hydroxyzine hydrochloride

Generic: hydroxyzine hydrochloride

Labeler: major pharmaceuticals
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name hydroxyzine hydrochloride
Generic Name hydroxyzine hydrochloride
Labeler major pharmaceuticals
Dosage Form TABLET, FILM COATED
Routes
ORAL
Active Ingredients

hydroxyzine dihydrochloride 50 mg/1

Manufacturer
Major Pharmaceuticals

Identifiers & Regulatory

Product NDC 0904-6618
Product ID 0904-6618_f78ac709-6b0b-438b-8333-bd4a7509cfed
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 09046618
Hyphenated Format 0904-6618

Supplemental Identifiers

RxCUI
995258 995281
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 ANDA040604 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 50 mg/1
source: ndc
Packaging
  • 100 BLISTER PACK in 1 CARTON (0904-6618-61) / 1 TABLET, FILM COATED in 1 BLISTER PACK
source: ndc

Packages (1)

0904-6618-61 100 BLISTER PACK in 1 CARTON (0904-6618-61) / 1 TABLET, FILM COATED in 1 BLISTER PACK

Ingredients (1)

hydroxyzine dihydrochloride (50 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": "f78ac709-6b0b-438b-8333-bd4a7509cfed", "openfda": {"unii": ["76755771U3"], "rxcui": ["995258", "995281"], "spl_set_id": ["7534a3bb-b4cd-415f-8612-53b37dc6d55f"], "manufacturer_name": ["Major Pharmaceuticals"]}, "finished": true, "packaging": [{"sample": false, "description": "100 BLISTER PACK in 1 CARTON (0904-6618-61)  / 1 TABLET, FILM COATED in 1 BLISTER PACK", "package_ndc": "0904-6618-61", "marketing_start_date": "20150331"}], "brand_name": "Hydroxyzine Hydrochloride", "product_id": "0904-6618_f78ac709-6b0b-438b-8333-bd4a7509cfed", "dosage_form": "TABLET, FILM COATED", "pharm_class": ["Antihistamine [EPC]", "Histamine Receptor Antagonists [MoA]"], "product_ndc": "0904-6618", "generic_name": "Hydroxyzine Hydrochloride", "labeler_name": "Major Pharmaceuticals", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Hydroxyzine Hydrochloride", "active_ingredients": [{"name": "HYDROXYZINE DIHYDROCHLORIDE", "strength": "50 mg/1"}], "application_number": "ANDA040604", "marketing_category": "ANDA", "marketing_start_date": "20150331", "listing_expiration_date": "20261231"}