fluphenazine decanoate

Generic: fluphenazine decanoate

Labeler: sagent pharmaceuticals
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name fluphenazine decanoate
Generic Name fluphenazine decanoate
Labeler sagent pharmaceuticals
Dosage Form INJECTION, SOLUTION
Routes
INTRAMUSCULAR SUBCUTANEOUS
Active Ingredients

fluphenazine decanoate 25 mg/mL

Manufacturer
Sagent Pharmaceuticals

Identifiers & Regulatory

Product NDC 25021-838
Product ID 25021-838_bd85ef0f-3c47-4d48-9ba0-9d4e012698cf
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA215509
Listing Expiration 2026-12-31
Marketing Start 2023-08-01

Pharmacologic Class

Classes
phenothiazine [epc] phenothiazines [cs]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 25021838
Hyphenated Format 25021-838

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 ANDA215509 (source: ndc)
Routes
INTRAMUSCULAR SUBCUTANEOUS
source: ndc

Resolved Composition

Strengths
  • 25 mg/mL
source: ndc
Packaging
  • 1 VIAL in 1 CARTON (25021-838-05) / 5 mL in 1 VIAL
source: ndc

Packages (1)

25021-838-05 1 VIAL in 1 CARTON (25021-838-05) / 5 mL in 1 VIAL

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": "bd85ef0f-3c47-4d48-9ba0-9d4e012698cf", "openfda": {"unii": ["FMU62K1L3C"], "rxcui": ["859824"], "spl_set_id": ["1842a678-c32b-4e81-998e-597fc370fb9e"], "manufacturer_name": ["Sagent Pharmaceuticals"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 VIAL in 1 CARTON (25021-838-05)  / 5 mL in 1 VIAL", "package_ndc": "25021-838-05", "marketing_start_date": "20230801"}], "brand_name": "Fluphenazine Decanoate", "product_id": "25021-838_bd85ef0f-3c47-4d48-9ba0-9d4e012698cf", "dosage_form": "INJECTION, SOLUTION", "pharm_class": ["Phenothiazine [EPC]", "Phenothiazines [CS]"], "product_ndc": "25021-838", "generic_name": "Fluphenazine Decanoate", "labeler_name": "Sagent Pharmaceuticals", "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": "20230801", "listing_expiration_date": "20261231"}