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NDC 69639-0105-01 AKYNZEO 260; .28 mg/20mL; mg/20mL Details
AKYNZEO 260; .28 mg/20mL; mg/20mL
AKYNZEO is a INTRAVENOUS INJECTION in the HUMAN PRESCRIPTION DRUG category. It is labeled and distributed by Helsinn Therapeutics (U.S.), Inc.. The primary component is FOSNETUPITANT; PALONOSETRON HYDROCHLORIDE.
Product Information
| NDC | 69639-0105 |
|---|---|
| Product ID | 69639-105_3730c0de-198d-4359-8dbd-aaaf47814560 |
| Associated GPIs | 50309902222020 |
| GCN Sequence Number | 081424 |
| GCN Sequence Number Description | fosnetupitant/palonosetron VIAL 235-0.25MG INTRAVEN |
| HIC3 | H6J |
| HIC3 Description | ANTIEMETIC/ANTIVERTIGO AGENTS |
| GCN | 48526 |
| HICL Sequence Number | 044890 |
| HICL Sequence Number Description | FOSNETUPITANT CHLORIDE HCL/PALONOSETRON HCL |
| Brand/Generic | Brand |
| Proprietary Name | AKYNZEO |
| Proprietary Name Suffix | n/a |
| Non-Proprietary Name | Fosnetupitant and Palonosetron |
| Product Type | HUMAN PRESCRIPTION DRUG |
| Dosage Form | INJECTION |
| Route | INTRAVENOUS |
| Active Ingredient Strength | 260; .28 |
| Active Ingredient Units | mg/20mL; mg/20mL |
| Substance Name | FOSNETUPITANT; PALONOSETRON HYDROCHLORIDE |
| Labeler Name | Helsinn Therapeutics (U.S.), Inc. |
| Pharmaceutical Class | Serotonin 3 Receptor Antagonists [MoA], Serotonin-3 Receptor Antagonist [EPC] |
| DEA Schedule | n/a |
| Marketing Category | NDA |
| Application Number | NDA210493 |
| Listing Certified Through | 2024-12-31 |
Package
NDC 69639-0105-01 (69639010501)
| NDC Package Code | 69639-105-01 |
|---|---|
| Billing NDC | 69639010501 |
| Package | 1 VIAL in 1 CARTON (69639-105-01) / 20 mL in 1 VIAL |
| Marketing Start Date | 2020-06-15 |
| NDC Exclude Flag | N |
| Pricing Information | N/A |