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NDC 69639-0101-04 AKYNZEO 300; .5 mg/1; mg/1 Details
AKYNZEO 300; .5 mg/1; mg/1
AKYNZEO is a ORAL CAPSULE in the HUMAN PRESCRIPTION DRUG category. It is labeled and distributed by Helsinn Therapeutics (U.S.), Inc.. The primary component is NETUPITANT; PALONOSETRON.
MedlinePlus Drug Summary
The combination of netupitant and palonosetron is used to prevent nausea and vomiting caused by cancer chemotherapy. Netupitant is in a class of medications called neurokinin (NK1) antagonists. It works by blocking neurokinin, a natural substance in the brain that causes nausea and vomiting. Palonosetron is in a class of medications called 5-HT3 receptor antagonists. It works by blocking serotonin, a natural substance in the body that causes nausea and vomiting.
Related Packages: 69639-0101-04Last Updated: 12/01/2022
MedLinePlus Full Drug Details: Netupitant and Palonosetron
Product Information
| NDC | 69639-0101 |
|---|---|
| Product ID | 69639-101_3730c0de-198d-4359-8dbd-aaaf47814560 |
| Associated GPIs | 50309902290120 |
| GCN Sequence Number | 072935 |
| GCN Sequence Number Description | netupitant/palonosetron HCl CAPSULE 300-0.5 MG ORAL |
| HIC3 | H6J |
| HIC3 Description | ANTIEMETIC/ANTIVERTIGO AGENTS |
| GCN | 37239 |
| HICL Sequence Number | 041467 |
| HICL Sequence Number Description | NETUPITANT/PALONOSETRON HCL |
| Brand/Generic | Brand |
| Proprietary Name | AKYNZEO |
| Proprietary Name Suffix | n/a |
| Non-Proprietary Name | Netupitant and Palonosetron |
| Product Type | HUMAN PRESCRIPTION DRUG |
| Dosage Form | CAPSULE |
| Route | ORAL |
| Active Ingredient Strength | 300; .5 |
| Active Ingredient Units | mg/1; mg/1 |
| Substance Name | NETUPITANT; PALONOSETRON |
| Labeler Name | Helsinn Therapeutics (U.S.), Inc. |
| Pharmaceutical Class | Breast Cancer Resistance Protein Inhibitors [MoA], Cytochrome P450 3A4 Inhibitors [MoA], Neurokinin 1 Antagonists [MoA], P-Glycoprotein Inhibitors [MoA], Serotonin 3 Receptor Antagonists [MoA], Serotonin-3 Receptor Antagonist [EPC], Substance P/Neurokinin |
| DEA Schedule | n/a |
| Marketing Category | NDA |
| Application Number | NDA205718 |
| Listing Certified Through | 2024-12-31 |
Package
NDC 69639-0101-04 (69639010104)
| NDC Package Code | 69639-101-04 |
|---|---|
| Billing NDC | 69639010104 |
| Package | 2 BLISTER PACK in 1 CARTON (69639-101-04) / 2 CAPSULE in 1 BLISTER PACK |
| Marketing Start Date | 2014-10-13 |
| NDC Exclude Flag | N |
| Pricing Information | N/A |