gvoke vialdx

Generic: glucagon injection

Labeler: american regent, inc.
NDC Directory HUMAN PRESCRIPTION DRUG NDA Inactive Finished

Drug Facts

Product Profile

Brand Name gvoke vialdx
Generic Name glucagon injection
Labeler american regent, inc.
Dosage Form INJECTION, SOLUTION
Routes
INTRAVENOUS
Active Ingredients

glucagon 1 mg/.2mL

Manufacturer
American Regent, Inc.

Identifiers & Regulatory

Product NDC 0517-2901
Product ID 0517-2901_394a5780-8ead-4c26-890c-37edfb879599
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category NDA
Application Number NDA212097
Listing Expiration 2026-12-31
Marketing Start 2025-08-19

Pharmacologic Class

Established (EPC)
antihypoglycemic agent [epc] gastrointestinal motility inhibitor [epc]
Physiologic Effect
increased gluconeogenesis [pe] increased glycogenolysis [pe] decreased gi smooth muscle tone [pe] decreased gi motility [pe] decreased glycolysis [pe]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 05172901
Hyphenated Format 0517-2901

Supplemental Identifiers

RxCUI
2587358 2587361
UNII
76LA80IG2G
NUI
N0000190852 N0000190853 N0000009340 N0000009345 N0000008636 N0000008635 N0000008652

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 gvoke vialdx (source: ndc)
Generic Name glucagon injection (source: ndc)
Application Number NDA212097 (source: ndc)
Routes
INTRAVENOUS
source: ndc

Resolved Composition

Strengths
  • 1 mg/.2mL
source: ndc
Packaging
  • 1 VIAL in 1 CARTON (0517-2901-01) / .2 mL in 1 VIAL
  • 10 VIAL in 1 CARTON (0517-2901-10) / .2 mL in 1 VIAL
source: ndc

Packages (2)

0517-2901-01 1 VIAL in 1 CARTON (0517-2901-01) / .2 mL in 1 VIAL 0517-2901-10 10 VIAL in 1 CARTON (0517-2901-10) / .2 mL in 1 VIAL

Ingredients (1)

glucagon (1 mg/.2mL)

Linked Drug Pages (1)

Gvoke VialDx ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["INTRAVENOUS"], "spl_id": "394a5780-8ead-4c26-890c-37edfb879599", "openfda": {"nui": ["N0000190852", "N0000190853", "N0000009340", "N0000009345", "N0000008636", "N0000008635", "N0000008652"], "unii": ["76LA80IG2G"], "rxcui": ["2587358", "2587361"], "spl_set_id": ["359982a8-ec5c-4927-8c0f-89771e0f942b"], "pharm_class_pe": ["Increased Gluconeogenesis [PE]", "Increased Glycogenolysis [PE]", "Decreased GI Smooth Muscle Tone [PE]", "Decreased GI Motility [PE]", "Decreased Glycolysis [PE]"], "pharm_class_epc": ["Antihypoglycemic Agent [EPC]", "Gastrointestinal Motility Inhibitor [EPC]"], "manufacturer_name": ["American Regent, Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 VIAL in 1 CARTON (0517-2901-01)  / .2 mL in 1 VIAL", "package_ndc": "0517-2901-01", "marketing_start_date": "20250819"}, {"sample": false, "description": "10 VIAL in 1 CARTON (0517-2901-10)  / .2 mL in 1 VIAL", "package_ndc": "0517-2901-10", "marketing_start_date": "20250819"}], "brand_name": "Gvoke VialDx", "product_id": "0517-2901_394a5780-8ead-4c26-890c-37edfb879599", "dosage_form": "INJECTION, SOLUTION", "pharm_class": ["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]"], "product_ndc": "0517-2901", "generic_name": "glucagon injection", "labeler_name": "American Regent, Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Gvoke VialDx", "active_ingredients": [{"name": "GLUCAGON", "strength": "1 mg/.2mL"}], "application_number": "NDA212097", "marketing_category": "NDA", "marketing_start_date": "20250819", "listing_expiration_date": "20261231"}