AXYCIS
- Product NDC
- 83831-158
- 11-digit product format
- 838310158
- Labeler code
- 83831
- Product ID
- 83831-158_08ec8c6b-dbd6-43ba-b93c-792d8b82d523
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Cisplatin
- Dosage form
- INJECTION, SOLUTION
- Route
- INTRAVENOUS
- Labeler
- AVYXA Pharma, LLC
- Application
- NDA220748
- Marketing category
- NDA
- Marketing start
- 2026-10-29
- 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.
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 | 2026-10-29 | No | No | Current |