Home NDC 83831-143 FAVLYXA
Product NDC 83831-143
11-digit product format 838310143
Labeler code 83831
Product ID 83831-143_c8c3a5e0-277e-4d3e-910c-62cbc241cc3a
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Fluorouracil
Dosage form INJECTION, SOLUTION
Route INTRAVENOUS
Labeler Avyxa Pharma, LLC
Application NDA220201
Marketing category NDA
Marketing start 2026-04-01
Substance FLUOROURACIL
Active strength 25 mg/mL
Pharmacologic classes Nucleic Acid Synthesis Inhibitors [MoA], Nucleoside Metabolic Inhibitor [EPC]
NDC exclude flag No
Listing certified through 2027-12-31
Current FDA listing Yes Source provenance: Browse the complete Orange Book source catalog · source snapshot 42 .
Orange Book products# Current product rows page 1 of 1 · 2 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date N220201-001 FAVLYXA FLUOROURACIL 250MG/10ML (25MG/ML) SOLUTION / INTRAVENOUS RLD, RS 2026-02-20 N220201-002 FAVLYXA FLUOROURACIL 2.5GM/100ML (25MG/ML) SOLUTION / INTRAVENOUS RLD, RS 2026-07-06
Observed Orange Book product history# Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.
Captured, Edition, Application-product table Captured Edition Application-product Trade name Strength Dosage form / route Product TE source text RLD / RS Approval date Source SHA-256 2026-08-18 06:07:40 2026-07 N220201-001 FAVLYXA 250MG/10ML (25MG/ML) SOLUTION / INTRAVENOUS RLD, RS 2026-02-20 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N220201-002 FAVLYXA 2.5GM/100ML (25MG/ML) SOLUTION / INTRAVENOUS RLD, RS 2026-07-06 caaa826d4ba7…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 N220201-001 FAVLYXA 250MG/10ML (25MG/ML) SOLUTION / INTRAVENOUS RLD, RS 2026-02-20 a50c72e98297…
Additional Listing Data#
Finished product Yes
Brand name base FAVLYXA
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength FLUOROURACIL 25 mg/mL
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination U3P01618RT Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 4 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 199316 Internal RxNorm lookup 2738666 Internal RxNorm lookup 2738672 Internal RxNorm lookup 2746960 Internal RxNorm lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
DailyMed Product Concepts# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 83831-143-01 FAVLYXA 10 mL in 1 VIAL, SINGLE-DOSE INJECTION, SOLUTION 10 2 83831-143-01 FAVLYXA 1 in 1 CARTON INJECTION, SOLUTION 1 2
openFDA label cross-check# OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.
Matched openFDA labels page 1 of 1 · 1 matching rows.
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Marketing start Sample Exclude flag Status 83831-143-01 83831014301 1 VIAL, SINGLE-DOSE in 1 CARTON (83831-143-01) / 10 mL in 1 VIAL, SINGLE-DOSE 2026-04-01 No No Current