Home NDC 52959-074 Hydroxyzine Hydrochloride
Product NDC 52959-074
11-digit product format 529590074
Labeler code 52959
Product ID 52959-074_104d12ea-e22c-46e6-b3c6-7bb45c4c01c9
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Hydroxyzine Hydrochloride
Dosage form TABLET, FILM COATED
Route ORAL
Labeler H.J. Harkins Company, Inc.
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 E
Listing certified through 2017-12-31
Current FDA listing Historical FDA.report record 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 5 · 286 matching rows.
View current auxiliary records. · View the auxiliary file history.
Source provenance: Browse the complete Orange Book source catalog · source snapshot 43 .
Orange Book products# Current product rows page 1 of 1 · 3 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date A040804-001 HYDROXYZINE HYDROCHLORIDE HYDROXYZINE HYDROCHLORIDE 10MG TABLET / ORAL AB 2008-06-30 A040804-002 HYDROXYZINE HYDROCHLORIDE HYDROXYZINE HYDROCHLORIDE 25MG TABLET / ORAL AB 2008-06-30 A040804-003 HYDROXYZINE HYDROCHLORIDE HYDROXYZINE HYDROCHLORIDE 50MG TABLET / ORAL AB 2008-06-30
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 3 matching rows.
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 · 129 observed states.
Captured, Edition, Application-product table Captured Edition Application-product Trade name Strength Dosage form / route Product TE source text RLD / RS Approval date Source SHA-256 2026-09-14 22:38:34 2026-08 A040804-001 HYDROXYZINE HYDROCHLORIDE 10MG TABLET / ORAL AB 2008-06-30 84e616aacf4f…2026-09-14 22:38:34 2026-08 A040804-002 HYDROXYZINE HYDROCHLORIDE 25MG TABLET / ORAL AB 2008-06-30 84e616aacf4f…2026-09-14 22:38:34 2026-08 A040804-003 HYDROXYZINE HYDROCHLORIDE 50MG TABLET / ORAL AB 2008-06-30 84e616aacf4f…2026-08-18 06:07:40 2026-07 A040804-001 HYDROXYZINE HYDROCHLORIDE 10MG TABLET / ORAL AB 2008-06-30 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A040804-002 HYDROXYZINE HYDROCHLORIDE 25MG TABLET / ORAL AB 2008-06-30 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A040804-003 HYDROXYZINE HYDROCHLORIDE 50MG TABLET / ORAL AB 2008-06-30 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A040804-001 HYDROXYZINE HYDROCHLORIDE 10MG TABLET / ORAL AB 2008-06-30 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A040804-002 HYDROXYZINE HYDROCHLORIDE 25MG TABLET / ORAL AB 2008-06-30 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A040804-003 HYDROXYZINE HYDROCHLORIDE 50MG TABLET / ORAL AB 2008-06-30 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A040804-001 HYDROXYZINE HYDROCHLORIDE 10MG TABLET / ORAL AB 2008-06-30 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A040804-002 HYDROXYZINE HYDROCHLORIDE 25MG TABLET / ORAL AB 2008-06-30 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A040804-003 HYDROXYZINE HYDROCHLORIDE 50MG TABLET / ORAL AB 2008-06-30 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A040804-001 HYDROXYZINE HYDROCHLORIDE 10MG TABLET / ORAL AB 2008-06-30 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A040804-002 HYDROXYZINE HYDROCHLORIDE 25MG TABLET / ORAL AB 2008-06-30 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A040804-003 HYDROXYZINE HYDROCHLORIDE 50MG TABLET / ORAL AB 2008-06-30 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A040804-001 HYDROXYZINE HYDROCHLORIDE 10MG TABLET / ORAL AB 2008-06-30 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A040804-002 HYDROXYZINE HYDROCHLORIDE 25MG TABLET / ORAL AB 2008-06-30 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A040804-003 HYDROXYZINE HYDROCHLORIDE 50MG TABLET / ORAL AB 2008-06-30 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A040804-001 HYDROXYZINE HYDROCHLORIDE 10MG TABLET / ORAL AB 2008-06-30 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A040804-002 HYDROXYZINE HYDROCHLORIDE 25MG TABLET / ORAL AB 2008-06-30 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A040804-003 HYDROXYZINE HYDROCHLORIDE 50MG TABLET / ORAL AB 2008-06-30 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A040804-001 HYDROXYZINE HYDROCHLORIDE 10MG TABLET / ORAL AB 2008-06-30 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A040804-002 HYDROXYZINE HYDROCHLORIDE 25MG TABLET / ORAL AB 2008-06-30 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A040804-003 HYDROXYZINE HYDROCHLORIDE 50MG TABLET / ORAL AB 2008-06-30 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A040804-001 HYDROXYZINE HYDROCHLORIDE 10MG TABLET / ORAL AB 2008-06-30 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A040804-002 HYDROXYZINE HYDROCHLORIDE 25MG TABLET / ORAL AB 2008-06-30 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A040804-003 HYDROXYZINE HYDROCHLORIDE 50MG TABLET / ORAL AB 2008-06-30 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A040804-001 HYDROXYZINE HYDROCHLORIDE 10MG TABLET / ORAL AB 2008-06-30 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A040804-002 HYDROXYZINE HYDROCHLORIDE 25MG TABLET / ORAL AB 2008-06-30 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A040804-003 HYDROXYZINE HYDROCHLORIDE 50MG TABLET / ORAL AB 2008-06-30 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A040804-001 HYDROXYZINE HYDROCHLORIDE 10MG TABLET / ORAL AB 2008-06-30 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A040804-002 HYDROXYZINE HYDROCHLORIDE 25MG TABLET / ORAL AB 2008-06-30 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A040804-003 HYDROXYZINE HYDROCHLORIDE 50MG TABLET / ORAL AB 2008-06-30 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A040804-001 HYDROXYZINE HYDROCHLORIDE 10MG TABLET / ORAL AB 2008-06-30 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A040804-002 HYDROXYZINE HYDROCHLORIDE 25MG TABLET / ORAL AB 2008-06-30 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A040804-003 HYDROXYZINE HYDROCHLORIDE 50MG TABLET / ORAL AB 2008-06-30 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A040804-001 HYDROXYZINE HYDROCHLORIDE 10MG TABLET / ORAL AB 2008-06-30 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A040804-002 HYDROXYZINE HYDROCHLORIDE 25MG TABLET / ORAL AB 2008-06-30 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A040804-003 HYDROXYZINE HYDROCHLORIDE 50MG TABLET / ORAL AB 2008-06-30 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A040804-001 HYDROXYZINE HYDROCHLORIDE 10MG TABLET / ORAL AB 2008-06-30 301d65b070ca…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 4 · 129 observed states.
Reported adverse events (FAERS/openFDA)# Adverse event summaries are temporarily unavailable. Other product information remains available.
DailyMed Product Concepts# FDA-Initiated Inactive NDC Indexing# NDC, Related label table NDC Related label 52959-074-12 HYDROXYZINE HYDROCHLORIDE TABLETS, USP Rx only 52959-074-13 HYDROXYZINE HYDROCHLORIDE TABLETS, USP Rx only 52959-074-15 HYDROXYZINE HYDROCHLORIDE TABLETS, USP Rx only 52959-074-16 HYDROXYZINE HYDROCHLORIDE TABLETS, USP Rx only 52959-074-20 HYDROXYZINE HYDROCHLORIDE TABLETS, USP Rx only 52959-074-21 HYDROXYZINE HYDROCHLORIDE TABLETS, USP Rx only 52959-074-24 HYDROXYZINE HYDROCHLORIDE TABLETS, USP Rx only 52959-074-30 HYDROXYZINE HYDROCHLORIDE TABLETS, USP Rx only 52959-074-40 HYDROXYZINE HYDROCHLORIDE TABLETS, USP Rx only 52959-074-50 HYDROXYZINE HYDROCHLORIDE TABLETS, USP Rx only 52959-074-60 HYDROXYZINE HYDROCHLORIDE TABLETS, USP Rx only 52959-074-90 HYDROXYZINE HYDROCHLORIDE TABLETS, USP Rx only
DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 52959-074-12 Hydroxyzine Hydrochloride 12 in 1 BOTTLE TABLET, FILM COATED 12 3 52959-074-13 Hydroxyzine Hydrochloride 13 in 1 BOTTLE TABLET, FILM COATED 13 3 52959-074-15 Hydroxyzine Hydrochloride 15 in 1 BOTTLE TABLET, FILM COATED 15 3 52959-074-16 Hydroxyzine Hydrochloride 16 in 1 BOTTLE TABLET, FILM COATED 16 3 52959-074-20 Hydroxyzine Hydrochloride 20 in 1 BOTTLE TABLET, FILM COATED 20 3 52959-074-21 Hydroxyzine Hydrochloride 21 in 1 BOTTLE TABLET, FILM COATED 21 3 52959-074-24 Hydroxyzine Hydrochloride 24 in 1 BOTTLE TABLET, FILM COATED 24 3 52959-074-30 Hydroxyzine Hydrochloride 30 in 1 BOTTLE TABLET, FILM COATED 30 3 52959-074-40 Hydroxyzine Hydrochloride 40 in 1 BOTTLE TABLET, FILM COATED 40 3 52959-074-50 Hydroxyzine Hydrochloride 50 in 1 BOTTLE TABLET, FILM COATED 50 3 52959-074-60 Hydroxyzine Hydrochloride 60 in 1 BOTTLE TABLET, FILM COATED 60 3 52959-074-90 Hydroxyzine Hydrochloride 90 in 1 BOTTLE TABLET, FILM COATED 90 3
DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded HYDROXYZINE HYDROCHLORIDE ACTIVE INGREDIENT 76755771U3 HYDROXYZINE HYDROCHLORIDE TABLET, FILM COATED [H.J. HARKINS COMPANY, INC.] 3 HYDROXYZINE ACTIVE MOIETY 30S50YM8OG HYDROXYZINE HYDROCHLORIDE TABLET, FILM COATED [H.J. HARKINS COMPANY, INC.] 3 CELLULOSE, MICROCRYSTALLINE INACTIVE INGREDIENT OP1R32D61U HYDROXYZINE HYDROCHLORIDE TABLET, FILM COATED [H.J. HARKINS COMPANY, INC.] 3 HYPROMELLOSES INACTIVE INGREDIENT 3NXW29V3WO HYDROXYZINE HYDROCHLORIDE TABLET, FILM COATED [H.J. HARKINS COMPANY, INC.] 3 LACTOSE MONOHYDRATE INACTIVE INGREDIENT EWQ57Q8I5X HYDROXYZINE HYDROCHLORIDE TABLET, FILM COATED [H.J. HARKINS COMPANY, INC.] 3 MAGNESIUM STEARATE INACTIVE INGREDIENT 70097M6I30 HYDROXYZINE HYDROCHLORIDE TABLET, FILM COATED [H.J. HARKINS COMPANY, INC.] 3 POLYETHYLENE GLYCOL INACTIVE INGREDIENT 3WJQ0SDW1A HYDROXYZINE HYDROCHLORIDE TABLET, FILM COATED [H.J. HARKINS COMPANY, INC.] 3 POLYSORBATE 80 INACTIVE INGREDIENT 6OZP39ZG8H HYDROXYZINE HYDROCHLORIDE TABLET, FILM COATED [H.J. HARKINS COMPANY, INC.] 3 SILICON DIOXIDE INACTIVE INGREDIENT ETJ7Z6XBU4 HYDROXYZINE HYDROCHLORIDE TABLET, FILM COATED [H.J. HARKINS COMPANY, INC.] 3 SODIUM STARCH GLYCOLATE TYPE A POTATO INACTIVE INGREDIENT 5856J3G2A2 HYDROXYZINE HYDROCHLORIDE TABLET, FILM COATED [H.J. HARKINS COMPANY, INC.] 3 STEARIC ACID INACTIVE INGREDIENT 4ELV7Z65AP HYDROXYZINE HYDROCHLORIDE TABLET, FILM COATED [H.J. HARKINS COMPANY, INC.] 3 TITANIUM DIOXIDE INACTIVE INGREDIENT 15FIX9V2JP HYDROXYZINE HYDROCHLORIDE TABLET, FILM COATED [H.J. HARKINS COMPANY, INC.] 3
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 52959-074 HYDROXYZINE HYDROCHLORIDE TABLET, FILM COATED [H.J. HARKINS COMPANY, INC.] 3 Legacy NDC, 12 package rows 20120124_80833d7f-8a36-470a-b7ba-6343549e2273.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 · 1 matching rows.
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Status 52959-074-12 52959007412 12 in 1 BOTTLE Historical 52959-074-13 52959007413 13 in 1 BOTTLE Historical 52959-074-15 52959007415 15 in 1 BOTTLE Historical 52959-074-16 52959007416 16 in 1 BOTTLE Historical 52959-074-20 52959007420 20 in 1 BOTTLE Historical 52959-074-21 52959007421 21 in 1 BOTTLE Historical 52959-074-24 52959007424 24 in 1 BOTTLE Historical 52959-074-30 52959007430 30 in 1 BOTTLE Historical 52959-074-40 52959007440 40 in 1 BOTTLE Historical 52959-074-50 52959007450 50 in 1 BOTTLE Historical 52959-074-60 52959007460 60 in 1 BOTTLE Historical 52959-074-90 52959007490 90 in 1 BOTTLE Historical