Home NDC 63187-492 Hydroxyzine Hydrochloride
Product NDC 63187-492
11-digit product format 631870492
Labeler code 63187
Product ID 63187-492_2db68c39-21e9-45a4-93ef-4e0c1e8733c0
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Hydroxyzine
Dosage form TABLET, FILM COATED
Route ORAL
Labeler Proficient Rx LP
Application ANDA040808
Marketing category ANDA
Marketing start 2007-06-29
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 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 · 48 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 A040808-001 HYDROXYZINE HYDROCHLORIDE HYDROXYZINE HYDROCHLORIDE 10MG TABLET / ORAL 2008-09-24 A040808-002 HYDROXYZINE HYDROCHLORIDE HYDROXYZINE HYDROCHLORIDE 25MG TABLET / ORAL 2008-09-24 A040808-003 HYDROXYZINE HYDROCHLORIDE HYDROXYZINE HYDROCHLORIDE 50MG TABLET / ORAL 2008-09-24
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 A040808-001 HYDROXYZINE HYDROCHLORIDE 10MG TABLET / ORAL 2008-09-24 84e616aacf4f…2026-09-14 22:38:34 2026-08 A040808-002 HYDROXYZINE HYDROCHLORIDE 25MG TABLET / ORAL 2008-09-24 84e616aacf4f…2026-09-14 22:38:34 2026-08 A040808-003 HYDROXYZINE HYDROCHLORIDE 50MG TABLET / ORAL 2008-09-24 84e616aacf4f…2026-08-18 06:07:40 2026-07 A040808-001 HYDROXYZINE HYDROCHLORIDE 10MG TABLET / ORAL 2008-09-24 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A040808-002 HYDROXYZINE HYDROCHLORIDE 25MG TABLET / ORAL 2008-09-24 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A040808-003 HYDROXYZINE HYDROCHLORIDE 50MG TABLET / ORAL 2008-09-24 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A040808-001 HYDROXYZINE HYDROCHLORIDE 10MG TABLET / ORAL AB 2008-09-24 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A040808-002 HYDROXYZINE HYDROCHLORIDE 25MG TABLET / ORAL AB 2008-09-24 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A040808-003 HYDROXYZINE HYDROCHLORIDE 50MG TABLET / ORAL AB 2008-09-24 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A040808-001 HYDROXYZINE HYDROCHLORIDE 10MG TABLET / ORAL AB 2008-09-24 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A040808-002 HYDROXYZINE HYDROCHLORIDE 25MG TABLET / ORAL AB 2008-09-24 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A040808-003 HYDROXYZINE HYDROCHLORIDE 50MG TABLET / ORAL AB 2008-09-24 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A040808-001 HYDROXYZINE HYDROCHLORIDE 10MG TABLET / ORAL AB 2008-09-24 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A040808-002 HYDROXYZINE HYDROCHLORIDE 25MG TABLET / ORAL AB 2008-09-24 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A040808-003 HYDROXYZINE HYDROCHLORIDE 50MG TABLET / ORAL AB 2008-09-24 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A040808-001 HYDROXYZINE HYDROCHLORIDE 10MG TABLET / ORAL AB 2008-09-24 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A040808-002 HYDROXYZINE HYDROCHLORIDE 25MG TABLET / ORAL AB 2008-09-24 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A040808-003 HYDROXYZINE HYDROCHLORIDE 50MG TABLET / ORAL AB 2008-09-24 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A040808-001 HYDROXYZINE HYDROCHLORIDE 10MG TABLET / ORAL AB 2008-09-24 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A040808-002 HYDROXYZINE HYDROCHLORIDE 25MG TABLET / ORAL AB 2008-09-24 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A040808-003 HYDROXYZINE HYDROCHLORIDE 50MG TABLET / ORAL AB 2008-09-24 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A040808-001 HYDROXYZINE HYDROCHLORIDE 10MG TABLET / ORAL AB 2008-09-24 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A040808-002 HYDROXYZINE HYDROCHLORIDE 25MG TABLET / ORAL AB 2008-09-24 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A040808-003 HYDROXYZINE HYDROCHLORIDE 50MG TABLET / ORAL AB 2008-09-24 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A040808-001 HYDROXYZINE HYDROCHLORIDE 10MG TABLET / ORAL AB 2008-09-24 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A040808-002 HYDROXYZINE HYDROCHLORIDE 25MG TABLET / ORAL AB 2008-09-24 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A040808-003 HYDROXYZINE HYDROCHLORIDE 50MG TABLET / ORAL AB 2008-09-24 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A040808-001 HYDROXYZINE HYDROCHLORIDE 10MG TABLET / ORAL AB 2008-09-24 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A040808-002 HYDROXYZINE HYDROCHLORIDE 25MG TABLET / ORAL AB 2008-09-24 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A040808-003 HYDROXYZINE HYDROCHLORIDE 50MG TABLET / ORAL AB 2008-09-24 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A040808-001 HYDROXYZINE HYDROCHLORIDE 10MG TABLET / ORAL AB 2008-09-24 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A040808-002 HYDROXYZINE HYDROCHLORIDE 25MG TABLET / ORAL AB 2008-09-24 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A040808-003 HYDROXYZINE HYDROCHLORIDE 50MG TABLET / ORAL AB 2008-09-24 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A040808-001 HYDROXYZINE HYDROCHLORIDE 10MG TABLET / ORAL AB 2008-09-24 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A040808-002 HYDROXYZINE HYDROCHLORIDE 25MG TABLET / ORAL AB 2008-09-24 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A040808-003 HYDROXYZINE HYDROCHLORIDE 50MG TABLET / ORAL AB 2008-09-24 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A040808-001 HYDROXYZINE HYDROCHLORIDE 10MG TABLET / ORAL AB 2008-09-24 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A040808-002 HYDROXYZINE HYDROCHLORIDE 25MG TABLET / ORAL AB 2008-09-24 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A040808-003 HYDROXYZINE HYDROCHLORIDE 50MG TABLET / ORAL AB 2008-09-24 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A040808-001 HYDROXYZINE HYDROCHLORIDE 10MG TABLET / ORAL AB 2008-09-24 301d65b070ca…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 3 · 120 observed states.
DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded HYDROXYZINE HYDROCHLORIDE ACTIVE INGREDIENT 76755771U3 HYDROXYZINE HYDROCHLORIDE (HYDROXYZINE) TABLET, FILM COATED [PROFICIENT RX LP] 1 HYDROXYZINE ACTIVE MOIETY 30S50YM8OG HYDROXYZINE HYDROCHLORIDE (HYDROXYZINE) TABLET, FILM COATED [PROFICIENT RX LP] 1 ANHYDROUS LACTOSE INACTIVE INGREDIENT 3SY5LH9PMK HYDROXYZINE HYDROCHLORIDE (HYDROXYZINE) TABLET, FILM COATED [PROFICIENT RX LP] 1 CARNAUBA WAX INACTIVE INGREDIENT R12CBM0EIZ HYDROXYZINE HYDROCHLORIDE (HYDROXYZINE) TABLET, FILM COATED [PROFICIENT RX LP] 1 CELLULOSE, MICROCRYSTALLINE INACTIVE INGREDIENT OP1R32D61U HYDROXYZINE HYDROCHLORIDE (HYDROXYZINE) TABLET, FILM COATED [PROFICIENT RX LP] 1 CROSPOVIDONE INACTIVE INGREDIENT 68401960MK HYDROXYZINE HYDROCHLORIDE (HYDROXYZINE) TABLET, FILM COATED [PROFICIENT RX LP] 1 HYPROMELLOSES INACTIVE INGREDIENT 3NXW29V3WO HYDROXYZINE HYDROCHLORIDE (HYDROXYZINE) TABLET, FILM COATED [PROFICIENT RX LP] 1 MAGNESIUM STEARATE INACTIVE INGREDIENT 70097M6I30 HYDROXYZINE HYDROCHLORIDE (HYDROXYZINE) TABLET, FILM COATED [PROFICIENT RX LP] 1 POLYDEXTROSE INACTIVE INGREDIENT VH2XOU12IE HYDROXYZINE HYDROCHLORIDE (HYDROXYZINE) TABLET, FILM COATED [PROFICIENT RX LP] 1 POLYETHYLENE GLYCOLS INACTIVE INGREDIENT 3WJQ0SDW1A HYDROXYZINE HYDROCHLORIDE (HYDROXYZINE) TABLET, FILM COATED [PROFICIENT RX LP] 1 SILICON DIOXIDE INACTIVE INGREDIENT ETJ7Z6XBU4 HYDROXYZINE HYDROCHLORIDE (HYDROXYZINE) TABLET, FILM COATED [PROFICIENT RX LP] 1 SODIUM STARCH GLYCOLATE TYPE A POTATO INACTIVE INGREDIENT 5856J3G2A2 HYDROXYZINE HYDROCHLORIDE (HYDROXYZINE) TABLET, FILM COATED [PROFICIENT RX LP] 1 TITANIUM DIOXIDE INACTIVE INGREDIENT 15FIX9V2JP HYDROXYZINE HYDROCHLORIDE (HYDROXYZINE) TABLET, FILM COATED [PROFICIENT RX LP] 1 TRIACETIN INACTIVE INGREDIENT XHX3C3X673 HYDROXYZINE HYDROCHLORIDE (HYDROXYZINE) TABLET, FILM COATED [PROFICIENT RX LP] 1
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.
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Marketing start Marketing end Sample Exclude flag Status 63187-492-30 63187049230 30 TABLET, FILM COATED in 1 BOTTLE (63187-492-30) 2015-02-02 0000-00-00 No No Current 63187-492-60 63187049260 60 TABLET, FILM COATED in 1 BOTTLE (63187-492-60) 2015-02-02 0000-00-00 No No Current 63187-492-90 63187049290 90 TABLET, FILM COATED in 1 BOTTLE (63187-492-90) 2015-02-02 0000-00-00 No No Current