hydroxyzine hydrochloride

Generic: hydroxyzine hydrochloride

Labeler: rising pharma holdings, inc.
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name hydroxyzine hydrochloride
Generic Name hydroxyzine hydrochloride
Labeler rising pharma holdings, inc.
Dosage Form TABLET, FILM COATED
Routes
ORAL
Active Ingredients

hydroxyzine dihydrochloride 10 mg/1

Manufacturer
Rising Pharma Holdings, Inc.

Identifiers & Regulatory

Product NDC 16571-113
Product ID 16571-113_20aba551-c0c0-4ea1-8200-ad81956ff294
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA217652
Listing Expiration 2026-12-31
Marketing Start 2023-08-22

Pharmacologic Class

Classes
antihistamine [epc] histamine receptor antagonists [moa]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 16571113
Hyphenated Format 16571-113

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 ANDA217652 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 10 mg/1
source: ndc
Packaging
  • 100 TABLET, FILM COATED in 1 BOTTLE (16571-113-01)
  • 500 TABLET, FILM COATED in 1 BOTTLE (16571-113-50)
source: ndc

Packages (2)

16571-113-01 100 TABLET, FILM COATED in 1 BOTTLE (16571-113-01) 16571-113-50 500 TABLET, FILM COATED in 1 BOTTLE (16571-113-50)

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": "20aba551-c0c0-4ea1-8200-ad81956ff294", "openfda": {"unii": ["76755771U3"], "rxcui": ["995218", "995258", "995281"], "spl_set_id": ["6a1a48ac-8ad5-4363-b298-d9825ae2a448"], "manufacturer_name": ["Rising Pharma Holdings, Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "100 TABLET, FILM COATED in 1 BOTTLE (16571-113-01)", "package_ndc": "16571-113-01", "marketing_start_date": "20230822"}, {"sample": false, "description": "500 TABLET, FILM COATED in 1 BOTTLE (16571-113-50)", "package_ndc": "16571-113-50", "marketing_start_date": "20230822"}], "brand_name": "HYDROXYZINE HYDROCHLORIDE", "product_id": "16571-113_20aba551-c0c0-4ea1-8200-ad81956ff294", "dosage_form": "TABLET, FILM COATED", "pharm_class": ["Antihistamine [EPC]", "Histamine Receptor Antagonists [MoA]"], "product_ndc": "16571-113", "generic_name": "hydroxyzine hydrochloride", "labeler_name": "Rising Pharma Holdings, Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "HYDROXYZINE HYDROCHLORIDE", "active_ingredients": [{"name": "HYDROXYZINE DIHYDROCHLORIDE", "strength": "10 mg/1"}], "application_number": "ANDA217652", "marketing_category": "ANDA", "marketing_start_date": "20230822", "listing_expiration_date": "20261231"}