Home NDC 67296-0648-2 HYDROXYZINE HYDROCHLORIDE
Product NDC 67296-0648
Requested package NDC 67296-0648-2
11-digit product format 672960648
Labeler code 67296
Product ID 67296-0648_9c9af7ee-602c-5314-e053-2995a90a8f25
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name HYDROXYZINE HYDROCHLORIDE
Dosage form TABLET, FILM COATED
Route ORAL
Labeler RedPharm Drug, 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 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 · 18 matching rows.
View current auxiliary records. · View the auxiliary file history.
Captured / source date, Snapshot, Source SHA-256 table Captured / source date Snapshot Source SHA-256 2025-12-14 17:58 UTC · source 2025-12-05 d630ba8d3edf…732f749b63fb…2025-08-27 00:01 UTC · source 2025-08-26 f5e01cc5f278…a2eaf40c39c3…2025-04-01 02:39 UTC · source 2025-03-31 2ef7874e63bc…57b86245f4fa…2025-03-28 20:22 UTC · source 2025-03-28 a1b67e2a42f9…c4cf2c586c0d…2025-03-22 03:12 UTC · source 2025-03-21 cfe11265f3b6…090c488252e2…2025-03-10 12:48 UTC · source 2025-03-10 cdf11ea48f46…ba0047e9e063…2025-02-02 03:52 UTC · source 2025-01-31 302b2466d912…e7b80fea0513…2025-01-20 13:05 UTC · source 2025-01-20 ed331223b511…672a5bd82f5f…2025-01-11 03:41 UTC · source 2025-01-10 0efc9e666f02…f202fb6c5f17…2024-11-09 02:27 UTC · source 2024-11-08 ad56d346431e…cc804d4bbf1e…2024-10-04 04:10 UTC · source 2024-10-03 367a005e9d99…383a685ebd0f…2024-07-10 04:00 UTC · source 2024-07-09 557ba5c1ecfa…9c80585c8c6e…2024-05-28 21:12 UTC · source 2024-05-28 8af77b9d5b6f…d9bbb34c5368…2024-05-15 03:39 UTC · source 2024-05-14 834df4deac94…adcc014656a3…2024-03-11 06:39 UTC · source 2024-03-08 1332a3947898…d4bfe170f9cd…2022-08-30 03:57 UTC · source 2022-08-29 fb8cb913e6d1…eb8c232b6be0…2022-04-09 23:13 UTC · source 2022-04-08 86f5da6cb304…a595104c45d7…2022-04-04 05:40 UTC · source 2022-04-01 bd6a592717d7…303034d00443…
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# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 67296-0648-2 HYDROXYZINE HYDROCHLORIDE 15 in 1 BOTTLE TABLET, FILM COATED 15 7 67296-0648-1 Hydroxyzine Hydrochloride 30 in 1 BOTTLE TABLET, FILM COATED 30 4
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 [REDPHARM DRUG INC.] 4 HYDROXYZINE ACTIVE MOIETY 30S50YM8OG HYDROXYZINE HYDROCHLORIDE TABLET, FILM COATED [REDPHARM DRUG INC.] 4 CELLULOSE, MICROCRYSTALLINE INACTIVE INGREDIENT OP1R32D61U HYDROXYZINE HYDROCHLORIDE TABLET, FILM COATED [REDPHARM DRUG INC.] 4 HYPROMELLOSES INACTIVE INGREDIENT 3NXW29V3WO HYDROXYZINE HYDROCHLORIDE TABLET, FILM COATED [REDPHARM DRUG INC.] 4 LACTOSE MONOHYDRATE INACTIVE INGREDIENT EWQ57Q8I5X HYDROXYZINE HYDROCHLORIDE TABLET, FILM COATED [REDPHARM DRUG INC.] 4 MAGNESIUM STEARATE INACTIVE INGREDIENT 70097M6I30 HYDROXYZINE HYDROCHLORIDE TABLET, FILM COATED [REDPHARM DRUG INC.] 4 POLYETHYLENE GLYCOL INACTIVE INGREDIENT 3WJQ0SDW1A HYDROXYZINE HYDROCHLORIDE TABLET, FILM COATED [REDPHARM DRUG INC.] 4 POLYSORBATE 80 INACTIVE INGREDIENT 6OZP39ZG8H HYDROXYZINE HYDROCHLORIDE TABLET, FILM COATED [REDPHARM DRUG INC.] 4 SILICON DIOXIDE INACTIVE INGREDIENT ETJ7Z6XBU4 HYDROXYZINE HYDROCHLORIDE TABLET, FILM COATED [REDPHARM DRUG INC.] 4 SODIUM STARCH GLYCOLATE TYPE A POTATO INACTIVE INGREDIENT 5856J3G2A2 HYDROXYZINE HYDROCHLORIDE TABLET, FILM COATED [REDPHARM DRUG INC.] 4 STEARIC ACID INACTIVE INGREDIENT 4ELV7Z65AP HYDROXYZINE HYDROCHLORIDE TABLET, FILM COATED [REDPHARM DRUG INC.] 4 TITANIUM DIOXIDE INACTIVE INGREDIENT 15FIX9V2JP HYDROXYZINE HYDROCHLORIDE TABLET, FILM COATED [REDPHARM DRUG INC.] 4
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 67296-0648 HYDROXYZINE HYDROCHLORIDE TABLET, FILM COATED [REDPHARM DRUG, INC.] 7 Legacy NDC, 1 package rows 20200123_4138311a-7764-3de5-e054-00144ff88e88.zip 67296-0648 HYDROXYZINE HYDROCHLORIDE TABLET, FILM COATED [REDPHARM DRUG INC.] 4 Legacy NDC, 1 package rows 20110727_42226ef6-7467-4fe8-8f07-4911c0b916af.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 Marketing start Marketing end Sample Exclude flag Status 67296-0648-2 67296064802 15 TABLET, FILM COATED in 1 BOTTLE (67296-0648-2) 2008-06-30 0000-00-00 No No Current