hydroxyzine hydrochloride

Generic: hydroxyzine hydrochloride

Labeler: sunrise pharmaceutical, inc.
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name hydroxyzine hydrochloride
Generic Name hydroxyzine hydrochloride
Labeler sunrise pharmaceutical, inc.
Dosage Form TABLET, FILM COATED
Routes
ORAL
Active Ingredients

hydroxyzine dihydrochloride 10 mg/1

Manufacturer
Sunrise Pharmaceutical, Inc.

Identifiers & Regulatory

Product NDC 11534-204
Product ID 11534-204_4f0e9eea-4f47-49fe-a609-790dada173d0
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA207121
Listing Expiration 2026-12-31
Marketing Start 2024-04-16

Pharmacologic Class

Classes
antihistamine [epc] histamine receptor antagonists [moa]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 11534204
Hyphenated Format 11534-204

Supplemental Identifiers

RxCUI
995218 995258 995281
UPC
0311534204032 0311534206036
UNII
76755771U3

Packaging Origin

Original Packager
true

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 ANDA207121 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 10 mg/1
source: ndc
Packaging
  • 100 TABLET, FILM COATED in 1 BOTTLE (11534-204-01)
  • 1000 TABLET, FILM COATED in 1 BOTTLE (11534-204-03)
  • 500 TABLET, FILM COATED in 1 BOTTLE (11534-204-04)
source: ndc

Packages (3)

11534-204-01 100 TABLET, FILM COATED in 1 BOTTLE (11534-204-01) 11534-204-03 1000 TABLET, FILM COATED in 1 BOTTLE (11534-204-03) 11534-204-04 500 TABLET, FILM COATED in 1 BOTTLE (11534-204-04)

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": "4f0e9eea-4f47-49fe-a609-790dada173d0", "openfda": {"upc": ["0311534204032", "0311534206036"], "unii": ["76755771U3"], "rxcui": ["995218", "995258", "995281"], "spl_set_id": ["94561525-a565-4193-b64d-e1459ab05678"], "manufacturer_name": ["Sunrise Pharmaceutical, Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "100 TABLET, FILM COATED in 1 BOTTLE (11534-204-01)", "package_ndc": "11534-204-01", "marketing_start_date": "20240416"}, {"sample": false, "description": "1000 TABLET, FILM COATED in 1 BOTTLE (11534-204-03)", "package_ndc": "11534-204-03", "marketing_start_date": "20240416"}, {"sample": false, "description": "500 TABLET, FILM COATED in 1 BOTTLE (11534-204-04)", "package_ndc": "11534-204-04", "marketing_start_date": "20250110"}], "brand_name": "HYDROXYZINE HYDROCHLORIDE", "product_id": "11534-204_4f0e9eea-4f47-49fe-a609-790dada173d0", "dosage_form": "TABLET, FILM COATED", "pharm_class": ["Antihistamine [EPC]", "Histamine Receptor Antagonists [MoA]"], "product_ndc": "11534-204", "generic_name": "hydroxyzine hydrochloride", "labeler_name": "Sunrise Pharmaceutical, Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "HYDROXYZINE HYDROCHLORIDE", "active_ingredients": [{"name": "HYDROXYZINE DIHYDROCHLORIDE", "strength": "10 mg/1"}], "application_number": "ANDA207121", "marketing_category": "ANDA", "marketing_start_date": "20240416", "listing_expiration_date": "20261231"}