FDA.reportPublic FDA data

Gvoke VialDx

Product NDC
0517-2901
11-digit product format
005172901
Labeler code
0517
Product ID
0517-2901_394a5780-8ead-4c26-890c-37edfb879599
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
glucagon injection
Dosage form
INJECTION, SOLUTION
Route
INTRAVENOUS
Labeler
American Regent, Inc.
Application
NDA212097
Marketing category
NDA
Marketing start
2025-08-19
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
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Gvoke VialDx
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
GLUCAGON1 mg/.2mL

Harmonized Identifiers#

Field, Values table
FieldValues
Unii76LA80IG2G
Rxcui2587358, 2587361

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
83f7a8cc-8fbf-4478-9a44-b6214b840d9aProduct name220250812
1e832aa0-608b-424f-9ced-615cef2ff5c5Product name120200220
6ee0758f-9a1a-41ee-90c4-3adce06b52b4Product name120191120
750a4794-c0e1-4ac9-9af5-006ecec3bb04Product name120150608

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0517-2901-01Gvoke VialDx0.2 mL in 1 VIALINJECTION, SOLUTION0.21
0517-2901-01Gvoke VialDx1 in 1 CARTONINJECTION, SOLUTION11
0517-2901-10Gvoke VialDx0.2 mL in 1 VIALINJECTION, SOLUTION0.21
0517-2901-10Gvoke VialDx10 in 1 CARTONINJECTION, SOLUTION101

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0517-2901-01ML - Milliliter0517-2901bde3f959-b3d8-4d26-8d91-7d7e60c7433912025-09-12
0517-2901-10ML - Milliliter0517-29013c8a8c14-27da-4a2b-b5d7-236b1e154f7c12025-09-12

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
2587358glucagon 1 MG in 0.2 ML InjectionPSN359982a8-ec5c-4927-8c0f-89771e0f942b1
2587361Gvoke 1 MG in 0.2 ML InjectionPSN359982a8-ec5c-4927-8c0f-89771e0f942b1
25873610.2 ML glucagon 5 MG/ML Injection [Gvoke]SBD359982a8-ec5c-4927-8c0f-89771e0f942b1
25873580.2 ML glucagon 5 MG/ML InjectionSCD359982a8-ec5c-4927-8c0f-89771e0f942b1
2587358glucagon 1 MG per 0.2 ML InjectionSY359982a8-ec5c-4927-8c0f-89771e0f942b1
2587358glucagon 5 MG/ML per 0.2 ML InjectionSY359982a8-ec5c-4927-8c0f-89771e0f942b1
2587361Gvoke 1 MG per 0.2 ML InjectionSY359982a8-ec5c-4927-8c0f-89771e0f942b1
2587361Gvoke 5 MG/ML per 0.2 ML InjectionSY359982a8-ec5c-4927-8c0f-89771e0f942b1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
0517-2901-01005172901011 VIAL in 1 CARTON (0517-2901-01) / .2 mL in 1 VIAL1 vial2025-08-19NoNoHistorical
0517-2901-100051729011010 VIAL in 1 CARTON (0517-2901-10) / .2 mL in 1 VIAL10 vial2025-08-19NoNoHistorical