Home NDC 83831-158-01 AXYCIS
Product NDC 83831-158
Requested package NDC 83831-158-01
11-digit product format 838310158
Labeler code 83831
Product ID 83831-158_11d9dc37-e6e9-471c-aed6-496d0c9a3e88
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Cisplatin
Dosage form INJECTION, SOLUTION
Route INTRAVENOUS
Labeler AVYXA Pharma, LLC
Application NDA220748
Marketing category NDA
Marketing start 2026-11-11
Substance CISPLATIN
Active strength 1 mg/mL
Pharmacologic classes Platinum-based Drug [EPC], Platinum-containing Compounds [EXT]
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 45 .
Orange Book products# Current product rows page 1 of 1 · 1 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date N220748-001 AXYCIS CISPLATIN 50MG/50ML (1MG/ML) SOLUTION / INTRAVENOUS RLD, RS 2026-10-29
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 2026-11-14 07:37:17 2026-10 N220748-001 AXYCIS 50MG/50ML (1MG/ML) SOLUTION / INTRAVENOUS RLD, RS 2026-10-29 d4dbc9d85df4…
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 AXYCIS
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength CISPLATIN 1 mg/mL
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Marketing start Sample Exclude flag Status 83831-158-01 83831015801 1 VIAL, MULTI-DOSE in 1 CARTON (83831-158-01) / 50 mL in 1 VIAL, MULTI-DOSE 2026-11-11 No No Current