akynzeo

Generic: fosnetupitant and palonosetron

Labeler: helsinn therapeutics (u.s.), inc.
NDC Directory HUMAN PRESCRIPTION DRUG NDA Inactive Finished

Drug Facts

Product Profile

Brand Name akynzeo
Generic Name fosnetupitant and palonosetron
Labeler helsinn therapeutics (u.s.), inc.
Dosage Form INJECTION
Routes
INTRAVENOUS
Active Ingredients

fosnetupitant 260 mg/20mL, palonosetron hydrochloride .28 mg/20mL

Manufacturer
Helsinn Therapeutics (U.S.), Inc.

Identifiers & Regulatory

Product NDC 69639-106
Product ID 69639-106_4a6ba486-f8be-41a3-847e-429548867605
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category NDA
Application Number NDA210493
Listing Expiration 2027-12-31
Marketing Start 2023-08-01

Pharmacologic Class

Established (EPC)
substance p/neurokinin-1 receptor antagonist [epc] serotonin-3 receptor antagonist [epc]
Mechanism of Action
neurokinin 1 antagonists [moa] cytochrome p450 3a4 inhibitors [moa] p-glycoprotein inhibitors [moa] breast cancer resistance protein inhibitors [moa] serotonin 3 receptor antagonists [moa]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 69639106
Hyphenated Format 69639-106

Supplemental Identifiers

RxCUI
1552343 1552349 2044429 2044431 2374366 2374368
UPC
0369639101046
UNII
T672P80L2S 7732P08TIR 23310D4I19 5D06587D6R
NUI
N0000010262 N0000175786 N0000182141 N0000185503 N0000190113 N0000175817 N0000175818

Packaging Origin

Original Packager
true

Resolved Product View

Precedence rule: structured NDC data is preferred, falling back to linked label metadata when unavailable. Source tags show the origin of each value.

Resolved Identity

Brand Name akynzeo (source: ndc)
Generic Name fosnetupitant and palonosetron (source: ndc)
Application Number NDA210493 (source: ndc)
Routes
INTRAVENOUS
source: ndc

Resolved Composition

Strengths
  • 260 mg/20mL
  • .28 mg/20mL
source: ndc
Packaging
  • 1 VIAL, SINGLE-DOSE in 1 CARTON (69639-106-01) / 20 mL in 1 VIAL, SINGLE-DOSE
source: ndc

Packages (1)

69639-106-01 1 VIAL, SINGLE-DOSE in 1 CARTON (69639-106-01) / 20 mL in 1 VIAL, SINGLE-DOSE

Ingredients (2)

fosnetupitant (260 mg/20mL) palonosetron hydrochloride (.28 mg/20mL)

Linked Drug Pages (1)

AKYNZEO ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["INTRAVENOUS"], "spl_id": "4a6ba486-f8be-41a3-847e-429548867605", "openfda": {"nui": ["N0000010262", "N0000175786", "N0000182141", "N0000185503", "N0000190113", "N0000175817", "N0000175818"], "upc": ["0369639101046"], "unii": ["T672P80L2S", "7732P08TIR", "23310D4I19", "5D06587D6R"], "rxcui": ["1552343", "1552349", "2044429", "2044431", "2374366", "2374368"], "spl_set_id": ["8e47618e-af46-4d82-94e8-1507c042252d"], "pharm_class_epc": ["Substance P/Neurokinin-1 Receptor Antagonist [EPC]", "Serotonin-3 Receptor Antagonist [EPC]"], "pharm_class_moa": ["Neurokinin 1 Antagonists [MoA]", "Cytochrome P450 3A4 Inhibitors [MoA]", "P-Glycoprotein Inhibitors [MoA]", "Breast Cancer Resistance Protein Inhibitors [MoA]", "Serotonin 3 Receptor Antagonists [MoA]"], "manufacturer_name": ["Helsinn Therapeutics (U.S.), Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 VIAL, SINGLE-DOSE in 1 CARTON (69639-106-01)  / 20 mL in 1 VIAL, SINGLE-DOSE", "package_ndc": "69639-106-01", "marketing_start_date": "20230801"}], "brand_name": "AKYNZEO", "product_id": "69639-106_4a6ba486-f8be-41a3-847e-429548867605", "dosage_form": "INJECTION", "pharm_class": ["Serotonin 3 Receptor Antagonists [MoA]", "Serotonin-3 Receptor Antagonist [EPC]"], "product_ndc": "69639-106", "generic_name": "Fosnetupitant and Palonosetron", "labeler_name": "Helsinn Therapeutics (U.S.), Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "AKYNZEO", "active_ingredients": [{"name": "FOSNETUPITANT", "strength": "260 mg/20mL"}, {"name": "PALONOSETRON HYDROCHLORIDE", "strength": ".28 mg/20mL"}], "application_number": "NDA210493", "marketing_category": "NDA", "marketing_start_date": "20230801", "listing_expiration_date": "20271231"}