fluphenazine hydrochloride

Generic: fluphenazine hydrochloride

Labeler: fresenius kabi usa, llc
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name fluphenazine hydrochloride
Generic Name fluphenazine hydrochloride
Labeler fresenius kabi usa, llc
Dosage Form INJECTION, SOLUTION
Routes
INTRAMUSCULAR
Active Ingredients

fluphenazine hydrochloride 2.5 mg/mL

Manufacturer
Fresenius Kabi USA, LLC

Identifiers & Regulatory

Product NDC 63323-281
Product ID 63323-281_cefdb059-d32b-44f2-8dd6-fd2a29b3ba70
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA089556
Listing Expiration 2026-12-31
Marketing Start 2010-12-28

Pharmacologic Class

Classes
phenothiazine [epc] phenothiazines [cs]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 63323281
Hyphenated Format 63323-281

Supplemental Identifiers

RxCUI
865129
UNII
ZOU145W1XL

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 fluphenazine hydrochloride (source: ndc)
Generic Name fluphenazine hydrochloride (source: ndc)
Application Number ANDA089556 (source: ndc)
Routes
INTRAMUSCULAR
source: ndc

Resolved Composition

Strengths
  • 2.5 mg/mL
source: ndc
Packaging
  • 1 VIAL in 1 BOX (63323-281-10) / 10 mL in 1 VIAL
source: ndc

Packages (1)

63323-281-10 1 VIAL in 1 BOX (63323-281-10) / 10 mL in 1 VIAL

Ingredients (1)

fluphenazine hydrochloride (2.5 mg/mL)

Linked Drug Pages (1)

Fluphenazine Hydrochloride ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["INTRAMUSCULAR"], "spl_id": "cefdb059-d32b-44f2-8dd6-fd2a29b3ba70", "openfda": {"unii": ["ZOU145W1XL"], "rxcui": ["865129"], "spl_set_id": ["d571f04f-6190-42f2-932c-5a075fd978b9"], "manufacturer_name": ["Fresenius Kabi USA, LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 VIAL in 1 BOX (63323-281-10)  / 10 mL in 1 VIAL", "package_ndc": "63323-281-10", "marketing_start_date": "20101228"}], "brand_name": "Fluphenazine Hydrochloride", "product_id": "63323-281_cefdb059-d32b-44f2-8dd6-fd2a29b3ba70", "dosage_form": "INJECTION, SOLUTION", "pharm_class": ["Phenothiazine [EPC]", "Phenothiazines [CS]"], "product_ndc": "63323-281", "generic_name": "FLUPHENAZINE HYDROCHLORIDE", "labeler_name": "Fresenius Kabi USA, LLC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Fluphenazine Hydrochloride", "active_ingredients": [{"name": "FLUPHENAZINE HYDROCHLORIDE", "strength": "2.5 mg/mL"}], "application_number": "ANDA089556", "marketing_category": "ANDA", "marketing_start_date": "20101228", "listing_expiration_date": "20261231"}