Home NDC 67386-130-91 Vyepti
Product NDC 67386-130
Requested package NDC 67386-130-91
11-digit product format 673860130
Labeler code 67386
Product ID 67386-130_ae1b6705-69c6-4f31-8017-2a3abc032d53
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name eptinezumab-jjmr
Dosage form INJECTION
Route INTRAVENOUS
Labeler Lundbeck Pharmaceuticals LLC
Application BLA761119
Marketing category BLA
Marketing start 2020-02-21
Substance EPTINEZUMAB
Active strength 100 mg/mL
Pharmacologic classes Calcitonin Gene-related Peptide Antagonist [EPC], Calcitonin Gene-related Peptide Antagonists [MoA]
NDC exclude flag No
Listing certified through 2027-12-31
Current FDA listing Yes Reported adverse events (FAERS/openFDA)# Adverse event summaries are temporarily unavailable. Other product information remains available.
Additional Listing Data#
Finished product Yes
Brand name base Vyepti
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength EPTINEZUMAB 100 mg/mL
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 8202AY8I7H Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 2 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 2283049 Internal RxNorm lookup 2283054 Internal RxNorm lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
DailyMed Product Concepts# FDA-Initiated Inactive NDC Indexing# Effective, Related label table Effective Related label 2021-09-24 These highlights do not include all the information needed to use VYEPTI safely and effectively. See full prescribing information for VYEPTI. VYEPTI ® (eptinezumab-jjmr) injection, for intravenous use Initial U.S. Approval: 2020 2021-09-24 These highlights do not include all the information needed to use VYEPTI safely and effectively. See full prescribing information for VYEPTI. VYEPTI ® (eptinezumab-jjmr) injection, for intravenous use Initial U.S. Approval: 2020 2021-09-24 These highlights do not include all the information needed to use VYEPTI safely and effectively. See full prescribing information for VYEPTI. VYEPTI ® (eptinezumab-jjmr) injection, for intravenous use Initial U.S. Approval: 2020 2021-09-24 These highlights do not include all the information needed to use VYEPTI safely and effectively. See full prescribing information for VYEPTI. VYEPTI ® (eptinezumab-jjmr) injection, for intravenous use Initial U.S. Approval: 2020 2021-09-24 These highlights do not include all the information needed to use VYEPTI safely and effectively. See full prescribing information for VYEPTI. VYEPTI ® (eptinezumab-jjmr) injection, for intravenous use Initial U.S. Approval: 2020 2021-09-24 These highlights do not include all the information needed to use VYEPTI safely and effectively. See full prescribing information for VYEPTI. VYEPTI ® (eptinezumab-jjmr) injection, for intravenous use Initial U.S. Approval: 2020 2021-07-23 These highlights do not include all the information needed to use VYEPTI safely and effectively. See full prescribing information for VYEPTI. VYEPTI ® (eptinezumab-jjmr) injection, for intravenous use Initial U.S. Approval: 2020 2021-07-23 These highlights do not include all the information needed to use VYEPTI safely and effectively. See full prescribing information for VYEPTI. VYEPTI ® (eptinezumab-jjmr) injection, for intravenous use Initial U.S. Approval: 2020 2021-07-23 These highlights do not include all the information needed to use VYEPTI safely and effectively. See full prescribing information for VYEPTI. VYEPTI ® (eptinezumab-jjmr) injection, for intravenous use Initial U.S. Approval: 2020 2021-07-23 These highlights do not include all the information needed to use VYEPTI safely and effectively. See full prescribing information for VYEPTI. VYEPTI ® (eptinezumab-jjmr) injection, for intravenous use Initial U.S. Approval: 2020 2021-07-23 These highlights do not include all the information needed to use VYEPTI safely and effectively. See full prescribing information for VYEPTI. VYEPTI ® (eptinezumab-jjmr) injection, for intravenous use Initial U.S. Approval: 2020 2021-07-23 These highlights do not include all the information needed to use VYEPTI safely and effectively. See full prescribing information for VYEPTI. VYEPTI ® (eptinezumab-jjmr) injection, for intravenous use Initial U.S. Approval: 2020
DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 67386-130-51 Vyepti 1 in 1 CARTON INJECTION 1 25 67386-130-51 Vyepti 1 mL in 1 VIAL, SINGLE-DOSE INJECTION 1 25 67386-130-91 Vyepti 1 in 1 CARTON INJECTION 1 25 67386-130-91 Vyepti 1 mL in 1 VIAL, SINGLE-DOSE INJECTION 1 25
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 67386-130 VYEPTI (EPTINEZUMAB-JJMR) INJECTION [LUNDBECK PHARMACEUTICALS LLC] 21 Current NDC, Legacy NDC, 4 package rows 20250406_79065861-6aa5-4d1f-829f-3a6471286b36.zip
openFDA label cross-check# OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.
Matched openFDA labels page 1 of 1 · 1 matching rows.
Purple Book Biologic Products# BLA, Proprietary name, Proper name table BLA Proprietary name Proper name License type Status Latest source 761119 Vyepti eptinezumab-jjmr 351(a) Rx 2026-09-01
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Marketing start Sample Exclude flag Status 67386-130-91 67386013091 1 VIAL, SINGLE-DOSE in 1 CARTON (67386-130-91) / 1 mL in 1 VIAL, SINGLE-DOSE 2023-04-01 Yes No Current