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, FILM COATED
Routes
ORAL
Active Ingredients

hydroxyzine dihydrochloride 50 mg/1

Manufacturer
Proficient Rx LP

Identifiers & Regulatory

Product NDC 71205-083
Product ID 71205-083_6eebea17-bc98-49a2-854c-35267194f4c4
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA088619
Listing Expiration 2026-12-31
Marketing Start 2012-10-22

Pharmacologic Class

Classes
antihistamine [epc] histamine receptor antagonists [moa]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 71205083
Hyphenated Format 71205-083

Supplemental Identifiers

RxCUI
995281
UPC
0371205083151
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 ANDA088619 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 50 mg/1
source: ndc
Packaging
  • 15 TABLET, FILM COATED in 1 BOTTLE (71205-083-15)
  • 20 TABLET, FILM COATED in 1 BOTTLE (71205-083-20)
  • 30 TABLET, FILM COATED in 1 BOTTLE (71205-083-30)
  • 60 TABLET, FILM COATED in 1 BOTTLE (71205-083-60)
  • 90 TABLET, FILM COATED in 1 BOTTLE (71205-083-90)
source: ndc

Packages (5)

71205-083-15 15 TABLET, FILM COATED in 1 BOTTLE (71205-083-15) 71205-083-20 20 TABLET, FILM COATED in 1 BOTTLE (71205-083-20) 71205-083-30 30 TABLET, FILM COATED in 1 BOTTLE (71205-083-30) 71205-083-60 60 TABLET, FILM COATED in 1 BOTTLE (71205-083-60) 71205-083-90 90 TABLET, FILM COATED in 1 BOTTLE (71205-083-90)

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": "6eebea17-bc98-49a2-854c-35267194f4c4", "openfda": {"upc": ["0371205083151"], "unii": ["76755771U3"], "rxcui": ["995281"], "spl_set_id": ["642ff329-c551-44f0-b340-49313db868c5"], "manufacturer_name": ["Proficient Rx LP"]}, "finished": true, "packaging": [{"sample": false, "description": "15 TABLET, FILM COATED in 1 BOTTLE (71205-083-15)", "package_ndc": "71205-083-15", "marketing_start_date": "20180801"}, {"sample": false, "description": "20 TABLET, FILM COATED in 1 BOTTLE (71205-083-20)", "package_ndc": "71205-083-20", "marketing_start_date": "20180801"}, {"sample": false, "description": "30 TABLET, FILM COATED in 1 BOTTLE (71205-083-30)", "package_ndc": "71205-083-30", "marketing_start_date": "20180801"}, {"sample": false, "description": "60 TABLET, FILM COATED in 1 BOTTLE (71205-083-60)", "package_ndc": "71205-083-60", "marketing_start_date": "20180801"}, {"sample": false, "description": "90 TABLET, FILM COATED in 1 BOTTLE (71205-083-90)", "package_ndc": "71205-083-90", "marketing_start_date": "20180801"}], "brand_name": "Hydroxyzine Hydrochloride", "product_id": "71205-083_6eebea17-bc98-49a2-854c-35267194f4c4", "dosage_form": "TABLET, FILM COATED", "pharm_class": ["Antihistamine [EPC]", "Histamine Receptor Antagonists [MoA]"], "product_ndc": "71205-083", "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": "50 mg/1"}], "application_number": "ANDA088619", "marketing_category": "ANDA", "marketing_start_date": "20121022", "listing_expiration_date": "20261231"}