FDA.reportPublic FDA data

Glucagon

Product NDC
63323-594
11-digit product format
633230594
Labeler code
63323
Product ID
63323-594_9e17207f-b348-4be8-8416-2f0aa1392390
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Glucagon
Dosage form
KIT
Labeler
Fresenius Kabi USA, LLC
Application
NDA201849
Marketing category
NDA
Marketing start
2015-12-01
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

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

Harmonized Identifiers#

Field, Values table
FieldValues
Unii1H87NVF4DB
Rxcui310497

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
83f7a8cc-8fbf-4478-9a44-b6214b840d9aProduct name220250812
1e832aa0-608b-424f-9ced-615cef2ff5c5Product name120200220
6ee0758f-9a1a-41ee-90c4-3adce06b52b4Product name120191120
750a4794-c0e1-4ac9-9af5-006ecec3bb04Product name120150608

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
63323-185-03Glucagon1 mL in 1 VIAL, SINGLE-DOSEINJECTION1 mL1 mL in 1mL6
63323-594-03Glucagon1 in 1 CARTONKIT16

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
63323-594-03EA - Each63323-59443024a7b-3a59-4e5b-b0cd-0c84bbb0cf4012016-06-14

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
GLUCAGON HYDROCHLORIDEACTIVE INGREDIENT1H87NVF4DBGLUCAGON INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [FRESENIUS KABI USA, LLC]1
GLUCAGONACTIVE MOIETY76LA80IG2GGLUCAGON INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [FRESENIUS KABI USA, LLC]1
HYDROCHLORIC ACIDINACTIVE INGREDIENTQTT17582CBGLUCAGON INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [FRESENIUS KABI USA, LLC]1
LACTOSE MONOHYDRATEINACTIVE INGREDIENTEWQ57Q8I5XGLUCAGON INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [FRESENIUS KABI USA, LLC]1
SODIUM HYDROXIDEINACTIVE INGREDIENT55X04QC32IGLUCAGON INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [FRESENIUS KABI USA, LLC]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
63323-594GLUCAGON INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION GLUCAGON KIT [FRESENIUS KABI USA, LLC]6Current NDC, Legacy NDC, 2 package rows20220420_8c8acad6-44cc-43aa-966b-027e053be8f5.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
310497glucagon (rDNA) 1 MG InjectionPSN8c8acad6-44cc-43aa-966b-027e053be8f56
310497glucagon (rDNA) 1 MG InjectionSCD8c8acad6-44cc-43aa-966b-027e053be8f56

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
63323-185-03633230185031 mL in 1 VIAL, SINGLE-DOSE1 mlHistorical
63323-594-03633230594031 KIT in 1 CARTON (63323-594-03) * 1 mL in 1 VIAL, SINGLE-DOSE (63323-596-06) * 1 mL in 1 VIAL, SINGLE-DOSE (63323-185-03) 1 kit2015-12-010000-00-00NoNoCurrent