Zegalogue

Product NDC
80644-0013
11-digit product format
806440013
Labeler code
80644
Product ID
80644-0013_ed6f6c3a-a8ea-7c74-e053-2a95a90a232b
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
dasiglucagon
Dosage form
INJECTION, SOLUTION
Route
SUBCUTANEOUS
Labeler
Zealand Pharma US, Inc
Application
NDA214231
Marketing category
NDA
Marketing start
2021-04-05
Marketing end
0000-00-00
Substance
DASIGLUCAGON
Active strength
1 mg/.6mL
Pharmacologic classes
Antihypoglycemic Agent [EPC], Glucagon Receptor Agonists [MoA], Increased Glycogenolysis [PE]
NDC exclude flag
No
Listing certified through
2023-12-31
Current FDA listing
Historical FDA.report record

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
80644-0013-1ML - Milliliter80644-0013531bc32e-9d73-4644-bdba-a27dc6750eeb12021-05-05
80644-0013-2ML - Milliliter80644-00136bce9cd4-eb28-4555-b206-94f27cd2bbe012021-05-05

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
80644-0013ZEGALOGUE (DASIGLUCAGON) INJECTION, SOLUTION [ZEALAND PHARMA US, INC]9Legacy NDC20250101_c6c32b47-c47c-4a7f-8d4d-23578f663217.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
80644-0013-1806440013011 CONTAINER in 1 PACKAGE (80644-0013-1) > 1 SYRINGE, GLASS in 1 CONTAINER > .6 mL in 1 SYRINGE, GLASS1 container2021-04-050000-00-00NoNoCurrent
80644-0013-2806440013022 PACKAGE in 1 CARTON (80644-0013-2) > 1 CONTAINER in 1 PACKAGE > 1 SYRINGE, GLASS in 1 CONTAINER > .6 mL in 1 SYRINGE, GLASS2 package2021-04-050000-00-00NoNoCurrent