Hydroxyzine Hydrochloride

Product NDC
70934-285
Requested package NDC
70934-285-30
11-digit product format
709340285
Labeler code
70934
Product ID
70934-285_a12b33f3-4853-26e8-e053-2995a90afb0a
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Hydroxyzine Hydrochloride
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Denton Pharma, Inc. DBA Northwind Pharmaceuticals
Application
ANDA040604
Marketing category
ANDA
Marketing start
2019-02-15
Marketing end
0000-00-00
Substance
HYDROXYZINE HYDROCHLORIDE
Active strength
50 mg/1
Pharmacologic classes
Antihistamine [EPC],Histamine Receptor Antagonists [MoA]
NDC exclude flag
No
Listing certified through
2021-12-31
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 packagepackage70934-28570934-285-30IInactivated by FDA2026-08-17

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 1 · 15 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…
2024-05-28 21:12 UTC · source 2024-05-288af77b9d5b6f…d9bbb34c5368…
2024-05-15 03:39 UTC · source 2024-05-14834df4deac94…adcc014656a3…
2024-03-11 06:39 UTC · source 2024-03-081332a3947898…d4bfe170f9cd…

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

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
A040604-001HYDROXYZINE HYDROCHLORIDEHYDROXYZINE HYDROCHLORIDE50MGTABLET / ORALAB2004-12-28
A040604-002HYDROXYZINE HYDROCHLORIDEHYDROXYZINE HYDROCHLORIDE10MGTABLET / ORALAB2004-12-28
A040604-003HYDROXYZINE HYDROCHLORIDEHYDROXYZINE HYDROCHLORIDE25MGTABLET / ORALAB2004-12-28

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A040604-001AB
A040604-002AB
A040604-003AB

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 · 126 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-08-18 06:07:402026-07A040604-001HYDROXYZINE HYDROCHLORIDE50MGTABLET / ORALAB2004-12-28caaa826d4ba7…
2026-08-18 06:07:402026-07A040604-002HYDROXYZINE HYDROCHLORIDE10MGTABLET / ORALAB2004-12-28caaa826d4ba7…
2026-08-18 06:07:402026-07A040604-003HYDROXYZINE HYDROCHLORIDE25MGTABLET / ORALAB2004-12-28caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A040604-001HYDROXYZINE HYDROCHLORIDE50MGTABLET / ORALAB2004-12-28011fe1cb6892…
2026-02-19 14:30 UTC2026-02A040604-002HYDROXYZINE HYDROCHLORIDE10MGTABLET / ORALAB2004-12-28011fe1cb6892…
2026-02-19 14:30 UTC2026-02A040604-003HYDROXYZINE HYDROCHLORIDE25MGTABLET / ORALAB2004-12-28011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A040604-001HYDROXYZINE HYDROCHLORIDE50MGTABLET / ORALAB2004-12-2831067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A040604-002HYDROXYZINE HYDROCHLORIDE10MGTABLET / ORALAB2004-12-2831067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A040604-003HYDROXYZINE HYDROCHLORIDE25MGTABLET / ORALAB2004-12-2831067a03dcf5…
2025-08-23 18:47 UTC2025-08A040604-001HYDROXYZINE HYDROCHLORIDE50MGTABLET / ORALAB2004-12-286a471c1ec25d…
2025-08-23 18:47 UTC2025-08A040604-002HYDROXYZINE HYDROCHLORIDE10MGTABLET / ORALAB2004-12-286a471c1ec25d…
2025-08-23 18:47 UTC2025-08A040604-003HYDROXYZINE HYDROCHLORIDE25MGTABLET / ORALAB2004-12-286a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A040604-001HYDROXYZINE HYDROCHLORIDE50MGTABLET / ORALAB2004-12-28fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A040604-002HYDROXYZINE HYDROCHLORIDE10MGTABLET / ORALAB2004-12-28fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A040604-003HYDROXYZINE HYDROCHLORIDE25MGTABLET / ORALAB2004-12-28fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A040604-001HYDROXYZINE HYDROCHLORIDE50MGTABLET / ORALAB2004-12-28b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A040604-002HYDROXYZINE HYDROCHLORIDE10MGTABLET / ORALAB2004-12-28b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A040604-003HYDROXYZINE HYDROCHLORIDE25MGTABLET / ORALAB2004-12-28b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A040604-001HYDROXYZINE HYDROCHLORIDE50MGTABLET / ORALAB2004-12-2803ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A040604-002HYDROXYZINE HYDROCHLORIDE10MGTABLET / ORALAB2004-12-2803ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A040604-003HYDROXYZINE HYDROCHLORIDE25MGTABLET / ORALAB2004-12-2803ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A040604-001HYDROXYZINE HYDROCHLORIDE50MGTABLET / ORALAB2004-12-282680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A040604-002HYDROXYZINE HYDROCHLORIDE10MGTABLET / ORALAB2004-12-282680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A040604-003HYDROXYZINE HYDROCHLORIDE25MGTABLET / ORALAB2004-12-282680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A040604-001HYDROXYZINE HYDROCHLORIDE50MGTABLET / ORALAB2004-12-285bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A040604-002HYDROXYZINE HYDROCHLORIDE10MGTABLET / ORALAB2004-12-285bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A040604-003HYDROXYZINE HYDROCHLORIDE25MGTABLET / ORALAB2004-12-285bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A040604-001HYDROXYZINE HYDROCHLORIDE50MGTABLET / ORALAB2004-12-28d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A040604-002HYDROXYZINE HYDROCHLORIDE10MGTABLET / ORALAB2004-12-28d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A040604-003HYDROXYZINE HYDROCHLORIDE25MGTABLET / ORALAB2004-12-28d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A040604-001HYDROXYZINE HYDROCHLORIDE50MGTABLET / ORALAB2004-12-28d06236e962d9…
2024-10-29 15:01 UTC2024-10A040604-002HYDROXYZINE HYDROCHLORIDE10MGTABLET / ORALAB2004-12-28d06236e962d9…
2024-10-29 15:01 UTC2024-10A040604-003HYDROXYZINE HYDROCHLORIDE25MGTABLET / ORALAB2004-12-28d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A040604-001HYDROXYZINE HYDROCHLORIDE50MGTABLET / ORALAB2004-12-2879d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A040604-002HYDROXYZINE HYDROCHLORIDE10MGTABLET / ORALAB2004-12-2879d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A040604-003HYDROXYZINE HYDROCHLORIDE25MGTABLET / ORALAB2004-12-2879d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A040604-001HYDROXYZINE HYDROCHLORIDE50MGTABLET / ORALAB2004-12-28301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A040604-002HYDROXYZINE HYDROCHLORIDE10MGTABLET / ORALAB2004-12-28301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A040604-003HYDROXYZINE HYDROCHLORIDE25MGTABLET / ORALAB2004-12-28301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A040604-001HYDROXYZINE HYDROCHLORIDE50MGTABLET / ORALAB2004-12-281e350fbaab3a…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 4 · 126 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-08-18 06:07:402026-07A040604-001AB1caaa826d4ba7…
2026-08-18 06:07:402026-07A040604-002AB1caaa826d4ba7…
2026-08-18 06:07:402026-07A040604-003AB1caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A040604-001AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A040604-002AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A040604-003AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A040604-001AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A040604-002AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A040604-003AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08A040604-001AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A040604-002AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A040604-003AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A040604-001AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A040604-002AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A040604-003AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A040604-001AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A040604-002AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A040604-003AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A040604-001AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A040604-002AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A040604-003AB103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A040604-001AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A040604-002AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A040604-003AB12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A040604-001AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A040604-002AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A040604-003AB15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A040604-001AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A040604-002AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A040604-003AB1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A040604-001AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A040604-002AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A040604-003AB1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A040604-001AB179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A040604-002AB179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A040604-003AB179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A040604-001AB1301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A040604-002AB1301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A040604-003AB1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A040604-001AB11e350fbaab3a…

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#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
70934-285-302023-01-30C16284748780-1f386c649-d0f2-0266-e053-dadaa90a7c1aHydroxyzine Hydrochloride Tablets USP, Film-Coated Rx Only

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
70934-285-30Hydroxyzine Hydrochloride30 in 1 BOTTLE, PLASTICTABLET, FILM COATED302

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
70934-285HYDROXYZINE HYDROCHLORIDE TABLET, FILM COATED [DENTON PHARMA, INC. DBA NORTHWIND PHARMACEUTICALS]2Legacy NDC, 1 package rows20200319_8b371b95-7f94-9efe-e053-2a95a90a87b0.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 · 8 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Hydroxyzine HydrochlorideHYDROXYZINE HYDROCHLORIDEMajor Pharmaceuticals7534a3bb-b4cd-415f-8612-53b37dc6d55f2026-06-15Warnings, Adverse reactionsExact identifier
application applno (ANDA): 040604
application number: ANDA040604
Hydroxyzine HydrochlorideHYDROXYZINE HYDROCHLORIDECardinal Health 107, LLC157fbedc-b65d-455f-adb5-e7554282e0332026-06-03Warnings, Adverse reactionsExact identifier
application applno (ANDA): 040604
application number: ANDA040604
Hydroxyzine HydrochlorideHYDROXYZINE HYDROCHLORIDEPURACAP LABORATORIES LLC DBA BLU PHARMACEUTICALS19fe26a9-eb1a-4c5b-a5e4-65223ee56ad12026-02-02Warnings, Adverse reactionsExact identifier
application applno (ANDA): 040604
application number: ANDA040604
Hydroxyzine HydrochlorideHYDROXYZINE HYDROCHLORIDEBryant Ranch Prepack5ff091be-6e30-4305-a172-769ee45e110b2025-04-02Warnings, Adverse reactionsExact identifier
application applno (ANDA): 040604
application number: ANDA040604
Hydroxyzine HydrochlorideHYDROXYZINE HYDROCHLORIDEEpic Pharma, LLC82b015dc-999c-46a4-bcaa-a4c81a193b682025-01-31Warnings, Adverse reactionsExact identifier
application applno (ANDA): 040604
application number: ANDA040604
Hydroxyzine HydrochlorideHYDROXYZINE HYDROCHLORIDENuCare Pharmaceuticals,Inc.99995bdb-a35f-7753-e053-2995a90a683c2024-10-15Warnings, Adverse reactionsExact identifier
application applno (ANDA): 040604
application number: ANDA040604
Hydroxyzine HydrochlorideHYDROXYZINE HYDROCHLORIDEBryant Ranch Prepackf6f688d0-cb13-40af-a65f-480c37334e372024-04-03Warnings, Adverse reactionsExact identifier
application applno (ANDA): 040604
application number: ANDA040604
Hydroxyzine HydrochlorideHYDROXYZINE HYDROCHLORIDEProficient Rx LP3edfac5c-a08b-4270-a343-9b2dc10a4a6e2022-11-01Warnings, Adverse reactionsExact identifier
application applno (ANDA): 040604
application number: ANDA040604

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
995258hydrOXYzine HCl 25 MG Oral TabletPSN8b371b95-7f94-9efe-e053-2a95a90a87b02
995281hydrOXYzine HCl 50 MG Oral TabletPSN8b371b95-7f94-9efe-e053-2a95a90a87b02
995258hydroxyzine hydrochloride 25 MG Oral TabletSCD8b371b95-7f94-9efe-e053-2a95a90a87b02
995281hydroxyzine hydrochloride 50 MG Oral TabletSCD8b371b95-7f94-9efe-e053-2a95a90a87b02

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
70934-285-307093402853030 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (70934-285-30) 2019-02-150000-00-00NoNoCurrent