Home NDC 83831-164 FAVLYXA
Product NDC 83831-164
11-digit product format 838310164
Labeler code 83831
Product ID 83831-164_7b9ac015-b819-4a04-87f9-3ab142cf14d0
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Fluorouracil
Dosage form INJECTION, SOLUTION
Route INTRAVENOUS
Labeler Avyxa Pharma, LLC
Application NDA220201
Marketing category NDA
Marketing start 2026-07-15
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 43 .
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 2026-09-14 22:38:34 2026-08 N220201-001 FAVLYXA 250MG/10ML (25MG/ML) SOLUTION / INTRAVENOUS RLD, RS 2026-02-20 84e616aacf4f…2026-09-14 22:38:34 2026-08 N220201-002 FAVLYXA 2.5GM/100ML (25MG/ML) SOLUTION / INTRAVENOUS RLD, RS 2026-07-06 84e616aacf4f…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…
Reported adverse events (FAERS/openFDA)# Adverse event summaries are temporarily unavailable. Other product information remains available.
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
DailyMed Product Concepts# DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Marketing start Sample Exclude flag Status 83831-164-10 83831016410 1 VIAL, MULTI-DOSE in 1 CARTON (83831-164-10) / 100 mL in 1 VIAL, MULTI-DOSE 2026-07-15 No No Current