fluphenazine decanoate

Generic: fluphenazine decanoate

Labeler: mylan institutional llc
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name fluphenazine decanoate
Generic Name fluphenazine decanoate
Labeler mylan institutional llc
Dosage Form INJECTION, SOLUTION
Routes
INTRAMUSCULAR SUBCUTANEOUS
Active Ingredients

fluphenazine decanoate 25 mg/mL

Manufacturer
Mylan Institutional LLC

Identifiers & Regulatory

Product NDC 67457-359
Product ID 67457-359_08baa8e5-a317-4529-9b2b-9a9c2ba5e7ae
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA075918
Listing Expiration 2026-12-31
Marketing Start 2018-09-28

Pharmacologic Class

Classes
phenothiazine [epc] phenothiazines [cs]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 67457359
Hyphenated Format 67457-359

Supplemental Identifiers

RxCUI
859824
UNII
FMU62K1L3C

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 decanoate (source: ndc)
Generic Name fluphenazine decanoate (source: ndc)
Application Number ANDA075918 (source: ndc)
Routes
INTRAMUSCULAR SUBCUTANEOUS
source: ndc

Resolved Composition

Strengths
  • 25 mg/mL
source: ndc
Packaging
  • 1 VIAL, MULTI-DOSE in 1 CARTON (67457-359-59) / 5 mL in 1 VIAL, MULTI-DOSE
source: ndc

Packages (1)

67457-359-59 1 VIAL, MULTI-DOSE in 1 CARTON (67457-359-59) / 5 mL in 1 VIAL, MULTI-DOSE

Ingredients (1)

fluphenazine decanoate (25 mg/mL)

Linked Drug Pages (1)

Fluphenazine Decanoate ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["INTRAMUSCULAR", "SUBCUTANEOUS"], "spl_id": "08baa8e5-a317-4529-9b2b-9a9c2ba5e7ae", "openfda": {"unii": ["FMU62K1L3C"], "rxcui": ["859824"], "spl_set_id": ["3832d3d3-15ce-4d41-8431-11e9bd04cf4d"], "manufacturer_name": ["Mylan Institutional LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 VIAL, MULTI-DOSE in 1 CARTON (67457-359-59)  / 5 mL in 1 VIAL, MULTI-DOSE", "package_ndc": "67457-359-59", "marketing_start_date": "20180928"}], "brand_name": "Fluphenazine Decanoate", "product_id": "67457-359_08baa8e5-a317-4529-9b2b-9a9c2ba5e7ae", "dosage_form": "INJECTION, SOLUTION", "pharm_class": ["Phenothiazine [EPC]", "Phenothiazines [CS]"], "product_ndc": "67457-359", "generic_name": "FLUPHENAZINE DECANOATE", "labeler_name": "Mylan Institutional LLC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Fluphenazine Decanoate", "active_ingredients": [{"name": "FLUPHENAZINE DECANOATE", "strength": "25 mg/mL"}], "application_number": "ANDA075918", "marketing_category": "ANDA", "marketing_start_date": "20180928", "listing_expiration_date": "20261231"}