Home NDC 69452-395-88 Hydroxyzine Hydrochloride
Product NDC 69452-395
Requested package NDC 69452-395-88
11-digit product format 694520395
Labeler code 69452
Product ID 69452-395_39f93640-6535-6c3b-e063-6394a90a7f2d
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Hydroxyzine Hydrochloride Oral
Dosage form SOLUTION
Route ORAL
Labeler Bionpharma Inc.
Application ANDA219289
Marketing category ANDA
Marketing start 2025-07-17
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 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 A219289-001 HYDROXYZINE HYDROCHLORIDE HYDROXYZINE HYDROCHLORIDE 10MG/5ML SYRUP / ORAL AA 2025-04-28
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code A219289-001 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.
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 A219289-001 HYDROXYZINE HYDROCHLORIDE 10MG/5ML SYRUP / ORAL AA 2025-04-28 84e616aacf4f…2026-08-18 06:07:40 2026-07 A219289-001 HYDROXYZINE HYDROCHLORIDE 10MG/5ML SYRUP / ORAL AA 2025-04-28 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A219289-001 HYDROXYZINE HYDROCHLORIDE 10MG/5ML SYRUP / ORAL AA 2025-04-28 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A219289-001 HYDROXYZINE HYDROCHLORIDE 10MG/5ML SYRUP / ORAL AA 2025-04-28 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A219289-001 HYDROXYZINE HYDROCHLORIDE 10MG/5ML SYRUP / ORAL AA 2025-04-28 6a471c1ec25d…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A219289-001 HYDROXYZINE HYDROCHLORIDE 10MG/5ML SYRUP / ORAL AA 2025-04-28 a50c72e98297…
Observed Orange Book normalized TE history# 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 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 69452-395-88 Hydroxyzine Hydrochloride 473 mL in 1 BOTTLE SOLUTION 473 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 · 2 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 69452-395-88 69452039588 473 mL in 1 BOTTLE (69452-395-88) 473 ml 2025-07-17 No No Current