Home NDC 54838-502 Hydroxyzine Hydrochloride
Product NDC 54838-502
11-digit product format 548380502
Labeler code 54838
Product ID 54838-502_823645dc-4e60-4279-97fa-ca0d1c1d7ad8
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Hydroxyzine Hydrochloride
Dosage form SOLUTION
Route ORAL
Labeler Lannett Company, Inc.
Application ANDA201674
Marketing category ANDA
Marketing start 2013-08-21
Substance HYDROXYZINE DIHYDROCHLORIDE
Active strength 10 mg/5mL
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 1 .
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 A201674-001 HYDROXYZINE HYDROCHLORIDE HYDROXYZINE HYDROCHLORIDE 10MG/5ML SYRUP / ORAL AA 2013-08-21
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code A201674-001 AA
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 · 41 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 2026-02-19 14:30 UTC 2026-02 A201674-001 HYDROXYZINE HYDROCHLORIDE 10MG/5ML SYRUP / ORAL AA 2013-08-21 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A201674-001 HYDROXYZINE HYDROCHLORIDE 10MG/5ML SYRUP / ORAL AA 2013-08-21 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A201674-001 HYDROXYZINE HYDROCHLORIDE 10MG/5ML SYRUP / ORAL AA 2013-08-21 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A201674-001 HYDROXYZINE HYDROCHLORIDE 10MG/5ML SYRUP / ORAL AA 2013-08-21 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A201674-001 HYDROXYZINE HYDROCHLORIDE 10MG/5ML SYRUP / ORAL AA 2013-08-21 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A201674-001 HYDROXYZINE HYDROCHLORIDE 10MG/5ML SYRUP / ORAL AA 2013-08-21 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A201674-001 HYDROXYZINE HYDROCHLORIDE 10MG/5ML SYRUP / ORAL AA 2013-08-21 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A201674-001 HYDROXYZINE HYDROCHLORIDE 10MG/5ML SYRUP / ORAL AA 2013-08-21 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A201674-001 HYDROXYZINE HYDROCHLORIDE 10MG/5ML SYRUP / ORAL AA 2013-08-21 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A201674-001 HYDROXYZINE HYDROCHLORIDE 10MG/5ML SYRUP / ORAL AA 2013-08-21 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A201674-001 HYDROXYZINE HYDROCHLORIDE 10MG/5ML SYRUP / ORAL AA 2013-08-21 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A201674-001 HYDROXYZINE HYDROCHLORIDE 10MG/5ML SYRUP / ORAL AA 2013-08-21 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A201674-001 HYDROXYZINE HYDROCHLORIDE 10MG/5ML SYRUP / ORAL AA 2013-08-21 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A201674-001 HYDROXYZINE HYDROCHLORIDE 10MG/5ML SYRUP / ORAL AA 2013-08-21 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A201674-001 HYDROXYZINE HYDROCHLORIDE 10MG/5ML SYRUP / ORAL AA 2013-08-21 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A201674-001 HYDROXYZINE HYDROCHLORIDE 10MG/5ML SYRUP / ORAL AA 2013-08-21 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A201674-001 HYDROXYZINE HYDROCHLORIDE 10MG/5ML SYRUP / ORAL AA 2013-08-21 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A201674-001 HYDROXYZINE HYDROCHLORIDE 10MG/5ML SYRUP / ORAL AA 2013-08-21 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A201674-001 HYDROXYZINE HYDROCHLORIDE 10MG/5ML SYRUP / ORAL AA 2013-08-21 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A201674-001 HYDROXYZINE HYDROCHLORIDE 10MG/5ML SYRUP / ORAL AA 2013-08-21 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 A201674-001 HYDROXYZINE HYDROCHLORIDE 10MG/5ML SYRUP / ORAL AA 2013-08-21 87673890dc5c…2021-03-12 10:30 UTC 2021-03 A201674-001 HYDROXYZINE HYDROCHLORIDE 10MG/5ML SYRUP / ORAL AA 2013-08-21 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 A201674-001 HYDROXYZINE HYDROCHLORIDE 10MG/5ML SYRUP / ORAL AA 2013-08-21 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 A201674-001 HYDROXYZINE HYDROCHLORIDE 10MG/5ML SYRUP / ORAL AA 2013-08-21 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 A201674-001 HYDROXYZINE HYDROCHLORIDE 10MG/5ML SYRUP / ORAL AA 2013-08-21 3f01610625f2…2019-09-15 20:21 UTC 2019-09 A201674-001 HYDROXYZINE HYDROCHLORIDE 10MG/5ML SYRUP / ORAL AA 2013-08-21 b00525d2431f…2019-07-19 19:46 UTC 2019-07 A201674-001 HYDROXYZINE HYDROCHLORIDE 10MG/5ML SYRUP / ORAL AA 2013-08-21 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A201674-001 HYDROXYZINE HYDROCHLORIDE 10MG/5ML SYRUP / ORAL AA 2013-08-21 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A201674-001 HYDROXYZINE HYDROCHLORIDE 10MG/5ML SYRUP / ORAL AA 2013-08-21 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A201674-001 HYDROXYZINE HYDROCHLORIDE 10MG/5ML SYRUP / ORAL AA 2013-08-21 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A201674-001 HYDROXYZINE HYDROCHLORIDE 10MG/5ML SYRUP / ORAL AA 2013-08-21 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A201674-001 HYDROXYZINE HYDROCHLORIDE 10MG/5ML SYRUP / ORAL AA 2013-08-21 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A201674-001 HYDROXYZINE HYDROCHLORIDE 10MG/5ML SYRUP / ORAL AA 2013-08-21 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A201674-001 HYDROXYZINE HYDROCHLORIDE 10MG/5ML SYRUP / ORAL AA 2013-08-21 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 A201674-001 HYDROXYZINE HYDROCHLORIDE 10MG/5ML SYRUP / ORAL AA 2013-08-21 053a50430f4f…2023-01-26 05:58 UTC 2023-01 A201674-001 HYDROXYZINE HYDROCHLORIDE 10MG/5ML SYRUP / ORAL AA 2013-08-21 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 A201674-001 HYDROXYZINE HYDROCHLORIDE 10MG/5ML SYRUP / ORAL AA 2013-08-21 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 A201674-001 HYDROXYZINE HYDROCHLORIDE 10MG/5ML SYRUP / ORAL AA 2013-08-21 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 A201674-001 HYDROXYZINE HYDROCHLORIDE 10MG/5ML SYRUP / ORAL AA 2013-08-21 e64feba35796…2022-07-09 03:26 UTC · 3 captures of this ZIP 2022-07 A201674-001 HYDROXYZINE HYDROCHLORIDE 10MG/5ML SYRUP / ORAL AA 2013-08-21 cb3db0bc1861…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 2 · 41 observed states.
Additional Listing Data#
Finished product Yes
Brand name base Hydroxyzine Hydrochloride
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength HYDROXYZINE DIHYDROCHLORIDE 10 mg/5mL
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 995241 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 54838-502-80 Hydroxyzine Hydrochloride 473 mL in 1 BOTTLE, PLASTIC SOLUTION 473 21
DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded Hydroxyzine Hydrochloride ACTIVE INGREDIENT 76755771U3 HYDROXYZINE (HYDROXYZINE HYDROCHLORIDE) SOLUTION [SILARX PHARMACEUTICALS, INC] 7 Hydroxyzine ACTIVE MOIETY 30S50YM8OG HYDROXYZINE (HYDROXYZINE HYDROCHLORIDE) SOLUTION [SILARX PHARMACEUTICALS, INC] 7 anhydrous citric acid INACTIVE INGREDIENT XF417D3PSL HYDROXYZINE (HYDROXYZINE HYDROCHLORIDE) SOLUTION [SILARX PHARMACEUTICALS, INC] 7 sodium benzoate INACTIVE INGREDIENT OJ245FE5EU HYDROXYZINE (HYDROXYZINE HYDROCHLORIDE) SOLUTION [SILARX PHARMACEUTICALS, INC] 7 sodium citrate INACTIVE INGREDIENT 1Q73Q2JULR HYDROXYZINE (HYDROXYZINE HYDROCHLORIDE) SOLUTION [SILARX PHARMACEUTICALS, INC] 7 sucrose INACTIVE INGREDIENT C151H8M554 HYDROXYZINE (HYDROXYZINE HYDROCHLORIDE) SOLUTION [SILARX PHARMACEUTICALS, INC] 7 water INACTIVE INGREDIENT 059QF0KO0R HYDROXYZINE (HYDROXYZINE HYDROCHLORIDE) SOLUTION [SILARX PHARMACEUTICALS, INC] 7 Hydroxyzine Hydrochloride ACTIVE INGREDIENT 76755771U3 HYDROXYZINE (HYDROXYZINE HYDROCHLORIDE) SOLUTION [PREFERRED PHARMACEUTICALS, INC.] 1 Hydroxyzine ACTIVE MOIETY 30S50YM8OG HYDROXYZINE (HYDROXYZINE HYDROCHLORIDE) SOLUTION [PREFERRED PHARMACEUTICALS, INC.] 1 anhydrous citric acid INACTIVE INGREDIENT XF417D3PSL HYDROXYZINE (HYDROXYZINE HYDROCHLORIDE) SOLUTION [PREFERRED PHARMACEUTICALS, INC.] 1 sodium benzoate INACTIVE INGREDIENT OJ245FE5EU HYDROXYZINE (HYDROXYZINE HYDROCHLORIDE) SOLUTION [PREFERRED PHARMACEUTICALS, INC.] 1 sodium citrate INACTIVE INGREDIENT 1Q73Q2JULR HYDROXYZINE (HYDROXYZINE HYDROCHLORIDE) SOLUTION [PREFERRED PHARMACEUTICALS, INC.] 1 sucrose INACTIVE INGREDIENT C151H8M554 HYDROXYZINE (HYDROXYZINE HYDROCHLORIDE) SOLUTION [PREFERRED PHARMACEUTICALS, INC.] 1 water INACTIVE INGREDIENT 059QF0KO0R HYDROXYZINE (HYDROXYZINE HYDROCHLORIDE) SOLUTION [PREFERRED PHARMACEUTICALS, INC.] 1
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 54838-502 HYDROXYZINE HYDROCHLORIDE SOLUTION [LANNETT COMPANY, INC.] 21 Current NDC, Legacy NDC, 1 package rows 20240809_a4fb61ae-aad6-4bd6-83fc-8b227f175df9.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 · 3 matching rows.
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 54838-502-80 54838050280 473 mL in 1 BOTTLE, PLASTIC (54838-502-80) 473 ml 2013-08-21 0000-00-00 No No Current