hydroxyzine hydrochloride

Generic: hydroxyzine hydrochloride

Labeler: american health packaging
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name hydroxyzine hydrochloride
Generic Name hydroxyzine hydrochloride
Labeler american health packaging
Dosage Form TABLET, FILM COATED
Routes
ORAL
Active Ingredients

hydroxyzine dihydrochloride 25 mg/1

Manufacturer
American Health Packaging

Identifiers & Regulatory

Product NDC 60687-675
Product ID 60687-675_21b18b38-063e-eca0-e063-6294a90a6a86
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA088618
Listing Expiration 2026-12-31
Marketing Start 2022-10-20

Pharmacologic Class

Classes
antihistamine [epc] histamine receptor antagonists [moa]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 60687675
Hyphenated Format 60687-675

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 ANDA088618 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 25 mg/1
source: ndc
Packaging
  • 100 BLISTER PACK in 1 CARTON (60687-675-01) / 1 TABLET, FILM COATED in 1 BLISTER PACK (60687-675-11)
source: ndc

Packages (1)

60687-675-01 100 BLISTER PACK in 1 CARTON (60687-675-01) / 1 TABLET, FILM COATED in 1 BLISTER PACK (60687-675-11)

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": "21b18b38-063e-eca0-e063-6294a90a6a86", "openfda": {"unii": ["76755771U3"], "rxcui": ["995218", "995258", "995281"], "spl_set_id": ["47bda4fe-ddb7-4140-900a-970373cc7acc"], "manufacturer_name": ["American Health Packaging"]}, "finished": true, "packaging": [{"sample": false, "description": "100 BLISTER PACK in 1 CARTON (60687-675-01)  / 1 TABLET, FILM COATED in 1 BLISTER PACK (60687-675-11)", "package_ndc": "60687-675-01", "marketing_start_date": "20221020"}], "brand_name": "Hydroxyzine Hydrochloride", "product_id": "60687-675_21b18b38-063e-eca0-e063-6294a90a6a86", "dosage_form": "TABLET, FILM COATED", "pharm_class": ["Antihistamine [EPC]", "Histamine Receptor Antagonists [MoA]"], "product_ndc": "60687-675", "generic_name": "Hydroxyzine Hydrochloride", "labeler_name": "American Health Packaging", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Hydroxyzine Hydrochloride", "active_ingredients": [{"name": "HYDROXYZINE DIHYDROCHLORIDE", "strength": "25 mg/1"}], "application_number": "ANDA088618", "marketing_category": "ANDA", "marketing_start_date": "20221020", "listing_expiration_date": "20261231"}