Home NDC 71335-2451 Hydroxyzine Hydrochloride
Product NDC 71335-2451
11-digit product format 713352451
Labeler code 71335
Product ID 71335-2451_897a39b6-65b1-4e52-85e9-2650d23a4dc0
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Hydroxyzine Hydrochloride
Dosage form TABLET, FILM COATED
Route ORAL
Labeler Bryant Ranch Prepack
Application ANDA040786
Marketing category ANDA
Marketing start 2012-07-24
Substance HYDROXYZINE DIHYDROCHLORIDE
Active strength 25 mg/1
Pharmacologic classes Antihistamine [EPC], Histamine Receptor Antagonists [MoA]
NDC exclude flag No
Listing certified through 2026-12-31
Current FDA listing Yes 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 A040786-001 HYDROXYZINE HYDROCHLORIDE HYDROXYZINE HYDROCHLORIDE 10MG TABLET / ORAL AB 2007-03-20 A040786-002 HYDROXYZINE HYDROCHLORIDE HYDROXYZINE HYDROCHLORIDE 25MG TABLET / ORAL AB 2007-03-20 A040786-003 HYDROXYZINE HYDROCHLORIDE HYDROXYZINE HYDROCHLORIDE 50MG TABLET / ORAL AB 2007-03-20
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 A040786-001 HYDROXYZINE HYDROCHLORIDE 10MG TABLET / ORAL AB 2007-03-20 84e616aacf4f…2026-09-14 22:38:34 2026-08 A040786-002 HYDROXYZINE HYDROCHLORIDE 25MG TABLET / ORAL AB 2007-03-20 84e616aacf4f…2026-09-14 22:38:34 2026-08 A040786-003 HYDROXYZINE HYDROCHLORIDE 50MG TABLET / ORAL AB 2007-03-20 84e616aacf4f…2026-08-18 06:07:40 2026-07 A040786-001 HYDROXYZINE HYDROCHLORIDE 10MG TABLET / ORAL AB 2007-03-20 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A040786-002 HYDROXYZINE HYDROCHLORIDE 25MG TABLET / ORAL AB 2007-03-20 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A040786-003 HYDROXYZINE HYDROCHLORIDE 50MG TABLET / ORAL AB 2007-03-20 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A040786-001 HYDROXYZINE HYDROCHLORIDE 10MG TABLET / ORAL AB 2007-03-20 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A040786-002 HYDROXYZINE HYDROCHLORIDE 25MG TABLET / ORAL AB 2007-03-20 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A040786-003 HYDROXYZINE HYDROCHLORIDE 50MG TABLET / ORAL AB 2007-03-20 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A040786-001 HYDROXYZINE HYDROCHLORIDE 10MG TABLET / ORAL AB 2007-03-20 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A040786-002 HYDROXYZINE HYDROCHLORIDE 25MG TABLET / ORAL AB 2007-03-20 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A040786-003 HYDROXYZINE HYDROCHLORIDE 50MG TABLET / ORAL AB 2007-03-20 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A040786-001 HYDROXYZINE HYDROCHLORIDE 10MG TABLET / ORAL AB 2007-03-20 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A040786-002 HYDROXYZINE HYDROCHLORIDE 25MG TABLET / ORAL AB 2007-03-20 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A040786-003 HYDROXYZINE HYDROCHLORIDE 50MG TABLET / ORAL AB 2007-03-20 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A040786-001 HYDROXYZINE HYDROCHLORIDE 10MG TABLET / ORAL AB 2007-03-20 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A040786-002 HYDROXYZINE HYDROCHLORIDE 25MG TABLET / ORAL AB 2007-03-20 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A040786-003 HYDROXYZINE HYDROCHLORIDE 50MG TABLET / ORAL AB 2007-03-20 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A040786-001 HYDROXYZINE HYDROCHLORIDE 10MG TABLET / ORAL AB 2007-03-20 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A040786-002 HYDROXYZINE HYDROCHLORIDE 25MG TABLET / ORAL AB 2007-03-20 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A040786-003 HYDROXYZINE HYDROCHLORIDE 50MG TABLET / ORAL AB 2007-03-20 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A040786-001 HYDROXYZINE HYDROCHLORIDE 10MG TABLET / ORAL AB 2007-03-20 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A040786-002 HYDROXYZINE HYDROCHLORIDE 25MG TABLET / ORAL AB 2007-03-20 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A040786-003 HYDROXYZINE HYDROCHLORIDE 50MG TABLET / ORAL AB 2007-03-20 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A040786-001 HYDROXYZINE HYDROCHLORIDE 10MG TABLET / ORAL AB 2007-03-20 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A040786-002 HYDROXYZINE HYDROCHLORIDE 25MG TABLET / ORAL AB 2007-03-20 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A040786-003 HYDROXYZINE HYDROCHLORIDE 50MG TABLET / ORAL AB 2007-03-20 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A040786-001 HYDROXYZINE HYDROCHLORIDE 10MG TABLET / ORAL AB 2007-03-20 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A040786-002 HYDROXYZINE HYDROCHLORIDE 25MG TABLET / ORAL AB 2007-03-20 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A040786-003 HYDROXYZINE HYDROCHLORIDE 50MG TABLET / ORAL AB 2007-03-20 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A040786-001 HYDROXYZINE HYDROCHLORIDE 10MG TABLET / ORAL AB 2007-03-20 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A040786-002 HYDROXYZINE HYDROCHLORIDE 25MG TABLET / ORAL AB 2007-03-20 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A040786-003 HYDROXYZINE HYDROCHLORIDE 50MG TABLET / ORAL AB 2007-03-20 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A040786-001 HYDROXYZINE HYDROCHLORIDE 10MG TABLET / ORAL AB 2007-03-20 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A040786-002 HYDROXYZINE HYDROCHLORIDE 25MG TABLET / ORAL AB 2007-03-20 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A040786-003 HYDROXYZINE HYDROCHLORIDE 50MG TABLET / ORAL AB 2007-03-20 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A040786-001 HYDROXYZINE HYDROCHLORIDE 10MG TABLET / ORAL AB 2007-03-20 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A040786-002 HYDROXYZINE HYDROCHLORIDE 25MG TABLET / ORAL AB 2007-03-20 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A040786-003 HYDROXYZINE HYDROCHLORIDE 50MG TABLET / ORAL AB 2007-03-20 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A040786-001 HYDROXYZINE HYDROCHLORIDE 10MG TABLET / ORAL AB 2007-03-20 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.
Additional Listing Data#
Finished product Yes
Brand name base Hydroxyzine Hydrochloride
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength HYDROXYZINE DIHYDROCHLORIDE 25 mg/1
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 76755771U3 Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 995258 Internal RxNorm lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
DailyMed Product Concepts# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 71335-2451-1 Hydroxyzine Hydrochloride 30 in 1 BOTTLE TABLET, FILM COATED 30 1 71335-2451-2 Hydroxyzine Hydrochloride 60 in 1 BOTTLE TABLET, FILM COATED 60 1 71335-2451-3 Hydroxyzine Hydrochloride 20 in 1 BOTTLE TABLET, FILM COATED 20 1 71335-2451-4 Hydroxyzine Hydrochloride 100 in 1 BOTTLE TABLET, FILM COATED 100 1 71335-2451-5 Hydroxyzine Hydrochloride 15 in 1 BOTTLE TABLET, FILM COATED 15 1 71335-2451-6 Hydroxyzine Hydrochloride 90 in 1 BOTTLE TABLET, FILM COATED 90 1 71335-2451-7 Hydroxyzine Hydrochloride 19 in 1 BOTTLE TABLET, FILM COATED 19 1 71335-2451-8 Hydroxyzine Hydrochloride 10 in 1 BOTTLE TABLET, FILM COATED 10 1
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 71335-2451 HYDROXYZINE HYDROCHLORIDE TABLET, FILM COATED [BRYANT RANCH PREPACK] 1 Current NDC, 8 package rows 20240907_3f5be725-8ade-4889-b6b1-7d45f5458546.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 · 5 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join Hydroxyzine Hydrochloride HYDROXYZINE HYDROCHLORIDE PD-Rx Pharmaceuticals, Inc. 4789b7ae-314c-43c0-ad33-92ff50085f27 2025-10-17 Warnings, Adverse reactions Exact identifier application applno (ANDA): 040786 application number: ANDA040786 Hydroxyzine Hydrochloride HYDROXYZINE HYDROCHLORIDE PD-Rx Pharmaceuticals, Inc. 1a3e389f-391d-4f37-9e34-ce3c6f5fe8c1 2025-10-17 Warnings, Adverse reactions Exact identifier application applno (ANDA): 040786 application number: ANDA040786 Hydroxyzine Hydrochloride HYDROXYZINE HYDROCHLORIDE PD-Rx Pharmaceuticals, Inc. cc6a12ed-411b-4b0c-8108-58ef7db8da55 2025-10-15 Warnings, Adverse reactions Exact identifier application applno (ANDA): 040786 application number: ANDA040786 Hydroxyzine Hydrochloride HYDROXYZINE HYDROCHLORIDE Bryant Ranch Prepack 3f5be725-8ade-4889-b6b1-7d45f5458546 2024-08-20 Warnings, Adverse reactions Exact identifier application applno (ANDA): 040786 application number: ANDA040786 ndc (product): 71335-2451 Hydroxyzine Hydrochloride HYDROXYZINE HYDROCHLORIDE KVK-Tech, Inc. adc4cb73-77c6-48ff-aaf2-b3568d53de1f 2023-01-04 Warnings, Adverse reactions Exact identifier application applno (ANDA): 040786 application number: ANDA040786
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Marketing start Sample Exclude flag Status 71335-2451-1 71335245101 30 TABLET, FILM COATED in 1 BOTTLE (71335-2451-1) 2024-08-20 No No Current 71335-2451-2 71335245102 60 TABLET, FILM COATED in 1 BOTTLE (71335-2451-2) 2024-08-20 No No Current 71335-2451-3 71335245103 20 TABLET, FILM COATED in 1 BOTTLE (71335-2451-3) 2024-08-20 No No Current 71335-2451-4 71335245104 100 TABLET, FILM COATED in 1 BOTTLE (71335-2451-4) 2024-08-20 No No Current 71335-2451-5 71335245105 15 TABLET, FILM COATED in 1 BOTTLE (71335-2451-5) 2024-08-20 No No Current 71335-2451-6 71335245106 90 TABLET, FILM COATED in 1 BOTTLE (71335-2451-6) 2024-08-20 No No Current 71335-2451-7 71335245107 19 TABLET, FILM COATED in 1 BOTTLE (71335-2451-7) 2024-08-20 No No Current 71335-2451-8 71335245108 10 TABLET, FILM COATED in 1 BOTTLE (71335-2451-8) 2024-08-20 No No Current