hydroxyzine hydrochloride

Generic: hydroxyzine hydrochloride

Labeler: henry schein, inc.
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

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

hydroxyzine dihydrochloride 50 mg/mL

Manufacturer
Henry Schein, Inc.

Identifiers & Regulatory

Product NDC 0404-9877
Product ID 0404-9877_0c90956b-50b1-4f90-97b3-e2f831693504
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA087408
Listing Expiration 2026-12-31
Marketing Start 2022-01-17

Pharmacologic Class

Classes
antihistamine [epc] histamine receptor antagonists [moa]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 04049877
Hyphenated Format 0404-9877

Supplemental Identifiers

RxCUI
1794554
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 ANDA087408 (source: ndc)
Routes
INTRAMUSCULAR
source: ndc

Resolved Composition

Strengths
  • 50 mg/mL
source: ndc
Packaging
  • 1 VIAL, SINGLE-DOSE in 1 BAG (0404-9877-01) / 1 mL in 1 VIAL, SINGLE-DOSE
source: ndc

Packages (1)

0404-9877-01 1 VIAL, SINGLE-DOSE in 1 BAG (0404-9877-01) / 1 mL in 1 VIAL, SINGLE-DOSE

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": "0c90956b-50b1-4f90-97b3-e2f831693504", "openfda": {"unii": ["76755771U3"], "rxcui": ["1794554"], "spl_set_id": ["7279ad5a-0a49-432d-8fa2-17e4c6ecbadc"], "manufacturer_name": ["Henry Schein, Inc."]}, "finished": true, "packaging": [{"sample": false, "description": "1 VIAL, SINGLE-DOSE in 1 BAG (0404-9877-01)  / 1 mL in 1 VIAL, SINGLE-DOSE", "package_ndc": "0404-9877-01", "marketing_start_date": "20220117"}], "brand_name": "Hydroxyzine Hydrochloride", "product_id": "0404-9877_0c90956b-50b1-4f90-97b3-e2f831693504", "dosage_form": "INJECTION, SOLUTION", "pharm_class": ["Antihistamine [EPC]", "Histamine Receptor Antagonists [MoA]"], "product_ndc": "0404-9877", "generic_name": "Hydroxyzine Hydrochloride", "labeler_name": "Henry Schein, 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": "20220117", "listing_expiration_date": "20261231"}