Home NDC 50383-796 HydrOXYzine Hydrochloride
Product NDC 50383-796
11-digit product format 503830796
Labeler code 50383
Product ID 50383-796_6524cff2-ad89-4fc4-adc3-6c2476cdffa4
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name HydrOXYzine Hydrochloride
Dosage form SOLUTION
Route ORAL
Labeler Hi-Tech Pharmacal Co., Inc.
Application ANDA040010
Marketing category ANDA
Marketing start 1994-10-28
Marketing end 0000-00-00
Substance HYDROXYZINE HYDROCHLORIDE
Active strength 10 mg/5mL
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 · 24 matching rows.
View current auxiliary records. · View the auxiliary file history.
Captured / source date, Dataset, Scope table Captured / source date Dataset Scope Package NDC Snapshot Source SHA-256 2025-12-14 17:58 UTC · source 2025-12-05 excluded product product d630ba8d3edf…732f749b63fb…2025-12-14 17:58 UTC · source 2025-12-05 excluded package package 50383-796-16 d630ba8d3edf…732f749b63fb…2025-08-27 00:01 UTC · source 2025-08-26 excluded product product f5e01cc5f278…a2eaf40c39c3…2025-08-27 00:01 UTC · source 2025-08-26 excluded package package 50383-796-16 f5e01cc5f278…a2eaf40c39c3…2025-04-01 02:39 UTC · source 2025-03-31 excluded product product 2ef7874e63bc…57b86245f4fa…2025-04-01 02:39 UTC · source 2025-03-31 excluded package package 50383-796-16 2ef7874e63bc…57b86245f4fa…2025-03-28 20:22 UTC · source 2025-03-28 excluded product product a1b67e2a42f9…c4cf2c586c0d…2025-03-28 20:22 UTC · source 2025-03-28 excluded package package 50383-796-16 a1b67e2a42f9…c4cf2c586c0d…2025-03-22 03:12 UTC · source 2025-03-21 excluded product product cfe11265f3b6…090c488252e2…2025-03-22 03:12 UTC · source 2025-03-21 excluded package package 50383-796-16 cfe11265f3b6…090c488252e2…2025-03-10 12:48 UTC · source 2025-03-10 excluded product product cdf11ea48f46…ba0047e9e063…2025-03-10 12:48 UTC · source 2025-03-10 excluded package package 50383-796-16 cdf11ea48f46…ba0047e9e063…2025-02-02 03:52 UTC · source 2025-01-31 excluded product product 302b2466d912…e7b80fea0513…2025-02-02 03:52 UTC · source 2025-01-31 excluded package package 50383-796-16 302b2466d912…e7b80fea0513…2025-01-20 13:05 UTC · source 2025-01-20 excluded product product ed331223b511…672a5bd82f5f…2025-01-20 13:05 UTC · source 2025-01-20 excluded package package 50383-796-16 ed331223b511…672a5bd82f5f…2025-01-11 03:41 UTC · source 2025-01-10 excluded product product 0efc9e666f02…f202fb6c5f17…2025-01-11 03:41 UTC · source 2025-01-10 excluded package package 50383-796-16 0efc9e666f02…f202fb6c5f17…2024-11-09 02:27 UTC · source 2024-11-08 excluded product product ad56d346431e…cc804d4bbf1e…2024-11-09 02:27 UTC · source 2024-11-08 excluded package package 50383-796-16 ad56d346431e…cc804d4bbf1e…2024-10-04 04:10 UTC · source 2024-10-03 excluded product product 367a005e9d99…383a685ebd0f…2024-10-04 04:10 UTC · source 2024-10-03 excluded package package 50383-796-16 367a005e9d99…383a685ebd0f…2024-07-10 04:00 UTC · source 2024-07-09 excluded product product 557ba5c1ecfa…9c80585c8c6e…2024-07-10 04:00 UTC · source 2024-07-09 excluded package package 50383-796-16 557ba5c1ecfa…9c80585c8c6e…
Source provenance: Browse the complete Orange Book source catalog · source snapshot 43 .
Orange Book products# Current product rows page 1 of 1 · 1 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date A040010-001 HYDROXYZINE HYDROCHLORIDE HYDROXYZINE HYDROCHLORIDE 10MG/5ML SYRUP / ORAL 1994-10-28
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 · 43 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 A040010-001 HYDROXYZINE HYDROCHLORIDE 10MG/5ML SYRUP / ORAL 1994-10-28 84e616aacf4f…2026-08-18 06:07:40 2026-07 A040010-001 HYDROXYZINE HYDROCHLORIDE 10MG/5ML SYRUP / ORAL 1994-10-28 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A040010-001 HYDROXYZINE HYDROCHLORIDE 10MG/5ML SYRUP / ORAL 1994-10-28 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A040010-001 HYDROXYZINE HYDROCHLORIDE 10MG/5ML SYRUP / ORAL 1994-10-28 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A040010-001 HYDROXYZINE HYDROCHLORIDE 10MG/5ML SYRUP / ORAL 1994-10-28 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A040010-001 HYDROXYZINE HYDROCHLORIDE 10MG/5ML SYRUP / ORAL 1994-10-28 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A040010-001 HYDROXYZINE HYDROCHLORIDE 10MG/5ML SYRUP / ORAL 1994-10-28 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A040010-001 HYDROXYZINE HYDROCHLORIDE 10MG/5ML SYRUP / ORAL 1994-10-28 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A040010-001 HYDROXYZINE HYDROCHLORIDE 10MG/5ML SYRUP / ORAL 1994-10-28 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A040010-001 HYDROXYZINE HYDROCHLORIDE 10MG/5ML SYRUP / ORAL 1994-10-28 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A040010-001 HYDROXYZINE HYDROCHLORIDE 10MG/5ML SYRUP / ORAL 1994-10-28 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A040010-001 HYDROXYZINE HYDROCHLORIDE 10MG/5ML SYRUP / ORAL 1994-10-28 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A040010-001 HYDROXYZINE HYDROCHLORIDE 10MG/5ML SYRUP / ORAL 1994-10-28 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A040010-001 HYDROXYZINE HYDROCHLORIDE 10MG/5ML SYRUP / ORAL 1994-10-28 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A040010-001 HYDROXYZINE HYDROCHLORIDE 10MG/5ML SYRUP / ORAL 1994-10-28 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A040010-001 HYDROXYZINE HYDROCHLORIDE 10MG/5ML SYRUP / ORAL 1994-10-28 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A040010-001 HYDROXYZINE HYDROCHLORIDE 10MG/5ML SYRUP / ORAL AA RS 1994-10-28 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A040010-001 HYDROXYZINE HYDROCHLORIDE 10MG/5ML SYRUP / ORAL AA RS 1994-10-28 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A040010-001 HYDROXYZINE HYDROCHLORIDE 10MG/5ML SYRUP / ORAL AA RS 1994-10-28 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A040010-001 HYDROXYZINE HYDROCHLORIDE 10MG/5ML SYRUP / ORAL AA RS 1994-10-28 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A040010-001 HYDROXYZINE HYDROCHLORIDE 10MG/5ML SYRUP / ORAL AA RS 1994-10-28 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A040010-001 HYDROXYZINE HYDROCHLORIDE 10MG/5ML SYRUP / ORAL AA RS 1994-10-28 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 A040010-001 HYDROXYZINE HYDROCHLORIDE 10MG/5ML SYRUP / ORAL AA RS 1994-10-28 87673890dc5c…2021-03-12 10:30 UTC 2021-03 A040010-001 HYDROXYZINE HYDROCHLORIDE 10MG/5ML SYRUP / ORAL AA RS 1994-10-28 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 A040010-001 HYDROXYZINE HYDROCHLORIDE 10MG/5ML SYRUP / ORAL AA RS 1994-10-28 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 A040010-001 HYDROXYZINE HYDROCHLORIDE 10MG/5ML SYRUP / ORAL AA RS 1994-10-28 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 A040010-001 HYDROXYZINE HYDROCHLORIDE 10MG/5ML SYRUP / ORAL AA RS 1994-10-28 3f01610625f2…2019-09-15 20:21 UTC 2019-09 A040010-001 HYDROXYZINE HYDROCHLORIDE 10MG/5ML SYRUP / ORAL AA RS 1994-10-28 b00525d2431f…2019-07-19 19:46 UTC 2019-07 A040010-001 HYDROXYZINE HYDROCHLORIDE 10MG/5ML SYRUP / ORAL AA RS 1994-10-28 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A040010-001 HYDROXYZINE HYDROCHLORIDE 10MG/5ML SYRUP / ORAL 1994-10-28 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A040010-001 HYDROXYZINE HYDROCHLORIDE 10MG/5ML SYRUP / ORAL 1994-10-28 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A040010-001 HYDROXYZINE HYDROCHLORIDE 10MG/5ML SYRUP / ORAL 1994-10-28 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A040010-001 HYDROXYZINE HYDROCHLORIDE 10MG/5ML SYRUP / ORAL 1994-10-28 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A040010-001 HYDROXYZINE HYDROCHLORIDE 10MG/5ML SYRUP / ORAL 1994-10-28 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A040010-001 HYDROXYZINE HYDROCHLORIDE 10MG/5ML SYRUP / ORAL 1994-10-28 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A040010-001 HYDROXYZINE HYDROCHLORIDE 10MG/5ML SYRUP / ORAL 1994-10-28 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 A040010-001 HYDROXYZINE HYDROCHLORIDE 10MG/5ML SYRUP / ORAL 1994-10-28 053a50430f4f…2023-01-26 05:58 UTC 2023-01 A040010-001 HYDROXYZINE HYDROCHLORIDE 10MG/5ML SYRUP / ORAL 1994-10-28 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 A040010-001 HYDROXYZINE HYDROCHLORIDE 10MG/5ML SYRUP / ORAL 1994-10-28 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 A040010-001 HYDROXYZINE HYDROCHLORIDE 10MG/5ML SYRUP / ORAL 1994-10-28 f41ea6bd6efb…
Observed Orange Book normalized TE history# Reported adverse events (FAERS/openFDA)# Adverse event summaries are temporarily unavailable. Other product information remains available.
DailyMed Product Concepts# DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded HYDROXYZINE HYDROCHLORIDE ACTIVE INGREDIENT 76755771U3 HYDROXYZINE HYDROCHLORIDE SOLUTION [HI-TECH PHARMACAL CO., INC] 5 HYDROXYZINE ACTIVE MOIETY 30S50YM8OG HYDROXYZINE HYDROCHLORIDE SOLUTION [HI-TECH PHARMACAL CO., INC] 5 ALCOHOL INACTIVE INGREDIENT 3K9958V90M HYDROXYZINE HYDROCHLORIDE SOLUTION [HI-TECH PHARMACAL CO., INC] 5 CORN SYRUP INACTIVE INGREDIENT 9G5L16BK6N HYDROXYZINE HYDROCHLORIDE SOLUTION [HI-TECH PHARMACAL CO., INC] 5 HYDROCHLORIC ACID INACTIVE INGREDIENT QTT17582CB HYDROXYZINE HYDROCHLORIDE SOLUTION [HI-TECH PHARMACAL CO., INC] 5 METHYLPARABEN INACTIVE INGREDIENT A2I8C7HI9T HYDROXYZINE HYDROCHLORIDE SOLUTION [HI-TECH PHARMACAL CO., INC] 5 PEPPERMINT INACTIVE INGREDIENT V95R5KMY2B HYDROXYZINE HYDROCHLORIDE SOLUTION [HI-TECH PHARMACAL CO., INC] 5 PROPYLENE GLYCOL INACTIVE INGREDIENT 6DC9Q167V3 HYDROXYZINE HYDROCHLORIDE SOLUTION [HI-TECH PHARMACAL CO., INC] 5 SODIUM BENZOATE INACTIVE INGREDIENT OJ245FE5EU HYDROXYZINE HYDROCHLORIDE SOLUTION [HI-TECH PHARMACAL CO., INC] 5 SODIUM HYDROXIDE INACTIVE INGREDIENT 55X04QC32I HYDROXYZINE HYDROCHLORIDE SOLUTION [HI-TECH PHARMACAL CO., INC] 5 SUCROSE INACTIVE INGREDIENT C151H8M554 HYDROXYZINE HYDROCHLORIDE SOLUTION [HI-TECH PHARMACAL CO., INC] 5 WATER INACTIVE INGREDIENT 059QF0KO0R HYDROXYZINE HYDROCHLORIDE SOLUTION [HI-TECH PHARMACAL CO., INC] 5 HYDROXYZINE HYDROCHLORIDE ACTIVE INGREDIENT 76755771U3 HYDROXYZINE HYDROCHLORIDE SOLUTION [PHYSICIANS TOTAL CARE, INC.] 1 HYDROXYZINE ACTIVE MOIETY 30S50YM8OG HYDROXYZINE HYDROCHLORIDE SOLUTION [PHYSICIANS TOTAL CARE, INC.] 1 ALCOHOL INACTIVE INGREDIENT 3K9958V90M HYDROXYZINE HYDROCHLORIDE SOLUTION [PHYSICIANS TOTAL CARE, INC.] 1 CORN SYRUP INACTIVE INGREDIENT 9G5L16BK6N HYDROXYZINE HYDROCHLORIDE SOLUTION [PHYSICIANS TOTAL CARE, INC.] 1 HYDROCHLORIC ACID INACTIVE INGREDIENT QTT17582CB HYDROXYZINE HYDROCHLORIDE SOLUTION [PHYSICIANS TOTAL CARE, INC.] 1 METHYLPARABEN INACTIVE INGREDIENT A2I8C7HI9T HYDROXYZINE HYDROCHLORIDE SOLUTION [PHYSICIANS TOTAL CARE, INC.] 1 PEPPERMINT INACTIVE INGREDIENT V95R5KMY2B HYDROXYZINE HYDROCHLORIDE SOLUTION [PHYSICIANS TOTAL CARE, INC.] 1 PROPYLENE GLYCOL INACTIVE INGREDIENT 6DC9Q167V3 HYDROXYZINE HYDROCHLORIDE SOLUTION [PHYSICIANS TOTAL CARE, INC.] 1 SODIUM BENZOATE INACTIVE INGREDIENT OJ245FE5EU HYDROXYZINE HYDROCHLORIDE SOLUTION [PHYSICIANS TOTAL CARE, INC.] 1 SODIUM HYDROXIDE INACTIVE INGREDIENT 55X04QC32I HYDROXYZINE HYDROCHLORIDE SOLUTION [PHYSICIANS TOTAL CARE, INC.] 1 SUCROSE INACTIVE INGREDIENT C151H8M554 HYDROXYZINE HYDROCHLORIDE SOLUTION [PHYSICIANS TOTAL CARE, INC.] 1 WATER INACTIVE INGREDIENT 059QF0KO0R HYDROXYZINE HYDROCHLORIDE SOLUTION [PHYSICIANS TOTAL CARE, INC.] 1
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 50383-796-16 50383079616 473 mL in 1 BOTTLE, PLASTIC (50383-796-16) 473 ml 1994-10-28 0000-00-00 No No Current