AKYNZEO
- Product NDC
- 69639-106
- 11-digit product format
- 696390106
- Labeler code
- 69639
- Product ID
- 69639-106_4a6ba486-f8be-41a3-847e-429548867605
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Fosnetupitant and Palonosetron
- Dosage form
- INJECTION
- Route
- INTRAVENOUS
- Labeler
- Helsinn Therapeutics (U.S.), Inc.
- Application
- NDA210493
- Marketing category
- NDA
- Marketing start
- 2023-08-01
- Substance
- FOSNETUPITANT; PALONOSETRON HYDROCHLORIDE
- Active strength
- 260; .28 mg/20mL; mg/20mL
- Pharmacologic classes
- Serotonin 3 Receptor Antagonists [MoA], Serotonin-3 Receptor Antagonist [EPC]
- NDC exclude flag
- No
- Listing certified through
- 2027-12-31
- Current FDA listing
- Yes
Related UNII Ingredients
| UNII | Preferred term | Registry number | Matched term |
|---|
| T672P80L2S | FOSNETUPITANT | 1703748-89-3 | FOSNETUPITANT |
| 23310D4I19 | PALONOSETRON HYDROCHLORIDE | 135729-62-3 | PALONOSETRON HYDROCHLORIDE |
Packages
| Package NDC | 11-digit format | Description | Marketing start | Sample | Exclude flag | Status |
|---|
| 69639-106-01 | 69639010601 | 1 VIAL, SINGLE-DOSE in 1 CARTON (69639-106-01) / 20 mL in 1 VIAL, SINGLE-DOSE | 2023-08-01 | No | No | Historical |
Related DailyMed Labels
| Title | Manufacturer | Effective date | Type | Version |
|---|
| AKYNZEO | Helsinn Therapeutics (U.S.), Inc. | Helsinn Healthcare SA | Helsinn Advanced Synthesis SA | Helsinn Birex Pharmaceuticals LTD | Patheon Italia S.p.A. | Baxter Oncology GmbH | 2026-01-26 | HUMAN PRESCRIPTION DRUG LABEL | 18 |