Prescription drug · NDA
Akynzeo (Netupitant and palonosetron) NDC 69639-101
Netupitant 300 mg/1; Palonosetron .5 mg/1 · Capsule · Oral · Helsinn Therapeutics (U.S.), Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 69639-101-01 | 6963901010169639010101 | 1 BLISTER PACK in 1 CARTON (69639-101-01) / 1 CAPSULE in 1 BLISTER PACKMarketed from Oct 13, 2014 | |
| 69639-101-04 | 6963901010469639010104 | 2 BLISTER PACK in 1 CARTON (69639-101-04) / 2 CAPSULE in 1 BLISTER PACKMarketed from Oct 13, 2014 |
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)
- netupitant and palonosetron
- Active ingredients
- Netupitant — 300 mg/1Palonosetron — .5 mg/1
- Dosage form
- Capsule
- Route
- Oral
- Labeler
- Helsinn Therapeutics (U.S.), Inc.NDC labeler code 69639
- Product type
- Prescription drug
- Marketing category
- NDA — New Drug ApplicationApplication NDA 205718
- Marketing start
- Listing expires
- Other FDA classes
- Breast Cancer Resistance Protein Inhibitors (Mechanism)Cytochrome P450 3A4 Inhibitors (Mechanism)Neurokinin 1 Antagonists (Mechanism)P-Glycoprotein Inhibitors (Mechanism)Serotonin 3 Receptor Antagonists (Mechanism)
- Identifiers
- Product ID 69639-101_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, T672P80L2S, 23310D4I19UPC 0369639101046
- Pharmacologic class
- Serotonin-3 Receptor Antagonist; Substance P/Neurokinin-1 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 HCPCS code in Med-Code's directory. Oral products like this are usually dispensed by a pharmacy and billed by NDC.
- NDC on a medical claim
N469639010101followed by a unit qualifier and the quantityPackage 69639-0101-01. 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 69639-101
- What is NDC 69639-101?
- 69639-101 is the product NDC for Akynzeo, Netupitant 300 mg/1; Palonosetron .5 mg/1 capsule, listed with the FDA by Helsinn Therapeutics (U.S.), Inc.. It has 2 package NDCs, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Akynzeo (Netupitant and Palonosetron).
- What is the active ingredient?
- Netupitant, Palonosetron.
- 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. | 69639-106 | 69639-0106-01 |
| Akynzeofosnetupitant and palonosetron | Fosnetupitant 260 mg/20mL; Palonosetron hydrochloride .28 mg/20mL | InjectionIntravenous | Helsinn Therapeutics (U.S.), Inc. | 69639-105 | 69639-0105-01 |