vyepti

Generic: eptinezumab-jjmr

Labeler: lundbeck pharmaceuticals llc
NDC Directory HUMAN PRESCRIPTION DRUG BLA Inactive Finished

Drug Facts

Product Profile

Brand Name vyepti
Generic Name eptinezumab-jjmr
Labeler lundbeck pharmaceuticals llc
Dosage Form INJECTION
Routes
INTRAVENOUS
Active Ingredients

eptinezumab 100 mg/mL

Manufacturer
Lundbeck Pharmaceuticals LLC

Identifiers & Regulatory

Product NDC 67386-130
Product ID 67386-130_9984df0e-33b9-4610-989d-0e186a7ee9e0
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category BLA
Application Number BLA761119
Listing Expiration 2026-12-31
Marketing Start 2020-02-21

Pharmacologic Class

Established (EPC)
calcitonin gene-related peptide antagonist [epc]
Mechanism of Action
calcitonin gene-related peptide antagonists [moa]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 67386130
Hyphenated Format 67386-130

Supplemental Identifiers

RxCUI
2283049 2283054
UNII
8202AY8I7H
NUI
N0000193952 N0000193953

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 vyepti (source: ndc)
Generic Name eptinezumab-jjmr (source: ndc)
Application Number BLA761119 (source: ndc)
Routes
INTRAVENOUS
source: ndc

Resolved Composition

Strengths
  • 100 mg/mL
source: ndc
Packaging
  • 1 VIAL, SINGLE-DOSE in 1 CARTON (67386-130-51) / 1 mL in 1 VIAL, SINGLE-DOSE
  • 1 VIAL, SINGLE-DOSE in 1 CARTON (67386-130-91) / 1 mL in 1 VIAL, SINGLE-DOSE
source: ndc

Packages (2)

67386-130-51 1 VIAL, SINGLE-DOSE in 1 CARTON (67386-130-51) / 1 mL in 1 VIAL, SINGLE-DOSE 67386-130-91 1 VIAL, SINGLE-DOSE in 1 CARTON (67386-130-91) / 1 mL in 1 VIAL, SINGLE-DOSE

Ingredients (1)

eptinezumab (100 mg/mL)

Linked Drug Pages (1)

Vyepti ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["INTRAVENOUS"], "spl_id": "9984df0e-33b9-4610-989d-0e186a7ee9e0", "openfda": {"nui": ["N0000193952", "N0000193953"], "unii": ["8202AY8I7H"], "rxcui": ["2283049", "2283054"], "spl_set_id": ["79065861-6aa5-4d1f-829f-3a6471286b36"], "pharm_class_epc": ["Calcitonin Gene-related Peptide Antagonist [EPC]"], "pharm_class_moa": ["Calcitonin Gene-related Peptide Antagonists [MoA]"], "manufacturer_name": ["Lundbeck Pharmaceuticals LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 VIAL, SINGLE-DOSE in 1 CARTON (67386-130-51)  / 1 mL in 1 VIAL, SINGLE-DOSE", "package_ndc": "67386-130-51", "marketing_start_date": "20200221"}, {"sample": true, "description": "1 VIAL, SINGLE-DOSE in 1 CARTON (67386-130-91)  / 1 mL in 1 VIAL, SINGLE-DOSE", "package_ndc": "67386-130-91", "marketing_start_date": "20230401"}], "brand_name": "Vyepti", "product_id": "67386-130_9984df0e-33b9-4610-989d-0e186a7ee9e0", "dosage_form": "INJECTION", "pharm_class": ["Calcitonin Gene-related Peptide Antagonist [EPC]", "Calcitonin Gene-related Peptide Antagonists [MoA]"], "product_ndc": "67386-130", "generic_name": "eptinezumab-jjmr", "labeler_name": "Lundbeck Pharmaceuticals LLC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Vyepti", "active_ingredients": [{"name": "EPTINEZUMAB", "strength": "100 mg/mL"}], "application_number": "BLA761119", "marketing_category": "BLA", "marketing_start_date": "20200221", "listing_expiration_date": "20261231"}