hydroxyzine hydrochloride

Generic: hydroxyzine hydrochloride

Labeler: aphena pharma solutions - tennessee, llc
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name hydroxyzine hydrochloride
Generic Name hydroxyzine hydrochloride
Labeler aphena pharma solutions - tennessee, llc
Dosage Form TABLET, FILM COATED
Routes
ORAL
Active Ingredients

hydroxyzine dihydrochloride 25 mg/1

Manufacturer
Aphena Pharma Solutions - Tennessee, LLC

Identifiers & Regulatory

Product NDC 71610-735
Product ID 71610-735_e5dbdb97-f222-43f5-b261-8e91950377e4
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA040602
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 71610735
Hyphenated Format 71610-735

Supplemental Identifiers

RxCUI
995258
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 ANDA040602 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 25 mg/1
source: ndc
Packaging
  • 30 TABLET, FILM COATED in 1 BOTTLE (71610-735-30)
  • 60 TABLET, FILM COATED in 1 BOTTLE (71610-735-53)
  • 90 TABLET, FILM COATED in 1 BOTTLE (71610-735-60)
  • 120 TABLET, FILM COATED in 1 BOTTLE (71610-735-70)
  • 180 TABLET, FILM COATED in 1 BOTTLE (71610-735-80)
source: ndc

Packages (5)

71610-735-30 30 TABLET, FILM COATED in 1 BOTTLE (71610-735-30) 71610-735-53 60 TABLET, FILM COATED in 1 BOTTLE (71610-735-53) 71610-735-60 90 TABLET, FILM COATED in 1 BOTTLE (71610-735-60) 71610-735-70 120 TABLET, FILM COATED in 1 BOTTLE (71610-735-70) 71610-735-80 180 TABLET, FILM COATED in 1 BOTTLE (71610-735-80)

Ingredients (1)

hydroxyzine dihydrochloride (25 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": "e5dbdb97-f222-43f5-b261-8e91950377e4", "openfda": {"unii": ["76755771U3"], "rxcui": ["995258"], "spl_set_id": ["d618157e-f43f-4b31-ba5b-8a13a94885bc"], "manufacturer_name": ["Aphena Pharma Solutions - Tennessee, LLC"]}, "finished": true, "packaging": [{"sample": false, "description": "30 TABLET, FILM COATED in 1 BOTTLE (71610-735-30)", "package_ndc": "71610-735-30", "marketing_start_date": "20230914"}, {"sample": false, "description": "60 TABLET, FILM COATED in 1 BOTTLE (71610-735-53)", "package_ndc": "71610-735-53", "marketing_start_date": "20230914"}, {"sample": false, "description": "90 TABLET, FILM COATED in 1 BOTTLE (71610-735-60)", "package_ndc": "71610-735-60", "marketing_start_date": "20230914"}, {"sample": false, "description": "120 TABLET, FILM COATED in 1 BOTTLE (71610-735-70)", "package_ndc": "71610-735-70", "marketing_start_date": "20230914"}, {"sample": false, "description": "180 TABLET, FILM COATED in 1 BOTTLE (71610-735-80)", "package_ndc": "71610-735-80", "marketing_start_date": "20230914"}], "brand_name": "Hydroxyzine Hydrochloride", "product_id": "71610-735_e5dbdb97-f222-43f5-b261-8e91950377e4", "dosage_form": "TABLET, FILM COATED", "pharm_class": ["Antihistamine [EPC]", "Histamine Receptor Antagonists [MoA]"], "product_ndc": "71610-735", "generic_name": "Hydroxyzine Hydrochloride", "labeler_name": "Aphena Pharma Solutions - Tennessee, LLC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Hydroxyzine Hydrochloride", "active_ingredients": [{"name": "HYDROXYZINE DIHYDROCHLORIDE", "strength": "25 mg/1"}], "application_number": "ANDA040602", "marketing_category": "ANDA", "marketing_start_date": "20150331", "listing_expiration_date": "20261231"}