hydroxyzine hydrochloride

Generic: hydroxyzine hydrochloride

Labeler: asclemed usa, inc.
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name hydroxyzine hydrochloride
Generic Name hydroxyzine hydrochloride
Labeler asclemed usa, inc.
Dosage Form TABLET
Routes
ORAL
Active Ingredients

hydroxyzine dihydrochloride 10 mg/1

Manufacturer
Asclemed USA, Inc.

Identifiers & Regulatory

Product NDC 76420-881
Product ID 76420-881_2979cc3d-941b-4936-e063-6394a90ab8f8
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 76420881
Hyphenated Format 76420-881

Supplemental Identifiers

RxCUI
995218 995258 995281
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
  • 100 TABLET in 1 BOTTLE (76420-881-01)
  • 500 TABLET in 1 BOTTLE (76420-881-05)
  • 1000 TABLET in 1 BOTTLE (76420-881-10)
  • 30 TABLET in 1 BOTTLE (76420-881-30)
  • 60 TABLET in 1 BOTTLE (76420-881-60)
  • 90 TABLET in 1 BOTTLE (76420-881-90)
source: ndc

Packages (6)

76420-881-01 100 TABLET in 1 BOTTLE (76420-881-01) 76420-881-05 500 TABLET in 1 BOTTLE (76420-881-05) 76420-881-10 1000 TABLET in 1 BOTTLE (76420-881-10) 76420-881-30 30 TABLET in 1 BOTTLE (76420-881-30) 76420-881-60 60 TABLET in 1 BOTTLE (76420-881-60) 76420-881-90 90 TABLET in 1 BOTTLE (76420-881-90)

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": "2979cc3d-941b-4936-e063-6394a90ab8f8", "openfda": {"unii": ["76755771U3"], "rxcui": ["995218", "995258", "995281"], "spl_set_id": ["4f3266f4-00a6-4c0c-bff2-e606913de894"], "manufacturer_name": ["Asclemed USA, Inc."]}, "finished": true, "packaging": [{"sample": false, "description": "100 TABLET in 1 BOTTLE (76420-881-01)", "package_ndc": "76420-881-01", "marketing_start_date": "20241217"}, {"sample": false, "description": "500 TABLET in 1 BOTTLE (76420-881-05)", "package_ndc": "76420-881-05", "marketing_start_date": "20241217"}, {"sample": false, "description": "1000 TABLET in 1 BOTTLE (76420-881-10)", "package_ndc": "76420-881-10", "marketing_start_date": "20241217"}, {"sample": false, "description": "30 TABLET in 1 BOTTLE (76420-881-30)", "package_ndc": "76420-881-30", "marketing_start_date": "20241217"}, {"sample": false, "description": "60 TABLET in 1 BOTTLE (76420-881-60)", "package_ndc": "76420-881-60", "marketing_start_date": "20241217"}, {"sample": false, "description": "90 TABLET in 1 BOTTLE (76420-881-90)", "package_ndc": "76420-881-90", "marketing_start_date": "20241217"}], "brand_name": "Hydroxyzine hydrochloride", "product_id": "76420-881_2979cc3d-941b-4936-e063-6394a90ab8f8", "dosage_form": "TABLET", "pharm_class": ["Antihistamine [EPC]", "Histamine Receptor Antagonists [MoA]"], "product_ndc": "76420-881", "generic_name": "Hydroxyzine hydrochloride", "labeler_name": "Asclemed USA, Inc.", "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"}