORIDA DOH CENTRAL PHARMACY]3
FD&C YELLOW NO. 6INACTIVE INGREDIENTH77VEI93A8HYDROXYZINE PAMOATE CAPSULE [STATE OF FLORIDA DOH CENTRAL PHARMACY]3
FD&C YELLOW NO. 6INACTIVE INGREDIENTH77VEI93A8HYDROXYZINE PAMOATE CAPSULE [PREFERRED PHARMACEUTICALS, INC.]3
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30HYDROXYZINE PAMOATE CAPSULE [STATE OF FLORIDA DOH CENTRAL PHARMACY]3
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30HYDROXYZINE PAMOATE CAPSULE [PREFERRED PHARMACEUTICALS, INC.]3
SODIUM LAURYL SULFATEINACTIVE INGREDIENT368GB5141JHYDROXYZINE PAMOATE CAPSULE [PREFERRED PHARMACEUTICALS, INC.]3
SODIUM LAURYL SULFATEINACTIVE INGREDIENT368GB5141JHYDROXYZINE PAMOATE CAPSULE [STATE OF FLORIDA DOH CENTRAL PHARMACY]3
SODIUM STARCH GLYCOLATE TYPE A POTATOINACTIVE INGREDIENT5856J3G2A2HYDROXYZINE PAMOATE CAPSULE [STATE OF FLORIDA DOH CENTRAL PHARMACY]3
SODIUM STARCH GLYCOLATE TYPE A POTATOINACTIVE INGREDIENT5856J3G2A2HYDROXYZINE PAMOATE CAPSULE [PREFERRED PHARMACEUTICALS, INC.]3
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJHYDROXYZINE PAMOATE CAPSULE [PREFERRED PHARMACEUTICALS, INC.]3
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJHYDROXYZINE PAMOATE CAPSULE [STATE OF FLORIDA DOH CENTRAL PHARMACY]3
HYDROXYZINE PAMOATEACTIVE INGREDIENTM20215MUFRHYDROXYZINE PAMOATE CAPSULE [GOLDEN STATE MEDICAL SUPPLY, INC.]1
HYDROXYZINEACTIVE MOIETY30S50YM8OGHYDROXYZINE PAMOATE CAPSULE [GOLDEN STATE MEDICAL SUPPLY, INC.]1
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UHYDROXYZINE PAMOATE CAPSULE [GOLDEN STATE MEDICAL SUPPLY, INC.]1
D&C YELLOW NO. 10INACTIVE INGREDIENT35SW5USQ3GHYDROXYZINE PAMOATE CAPSULE [GOLDEN STATE MEDICAL SUPPLY, INC.]1
FD&C BLUE NO. 1INACTIVE INGREDIENTH3R47K3TBDHYDROXYZINE PAMOATE CAPSULE [GOLDEN STATE MEDICAL SUPPLY, INC.]1
FD&C RED NO. 40INACTIVE INGREDIENTWZB9127XOAHYDROXYZINE PAMOATE CAPSULE [GOLDEN STATE MEDICAL SUPPLY, INC.]1
FD&C YELLOW NO. 6INACTIVE INGREDIENTH77VEI93A8HYDROXYZINE PAMOATE CAPSULE [GOLDEN STATE MEDICAL SUPPLY, INC.]1
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30HYDROXYZINE PAMOATE CAPSULE [GOLDEN STATE MEDICAL SUPPLY, INC.]1
SODIUM LAURYL SULFATEINACTIVE INGREDIENT368GB5141JHYDROXYZINE PAMOATE CAPSULE [GOLDEN STATE MEDICAL SUPPLY, INC.]1
SODIUM STARCH GLYCOLATE TYPE A POTATOINACTIVE INGREDIENT5856J3G2A2HYDROXYZINE PAMOATE CAPSULE [GOLDEN STATE MEDICAL SUPPLY, INC.]1
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJHYDROXYZINE PAMOATE CAPSULE [GOLDEN STATE MEDICAL SUPPLY, INC.]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
64980-169HYDROXYZINE PAMOATE CAPSULE [RISING PHARMACEUTICALS INC.]11Legacy NDC20170411_28cf4268-b8b6-4fd5-9bc6-3d44cba6cb38.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 · 21 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
hydroxyzine pamoateHYDROXYZINE PAMOATECardinal Health 107, LLC6ffb7c82-f780-4527-a7c3-e7d0f7b3b91e2026-05-18Warnings, Adverse reactionsExact identifier
application applno (ANDA): 201507
application number: ANDA201507
hydroxyzine pamoateHYDROXYZINE PAMOATECoupler LLC5020c699-6fc5-b166-e063-6294a90a58812026-04-23Warnings, Adverse reactionsExact identifier
application applno (ANDA): 201507
application number: ANDA201507
hydroxyzine pamoateHYDROXYZINE PAMOATEPreferred Pharmaceuticals Inc.b903f7e1-250d-46d8-a1ec-3f1dabc597f12026-01-23Warnings, Adverse reactionsExact identifier
application applno (ANDA): 201507
application number: ANDA201507
hydroxyzine pamoateHYDROXYZINE PAMOATENorthwind Health Company, LLC127617c2-9775-3859-e063-6394a90a77cd2026-01-05Warnings, Adverse reactionsExact identifier
application applno (ANDA): 201507
application number: ANDA201507
hydroxyzine pamoateHYDROXYZINE PAMOATENorthwind Health Company, LLCdb8987d6-9814-50f6-e053-2a95a90a82a92026-01-01Warnings, Adverse reactionsExact identifier
application applno (ANDA): 201507
application number: ANDA201507
Hydroxyzine pamoateHYDROXYZINE PAMOATEChartwell RX, LLCabe7280a-1f6a-404b-9874-7710121e20902025-12-10Warnings, Adverse reactionsExact identifier
application applno (ANDA): 201507
application number: ANDA201507
hydroxyzine pamoateHYDROXYZINE PAMOATEMajor Pharmaceuticalsf28f2a1b-8d65-4646-bd99-6e77617f9e1f2025-12-10Warnings, Adverse reactionsExact identifier
application applno (ANDA): 201507
application number: ANDA201507
hydroxyzine pamoateHYDROXYZINE PAMOATEBryant Ranch Prepack7996dfa3-7f34-4d20-acaa-7f6fc021fc802025-09-23Warnings, Adverse reactionsExact identifier
application applno (ANDA): 201507
application number: ANDA201507
hydroxyzine pamoateHYDROXYZINE PAMOATEREMEDYREPACK INC.c0f7f48d-e39c-4981-9c0e-5c2eccaba4242025-09-11Warnings, Adverse reactionsExact identifier
application applno (ANDA): 201507
application number: ANDA201507
hydroxyzine pamoateHYDROXYZINE PAMOATEGolden State Medical Supply, Inc.240fd428-15af-e7d0-e063-6394a90acbc52025-08-06Warnings, Adverse reactionsExact identifier
application applno (ANDA): 201507
application number: ANDA201507
hydroxyzine pamoateHYDROXYZINE PAMOATEHeritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc.734d32c8-38d3-430f-a2b3-539e03a3687a2025-07-08Warnings, Adverse reactionsExact identifier
application applno (ANDA): 201507
application number: ANDA201507
hydroxyzine pamoateHYDROXYZINE PAMOATEPreferred Pharmaceuticals, Inc.2a66117a-fcd4-4094-927c-3a7699ef96602025-06-27Warnings, Adverse reactionsExact identifier
application applno (ANDA): 201507
application number: ANDA201507
hydroxyzine pamoateHYDROXYZINE PAMOATEA-S Medication Solutions74bf62c3-b444-46dc-aab6-af74b101a68a2025-04-28Warnings, Adverse reactionsExact identifier
application applno (ANDA): 201507
application number: ANDA201507
hydroxyzine pamoateHYDROXYZINE PAMOATEAphena Pharma Solutions - Tennessee, LLC308cd178-a9d2-3132-e063-6394a90a73572025-04-28Warnings, Adverse reactionsExact identifier
application applno (ANDA): 201507
application number: ANDA201507
Hydroxyzine PamoateHYDROXYZINE PAMOATEDirect_Rx8c395a13-9da3-7b77-e053-2995a90a19162025-01-22Warnings, Adverse reactionsExact identifier
application applno (ANDA): 201507
application number: ANDA201507
hydroxyzine pamoateHYDROXYZINE PAMOATEA-S Medication Solutionsa31271f0-ac60-4fda-b1f5-ddf7241c8a0e2024-10-09Warnings, Adverse reactionsExact identifier
application applno (ANDA): 201507
application number: ANDA201507
hydroxyzine pamoateHYDROXYZINE PAMOATENuCare Pharmaceuticals,Inc.8cb94f1d-1e45-531a-e053-2a95a90a1ba02024-06-18Warnings, Adverse reactionsExact identifier
application applno (ANDA): 201507
application number: ANDA201507
hydroxyzine pamoateHYDROXYZINE PAMOATEBryant Ranch Prepackdde576e9-fb6b-40d2-a81f-ebb8656c4c9c2024-05-17Warnings, Adverse reactionsExact identifier
application applno (ANDA): 201507
application number: ANDA201507
hydroxyzine pamoateHYDROXYZINE PAMOATENuCare Pharmaceuticals,Inc.1302c511-eb25-5818-e063-6394a90a92252024-03-06Warnings, Adverse reactionsExact identifier
application applno (ANDA): 201507
application number: ANDA201507
hydroxyzine pamoateHYDROXYZINE PAMOATEAphena Pharma Solutions - Tennessee, LLC78005ad7-290c-4716-937f-f0ec82f4e6072024-02-06Warnings, Adverse reactionsExact identifier
application applno (ANDA): 201507
application number: ANDA201507

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
995253hydrOXYzine pamoate 25 MG Oral CapsulePSN873ccc16-b42f-408b-87ba-d336b09d79719
995253hydroxyzine pamoate 25 MG Oral CapsuleSCD873ccc16-b42f-408b-87ba-d336b09d79719
995253hydrOXYzine pamoate 25 MG Oral CapsulePSN29130fb6-7920-4cea-af10-7d23029a71404
995278hydrOXYzine pamoate 50 MG Oral CapsulePSN29130fb6-7920-4cea-af10-7d23029a71404
995253hydroxyzine pamoate 25 MG Oral CapsuleSCD29130fb6-7920-4cea-af10-7d23029a71404
995278hydroxyzine pamoate 50 MG Oral CapsuleSCD29130fb6-7920-4cea-af10-7d23029a71404
995278hydroxyzine pamoate 50 MG (hydroxyzine pamoate 85.2 MG eqv to hydroxyzine HCl 50 MG) Oral CapsuleSY29130fb6-7920-4cea-af10-7d23029a71404
995253hydrOXYzine pamoate 25 MG Oral CapsulePSNcc4651a4-7460-4fa8-8d21-26e1968682f63
995253hydrOXYzine pamoate 25 MG Oral CapsulePSN4d226b9a-bd9b-4bc0-e054-00144ff8d46c3
995253hydrOXYzine pamoate 25 MG Oral CapsulePSN7adec0fc-385b-4e2b-b7c5-318cc17ce9a53
995278hydrOXYzine pamoate 50 MG Oral CapsulePSN4d226b9a-bd9b-4bc0-e054-00144ff8d46c3
995253hydroxyzine pamoate 25 MG Oral CapsuleSCD7adec0fc-385b-4e2b-b7c5-318cc17ce9a53
995253hydroxyzine pamoate 25 MG Oral CapsuleSCD4d226b9a-bd9b-4bc0-e054-00144ff8d46c3
995253hydroxyzine pamoate 25 MG Oral CapsuleSCDcc4651a4-7460-4fa8-8d21-26e1968682f63
995278hydroxyzine pamoate 50 MG Oral CapsuleSCD4d226b9a-bd9b-4bc0-e054-00144ff8d46c3
995278hydroxyzine pamoate 50 MG (hydroxyzine pamoate 85.2 MG eqv to hydroxyzine HCl 50 MG) Oral CapsuleSY4d226b9a-bd9b-4bc0-e054-00144ff8d46c3
995253hydrOXYzine pamoate 25 MG Oral CapsulePSN480add5c-5f90-69d8-e054-00144ff88e882
995253hydroxyzine pamoate 25 MG Oral CapsuleSCD480add5c-5f90-69d8-e054-00144ff88e882
995253hydrOXYzine pamoate 25 MG Oral CapsulePSNa50ee238-faef-a1da-e053-2a95a90af9651
995253hydrOXYzine pamoate 25 MG Oral CapsulePSNa852d881-3c34-447e-9ed8-1d547cefb75e1
995253hydroxyzine pamoate 25 MG Oral CapsuleSCDa50ee238-faef-a1da-e053-2a95a90af9651
995253hydroxyzine pamoate 25 MG Oral CapsuleSCDa852d881-3c34-447e-9ed8-1d547cefb75e1