72065-131 NDC - GVOKE PFS (GLUCAGON INJECTION, SOLUTION)

Drug Information

Product NDC: 72065-131

Proprietary Name: Gvoke PFS

Non Proprietary Name: glucagon injection, solution

Active Ingredient(s):
  • 1 mg/.2mL GLUCAGON


Administration Route(s): SUBCUTANEOUS

Dosage Form(s): INJECTION, SOLUTION

Pharmacy Class(es):
  • Antihypoglycemic Agent [EPC];
  • Gastrointestinal Motility Inhibitor [EPC];
  • Increased Gluconeogenesis [PE];
  • Increased Glycogenolysis [PE];
  • Decreased GI Smooth Muscle Tone [PE];
  • Decreased GI Motility [PE];
  • Decreased Glycolysis [PE]

Labeler Information

Labeler Name: Xeris Pharmaceuticals, Inc.
Product Type: HUMAN PRESCRIPTION DRUG
FDA Application Number: NDA212097
Marketing Category: NDA
Start Marketing Date:9/10/2019

Package Information

No. Package Code Package Description Billing Unit
172065-131-111 POUCH in 1 CARTON (72065-131-11) > 1 SYRINGE, PLASTIC in 1 POUCH > .2 mL in 1 SYRINGE, PLASTICML
272065-131-122 POUCH in 1 CARTON (72065-131-12) > 1 SYRINGE, PLASTIC in 1 POUCH > .2 mL in 1 SYRINGE, PLASTICML
372065-131-991 POUCH in 1 CARTON (72065-131-99) > 1 SYRINGE, PLASTIC in 1 POUCH > .2 mL in 1 SYRINGE, PLASTIC

NDC Record

Field Name Field Value Definition
PRODUCT NDC72065-131The labeler code and product code segments of the National Drug Code number, separated by a hyphen. Asterisks are no longer used or included within the product code segment to indicate certain configurations of the NDC.
PRODUCT TYPE NAMEHUMAN PRESCRIPTION DRUGIndicates the type of product, such as Human Prescription Drug or Human Over the Counter Drug. This data element matches the “Document Type” field of the Structured Product Listing.
PROPRIETARY NAMEGvoke PFSThe proprietary name also known as the trade name is the name of the product chosen by the medication labeler for marketing purposes.
PROPRIETARY NAME SUFFIX1 mg Pre-filled SyringeA suffix to the proprietary name, a value here should be appended to the ProprietaryName field to obtain the complete name of the product. This suffix is often used to distinguish characteristics of a product such as extended release (“XR”) or sleep aid (“PM”). Although many companies follow certain naming conventions for suffices, there is no recognized standard.
NON PROPRIETARY NAMEglucagon injection, solutionThe non-proprietary name is sometimes called the generic name. The generic name usually includes the active ingredient(s) of the product.
DOSAGE FORM NAMEINJECTION, SOLUTIONThe translation of the dosage form Code submitted by the firm.
ROUTE NAMESUBCUTANEOUSThe translation of the route code submitted by the firm, indicating route of administration.
START MARKETING DATE9/10/2019This is the date that the labeler indicates was the start of its marketing of the drug product.
MARKETING CATEGORY NAMENDAProduct types are broken down into several potential Marketing Categories, such as NDA/ANDA/BLA, OTC Monograph, or Unapproved Drug. One and only one Marketing Category may be chosen for a product, not all marketing categories are available to all product types. Currently, only final marketed product categories are included. The complete list of codes and translations can be found at www.fda.gov/edrls under Structured Product Labeling Resources.
APPLICATION NUMBERNDA212097This corresponds to the NDA, ANDA, or BLA number reported by the labeler for products which have the corresponding Marketing Category designated. If the designated Marketing Category is OTC Monograph Final or OTC Monograph Not Final, then the Application number will be the CFR citation corresponding to the appropriate Monograph (e.g. “part 341”). For unapproved drugs, this field will be null.
LABELER NAMEXeris Pharmaceuticals, Inc.Name of Company corresponding to the labeler code segment of the Product NDC.
SUBSTANCE NAMEGLUCAGONThis is the active ingredient list. Each ingredient name is the preferred term of the UNII code submitted.
ACTIVE NUMERATOR STRENGTH1 
ACTIVE INGRED UNITmg/.2mL 
PHARM CLASSESAntihypoglycemic Agent [EPC],Gastrointestinal Motility Inhibitor [EPC],Increased Gluconeogenesis [PE],Increased Glycogenolysis [PE],Decreased GI Smooth Muscle Tone [PE],Decreased GI Motility [PE],Decreased Glycolysis [PE] 

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This page was last updated on: 7/22/2020