fluorouracil

Generic: fluorouracil

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

Drug Facts

Product Profile

Brand Name fluorouracil
Generic Name fluorouracil
Labeler sagent pharmaceuticals
Dosage Form INJECTION, SOLUTION
Routes
INTRAVENOUS
Active Ingredients

fluorouracil 50 mg/mL

Manufacturer
Sagent Pharmaceuticals

Identifiers & Regulatory

Product NDC 25021-215
Product ID 25021-215_223c5d8d-c064-4a0a-8490-b1c4aa0e706d
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA203609
Listing Expiration 2027-12-31
Marketing Start 2016-09-15

Pharmacologic Class

Established (EPC)
nucleoside metabolic inhibitor [epc]
Mechanism of Action
nucleic acid synthesis inhibitors [moa]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 25021215
Hyphenated Format 25021-215

Supplemental Identifiers

RxCUI
239177
UNII
U3P01618RT
NUI
N0000000233 N0000175595

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 fluorouracil (source: ndc)
Generic Name fluorouracil (source: ndc)
Application Number ANDA203609 (source: ndc)
Routes
INTRAVENOUS
source: ndc

Resolved Composition

Strengths
  • 50 mg/mL
source: ndc
Packaging
  • 1 BOTTLE in 1 CARTON (25021-215-98) / 50 mL in 1 BOTTLE
  • 1 BOTTLE in 1 CARTON (25021-215-99) / 100 mL in 1 BOTTLE
source: ndc

Packages (2)

25021-215-98 1 BOTTLE in 1 CARTON (25021-215-98) / 50 mL in 1 BOTTLE 25021-215-99 1 BOTTLE in 1 CARTON (25021-215-99) / 100 mL in 1 BOTTLE

Ingredients (1)

fluorouracil (50 mg/mL)

Linked Drug Pages (1)

fluorouracil ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["INTRAVENOUS"], "spl_id": "223c5d8d-c064-4a0a-8490-b1c4aa0e706d", "openfda": {"nui": ["N0000000233", "N0000175595"], "unii": ["U3P01618RT"], "rxcui": ["239177"], "spl_set_id": ["37e35e8c-5d51-413b-a3a0-b72a18caaf65"], "pharm_class_epc": ["Nucleoside Metabolic Inhibitor [EPC]"], "pharm_class_moa": ["Nucleic Acid Synthesis Inhibitors [MoA]"], "manufacturer_name": ["Sagent Pharmaceuticals"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 BOTTLE in 1 CARTON (25021-215-98)  / 50 mL in 1 BOTTLE", "package_ndc": "25021-215-98", "marketing_start_date": "20160915"}, {"sample": false, "description": "1 BOTTLE in 1 CARTON (25021-215-99)  / 100 mL in 1 BOTTLE", "package_ndc": "25021-215-99", "marketing_start_date": "20160915"}], "brand_name": "fluorouracil", "product_id": "25021-215_223c5d8d-c064-4a0a-8490-b1c4aa0e706d", "dosage_form": "INJECTION, SOLUTION", "pharm_class": ["Nucleic Acid Synthesis Inhibitors [MoA]", "Nucleoside Metabolic Inhibitor [EPC]"], "product_ndc": "25021-215", "generic_name": "fluorouracil", "labeler_name": "Sagent Pharmaceuticals", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "fluorouracil", "active_ingredients": [{"name": "FLUOROURACIL", "strength": "50 mg/mL"}], "application_number": "ANDA203609", "marketing_category": "ANDA", "marketing_start_date": "20160915", "listing_expiration_date": "20271231"}