Home NDC 83745-232-16 HYDROXYZINE HYDROCHLORIDE
Product NDC 83745-232
Requested package NDC 83745-232-16
11-digit product format 837450232
Labeler code 83745
Product ID 83745-232_832542b8-0454-465e-a50d-a749dcd1a84d
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name HYDROXYZINE HYDROCHLORIDE
Dosage form SOLUTION
Route ORAL
Labeler APOZEAL PHARMACEUTICALS INC
Application ANDA210634
Marketing category ANDA
Marketing start 2024-07-16
Substance HYDROXYZINE DIHYDROCHLORIDE
Active strength 10 mg/5mL
Pharmacologic classes Antihistamine [EPC], Histamine Receptor Antagonists [MoA]
NDC exclude flag No
Listing certified through 2027-12-31
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 A210634-001 HYDROXYZINE HYDROCHLORIDE HYDROXYZINE HYDROCHLORIDE 10MG/5ML SYRUP / ORAL AA 2019-02-26
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code A210634-001 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 2026-08-01 22:54:32 2026-06 A210634-001 HYDROXYZINE HYDROCHLORIDE 10MG/5ML SYRUP / ORAL AA 2019-02-26 a50c72e98297…
Observed Orange Book normalized TE history# Captured, Edition, Application-product table Captured Edition Application-product TE code Order Source SHA-256 2026-08-01 22:54:32 2026-06 A210634-001 AA 1 a50c72e98297…
openFDA label cross-check# Cross-check layer: openFDA label JSON enriches search and identifies hydration gaps. The DailyMed Structured Product Label remains the canonical label presentation on FDA.report. Every label matching the complete exact-identifier union is deduplicated and paginated below.
Matched openFDA labels page 1 of 1 · 1 matching rows.
Additional Listing Data#
Finished product Yes
Brand name base HYDROXYZINE HYDROCHLORIDE
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength HYDROXYZINE HYDROCHLORIDE 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 83745-232-16 HYDROXYZINE HYDROCHLORIDE 473 mL in 1 BOTTLE SOLUTION 473 8
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 83745-232 HYDROXYZINE HYDROCHLORIDE SOLUTION [APOZEAL PHARMACEUTICALS INC] 7 Current NDC, 1 package rows 20240730_87d4bbff-0498-4c26-86cb-7ce173afa0b6.zip
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Sample Exclude flag Status 83745-232-16 83745023216 473 mL in 1 BOTTLE (83745-232-16) 473 ml 2024-07-16 No No Current