hydroxyzine hydrochloride

Generic: hydroxyzine hydrochloride

Labeler: proficient rx lp
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name hydroxyzine hydrochloride
Generic Name hydroxyzine hydrochloride
Labeler proficient rx lp
Dosage Form TABLET
Routes
ORAL
Active Ingredients

hydroxyzine dihydrochloride 10 mg/1

Manufacturer
Proficient Rx LP

Identifiers & Regulatory

Product NDC 71205-541
Product ID 71205-541_db55bfa9-59e8-40d3-9bc3-4bdadb2eb389
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA204279
Listing Expiration 2026-12-31
Marketing Start 2014-08-20

Pharmacologic Class

Classes
antihistamine [epc] histamine receptor antagonists [moa]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 71205541
Hyphenated Format 71205-541

Supplemental Identifiers

RxCUI
995218
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 ANDA204279 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 10 mg/1
source: ndc
Packaging
  • 15 TABLET in 1 BOTTLE (71205-541-15)
  • 20 TABLET in 1 BOTTLE (71205-541-20)
  • 30 TABLET in 1 BOTTLE (71205-541-30)
  • 60 TABLET in 1 BOTTLE (71205-541-60)
  • 90 TABLET in 1 BOTTLE (71205-541-90)
source: ndc

Packages (5)

71205-541-15 15 TABLET in 1 BOTTLE (71205-541-15) 71205-541-20 20 TABLET in 1 BOTTLE (71205-541-20) 71205-541-30 30 TABLET in 1 BOTTLE (71205-541-30) 71205-541-60 60 TABLET in 1 BOTTLE (71205-541-60) 71205-541-90 90 TABLET in 1 BOTTLE (71205-541-90)

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": "db55bfa9-59e8-40d3-9bc3-4bdadb2eb389", "openfda": {"unii": ["76755771U3"], "rxcui": ["995218"], "spl_set_id": ["2da6dd2f-90e2-464a-ad2a-292575cb0428"], "manufacturer_name": ["Proficient Rx LP"]}, "finished": true, "packaging": [{"sample": false, "description": "15 TABLET in 1 BOTTLE (71205-541-15)", "package_ndc": "71205-541-15", "marketing_start_date": "20210304"}, {"sample": false, "description": "20 TABLET in 1 BOTTLE (71205-541-20)", "package_ndc": "71205-541-20", "marketing_start_date": "20210304"}, {"sample": false, "description": "30 TABLET in 1 BOTTLE (71205-541-30)", "package_ndc": "71205-541-30", "marketing_start_date": "20210304"}, {"sample": false, "description": "60 TABLET in 1 BOTTLE (71205-541-60)", "package_ndc": "71205-541-60", "marketing_start_date": "20210304"}, {"sample": false, "description": "90 TABLET in 1 BOTTLE (71205-541-90)", "package_ndc": "71205-541-90", "marketing_start_date": "20210304"}], "brand_name": "Hydroxyzine hydrochloride", "product_id": "71205-541_db55bfa9-59e8-40d3-9bc3-4bdadb2eb389", "dosage_form": "TABLET", "pharm_class": ["Antihistamine [EPC]", "Histamine Receptor Antagonists [MoA]"], "product_ndc": "71205-541", "generic_name": "Hydroxyzine hydrochloride", "labeler_name": "Proficient Rx LP", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Hydroxyzine hydrochloride", "active_ingredients": [{"name": "HYDROXYZINE DIHYDROCHLORIDE", "strength": "10 mg/1"}], "application_number": "ANDA204279", "marketing_category": "ANDA", "marketing_start_date": "20140820", "listing_expiration_date": "20261231"}