fluphenazine decanoate

Generic: fluphenazine decanoate

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

Drug Facts

Product Profile

Brand Name fluphenazine decanoate
Generic Name fluphenazine decanoate
Labeler gland pharma limited
Dosage Form INJECTION, SOLUTION
Routes
INTRAMUSCULAR SUBCUTANEOUS
Active Ingredients

fluphenazine decanoate 25 mg/mL

Manufacturer
Gland Pharma Limited

Identifiers & Regulatory

Product NDC 68083-476
Product ID 68083-476_8475631f-7d35-47e8-9b93-26357f757277
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA215509
Listing Expiration 2026-12-31
Marketing Start 2023-03-30

Pharmacologic Class

Classes
phenothiazine [epc] phenothiazines [cs]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 68083476
Hyphenated Format 68083-476

Supplemental Identifiers

RxCUI
859824
UPC
0368083476014
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 ANDA215509 (source: ndc)
Routes
INTRAMUSCULAR SUBCUTANEOUS
source: ndc

Resolved Composition

Strengths
  • 25 mg/mL
source: ndc
Packaging
  • 1 VIAL, MULTI-DOSE in 1 CARTON (68083-476-01) / 5 mL in 1 VIAL, MULTI-DOSE
source: ndc

Packages (1)

68083-476-01 1 VIAL, MULTI-DOSE in 1 CARTON (68083-476-01) / 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": "8475631f-7d35-47e8-9b93-26357f757277", "openfda": {"upc": ["0368083476014"], "unii": ["FMU62K1L3C"], "rxcui": ["859824"], "spl_set_id": ["8caa3896-cde1-4cb1-9332-2e92bcf5c1f6"], "manufacturer_name": ["Gland Pharma Limited"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 VIAL, MULTI-DOSE in 1 CARTON (68083-476-01)  / 5 mL in 1 VIAL, MULTI-DOSE", "package_ndc": "68083-476-01", "marketing_start_date": "20230330"}], "brand_name": "fluphenazine decanoate", "product_id": "68083-476_8475631f-7d35-47e8-9b93-26357f757277", "dosage_form": "INJECTION, SOLUTION", "pharm_class": ["Phenothiazine [EPC]", "Phenothiazines [CS]"], "product_ndc": "68083-476", "generic_name": "fluphenazine decanoate", "labeler_name": "Gland Pharma Limited", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "fluphenazine decanoate", "active_ingredients": [{"name": "FLUPHENAZINE DECANOATE", "strength": "25 mg/mL"}], "application_number": "ANDA215509", "marketing_category": "ANDA", "marketing_start_date": "20230330", "listing_expiration_date": "20261231"}