fluphenazine hydrochloride

Generic: fluphenazine hydrochloride

Labeler: pai holdings, llc dba pai pharma
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name fluphenazine hydrochloride
Generic Name fluphenazine hydrochloride
Labeler pai holdings, llc dba pai pharma
Dosage Form ELIXIR
Routes
ORAL
Active Ingredients

fluphenazine hydrochloride .5 mg/mL

Manufacturer
PAI Holdings, LLC dba PAI Pharma

Identifiers & Regulatory

Product NDC 0121-0654
Product ID 0121-0654_be2cdaa4-74b5-4256-90c0-e1410973b3f5
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA040146
Listing Expiration 2026-12-31
Marketing Start 2010-08-31

Pharmacologic Class

Classes
phenothiazine [epc] phenothiazines [cs]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 01210654
Hyphenated Format 0121-0654

Supplemental Identifiers

RxCUI
859835
UPC
0301210654022
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 ANDA040146 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • .5 mg/mL
source: ndc
Packaging
  • 60 mL in 1 BOTTLE (0121-0654-02)
  • 473 mL in 1 BOTTLE (0121-0654-16)
source: ndc

Packages (2)

0121-0654-02 60 mL in 1 BOTTLE (0121-0654-02) 0121-0654-16 473 mL in 1 BOTTLE (0121-0654-16)

Ingredients (1)

fluphenazine hydrochloride (.5 mg/mL)

Linked Drug Pages (1)

Fluphenazine Hydrochloride ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "be2cdaa4-74b5-4256-90c0-e1410973b3f5", "openfda": {"upc": ["0301210654022"], "unii": ["ZOU145W1XL"], "rxcui": ["859835"], "spl_set_id": ["f0a89d5d-01db-47f3-a873-33ab49c6e4f8"], "manufacturer_name": ["PAI Holdings, LLC dba PAI Pharma"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "60 mL in 1 BOTTLE (0121-0654-02)", "package_ndc": "0121-0654-02", "marketing_start_date": "20100831"}, {"sample": false, "description": "473 mL in 1 BOTTLE (0121-0654-16)", "package_ndc": "0121-0654-16", "marketing_start_date": "20100831"}], "brand_name": "Fluphenazine Hydrochloride", "product_id": "0121-0654_be2cdaa4-74b5-4256-90c0-e1410973b3f5", "dosage_form": "ELIXIR", "pharm_class": ["Phenothiazine [EPC]", "Phenothiazines [CS]"], "product_ndc": "0121-0654", "generic_name": "Fluphenazine Hydrochloride", "labeler_name": "PAI Holdings, LLC dba PAI Pharma", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Fluphenazine Hydrochloride", "active_ingredients": [{"name": "FLUPHENAZINE HYDROCHLORIDE", "strength": ".5 mg/mL"}], "application_number": "ANDA040146", "marketing_category": "ANDA", "marketing_start_date": "20100831", "listing_expiration_date": "20261231"}