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
Routes
ORAL
Active Ingredients

hydroxyzine dihydrochloride 25 mg/1

Manufacturer
Aphena Pharma Solutions - Tennessee, LLC

Identifiers & Regulatory

Product NDC 71610-851
Product ID 71610-851_a8284037-d6c6-4816-8469-0151f5761ae7
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 71610851
Hyphenated Format 71610-851

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 ANDA204279 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 25 mg/1
source: ndc
Packaging
  • 30 TABLET in 1 BOTTLE (71610-851-30)
  • 60 TABLET in 1 BOTTLE (71610-851-53)
  • 90 TABLET in 1 BOTTLE (71610-851-60)
  • 120 TABLET in 1 BOTTLE (71610-851-70)
  • 180 TABLET in 1 BOTTLE (71610-851-80)
source: ndc

Packages (5)

71610-851-30 30 TABLET in 1 BOTTLE (71610-851-30) 71610-851-53 60 TABLET in 1 BOTTLE (71610-851-53) 71610-851-60 90 TABLET in 1 BOTTLE (71610-851-60) 71610-851-70 120 TABLET in 1 BOTTLE (71610-851-70) 71610-851-80 180 TABLET in 1 BOTTLE (71610-851-80)

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": "a8284037-d6c6-4816-8469-0151f5761ae7", "openfda": {"unii": ["76755771U3"], "rxcui": ["995258"], "spl_set_id": ["7b6ebf69-77d5-434f-81a4-3d5587fd431e"], "manufacturer_name": ["Aphena Pharma Solutions - Tennessee, LLC"]}, "finished": true, "packaging": [{"sample": false, "description": "30 TABLET in 1 BOTTLE (71610-851-30)", "package_ndc": "71610-851-30", "marketing_start_date": "20240822"}, {"sample": false, "description": "60 TABLET in 1 BOTTLE (71610-851-53)", "package_ndc": "71610-851-53", "marketing_start_date": "20240822"}, {"sample": false, "description": "90 TABLET in 1 BOTTLE (71610-851-60)", "package_ndc": "71610-851-60", "marketing_start_date": "20240822"}, {"sample": false, "description": "120 TABLET in 1 BOTTLE (71610-851-70)", "package_ndc": "71610-851-70", "marketing_start_date": "20240822"}, {"sample": false, "description": "180 TABLET in 1 BOTTLE (71610-851-80)", "package_ndc": "71610-851-80", "marketing_start_date": "20240822"}], "brand_name": "Hydroxyzine hydrochloride", "product_id": "71610-851_a8284037-d6c6-4816-8469-0151f5761ae7", "dosage_form": "TABLET", "pharm_class": ["Antihistamine [EPC]", "Histamine Receptor Antagonists [MoA]"], "product_ndc": "71610-851", "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": "ANDA204279", "marketing_category": "ANDA", "marketing_start_date": "20140820", "listing_expiration_date": "20261231"}