Gvoke Kit

Product NDC
72065-141
11-digit product format
720650141
Labeler code
72065
Product ID
72065-141_f1eb1cb9-848c-cdaf-e053-2995a90a9195
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
glucagon injection, solution
Dosage form
INJECTION, SOLUTION
Route
SUBCUTANEOUS
Labeler
Xeris Pharmaceuticals, Inc.
Application
NDA212097
Marketing category
NDA
Marketing start
2021-10-11
Marketing end
0000-00-00
Substance
GLUCAGON
Active strength
1 mg/.2mL
Pharmacologic classes
Antihypoglycemic Agent [EPC], Decreased GI Motility [PE], Decreased GI Smooth Muscle Tone [PE], Decreased Glycolysis [PE], Gastrointestinal Motility Inhibitor [EPC], Increased Gluconeogenesis [PE], Increased Glycogenolysis [PE]
NDC exclude flag
No
Listing certified through
2024-12-31
Current FDA listing
Historical FDA.report record

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
72065-141-11ML - Milliliter72065-141b3035711-cfb5-4005-9ba3-15b53221f7e912021-12-08

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
72065-141GVOKE HYPOPEN 1 MG AUTO-INJECTOR (GLUCAGON INJECTION, SOLUTION) INJECTION, SOLUTION GVOKE HYPOPEN 0.5 MG AUTO-INJECTOR (GLUCAGON INJECTION, SOLUTION) INJECTION, SOLUTION GVOKE PFS 1 MG PRE-FILLED SYRINGE (GLUCAGON INJECTION, SOLUTION) INJECTION, SOLUTION GVOKE PFS 0.5 MG PRE-FILLED SYRINGE (GLUCAGON INJECTION, SOLUTION) INJECTION, SOLUTION GVOKE KIT VIAL (GLUCAGON INJECTION, SOLUTION) INJECTION, SOLUTION GVOKE KIT (GLUCAGON INJECTION, SOLUTION) INJECTION, SOLUTION [XERIS PHARMACEUTICALS, INC.]17Legacy NDC20250523_92385737-dbad-98c5-e053-2995a90a2805.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
72065-141-1172065014111.2 mL in 1 VIAL, GLASS (72065-141-11) 2021-10-110000-00-00NoNoCurrent