Home NDC 72189-577 Hydroxyzine HCL
Product NDC 72189-577
11-digit product format 721890577
Labeler code 72189
Product ID 72189-577_22049012-733f-6b45-e063-6294a90a670f
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Hydroxyzine HCL
Dosage form TABLET, FILM COATED
Route ORAL
Labeler Direct_rx
Application ANDA217652
Marketing category ANDA
Marketing start 2024-09-13
Substance HYDROXYZINE DIHYDROCHLORIDE
Active strength 50 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 A217652-001 HYDROXYZINE HYDROCHLORIDE HYDROXYZINE HYDROCHLORIDE 10MG TABLET / ORAL AB 2023-08-17 A217652-002 HYDROXYZINE HYDROCHLORIDE HYDROXYZINE HYDROCHLORIDE 25MG TABLET / ORAL AB 2023-08-17 A217652-003 HYDROXYZINE HYDROCHLORIDE HYDROXYZINE HYDROCHLORIDE 50MG TABLET / ORAL AB RS 2023-08-17
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 2 · 66 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 A217652-001 HYDROXYZINE HYDROCHLORIDE 10MG TABLET / ORAL AB 2023-08-17 84e616aacf4f…2026-09-14 22:38:34 2026-08 A217652-002 HYDROXYZINE HYDROCHLORIDE 25MG TABLET / ORAL AB 2023-08-17 84e616aacf4f…2026-09-14 22:38:34 2026-08 A217652-003 HYDROXYZINE HYDROCHLORIDE 50MG TABLET / ORAL AB RS 2023-08-17 84e616aacf4f…2026-08-18 06:07:40 2026-07 A217652-001 HYDROXYZINE HYDROCHLORIDE 10MG TABLET / ORAL AB 2023-08-17 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A217652-002 HYDROXYZINE HYDROCHLORIDE 25MG TABLET / ORAL AB 2023-08-17 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A217652-003 HYDROXYZINE HYDROCHLORIDE 50MG TABLET / ORAL AB RS 2023-08-17 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A217652-001 HYDROXYZINE HYDROCHLORIDE 10MG TABLET / ORAL AB 2023-08-17 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A217652-002 HYDROXYZINE HYDROCHLORIDE 25MG TABLET / ORAL AB 2023-08-17 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A217652-003 HYDROXYZINE HYDROCHLORIDE 50MG TABLET / ORAL AB RS 2023-08-17 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A217652-001 HYDROXYZINE HYDROCHLORIDE 10MG TABLET / ORAL AB 2023-08-17 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A217652-002 HYDROXYZINE HYDROCHLORIDE 25MG TABLET / ORAL AB 2023-08-17 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A217652-003 HYDROXYZINE HYDROCHLORIDE 50MG TABLET / ORAL AB RS 2023-08-17 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A217652-001 HYDROXYZINE HYDROCHLORIDE 10MG TABLET / ORAL AB 2023-08-17 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A217652-002 HYDROXYZINE HYDROCHLORIDE 25MG TABLET / ORAL AB 2023-08-17 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A217652-003 HYDROXYZINE HYDROCHLORIDE 50MG TABLET / ORAL AB RS 2023-08-17 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A217652-001 HYDROXYZINE HYDROCHLORIDE 10MG TABLET / ORAL AB 2023-08-17 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A217652-002 HYDROXYZINE HYDROCHLORIDE 25MG TABLET / ORAL AB 2023-08-17 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A217652-003 HYDROXYZINE HYDROCHLORIDE 50MG TABLET / ORAL AB 2023-08-17 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A217652-001 HYDROXYZINE HYDROCHLORIDE 10MG TABLET / ORAL AB 2023-08-17 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A217652-002 HYDROXYZINE HYDROCHLORIDE 25MG TABLET / ORAL AB 2023-08-17 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A217652-003 HYDROXYZINE HYDROCHLORIDE 50MG TABLET / ORAL AB 2023-08-17 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A217652-001 HYDROXYZINE HYDROCHLORIDE 10MG TABLET / ORAL AB 2023-08-17 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A217652-002 HYDROXYZINE HYDROCHLORIDE 25MG TABLET / ORAL AB 2023-08-17 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A217652-003 HYDROXYZINE HYDROCHLORIDE 50MG TABLET / ORAL AB 2023-08-17 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A217652-001 HYDROXYZINE HYDROCHLORIDE 10MG TABLET / ORAL AB 2023-08-17 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A217652-002 HYDROXYZINE HYDROCHLORIDE 25MG TABLET / ORAL AB 2023-08-17 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A217652-003 HYDROXYZINE HYDROCHLORIDE 50MG TABLET / ORAL AB 2023-08-17 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A217652-001 HYDROXYZINE HYDROCHLORIDE 10MG TABLET / ORAL AB 2023-08-17 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A217652-002 HYDROXYZINE HYDROCHLORIDE 25MG TABLET / ORAL AB 2023-08-17 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A217652-003 HYDROXYZINE HYDROCHLORIDE 50MG TABLET / ORAL AB 2023-08-17 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A217652-001 HYDROXYZINE HYDROCHLORIDE 10MG TABLET / ORAL AB 2023-08-17 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A217652-002 HYDROXYZINE HYDROCHLORIDE 25MG TABLET / ORAL AB 2023-08-17 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A217652-003 HYDROXYZINE HYDROCHLORIDE 50MG TABLET / ORAL AB 2023-08-17 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A217652-001 HYDROXYZINE HYDROCHLORIDE 10MG TABLET / ORAL AB 2023-08-17 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A217652-002 HYDROXYZINE HYDROCHLORIDE 25MG TABLET / ORAL AB 2023-08-17 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A217652-003 HYDROXYZINE HYDROCHLORIDE 50MG TABLET / ORAL AB 2023-08-17 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A217652-001 HYDROXYZINE HYDROCHLORIDE 10MG TABLET / ORAL AB 2023-08-17 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A217652-002 HYDROXYZINE HYDROCHLORIDE 25MG TABLET / ORAL AB 2023-08-17 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A217652-003 HYDROXYZINE HYDROCHLORIDE 50MG TABLET / ORAL AB 2023-08-17 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A217652-001 HYDROXYZINE HYDROCHLORIDE 10MG TABLET / ORAL AB 2023-08-17 301d65b070ca…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 2 · 66 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 HCL
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength HYDROXYZINE DIHYDROCHLORIDE 50 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 995281 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 72189-577-60 Hydroxyzine HCL 60 in 1 BOTTLE TABLET, FILM COATED 60 1
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 72189-577 HYDROXYZINE HCL TABLET, FILM COATED [DIRECT_RX] 1 Current NDC, 1 package rows 20240915_22049012-733e-6b45-e063-6294a90a670f.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 2 of 2 · 22 matching rows.
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Marketing start Sample Exclude flag Status 72189-577-60 72189057760 60 TABLET, FILM COATED in 1 BOTTLE (72189-577-60) 2024-09-13 No No Current