hydroxyzine hydrochloride

Generic: hydroxyzine hydrochloride

Labeler: american regent, inc.
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name hydroxyzine hydrochloride
Generic Name hydroxyzine hydrochloride
Labeler american regent, inc.
Dosage Form INJECTION, SOLUTION
Routes
INTRAMUSCULAR
Active Ingredients

hydroxyzine dihydrochloride 50 mg/mL

Manufacturer
American Regent, Inc.

Identifiers & Regulatory

Product NDC 0517-5601
Product ID 0517-5601_83de333d-1bf1-4168-8614-6bc79c26d5d0
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA087408
Listing Expiration 2026-12-31
Marketing Start 1990-09-30

Pharmacologic Class

Classes
antihistamine [epc] histamine receptor antagonists [moa]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 05175601
Hyphenated Format 0517-5601

Supplemental Identifiers

RxCUI
995270 995285 1794552 1794554
UPC
0305174201254 0305175601251 0305175602258
UNII
76755771U3

Packaging Origin

Original Packager
true

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 ANDA087408 (source: ndc)
Routes
INTRAMUSCULAR
source: ndc

Resolved Composition

Strengths
  • 50 mg/mL
source: ndc
Packaging
  • 25 VIAL, SINGLE-DOSE in 1 TRAY (0517-5601-25) / 1 mL in 1 VIAL, SINGLE-DOSE (0517-5601-01)
source: ndc

Packages (1)

0517-5601-25 25 VIAL, SINGLE-DOSE in 1 TRAY (0517-5601-25) / 1 mL in 1 VIAL, SINGLE-DOSE (0517-5601-01)

Ingredients (1)

hydroxyzine dihydrochloride (50 mg/mL)

Linked Drug Pages (1)

Hydroxyzine Hydrochloride ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["INTRAMUSCULAR"], "spl_id": "83de333d-1bf1-4168-8614-6bc79c26d5d0", "openfda": {"upc": ["0305174201254", "0305175601251", "0305175602258"], "unii": ["76755771U3"], "rxcui": ["995270", "995285", "1794552", "1794554"], "spl_set_id": ["8af7e5ce-d9d9-44cc-9f2f-4ddbc89e758a"], "manufacturer_name": ["American Regent, Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "25 VIAL, SINGLE-DOSE in 1 TRAY (0517-5601-25)  / 1 mL in 1 VIAL, SINGLE-DOSE (0517-5601-01)", "package_ndc": "0517-5601-25", "marketing_start_date": "19900930"}], "brand_name": "Hydroxyzine Hydrochloride", "product_id": "0517-5601_83de333d-1bf1-4168-8614-6bc79c26d5d0", "dosage_form": "INJECTION, SOLUTION", "pharm_class": ["Antihistamine [EPC]", "Histamine Receptor Antagonists [MoA]"], "product_ndc": "0517-5601", "generic_name": "Hydroxyzine Hydrochloride", "labeler_name": "American Regent, Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Hydroxyzine Hydrochloride", "active_ingredients": [{"name": "HYDROXYZINE DIHYDROCHLORIDE", "strength": "50 mg/mL"}], "application_number": "ANDA087408", "marketing_category": "ANDA", "marketing_start_date": "19900930", "listing_expiration_date": "20261231"}