Prescription drug · NDA
Akynzeo (Fosnetupitant and palonosetron) NDC 69639-106
Fosnetupitant 260 mg/20mL; Palonosetron hydrochloride .28 mg/20mL · Injection · Intravenous · Helsinn Therapeutics (U.S.), Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 69639-106-01 | 69639010601 | 1 VIAL, SINGLE-DOSE in 1 CARTON (69639-106-01) / 20 mL in 1 VIAL, SINGLE-DOSEMarketed from Aug 1, 2023 |
How the 11-digit form is made: The product segment has 3 digits, so one leading zero is added to it (5-3-2 → 5-4-2). Formatting the NDC does not by itself make it billable — the product, package and quantity must match what was dispensed or administered, and payer rules apply. Conversion rules
Product information
- Brand name (proprietary)
- Akynzeo
- Generic name (nonproprietary)
- fosnetupitant and palonosetron
- Active ingredients
- Fosnetupitant — 260 mg/20mLPalonosetron hydrochloride — .28 mg/20mL
- Dosage form
- Injection
- Route
- Intravenous
- Labeler
- Helsinn Therapeutics (U.S.), Inc.NDC labeler code 69639
- Product type
- Prescription drug
- Marketing category
- NDA — New Drug ApplicationApplication NDA 210493
- Marketing start
- Listing expires
- Other FDA classes
- Serotonin 3 Receptor Antagonists (Mechanism)
- Identifiers
- Product ID 69639-106_c1a46993-d1bf-4f84-8fac-e9c04a7d6bf1SPL ID c1a46993-d1bf-4f84-8fac-e9c04a7d6bf1SPL set ID 8e47618e-af46-4d82-94e8-1507c042252dRxCUI 1552343, 1552349, 2044429, 2044431, 2374366, 2374368UNII 5D06587D6R, 7732P08TIR, 23310D4I19, T672P80L2SUPC 0369639101046
- Pharmacologic class
- Serotonin-3 Receptor Antagonist
Billing references
What Med-Code can say about coding this product, and where each statement comes from. Nothing here is inferred from the name alone.
- HCPCS codeNo match
No drug-specific HCPCS code in Med-Code's directory for this product. The directory is curated and not complete — check the current CMS HCPCS file before billing.
- Administration
Drug administration (CPT 96360–96549)
When a clinician administers the drug, the administration is reported separately. Codes in this range cover hydration, therapeutic injections and infusions, and chemotherapy or other complex drug administration. The right code depends on route, duration and drug type, and self-administered drugs are not billed this way.
- NDC on a medical claim
N469639010601followed by a unit qualifier and the quantityPackage 69639-0106-01. Unit qualifiers: F2 (international unit), GR (gram), ME (milligram), ML (milliliter), UN (unit (each)). The qualifier and quantity depend on what was given. About the N4 qualifier
Product label
Current FDA label (SPL), effective .
Indications (excerpt from the label)
AKYNZEO capsules is indicated in combination with dexamethasone in adults for the prevention of acute and delayed nausea and vomiting associated with initial and repeat courses of cancer chemotherapy, including, but not limited to, highly emetogenic chemotherapy. AKYNZEO capsules is a combination of palonosetron and netupitant: palonosetron prevents nausea and vomiting during the acute phase and netupitant prevents nausea and vomiting during both the acute and delayed phase after cancer chemotherapy. AKYNZEO for injection and AKYNZEO injection are indicated in combination with dexamethasone in adults for the prevention of acute and delayed nausea and vomiting associated with initial and repe…
Excerpt only. Read the full label for complete information.
About NDC 69639-106
- What is NDC 69639-106?
- 69639-106 is the product NDC for Akynzeo, Fosnetupitant 260 mg/20mL; Palonosetron hydrochloride .28 mg/20mL injection, listed with the FDA by Helsinn Therapeutics (U.S.), Inc.. It has 1 package NDC, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Akynzeo (Fosnetupitant and Palonosetron).
- What is the active ingredient?
- Fosnetupitant, Palonosetron hydrochloride.
- Who is the labeler?
- Helsinn Therapeutics (U.S.), Inc., NDC labeler code 69639. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for Akynzeo?
- 2 other product NDCs are listed under this name. See all Akynzeo NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other Akynzeo products
Other finished products listed under the same name: strengths, forms and labelers.
| Product | Strength | Form · route | Labeler | Product NDC | Package NDCs (11-digit) |
|---|---|---|---|---|---|
| Akynzeofosnetupitant and palonosetron | Fosnetupitant 260 mg/20mL; Palonosetron hydrochloride .28 mg/20mL | InjectionIntravenous | Helsinn Therapeutics (U.S.), Inc. | 69639-105 | 69639-0105-01 |
| Akynzeonetupitant and palonosetron | Netupitant 300 mg/1; Palonosetron .5 mg/1 | CapsuleOral | Helsinn Therapeutics (U.S.), Inc. | 69639-101 | 69639-0101-0169639-0101-04 |
Other NDCs under NDA 210493
Products listed under the same FDA application: other strengths and forms, and repackagers who relabel the same product.
| Product | Strength | Form · route | Labeler | Product NDC |
|---|---|---|---|---|
| Akynzeofosnetupitant and palonosetron | Fosnetupitant 260 mg/20mL; Palonosetron hydrochloride .28 mg/20mL | InjectionIntravenous | Helsinn Therapeutics (U.S.), Inc. | 69639-105 |