gvoke hypopen 0.5 mg auto-injector

Generic: glucagon injection, solution

Labeler: xeris pharmaceuticals, inc.
NDC Directory HUMAN PRESCRIPTION DRUG NDA Inactive Finished

Drug Facts

Product Profile

Brand Name gvoke hypopen 0.5 mg auto-injector
Generic Name glucagon injection, solution
Labeler xeris pharmaceuticals, inc.
Dosage Form INJECTION, SOLUTION
Routes
SUBCUTANEOUS
Active Ingredients

glucagon .5 mg/.1mL

Manufacturer
Xeris Pharmaceuticals, Inc.

Identifiers & Regulatory

Product NDC 72065-120
Product ID 72065-120_0b8d0863-8a2a-4a46-9f96-a759f3858bed
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category NDA
Application Number NDA212097
Listing Expiration 2027-12-31
Marketing Start 2019-09-10

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 72065120
Hyphenated Format 72065-120

Supplemental Identifiers

RxCUI
2199299 2199304 2199307 2199308 2199310 2199312 2199315 2199316 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 hypopen 0.5 mg auto-injector (source: ndc)
Generic Name glucagon injection, solution (source: ndc)
Application Number NDA212097 (source: ndc)
Routes
SUBCUTANEOUS
source: ndc

Resolved Composition

Strengths
  • .5 mg/.1mL
source: ndc
Packaging
  • 1 POUCH in 1 CARTON (72065-120-11) / 1 SYRINGE, PLASTIC in 1 POUCH / .1 mL in 1 SYRINGE, PLASTIC
  • 2 POUCH in 1 CARTON (72065-120-12) / 1 SYRINGE, PLASTIC in 1 POUCH / .1 mL in 1 SYRINGE, PLASTIC
source: ndc

Packages (2)

72065-120-11 1 POUCH in 1 CARTON (72065-120-11) / 1 SYRINGE, PLASTIC in 1 POUCH / .1 mL in 1 SYRINGE, PLASTIC 72065-120-12 2 POUCH in 1 CARTON (72065-120-12) / 1 SYRINGE, PLASTIC in 1 POUCH / .1 mL in 1 SYRINGE, PLASTIC

Ingredients (1)

glucagon (.5 mg/.1mL)

Linked Drug Pages (1)

Gvoke HypoPen 0.5 mg Auto-Injector, Gvoke HypoPen 1 mg Auto-Injector, Gvoke PFS 1 mg Pre-filled Syringe, Gvoke Kit ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["SUBCUTANEOUS"], "spl_id": "0b8d0863-8a2a-4a46-9f96-a759f3858bed", "openfda": {"nui": ["N0000190852", "N0000190853", "N0000009340", "N0000009345", "N0000008636", "N0000008635", "N0000008652"], "unii": ["76LA80IG2G"], "rxcui": ["2199299", "2199304", "2199307", "2199308", "2199310", "2199312", "2199315", "2199316", "2587358", "2587361"], "spl_set_id": ["92385737-dbad-98c5-e053-2995a90a2805"], "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": ["Xeris Pharmaceuticals, Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 POUCH in 1 CARTON (72065-120-11)  / 1 SYRINGE, PLASTIC in 1 POUCH / .1 mL in 1 SYRINGE, PLASTIC", "package_ndc": "72065-120-11", "marketing_start_date": "20190910"}, {"sample": false, "description": "2 POUCH in 1 CARTON (72065-120-12)  / 1 SYRINGE, PLASTIC in 1 POUCH / .1 mL in 1 SYRINGE, PLASTIC", "package_ndc": "72065-120-12", "marketing_start_date": "20190910"}], "brand_name": "Gvoke HypoPen 0.5 mg Auto-Injector", "product_id": "72065-120_0b8d0863-8a2a-4a46-9f96-a759f3858bed", "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": "72065-120", "generic_name": "glucagon injection, solution", "labeler_name": "Xeris Pharmaceuticals, Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Gvoke HypoPen", "brand_name_suffix": "0.5 mg Auto-Injector", "active_ingredients": [{"name": "GLUCAGON", "strength": ".5 mg/.1mL"}], "application_number": "NDA212097", "marketing_category": "NDA", "marketing_start_date": "20190910", "listing_expiration_date": "20271231"}