akynzeo

Generic: netupitant 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 netupitant and palonosetron
Labeler helsinn therapeutics (u.s.), inc.
Dosage Form CAPSULE
Routes
ORAL
Active Ingredients

netupitant 300 mg/1, palonosetron .5 mg/1

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

Identifiers & Regulatory

Product NDC 69639-101
Product ID 69639-101_4a6ba486-f8be-41a3-847e-429548867605
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category NDA
Application Number NDA205718
Listing Expiration 2027-12-31
Marketing Start 2014-10-13

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 69639101
Hyphenated Format 69639-101

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 netupitant and palonosetron (source: ndc)
Application Number NDA205718 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 300 mg/1
  • .5 mg/1
source: ndc
Packaging
  • 1 BLISTER PACK in 1 CARTON (69639-101-01) / 1 CAPSULE in 1 BLISTER PACK
  • 2 BLISTER PACK in 1 CARTON (69639-101-04) / 2 CAPSULE in 1 BLISTER PACK
source: ndc

Packages (2)

69639-101-01 1 BLISTER PACK in 1 CARTON (69639-101-01) / 1 CAPSULE in 1 BLISTER PACK 69639-101-04 2 BLISTER PACK in 1 CARTON (69639-101-04) / 2 CAPSULE in 1 BLISTER PACK

Ingredients (2)

netupitant (300 mg/1) palonosetron (.5 mg/1)

Linked Drug Pages (1)

AKYNZEO ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "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 BLISTER PACK in 1 CARTON (69639-101-01)  / 1 CAPSULE in 1 BLISTER PACK", "package_ndc": "69639-101-01", "marketing_start_date": "20141013"}, {"sample": false, "description": "2 BLISTER PACK in 1 CARTON (69639-101-04)  / 2 CAPSULE in 1 BLISTER PACK", "package_ndc": "69639-101-04", "marketing_start_date": "20141013"}], "brand_name": "AKYNZEO", "product_id": "69639-101_4a6ba486-f8be-41a3-847e-429548867605", "dosage_form": "CAPSULE", "pharm_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-1 Receptor Antagonist [EPC]"], "product_ndc": "69639-101", "generic_name": "Netupitant and Palonosetron", "labeler_name": "Helsinn Therapeutics (U.S.), Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "AKYNZEO", "active_ingredients": [{"name": "NETUPITANT", "strength": "300 mg/1"}, {"name": "PALONOSETRON", "strength": ".5 mg/1"}], "application_number": "NDA205718", "marketing_category": "NDA", "marketing_start_date": "20141013", "listing_expiration_date": "20271231"}