fluphenazine hydrochoride

Generic: fluphenazine hydrochloride

Labeler: rising pharma holdings, inc.
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name fluphenazine hydrochoride
Generic Name fluphenazine hydrochloride
Labeler rising pharma holdings, inc.
Dosage Form TABLET, FILM COATED
Routes
ORAL
Active Ingredients

fluphenazine hydrochloride 1 mg/1

Manufacturer
Rising Pharma Holdings, Inc.

Identifiers & Regulatory

Product NDC 16571-889
Product ID 16571-889_5e7076f6-426b-45c2-865f-7be79fe81205
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA218283
Listing Expiration 2026-12-31
Marketing Start 2024-06-07

Pharmacologic Class

Classes
phenothiazine [epc] phenothiazines [cs]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 16571889
Hyphenated Format 16571-889

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 hydrochoride (source: ndc)
Generic Name fluphenazine hydrochloride (source: ndc)
Application Number ANDA218283 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 1 mg/1
source: ndc
Packaging
  • 90 TABLET, FILM COATED in 1 CONTAINER (16571-889-09)
  • 500 TABLET, FILM COATED in 1 CONTAINER (16571-889-50)
source: ndc

Packages (2)

16571-889-09 90 TABLET, FILM COATED in 1 CONTAINER (16571-889-09) 16571-889-50 500 TABLET, FILM COATED in 1 CONTAINER (16571-889-50)

Ingredients (1)

fluphenazine hydrochloride (1 mg/1)

Linked Drug Pages (1)

Fluphenazine Hydrochoride ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "5e7076f6-426b-45c2-865f-7be79fe81205", "openfda": {"unii": ["ZOU145W1XL"], "rxcui": ["859841", "860918", "865117", "865123"], "spl_set_id": ["9fd44ab9-79bb-472e-8434-c3d786b42de5"], "manufacturer_name": ["Rising Pharma Holdings, Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "90 TABLET, FILM COATED in 1 CONTAINER (16571-889-09)", "package_ndc": "16571-889-09", "marketing_start_date": "20240607"}, {"sample": false, "description": "500 TABLET, FILM COATED in 1 CONTAINER (16571-889-50)", "package_ndc": "16571-889-50", "marketing_start_date": "20240607"}], "brand_name": "Fluphenazine Hydrochoride", "product_id": "16571-889_5e7076f6-426b-45c2-865f-7be79fe81205", "dosage_form": "TABLET, FILM COATED", "pharm_class": ["Phenothiazine [EPC]", "Phenothiazines [CS]"], "product_ndc": "16571-889", "generic_name": "fluphenazine hydrochloride", "labeler_name": "Rising Pharma Holdings, Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Fluphenazine Hydrochoride", "active_ingredients": [{"name": "FLUPHENAZINE HYDROCHLORIDE", "strength": "1 mg/1"}], "application_number": "ANDA218283", "marketing_category": "ANDA", "marketing_start_date": "20240607", "listing_expiration_date": "20261231"}