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 71610-844
Product ID 71610-844_1bf865e6-f7b4-8a29-e063-6294a90ae048
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA204279
Listing Expiration 2026-12-31
Marketing Start 2023-08-01

Pharmacologic Class

Classes
antihistamine [epc] histamine receptor antagonists [moa]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 71610844
Hyphenated Format 71610-844

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
  • 60 TABLET in 1 BOTTLE (71610-844-53)
  • 90 TABLET in 1 BOTTLE (71610-844-60)
  • 180 TABLET in 1 BOTTLE (71610-844-80)
source: ndc

Packages (3)

71610-844-53 60 TABLET in 1 BOTTLE (71610-844-53) 71610-844-60 90 TABLET in 1 BOTTLE (71610-844-60) 71610-844-80 180 TABLET in 1 BOTTLE (71610-844-80)

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": "1bf865e6-f7b4-8a29-e063-6294a90ae048", "openfda": {"unii": ["76755771U3"], "rxcui": ["995258"], "spl_set_id": ["1bf88820-e5f9-06e7-e063-6294a90a80ad"], "manufacturer_name": ["Aphena Pharma Solutions - Tennessee, LLC"]}, "finished": true, "packaging": [{"sample": false, "description": "60 TABLET in 1 BOTTLE (71610-844-53)", "package_ndc": "71610-844-53", "marketing_start_date": "20240628"}, {"sample": false, "description": "90 TABLET in 1 BOTTLE (71610-844-60)", "package_ndc": "71610-844-60", "marketing_start_date": "20240628"}, {"sample": false, "description": "180 TABLET in 1 BOTTLE (71610-844-80)", "package_ndc": "71610-844-80", "marketing_start_date": "20240628"}], "brand_name": "Hydroxyzine hydrochloride", "product_id": "71610-844_1bf865e6-f7b4-8a29-e063-6294a90ae048", "dosage_form": "TABLET", "pharm_class": ["Antihistamine [EPC]", "Histamine Receptor Antagonists [MoA]"], "product_ndc": "71610-844", "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": "20230801", "listing_expiration_date": "20261231"}