hydroxyzine hydrochloride

Generic: hydroxyzine hydrochloride

Labeler: remedyrepack inc.
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name hydroxyzine hydrochloride
Generic Name hydroxyzine hydrochloride
Labeler remedyrepack inc.
Dosage Form TABLET
Routes
ORAL
Active Ingredients

hydroxyzine dihydrochloride 10 mg/1

Manufacturer
REMEDYREPACK INC.

Identifiers & Regulatory

Product NDC 70518-4360
Product ID 70518-4360_37c4a121-e66d-5ef1-e063-6294a90a15cc
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA040840
Listing Expiration 2026-12-31
Marketing Start 2025-06-16

Pharmacologic Class

Classes
antihistamine [epc] histamine receptor antagonists [moa]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 705184360
Hyphenated Format 70518-4360

Supplemental Identifiers

RxCUI
995218
UNII
76755771U3

Resolved Product View

Precedence rule: structured NDC data is preferred, falling back to linked label metadata when unavailable. Source tags show the origin of each value.

Resolved Identity

Brand Name hydroxyzine hydrochloride (source: ndc)
Generic Name hydroxyzine hydrochloride (source: ndc)
Application Number ANDA040840 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 10 mg/1
source: ndc
Packaging
  • 30 TABLET in 1 BLISTER PACK (70518-4360-0)
source: ndc

Packages (1)

70518-4360-0 30 TABLET in 1 BLISTER PACK (70518-4360-0)

Ingredients (1)

hydroxyzine dihydrochloride (10 mg/1)

Linked Drug Pages (1)

HydrOXYzine Hydrochloride ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "37c4a121-e66d-5ef1-e063-6294a90a15cc", "openfda": {"unii": ["76755771U3"], "rxcui": ["995218"], "spl_set_id": ["58d99cf6-2319-410b-b8be-de9c304541b6"], "manufacturer_name": ["REMEDYREPACK INC."]}, "finished": true, "packaging": [{"sample": false, "description": "30 TABLET in 1 BLISTER PACK (70518-4360-0)", "package_ndc": "70518-4360-0", "marketing_start_date": "20250616"}], "brand_name": "HydrOXYzine Hydrochloride", "product_id": "70518-4360_37c4a121-e66d-5ef1-e063-6294a90a15cc", "dosage_form": "TABLET", "pharm_class": ["Antihistamine [EPC]", "Histamine Receptor Antagonists [MoA]"], "product_ndc": "70518-4360", "generic_name": "HydrOXYzine Hydrochloride", "labeler_name": "REMEDYREPACK INC.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "HydrOXYzine Hydrochloride", "active_ingredients": [{"name": "HYDROXYZINE DIHYDROCHLORIDE", "strength": "10 mg/1"}], "application_number": "ANDA040840", "marketing_category": "ANDA", "marketing_start_date": "20250616", "listing_expiration_date": "20261231"}