hydroxyzine hydrochloride

Generic: hydroxyzine hydrochloride

Labeler: marlex pharmaceuticals, inc.
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

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

hydroxyzine dihydrochloride 50 mg/1

Manufacturer
Marlex Pharmaceuticals, Inc.

Identifiers & Regulatory

Product NDC 10135-812
Product ID 10135-812_31a907fc-2be0-1219-e063-6294a90ac00f
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA207121
Listing Expiration 2026-12-31
Marketing Start 2025-03-01

Pharmacologic Class

Classes
antihistamine [epc] histamine receptor antagonists [moa]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 10135812
Hyphenated Format 10135-812

Supplemental Identifiers

RxCUI
995218 995258 995281
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
  • 50 mg/1
source: ndc
Packaging
  • 100 TABLET, FILM COATED in 1 BOTTLE (10135-812-01)
  • 1000 TABLET, FILM COATED in 1 BOTTLE (10135-812-10)
source: ndc

Packages (2)

10135-812-01 100 TABLET, FILM COATED in 1 BOTTLE (10135-812-01) 10135-812-10 1000 TABLET, FILM COATED in 1 BOTTLE (10135-812-10)

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": "31a907fc-2be0-1219-e063-6294a90ac00f", "openfda": {"unii": ["76755771U3"], "rxcui": ["995218", "995258", "995281"], "spl_set_id": ["31a907e6-7fae-0682-e063-6294a90a24a5"], "manufacturer_name": ["Marlex Pharmaceuticals, Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "100 TABLET, FILM COATED in 1 BOTTLE (10135-812-01)", "package_ndc": "10135-812-01", "marketing_start_date": "20250301"}, {"sample": false, "description": "1000 TABLET, FILM COATED in 1 BOTTLE (10135-812-10)", "package_ndc": "10135-812-10", "marketing_start_date": "20250301"}], "brand_name": "HYDROXYZINE HYDROCHLORIDE", "product_id": "10135-812_31a907fc-2be0-1219-e063-6294a90ac00f", "dosage_form": "TABLET, FILM COATED", "pharm_class": ["Antihistamine [EPC]", "Histamine Receptor Antagonists [MoA]"], "product_ndc": "10135-812", "generic_name": "hydroxyzine hydrochloride", "labeler_name": "Marlex Pharmaceuticals, Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "HYDROXYZINE HYDROCHLORIDE", "active_ingredients": [{"name": "HYDROXYZINE DIHYDROCHLORIDE", "strength": "50 mg/1"}], "application_number": "ANDA207121", "marketing_category": "ANDA", "marketing_start_date": "20250301", "listing_expiration_date": "20261231"}