KYXATA
- Product NDC
- 83831-141
- 11-digit product format
- 838310141
- Labeler code
- 83831
- Product ID
- 83831-141_5c711945-70be-42f4-b153-e1459dd9929c
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- CARBOplatin
- Dosage form
- INJECTION
- Route
- INTRAVENOUS
- Labeler
- Avyxa Pharma, LLC
- Application
- NDA219921
- Marketing category
- NDA
- Marketing start
- 2025-09-10
- Substance
- CARBOPLATIN
- Active strength
- 80 mg/8mL
- Pharmacologic classes
- Platinum-based Drug [EPC], Platinum-containing Compounds [EXT]
- NDC exclude flag
- No
- Listing certified through
- 2026-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- KYXATA
- Listing expiration
- 2026-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| CARBOPLATIN | 80 mg/8mL |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | BG3F62OND5 |
| Rxcui | 597195, 2721602 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 83831-141-08 | KYXATA | 8 mL in 1 VIAL, MULTI-DOSE | INJECTION | 8 | | 6 |
| 83831-141-08 | KYXATA | 1 in 1 CARTON | INJECTION | 1 | | 6 |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Marketing start | Sample | Exclude flag | Status |
|---|
| 83831-141-08 | 83831014108 | 1 VIAL, MULTI-DOSE in 1 CARTON (83831-141-08) / 8 mL in 1 VIAL, MULTI-DOSE | 2025-09-10 | No | No | Current |