hydroxyzine

Generic: hydroxyzine

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

Drug Facts

Product Profile

Brand Name hydroxyzine
Generic Name hydroxyzine
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 0404-9878
Product ID 0404-9878_5d9b6c38-5a58-4278-999a-f430f34aafd4
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 04049878
Hyphenated Format 0404-9878

Supplemental Identifiers

RxCUI
1794552
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 (source: ndc)
Generic Name hydroxyzine (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 (0404-9878-02) / 2 mL in 1 VIAL, SINGLE-DOSE
source: ndc

Packages (1)

0404-9878-02 1 VIAL, SINGLE-DOSE in 1 BAG (0404-9878-02) / 2 mL in 1 VIAL, SINGLE-DOSE

Ingredients (1)

hydroxyzine dihydrochloride (50 mg/mL)

Linked Drug Pages (1)

Hydroxyzine ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["INTRAMUSCULAR"], "spl_id": "5d9b6c38-5a58-4278-999a-f430f34aafd4", "openfda": {"unii": ["76755771U3"], "rxcui": ["1794552"], "spl_set_id": ["851e7439-bb0a-4a09-9279-e3c33bff8965"], "manufacturer_name": ["Henry Schein, Inc."]}, "finished": true, "packaging": [{"sample": false, "description": "1 VIAL, SINGLE-DOSE in 1 BAG (0404-9878-02)  / 2 mL in 1 VIAL, SINGLE-DOSE", "package_ndc": "0404-9878-02", "marketing_start_date": "20220117"}], "brand_name": "Hydroxyzine", "product_id": "0404-9878_5d9b6c38-5a58-4278-999a-f430f34aafd4", "dosage_form": "INJECTION, SOLUTION", "pharm_class": ["Antihistamine [EPC]", "Histamine Receptor Antagonists [MoA]"], "product_ndc": "0404-9878", "generic_name": "Hydroxyzine", "labeler_name": "Henry Schein, Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Hydroxyzine", "active_ingredients": [{"name": "HYDROXYZINE DIHYDROCHLORIDE", "strength": "50 mg/mL"}], "application_number": "ANDA087408", "marketing_category": "ANDA", "marketing_start_date": "20220117", "listing_expiration_date": "20261231"}