Home NDC 67386-130 Vyepti
Product NDC 67386-130
11-digit product format 673860130
Labeler code 67386
Product ID 67386-130_9984df0e-33b9-4610-989d-0e186a7ee9e0
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 2026-12-31
Current FDA listing Yes openFDA label cross-check# Cross-check layer: openFDA label JSON enriches search and identifies hydration gaps. The DailyMed Structured Product Label remains the canonical label presentation on FDA.report. Every label matching the complete exact-identifier union is deduplicated and paginated below.
Matched openFDA labels page 1 of 1 · 1 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join Vyepti EPTINEZUMAB-JJMR Lundbeck Pharmaceuticals LLC 79065861-6aa5-4d1f-829f-3a6471286b36 2026-06-05 Warnings, Adverse reactions Exact identifier application number: BLA761119 ndc (product): 67386-130
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# NDC, Effective, Action table NDC Effective Action Document Indexing SPL Related label 67386-130-51 2021-09-24 C162847 48780-1 c7ccaba7-165c-fd44-e053-dadaa90aa01b 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 67386-130-51 2021-09-24 C162847 48780-1 c7ccaba7-165c-fd44-e053-dadaa90aa01b 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 67386-130-51 2021-09-24 C162847 48780-1 c7ccaba7-165c-fd44-e053-dadaa90aa01b 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 67386-130-51 2021-09-24 C162847 48780-1 c7ccaba7-165c-fd44-e053-dadaa90aa01b 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 67386-130-51 2021-09-24 C162847 48780-1 c7ccaba7-165c-fd44-e053-dadaa90aa01b 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 67386-130-51 2021-07-23 C162847 48780-1 c7ccaba7-165c-fd44-e053-dadaa90aa01b 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 67386-130-51 2021-07-23 C162847 48780-1 c7ccaba7-165c-fd44-e053-dadaa90aa01b 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 67386-130-51 2021-07-23 C162847 48780-1 c7ccaba7-165c-fd44-e053-dadaa90aa01b 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 67386-130-51 2021-07-23 C162847 48780-1 c7ccaba7-165c-fd44-e053-dadaa90aa01b 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 67386-130-51 2021-07-23 C162847 48780-1 c7ccaba7-165c-fd44-e053-dadaa90aa01b 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
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 2026-06-01
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Marketing start Marketing end Sample Exclude flag Status 67386-130-51 67386013051 1 VIAL, SINGLE-DOSE in 1 CARTON (67386-130-51) / 1 mL in 1 VIAL, SINGLE-DOSE 2020-02-21 0000-00-00 No No Current 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