HYDROXYZINE PAMOATE

Product NDC
63187-763
11-digit product format
631870763
Labeler code
63187
Product ID
63187-763_1a480466-6b36-42d0-b95f-c783acff1d90
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
HYDROXYZINE PAMOATE
Dosage form
CAPSULE
Route
ORAL
Labeler
Proficient Rx LP
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
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 · 6 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct63187-763DDiscontinued by firm2026-08-03
excluded packagepackage63187-76363187-763-15DDiscontinued by firm2026-08-03
excluded packagepackage63187-76363187-763-20DDiscontinued by firm2026-08-03
excluded packagepackage63187-76363187-763-30DDiscontinued by firm2026-08-03
excluded packagepackage63187-76363187-763-60DDiscontinued by firm2026-08-03
excluded packagepackage63187-76363187-763-90DDiscontinued 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 · 6 matching rows.

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

Dataset, Scope, Package NDC table
DatasetScopePackage NDC
excluded productproduct
excluded packagepackage63187-763-15
excluded packagepackage63187-763-30
excluded packagepackage63187-763-90
excluded packagepackage63187-763-20
excluded packagepackage63187-763-60

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 Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
63187-763-30EA - Each63187-7634c6a2867-538e-4ba8-9f5c-3e70c52f8b7e12017-03-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
63187-763HYDROXYZINE PAMOATE CAPSULE [PROFICIENT RX LP]3Legacy NDC20191115_1020d3cd-c7b8-405a-8538-a16bf10e3ea4.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

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
63187-763-156318707631515 CAPSULE in 1 BOTTLE (63187-763-15) 15 capsule2016-11-010000-00-00NoNoCurrent
63187-763-206318707632020 CAPSULE in 1 BOTTLE (63187-763-20) 20 capsule2016-11-010000-00-00NoNoCurrent
63187-763-306318707633030 CAPSULE in 1 BOTTLE (63187-763-30) 30 capsule2016-11-010000-00-00NoNoCurrent
63187-763-606318707636060 CAPSULE in 1 BOTTLE (63187-763-60) 60 capsule2016-11-010000-00-00NoNoCurrent
63187-763-906318707639090 CAPSULE in 1 BOTTLE (63187-763-90) 90 capsule2016-11-010000-00-00NoNoCurrent