Home NDC 68999-050-24 HYDROXYZINE HYDROCHLORIDE
Product NDC 68999-050
Requested package NDC 68999-050-24
11-digit product format 689990050
Labeler code 68999
Product ID 68999-050_4356ec2d-ecb8-1aed-e063-6394a90ad74e
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name HYDROXYZINE HYDROCHLORIDE
Dosage form SYRUP
Route ORAL
Labeler Chartwell Governmental & Specialty RX, LLC.
Application ANDA087294
Marketing category ANDA
Marketing start 1982-04-12
Substance HYDROXYZINE DIHYDROCHLORIDE
Active strength 50 mg/25mL
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 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 A087294-001 HYDROXYZINE HYDROCHLORIDE HYDROXYZINE HYDROCHLORIDE 10MG/5ML SYRUP / ORAL AA RLD, RS 1982-04-12
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code A087294-001 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 · 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 A087294-001 HYDROXYZINE HYDROCHLORIDE 10MG/5ML SYRUP / ORAL AA RLD, RS 1982-04-12 84e616aacf4f…2026-08-18 06:07:40 2026-07 A087294-001 HYDROXYZINE HYDROCHLORIDE 10MG/5ML SYRUP / ORAL AA RLD, RS 1982-04-12 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A087294-001 HYDROXYZINE HYDROCHLORIDE 10MG/5ML SYRUP / ORAL AA RLD, RS 1982-04-12 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A087294-001 HYDROXYZINE HYDROCHLORIDE 10MG/5ML SYRUP / ORAL AA RLD, RS 1982-04-12 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A087294-001 HYDROXYZINE HYDROCHLORIDE 10MG/5ML SYRUP / ORAL AA RLD, RS 1982-04-12 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A087294-001 HYDROXYZINE HYDROCHLORIDE 10MG/5ML SYRUP / ORAL AA RLD, RS 1982-04-12 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A087294-001 HYDROXYZINE HYDROCHLORIDE 10MG/5ML SYRUP / ORAL AA RLD, RS 1982-04-12 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A087294-001 HYDROXYZINE HYDROCHLORIDE 10MG/5ML SYRUP / ORAL AA RLD, RS 1982-04-12 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A087294-001 HYDROXYZINE HYDROCHLORIDE 10MG/5ML SYRUP / ORAL AA RLD, RS 1982-04-12 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A087294-001 HYDROXYZINE HYDROCHLORIDE 10MG/5ML SYRUP / ORAL AA RLD, RS 1982-04-12 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A087294-001 HYDROXYZINE HYDROCHLORIDE 10MG/5ML SYRUP / ORAL AA RLD, RS 1982-04-12 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A087294-001 HYDROXYZINE HYDROCHLORIDE 10MG/5ML SYRUP / ORAL AA RLD, RS 1982-04-12 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A087294-001 HYDROXYZINE HYDROCHLORIDE 10MG/5ML SYRUP / ORAL AA RLD, RS 1982-04-12 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A087294-001 HYDROXYZINE HYDROCHLORIDE 10MG/5ML SYRUP / ORAL AA RLD, RS 1982-04-12 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A087294-001 HYDROXYZINE HYDROCHLORIDE 10MG/5ML SYRUP / ORAL AA RLD, RS 1982-04-12 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A087294-001 HYDROXYZINE HYDROCHLORIDE 10MG/5ML SYRUP / ORAL AA RLD, RS 1982-04-12 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A087294-001 HYDROXYZINE HYDROCHLORIDE 10MG/5ML SYRUP / ORAL AA RLD, RS 1982-04-12 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A087294-001 HYDROXYZINE HYDROCHLORIDE 10MG/5ML SYRUP / ORAL AA RLD, RS 1982-04-12 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A087294-001 HYDROXYZINE HYDROCHLORIDE 10MG/5ML SYRUP / ORAL AA RLD, RS 1982-04-12 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A087294-001 HYDROXYZINE HYDROCHLORIDE 10MG/5ML SYRUP / ORAL AA RS 1982-04-12 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A087294-001 HYDROXYZINE HYDROCHLORIDE 10MG/5ML SYRUP / ORAL AA RLD, RS 1982-04-12 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A087294-001 HYDROXYZINE HYDROCHLORIDE 10MG/5ML SYRUP / ORAL AA RLD, RS 1982-04-12 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 A087294-001 HYDROXYZINE HYDROCHLORIDE 10MG/5ML SYRUP / ORAL AA RS 1982-04-12 87673890dc5c…2021-03-12 10:30 UTC 2021-03 A087294-001 HYDROXYZINE HYDROCHLORIDE 10MG/5ML SYRUP / ORAL AA RS 1982-04-12 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 A087294-001 HYDROXYZINE HYDROCHLORIDE 10MG/5ML SYRUP / ORAL AA RS 1982-04-12 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 A087294-001 HYDROXYZINE HYDROCHLORIDE 10MG/5ML SYRUP / ORAL AA RS 1982-04-12 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 A087294-001 HYDROXYZINE HYDROCHLORIDE 10MG/5ML SYRUP / ORAL AA RS 1982-04-12 3f01610625f2…2019-09-15 20:21 UTC 2019-09 A087294-001 HYDROXYZINE HYDROCHLORIDE 10MG/5ML SYRUP / ORAL AA RS 1982-04-12 b00525d2431f…2019-07-19 19:46 UTC 2019-07 A087294-001 HYDROXYZINE HYDROCHLORIDE 10MG/5ML SYRUP / ORAL AA RS 1982-04-12 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A087294-001 HYDROXYZINE HYDROCHLORIDE 10MG/5ML SYRUP / ORAL AA RLD, RS 1982-04-12 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A087294-001 HYDROXYZINE HYDROCHLORIDE 10MG/5ML SYRUP / ORAL AA RLD, RS 1982-04-12 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A087294-001 HYDROXYZINE HYDROCHLORIDE 10MG/5ML SYRUP / ORAL AA RLD, RS 1982-04-12 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A087294-001 HYDROXYZINE HYDROCHLORIDE 10MG/5ML SYRUP / ORAL AA RLD, RS 1982-04-12 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A087294-001 HYDROXYZINE HYDROCHLORIDE 10MG/5ML SYRUP / ORAL AA RLD, RS 1982-04-12 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A087294-001 HYDROXYZINE HYDROCHLORIDE 10MG/5ML SYRUP / ORAL AA RLD, RS 1982-04-12 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A087294-001 HYDROXYZINE HYDROCHLORIDE 10MG/5ML SYRUP / ORAL AA RLD, RS 1982-04-12 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 A087294-001 HYDROXYZINE HYDROCHLORIDE 10MG/5ML SYRUP / ORAL AA RLD, RS 1982-04-12 053a50430f4f…2023-01-26 05:58 UTC 2023-01 A087294-001 HYDROXYZINE HYDROCHLORIDE 10MG/5ML SYRUP / ORAL AA RLD, RS 1982-04-12 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 A087294-001 HYDROXYZINE HYDROCHLORIDE 10MG/5ML SYRUP / ORAL AA RLD, RS 1982-04-12 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 A087294-001 HYDROXYZINE HYDROCHLORIDE 10MG/5ML SYRUP / ORAL AA RLD, RS 1982-04-12 f41ea6bd6efb…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 2 · 43 observed states.
Reported adverse events (FAERS/openFDA)# Adverse event summaries are temporarily unavailable. Other product information remains available.
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 50 mg/25mL
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 68999-050-24 HYDROXYZINE HYDROCHLORIDE 2 in 1 BOX SYRUP 2 1 68999-050-24 HYDROXYZINE HYDROCHLORIDE 10 in 1 TRAY SYRUP 10 1 68999-050-52 HYDROXYZINE HYDROCHLORIDE 25 mL in 1 CUP SYRUP 25 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 · 3 matching rows.
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Sample Exclude flag Status 68999-050-24 68999005024 2 TRAY in 1 BOX (68999-050-24) / 10 CUP in 1 TRAY / 25 mL in 1 CUP (68999-050-52) 2 tray 2025-10-31 No No Current