Hydroxyzine Hydrochloride

Product NDC
63187-605
Requested package NDC
63187-605-30
11-digit product format
631870605
Labeler code
63187
Product ID
63187-605_189b4ff1-8308-4869-8e33-c0bb7c803b45
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Hydroxyzine Hydrochloride
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Proficient Rx LP
Application
ANDA040804
Marketing category
ANDA
Marketing start
2008-06-30
Marketing end
0000-00-00
Substance
HYDROXYZINE HYDROCHLORIDE
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 · 1 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded packagepackage63187-60563187-605-30DDiscontinued by firm2026-08-10

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 · 12 matching rows.

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

Captured / source date, Snapshot, Source SHA-256 table
Captured / source dateSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-05d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26f5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-312ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28a1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21cfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10cdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20ed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-100efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08ad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-09557ba5c1ecfa…9c80585c8c6e…

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

Orange Book products#

Current product rows page 1 of 1 · 3 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A040804-001HYDROXYZINE HYDROCHLORIDEHYDROXYZINE HYDROCHLORIDE10MGTABLET / ORALAB2008-06-30
A040804-002HYDROXYZINE HYDROCHLORIDEHYDROXYZINE HYDROCHLORIDE25MGTABLET / ORALAB2008-06-30
A040804-003HYDROXYZINE HYDROCHLORIDEHYDROXYZINE HYDROCHLORIDE50MGTABLET / ORALAB2008-06-30

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 3 matching rows.

Application-product, TE code table
Application-productTE code
A040804-001AB
A040804-002AB
A040804-003AB

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 4 · 123 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-02-19 14:30 UTC2026-02A040804-001HYDROXYZINE HYDROCHLORIDE10MGTABLET / ORALAB2008-06-30011fe1cb6892…
2026-02-19 14:30 UTC2026-02A040804-002HYDROXYZINE HYDROCHLORIDE25MGTABLET / ORALAB2008-06-30011fe1cb6892…
2026-02-19 14:30 UTC2026-02A040804-003HYDROXYZINE HYDROCHLORIDE50MGTABLET / ORALAB2008-06-30011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A040804-001HYDROXYZINE HYDROCHLORIDE10MGTABLET / ORALAB2008-06-3031067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A040804-002HYDROXYZINE HYDROCHLORIDE25MGTABLET / ORALAB2008-06-3031067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A040804-003HYDROXYZINE HYDROCHLORIDE50MGTABLET / ORALAB2008-06-3031067a03dcf5…
2025-08-23 18:47 UTC2025-08A040804-001HYDROXYZINE HYDROCHLORIDE10MGTABLET / ORALAB2008-06-306a471c1ec25d…
2025-08-23 18:47 UTC2025-08A040804-002HYDROXYZINE HYDROCHLORIDE25MGTABLET / ORALAB2008-06-306a471c1ec25d…
2025-08-23 18:47 UTC2025-08A040804-003HYDROXYZINE HYDROCHLORIDE50MGTABLET / ORALAB2008-06-306a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A040804-001HYDROXYZINE HYDROCHLORIDE10MGTABLET / ORALAB2008-06-30fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A040804-002HYDROXYZINE HYDROCHLORIDE25MGTABLET / ORALAB2008-06-30fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A040804-003HYDROXYZINE HYDROCHLORIDE50MGTABLET / ORALAB2008-06-30fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A040804-001HYDROXYZINE HYDROCHLORIDE10MGTABLET / ORALAB2008-06-30b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A040804-002HYDROXYZINE HYDROCHLORIDE25MGTABLET / ORALAB2008-06-30b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A040804-003HYDROXYZINE HYDROCHLORIDE50MGTABLET / ORALAB2008-06-30b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A040804-001HYDROXYZINE HYDROCHLORIDE10MGTABLET / ORALAB2008-06-3003ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A040804-002HYDROXYZINE HYDROCHLORIDE25MGTABLET / ORALAB2008-06-3003ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A040804-003HYDROXYZINE HYDROCHLORIDE50MGTABLET / ORALAB2008-06-3003ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A040804-001HYDROXYZINE HYDROCHLORIDE10MGTABLET / ORALAB2008-06-302680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A040804-002HYDROXYZINE HYDROCHLORIDE25MGTABLET / ORALAB2008-06-302680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A040804-003HYDROXYZINE HYDROCHLORIDE50MGTABLET / ORALAB2008-06-302680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A040804-001HYDROXYZINE HYDROCHLORIDE10MGTABLET / ORALAB2008-06-305bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A040804-002HYDROXYZINE HYDROCHLORIDE25MGTABLET / ORALAB2008-06-305bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A040804-003HYDROXYZINE HYDROCHLORIDE50MGTABLET / ORALAB2008-06-305bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A040804-001HYDROXYZINE HYDROCHLORIDE10MGTABLET / ORALAB2008-06-30d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A040804-002HYDROXYZINE HYDROCHLORIDE25MGTABLET / ORALAB2008-06-30d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A040804-003HYDROXYZINE HYDROCHLORIDE50MGTABLET / ORALAB2008-06-30d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A040804-001HYDROXYZINE HYDROCHLORIDE10MGTABLET / ORALAB2008-06-30d06236e962d9…
2024-10-29 15:01 UTC2024-10A040804-002HYDROXYZINE HYDROCHLORIDE25MGTABLET / ORALAB2008-06-30d06236e962d9…
2024-10-29 15:01 UTC2024-10A040804-003HYDROXYZINE HYDROCHLORIDE50MGTABLET / ORALAB2008-06-30d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A040804-001HYDROXYZINE HYDROCHLORIDE10MGTABLET / ORALAB2008-06-3079d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A040804-002HYDROXYZINE HYDROCHLORIDE25MGTABLET / ORALAB2008-06-3079d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A040804-003HYDROXYZINE HYDROCHLORIDE50MGTABLET / ORALAB2008-06-3079d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A040804-001HYDROXYZINE HYDROCHLORIDE10MGTABLET / ORALAB2008-06-30301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A040804-002HYDROXYZINE HYDROCHLORIDE25MGTABLET / ORALAB2008-06-30301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A040804-003HYDROXYZINE HYDROCHLORIDE50MGTABLET / ORALAB2008-06-30301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A040804-001HYDROXYZINE HYDROCHLORIDE10MGTABLET / ORALAB2008-06-301e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A040804-002HYDROXYZINE HYDROCHLORIDE25MGTABLET / ORALAB2008-06-301e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A040804-003HYDROXYZINE HYDROCHLORIDE50MGTABLET / ORALAB2008-06-301e350fbaab3a…
2024-05-31 18:47 UTC2024-05A040804-001HYDROXYZINE HYDROCHLORIDE10MGTABLET / ORALAB2008-06-308072bd15b7f6…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 4 · 123 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-02-19 14:30 UTC2026-02A040804-001AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A040804-002AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A040804-003AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A040804-001AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A040804-002AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A040804-003AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08A040804-001AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A040804-002AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A040804-003AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A040804-001AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A040804-002AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A040804-003AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A040804-001AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A040804-002AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A040804-003AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A040804-001AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A040804-002AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A040804-003AB103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A040804-001AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A040804-002AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A040804-003AB12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A040804-001AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A040804-002AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A040804-003AB15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A040804-001AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A040804-002AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A040804-003AB1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A040804-001AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A040804-002AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A040804-003AB1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A040804-001AB179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A040804-002AB179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A040804-003AB179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A040804-001AB1301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A040804-002AB1301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A040804-003AB1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A040804-001AB11e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A040804-002AB11e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A040804-003AB11e350fbaab3a…
2024-05-31 18:47 UTC2024-05A040804-001AB18072bd15b7f6…

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
63187-605-20EA - Each63187-605180a252c-3385-4dfc-bc0e-6cb58477709a12019-03-12

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 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Hydroxyzine HydrochlorideHYDROXYZINE HYDROCHLORIDEChartwell RX, LLC934afb42-fee8-415b-8090-2265bb299afe2024-10-28Warnings, Adverse reactionsExact identifier
application applno (ANDA): 040804
application number: ANDA040804

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
63187-605-306318706053030 TABLET, FILM COATED in 1 BOTTLE (63187-605-30) 2018-12-010000-00-00NoNoCurrent