hydroxyzine hydrochloride

Generic: hydroxyzine hydrochloride

Labeler: epic pharma, llc
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name hydroxyzine hydrochloride
Generic Name hydroxyzine hydrochloride
Labeler epic pharma, llc
Dosage Form TABLET, FILM COATED
Routes
ORAL
Active Ingredients

hydroxyzine dihydrochloride 25 mg/1

Manufacturer
Epic Pharma, LLC

Identifiers & Regulatory

Product NDC 42806-160
Product ID 42806-160_5e33c30d-cf33-4d61-98ca-eab9aab2ddf3
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA040604
Listing Expiration 2026-12-31
Marketing Start 2015-03-31

Pharmacologic Class

Classes
antihistamine [epc] histamine receptor antagonists [moa]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 42806160
Hyphenated Format 42806-160

Supplemental Identifiers

RxCUI
995218 995258 995281
UPC
0342806160015
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 ANDA040604 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 25 mg/1
source: ndc
Packaging
  • 100 TABLET, FILM COATED in 1 BOTTLE (42806-160-01)
  • 500 TABLET, FILM COATED in 1 BOTTLE (42806-160-05)
  • 1000 TABLET, FILM COATED in 1 BOTTLE (42806-160-10)
source: ndc

Packages (3)

42806-160-01 100 TABLET, FILM COATED in 1 BOTTLE (42806-160-01) 42806-160-05 500 TABLET, FILM COATED in 1 BOTTLE (42806-160-05) 42806-160-10 1000 TABLET, FILM COATED in 1 BOTTLE (42806-160-10)

Ingredients (1)

hydroxyzine dihydrochloride (25 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": "5e33c30d-cf33-4d61-98ca-eab9aab2ddf3", "openfda": {"upc": ["0342806160015"], "unii": ["76755771U3"], "rxcui": ["995218", "995258", "995281"], "spl_set_id": ["82b015dc-999c-46a4-bcaa-a4c81a193b68"], "manufacturer_name": ["Epic Pharma, LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "100 TABLET, FILM COATED in 1 BOTTLE (42806-160-01)", "package_ndc": "42806-160-01", "marketing_start_date": "20150331"}, {"sample": false, "description": "500 TABLET, FILM COATED in 1 BOTTLE (42806-160-05)", "package_ndc": "42806-160-05", "marketing_start_date": "20150331"}, {"sample": false, "description": "1000 TABLET, FILM COATED in 1 BOTTLE (42806-160-10)", "package_ndc": "42806-160-10", "marketing_start_date": "20150331"}], "brand_name": "Hydroxyzine Hydrochloride", "product_id": "42806-160_5e33c30d-cf33-4d61-98ca-eab9aab2ddf3", "dosage_form": "TABLET, FILM COATED", "pharm_class": ["Antihistamine [EPC]", "Histamine Receptor Antagonists [MoA]"], "product_ndc": "42806-160", "generic_name": "Hydroxyzine Hydrochloride", "labeler_name": "Epic Pharma, LLC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Hydroxyzine Hydrochloride", "active_ingredients": [{"name": "HYDROXYZINE DIHYDROCHLORIDE", "strength": "25 mg/1"}], "application_number": "ANDA040604", "marketing_category": "ANDA", "marketing_start_date": "20150331", "listing_expiration_date": "20261231"}