hydroxyzine hydrochloride

Generic: hydroxyzine hydrochloride

Labeler: cardinal health 107, llc
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name hydroxyzine hydrochloride
Generic Name hydroxyzine hydrochloride
Labeler cardinal health 107, llc
Dosage Form TABLET, FILM COATED
Routes
ORAL
Active Ingredients

hydroxyzine dihydrochloride 25 mg/1

Manufacturer
Cardinal Health 107, LLC

Identifiers & Regulatory

Product NDC 55154-7994
Product ID 55154-7994_9db03a3f-e0ed-46b1-948d-667383a6bf61
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA040604
Marketing Start 2015-03-31
Marketing End 2026-08-31

Pharmacologic Class

Classes
antihistamine [epc] histamine receptor antagonists [moa]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 551547994
Hyphenated Format 55154-7994

Supplemental Identifiers

RxCUI
995258
UPC
0055154799409
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 ANDA040604 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 25 mg/1
source: ndc
Packaging
  • 10 BLISTER PACK in 1 BAG (55154-7994-0) / 1 TABLET, FILM COATED in 1 BLISTER PACK
source: ndc

Packages (1)

55154-7994-0 10 BLISTER PACK in 1 BAG (55154-7994-0) / 1 TABLET, FILM COATED in 1 BLISTER PACK

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": "9db03a3f-e0ed-46b1-948d-667383a6bf61", "openfda": {"upc": ["0055154799409"], "unii": ["76755771U3"], "rxcui": ["995258"], "spl_set_id": ["157fbedc-b65d-455f-adb5-e7554282e033"], "manufacturer_name": ["Cardinal Health 107, LLC"]}, "finished": true, "packaging": [{"sample": false, "description": "10 BLISTER PACK in 1 BAG (55154-7994-0)  / 1 TABLET, FILM COATED in 1 BLISTER PACK", "package_ndc": "55154-7994-0", "marketing_end_date": "20260831", "marketing_start_date": "20150331"}], "brand_name": "Hydroxyzine Hydrochloride", "product_id": "55154-7994_9db03a3f-e0ed-46b1-948d-667383a6bf61", "dosage_form": "TABLET, FILM COATED", "pharm_class": ["Antihistamine [EPC]", "Histamine Receptor Antagonists [MoA]"], "product_ndc": "55154-7994", "generic_name": "Hydroxyzine Hydrochloride", "labeler_name": "Cardinal Health 107, LLC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Hydroxyzine Hydrochloride", "active_ingredients": [{"name": "HYDROXYZINE DIHYDROCHLORIDE", "strength": "25 mg/1"}], "application_number": "ANDA040604", "marketing_category": "ANDA", "marketing_end_date": "20260831", "marketing_start_date": "20150331"}