Home NDC 63629-6716-2 Hydroxyzine Hydrochloride
Product NDC 63629-6716
Requested package NDC 63629-6716-2
11-digit product format 636296716
Labeler code 63629
Product ID 63629-6716_78d16e10-7bab-41da-8184-fcbffbdc00e5
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Hydroxyzine
Dosage form TABLET, FILM COATED
Route ORAL
Labeler Bryant Ranch Prepack
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 2021-12-31
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 · 13 matching rows.
View current auxiliary records. · View the auxiliary file history.
Captured / source date, Code, Status table Captured / source date Code Status Snapshot Source SHA-256 2025-12-14 17:58 UTC · source 2025-12-05 D Discontinued by firm d630ba8d3edf…732f749b63fb…2025-08-27 00:01 UTC · source 2025-08-26 D Discontinued by firm f5e01cc5f278…a2eaf40c39c3…2025-04-01 02:39 UTC · source 2025-03-31 D Discontinued by firm 2ef7874e63bc…57b86245f4fa…2025-03-28 20:22 UTC · source 2025-03-28 D Discontinued by firm a1b67e2a42f9…c4cf2c586c0d…2025-03-22 03:12 UTC · source 2025-03-21 D Discontinued by firm cfe11265f3b6…090c488252e2…2025-03-10 12:48 UTC · source 2025-03-10 D Discontinued by firm cdf11ea48f46…ba0047e9e063…2025-02-02 03:52 UTC · source 2025-01-31 D Discontinued by firm 302b2466d912…e7b80fea0513…2025-01-20 13:05 UTC · source 2025-01-20 D Discontinued by firm ed331223b511…672a5bd82f5f…2025-01-11 03:41 UTC · source 2025-01-10 D Discontinued by firm 0efc9e666f02…f202fb6c5f17…2024-11-09 02:27 UTC · source 2024-11-08 D Discontinued by firm ad56d346431e…cc804d4bbf1e…2024-10-04 04:10 UTC · source 2024-10-03 D Discontinued by firm 367a005e9d99…383a685ebd0f…2024-07-10 04:00 UTC · source 2024-07-09 D Discontinued by firm 557ba5c1ecfa…9c80585c8c6e…2020-06-10 20:45 UTC · source 2020-06-10 I Inactivated by FDA 9bebd1f3094a…5416666fcb17…
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.
FDA-Initiated Inactive NDC Indexing# NDC, Effective, Related label table NDC Effective Related label 63629-6716-1 2020-10-16 HYDROXYZINE HYDROCHLORIDE TABLETS, USP Rx only 63629-6716-2 2020-10-16 HYDROXYZINE HYDROCHLORIDE TABLETS, USP Rx only 63629-6716-3 2020-10-16 HYDROXYZINE HYDROCHLORIDE TABLETS, USP Rx only 63629-6716-4 2020-10-16 HYDROXYZINE HYDROCHLORIDE TABLETS, USP Rx only 63629-6716-5 2020-10-16 HYDROXYZINE HYDROCHLORIDE TABLETS, USP Rx only 63629-6716-1 2020-01-31 HYDROXYZINE HYDROCHLORIDE TABLETS, USP Rx only 63629-6716-2 2020-01-31 HYDROXYZINE HYDROCHLORIDE TABLETS, USP Rx only 63629-6716-3 2020-01-31 HYDROXYZINE HYDROCHLORIDE TABLETS, USP Rx only 63629-6716-4 2020-01-31 HYDROXYZINE HYDROCHLORIDE TABLETS, USP Rx only 63629-6716-5 2020-01-31 HYDROXYZINE HYDROCHLORIDE TABLETS, USP Rx only
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 63629-6716-2 63629671602 90 TABLET, FILM COATED in 1 BOTTLE (63629-6716-2) 2015-08-31 0000-00-00 No No Current