lynkuet

Generic: elinzanetant

Labeler: bayer healthcare pharmaceuticals inc.
NDC Directory HUMAN PRESCRIPTION DRUG NDA Inactive Finished

Drug Facts

Product Profile

Brand Name lynkuet
Generic Name elinzanetant
Labeler bayer healthcare pharmaceuticals inc.
Dosage Form CAPSULE
Routes
ORAL
Active Ingredients

elinzanetant 60 mg/1

Manufacturer
Bayer HealthCare Pharmaceuticals Inc.

Identifiers & Regulatory

Product NDC 50419-475
Product ID 50419-475_3cff0968-bdc1-4388-a245-6e5390657c07
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category NDA
Application Number NDA219469
Listing Expiration 2027-12-31
Marketing Start 2025-10-24

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 50419475
Hyphenated Format 50419-475

Supplemental Identifiers

RxCUI
2725516 2725522
UNII
NZW2BOW35N

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 lynkuet (source: ndc)
Generic Name elinzanetant (source: ndc)
Application Number NDA219469 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 60 mg/1
source: ndc
Packaging
  • 5 BLISTER PACK in 1 CARTON (50419-475-05) / 12 CAPSULE in 1 BLISTER PACK (50419-475-01)
  • 2 BLISTER PACK in 1 CARTON (50419-475-72) / 12 CAPSULE in 1 BLISTER PACK (50419-475-71)
source: ndc

Packages (2)

50419-475-05 5 BLISTER PACK in 1 CARTON (50419-475-05) / 12 CAPSULE in 1 BLISTER PACK (50419-475-01) 50419-475-72 2 BLISTER PACK in 1 CARTON (50419-475-72) / 12 CAPSULE in 1 BLISTER PACK (50419-475-71)

Ingredients (1)

elinzanetant (60 mg/1)

Linked Drug Pages (1)

LYNKUET ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "3cff0968-bdc1-4388-a245-6e5390657c07", "openfda": {"unii": ["NZW2BOW35N"], "rxcui": ["2725516", "2725522"], "spl_set_id": ["f42884ff-7dff-419c-8a0c-affe2ed73818"], "manufacturer_name": ["Bayer HealthCare Pharmaceuticals Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "5 BLISTER PACK in 1 CARTON (50419-475-05)  / 12 CAPSULE in 1 BLISTER PACK (50419-475-01)", "package_ndc": "50419-475-05", "marketing_start_date": "20251024"}, {"sample": true, "description": "2 BLISTER PACK in 1 CARTON (50419-475-72)  / 12 CAPSULE in 1 BLISTER PACK (50419-475-71)", "package_ndc": "50419-475-72", "marketing_start_date": "20251024"}], "brand_name": "LYNKUET", "product_id": "50419-475_3cff0968-bdc1-4388-a245-6e5390657c07", "dosage_form": "CAPSULE", "product_ndc": "50419-475", "generic_name": "elinzanetant", "labeler_name": "Bayer HealthCare Pharmaceuticals Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "LYNKUET", "active_ingredients": [{"name": "ELINZANETANT", "strength": "60 mg/1"}], "application_number": "NDA219469", "marketing_category": "NDA", "marketing_start_date": "20251024", "listing_expiration_date": "20271231"}