Home NDC 43063-519 Hydroxyzine Hydrochloride
Product NDC 43063-519
11-digit product format 430630519
Labeler code 43063
Product ID 43063-519_4138e87f-3fda-bee4-e063-6294a90afa2b
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Hydroxyzine Hydrochloride
Dosage form TABLET, FILM COATED
Route ORAL
Labeler PD-Rx Pharmaceuticals, Inc.
Application ANDA040788
Marketing category ANDA
Marketing start 2012-07-24
Substance HYDROXYZINE DIHYDROCHLORIDE
Active strength 50 mg/1
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 .
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/1
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 995281 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 43063-519-30 Hydroxyzine Hydrochloride 30 in 1 BOTTLE, PLASTIC TABLET, FILM COATED 30 21
DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded HYDROXYZINE HYDROCHLORIDE ACTIVE INGREDIENT 76755771U3 HYDROXYZINE HYDROCHLORIDE TABLET, FILM COATED [PD-RX PHARMACEUTICALS, INC.] 2 HYDROXYZINE ACTIVE MOIETY 30S50YM8OG HYDROXYZINE HYDROCHLORIDE TABLET, FILM COATED [PD-RX PHARMACEUTICALS, INC.] 2 CARNAUBA WAX INACTIVE INGREDIENT R12CBM0EIZ HYDROXYZINE HYDROCHLORIDE TABLET, FILM COATED [PD-RX PHARMACEUTICALS, INC.] 2 CELLULOSE, MICROCRYSTALLINE INACTIVE INGREDIENT OP1R32D61U HYDROXYZINE HYDROCHLORIDE TABLET, FILM COATED [PD-RX PHARMACEUTICALS, INC.] 2 CROSPOVIDONE INACTIVE INGREDIENT 68401960MK HYDROXYZINE HYDROCHLORIDE TABLET, FILM COATED [PD-RX PHARMACEUTICALS, INC.] 2 LACTOSE MONOHYDRATE INACTIVE INGREDIENT EWQ57Q8I5X HYDROXYZINE HYDROCHLORIDE TABLET, FILM COATED [PD-RX PHARMACEUTICALS, INC.] 2 MAGNESIUM STEARATE INACTIVE INGREDIENT 70097M6I30 HYDROXYZINE HYDROCHLORIDE TABLET, FILM COATED [PD-RX PHARMACEUTICALS, INC.] 2 POLYETHYLENE GLYCOL 3350 INACTIVE INGREDIENT G2M7P15E5P HYDROXYZINE HYDROCHLORIDE TABLET, FILM COATED [PD-RX PHARMACEUTICALS, INC.] 2 POLYVINYL ALCOHOL INACTIVE INGREDIENT 532B59J990 HYDROXYZINE HYDROCHLORIDE TABLET, FILM COATED [PD-RX PHARMACEUTICALS, INC.] 2 SILICON DIOXIDE INACTIVE INGREDIENT ETJ7Z6XBU4 HYDROXYZINE HYDROCHLORIDE TABLET, FILM COATED [PD-RX PHARMACEUTICALS, INC.] 2 TALC INACTIVE INGREDIENT 7SEV7J4R1U HYDROXYZINE HYDROCHLORIDE TABLET, FILM COATED [PD-RX PHARMACEUTICALS, INC.] 2 TITANIUM DIOXIDE INACTIVE INGREDIENT 15FIX9V2JP HYDROXYZINE HYDROCHLORIDE TABLET, FILM COATED [PD-RX PHARMACEUTICALS, INC.] 2 WATER INACTIVE INGREDIENT 059QF0KO0R HYDROXYZINE HYDROCHLORIDE TABLET, FILM COATED [PD-RX PHARMACEUTICALS, INC.] 2
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 43063-519 HYDROXYZINE HYDROCHLORIDE TABLET, FILM COATED [PD-RX PHARMACEUTICALS, INC.] 20 Current NDC, Legacy NDC, 1 package rows 20241013_263d3f22-a105-4abb-8152-be2081eefcde.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 · 2 matching rows.
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Marketing start Marketing end Sample Exclude flag Status 43063-519-30 43063051930 30 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (43063-519-30) 2012-07-25 0000-00-00 No No Current