Zegalogue

Generic: dasiglucagon

Labeler: Zealand Pharma US, Inc
NDC Directory HUMAN PRESCRIPTION DRUG NDA Active

Drug Facts

Product Profile

Brand Name Zegalogue
Generic Name dasiglucagon
Labeler Zealand Pharma US, Inc
Dosage Form INJECTION, SOLUTION
Routes
SUBCUTANEOUS
Active Ingredients

DASIGLUCAGON .6 mg/.6mL

Identifiers & Regulatory

Product NDC 80644-0013
Product ID 80644-0013_45c0e8f1-4639-dbc8-e063-6394a90a7cd9
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category NDA
Application Number NDA214231
Listing Expiration 2026-12-31
Marketing Start 2021-04-05

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 806440013
Hyphenated Format 80644-0013

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 Zegalogue (source: ndc)
Generic Name dasiglucagon (source: ndc)
Application Number NDA214231 (source: ndc)
Routes
SUBCUTANEOUS
source: ndc

Resolved Composition

Strengths
  • .6 mg/.6mL
source: ndc
Packaging
  • 1 CONTAINER in 1 PACKAGE (80644-0013-1) / 1 SYRINGE, GLASS in 1 CONTAINER / .6 mL in 1 SYRINGE, GLASS
  • 2 PACKAGE in 1 CARTON (80644-0013-2) / 1 CONTAINER in 1 PACKAGE / 1 SYRINGE, GLASS in 1 CONTAINER / .6 mL in 1 SYRINGE, GLASS
source: ndc

Packages (2)

80644-0013-1 1 CONTAINER in 1 PACKAGE (80644-0013-1) / 1 SYRINGE, GLASS in 1 CONTAINER / .6 mL in 1 SYRINGE, GLASS 80644-0013-2 2 PACKAGE in 1 CARTON (80644-0013-2) / 1 CONTAINER in 1 PACKAGE / 1 SYRINGE, GLASS in 1 CONTAINER / .6 mL in 1 SYRINGE, GLASS

Ingredients (1)

DASIGLUCAGON (.6 mg/.6mL)

Linked Drug Pages (1)

Zegalogue ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["SUBCUTANEOUS"], "spl_id": "45c0e8f1-4639-dbc8-e063-6394a90a7cd9", "openfda": {"nui": ["N0000190852", "N0000193923", "N0000009345"], "unii": ["AD4J2O47FQ"], "rxcui": ["2535238", "2535243", "2535247", "2535249"], "spl_set_id": ["c6c32b47-c47c-4a7f-8d4d-23578f663217"], "pharm_class_pe": ["Increased Glycogenolysis [PE]"], "pharm_class_epc": ["Antihypoglycemic Agent [EPC]"], "pharm_class_moa": ["Glucagon Receptor Agonists [MoA]"], "manufacturer_name": ["Zealand Pharma US, Inc"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 CONTAINER in 1 PACKAGE (80644-0013-1)  / 1 SYRINGE, GLASS in 1 CONTAINER / .6 mL in 1 SYRINGE, GLASS", "package_ndc": "80644-0013-1", "marketing_start_date": "20210405"}, {"sample": false, "description": "2 PACKAGE in 1 CARTON (80644-0013-2)  / 1 CONTAINER in 1 PACKAGE / 1 SYRINGE, GLASS in 1 CONTAINER / .6 mL in 1 SYRINGE, GLASS", "package_ndc": "80644-0013-2", "marketing_start_date": "20210405"}], "brand_name": "Zegalogue", "product_id": "80644-0013_45c0e8f1-4639-dbc8-e063-6394a90a7cd9", "dosage_form": "INJECTION, SOLUTION", "pharm_class": ["Antihypoglycemic Agent [EPC]", "Glucagon Receptor Agonists [MoA]", "Increased Glycogenolysis [PE]"], "product_ndc": "80644-0013", "generic_name": "dasiglucagon", "labeler_name": "Zealand Pharma US, Inc", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Zegalogue", "active_ingredients": [{"name": "DASIGLUCAGON", "strength": ".6 mg/.6mL"}], "application_number": "NDA214231", "marketing_category": "NDA", "marketing_start_date": "20210405", "listing_expiration_date": "20261231"}