fluphenazine hydrochloride

Generic: fluphenazine hydrochloride

Labeler: aurobindo pharma limited
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name fluphenazine hydrochloride
Generic Name fluphenazine hydrochloride
Labeler aurobindo pharma limited
Dosage Form TABLET
Routes
ORAL
Active Ingredients

fluphenazine hydrochloride 10 mg/1

Manufacturer
Aurobindo Pharma Limited

Identifiers & Regulatory

Product NDC 59651-689
Product ID 59651-689_1109b107-f7af-45b7-b8ee-709c59123074
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA218055
Listing Expiration 2026-12-31
Marketing Start 2023-08-18

Pharmacologic Class

Classes
phenothiazine [epc] phenothiazines [cs]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 59651689
Hyphenated Format 59651-689

Supplemental Identifiers

RxCUI
859841 860918 865117 865123
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 ANDA218055 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 10 mg/1
source: ndc
Packaging
  • 100 TABLET in 1 BOTTLE (59651-689-01)
  • 500 TABLET in 1 BOTTLE (59651-689-05)
source: ndc

Packages (2)

59651-689-01 100 TABLET in 1 BOTTLE (59651-689-01) 59651-689-05 500 TABLET in 1 BOTTLE (59651-689-05)

Ingredients (1)

fluphenazine hydrochloride (10 mg/1)

Linked Drug Pages (1)

Fluphenazine Hydrochloride ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "1109b107-f7af-45b7-b8ee-709c59123074", "openfda": {"unii": ["ZOU145W1XL"], "rxcui": ["859841", "860918", "865117", "865123"], "spl_set_id": ["e73764e7-e666-4ad3-a029-04a528dc1c9e"], "manufacturer_name": ["Aurobindo Pharma Limited"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "100 TABLET in 1 BOTTLE (59651-689-01)", "package_ndc": "59651-689-01", "marketing_start_date": "20230818"}, {"sample": false, "description": "500 TABLET in 1 BOTTLE (59651-689-05)", "package_ndc": "59651-689-05", "marketing_start_date": "20230818"}], "brand_name": "Fluphenazine Hydrochloride", "product_id": "59651-689_1109b107-f7af-45b7-b8ee-709c59123074", "dosage_form": "TABLET", "pharm_class": ["Phenothiazine [EPC]", "Phenothiazines [CS]"], "product_ndc": "59651-689", "generic_name": "Fluphenazine Hydrochloride", "labeler_name": "Aurobindo Pharma Limited", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Fluphenazine Hydrochloride", "active_ingredients": [{"name": "FLUPHENAZINE HYDROCHLORIDE", "strength": "10 mg/1"}], "application_number": "ANDA218055", "marketing_category": "ANDA", "marketing_start_date": "20230818", "listing_expiration_date": "20261231"}