Zegalogue

Product NDC
0169-1913
11-digit product format
001691913
Labeler code
0169
Product ID
0169-1913_48d68219-2ba1-426f-a5a0-0cc35e69ff19
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
dasiglucagon
Dosage form
INJECTION, SOLUTION
Route
SUBCUTANEOUS
Labeler
Novo Nordisk
Application
NDA214231
Marketing category
NDA
Marketing start
2023-06-26
Substance
DASIGLUCAGON
Active strength
.6 mg/.6mL
Pharmacologic classes
Antihypoglycemic Agent [EPC], Glucagon Receptor Agonists [MoA], Increased Glycogenolysis [PE]
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Zegalogue
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
DASIGLUCAGON.6 mg/.6mL

Harmonized Identifiers#

Field, Values table
FieldValues
UniiAD4J2O47FQ
Rxcui2535238, 2535243, 2535247, 2535249

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
77dc03a4-fbfc-e6a3-fe95-285bbae40d75Product name220250814
362d7abb-94e6-4c60-9a58-266894157713Product name120231023
6bd95106-a412-1dad-b9cc-4cb74bfb27ceProduct name220230315
f1e0dc7e-7d61-4625-b6d9-4894927679d7Product name220211025
e737036e-16df-4168-8e18-c64b8deb5312Product name120210916
e4870509-7e28-6f92-f0be-dd3dd889a9cfProduct name520200810
6e9d4a47-c464-b93e-aebc-ad7bffc9c4cdProduct name220190619
444b3e50-f226-46ef-bfca-2e7035d140cdProduct name120190611
816b97af-edc5-4060-aff1-b814bdbcad50Product name120190415
7cda52fc-125f-421c-8fea-bc1974370c49Product name220180703
419aab54-5d5a-4146-9453-026d4a9991beProduct name220170525
d5e51f11-ad28-caa4-4b49-4143974782adProduct name120150831
290f523a-f9db-9774-b5a9-e1f908ac1782Product name120150828
89dac932-b90a-4410-9ab1-84c53e57de25Product name120150316
5668b646-cd56-c3c7-bdea-3f6b1a8840dbProduct name120140508
684ea482-2e8b-14af-5664-b98f1e402036Product name120140508
810ab97e-f109-f41c-7c83-6a652a9cbf43Product name120140508
87711080-88eb-65c5-b2dd-bf99e700a372Product name120140508
8dbefedf-0a0d-a224-5a3c-66dc9e11c2ddProduct name120140508
b060cc1a-fe47-856b-0b77-4448b5963de8Product name120140508
c6b65c52-69c7-df49-550a-a50c137f6218Product name120140508
ec2149b3-5c6d-5344-f757-c86411073075Product name120140508
ed912195-5da0-0f2f-6f4b-3ef17710cbe3Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0169-1913-01Zegalogue1 in 1 PACKAGEINJECTION, SOLUTION12
0169-1913-01Zegalogue1 in 1 CONTAINERINJECTION, SOLUTION12
0169-1913-02Zegalogue2 in 1 CARTONINJECTION, SOLUTION22
0169-1913-12Zegalogue1 in 1 CONTAINERINJECTION, SOLUTION12
0169-1913-12Zegalogue1 in 1 PACKAGEINJECTION, SOLUTION12

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0169-1913-01ML - Milliliter0169-191335f19109-7cf5-4b48-9721-1fc429c7077c12023-06-06
0169-1913-02ML - Milliliter0169-19134fdc35a6-19dd-4fb2-843e-b747bd056fb112023-06-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0169-1913ZEGALOGUE (DASIGLUCAGON) INJECTION, SOLUTION [NOVO NORDISK]2Current NDC, 5 package rows20230626_14704879-872c-4967-8779-04a3bbdfb4e6.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
2535247dasiglucagon 0.6 MG in 0.6 mL Auto-InjectorPSN14704879-872c-4967-8779-04a3bbdfb4e62
2535238dasiglucagon 0.6 MG in 0.6 mL Prefilled SyringePSN14704879-872c-4967-8779-04a3bbdfb4e62
2535249ZEGALOGUE 0.6 MG in 0.6 mL Auto-InjectorPSN14704879-872c-4967-8779-04a3bbdfb4e62
2535243ZEGALOGUE 0.6 MG in 0.6 mL Prefilled SyringePSN14704879-872c-4967-8779-04a3bbdfb4e62
25352490.6 ML dasiglucagon 1 MG/ML Auto-Injector [Zegalogue]SBD14704879-872c-4967-8779-04a3bbdfb4e62
25352430.6 ML dasiglucagon 1 MG/ML Prefilled Syringe [Zegalogue]SBD14704879-872c-4967-8779-04a3bbdfb4e62
25352470.6 ML dasiglucagon 1 MG/ML Auto-InjectorSCD14704879-872c-4967-8779-04a3bbdfb4e62
25352380.6 ML dasiglucagon 1 MG/ML Prefilled SyringeSCD14704879-872c-4967-8779-04a3bbdfb4e62
2535247dasiglucagon (as dasiglucagon hydrochloride) 0.6 MG per 0.6 ML Auto-InjectorSY14704879-872c-4967-8779-04a3bbdfb4e62
2535238dasiglucagon (as dasiglucagon hydrochloride) 1 MG/ML per 0.6 ML Prefilled SyringeSY14704879-872c-4967-8779-04a3bbdfb4e62
2535247dasiglucagon 0.6 MG per 0.6 ML Auto-InjectorSY14704879-872c-4967-8779-04a3bbdfb4e62
2535238dasiglucagon 0.6 MG per 0.6 ML Prefilled SyringeSY14704879-872c-4967-8779-04a3bbdfb4e62
2535249Zegalogue 0.6 MG per 0.6 ML Auto-InjectorSY14704879-872c-4967-8779-04a3bbdfb4e62
2535243Zegalogue 0.6 MG per 0.6 ML Prefilled SyringeSY14704879-872c-4967-8779-04a3bbdfb4e62
2535249Zegalogue 1 MG/ML per 0.6 ML Auto-InjectorSY14704879-872c-4967-8779-04a3bbdfb4e62
2535243Zegalogue 1 MG/ML per 0.6 ML Prefilled SyringeSY14704879-872c-4967-8779-04a3bbdfb4e62

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
0169-1913-01001691913011 CONTAINER in 1 PACKAGE (0169-1913-01) / 1 SYRINGE, GLASS in 1 CONTAINER / .6 mL in 1 SYRINGE, GLASS1 container2023-06-26NoNoHistorical
0169-1913-02001691913022 PACKAGE in 1 CARTON (0169-1913-02) / 1 CONTAINER in 1 PACKAGE (0169-1913-12) / 1 SYRINGE, GLASS in 1 CONTAINER / .6 mL in 1 SYRINGE, GLASS2 package2023-06-26NoNoHistorical
0169-1913-12001691913121 in 1 CONTAINERHistorical