FDA.reportPublic FDA data

Glucagon

Product NDC
63323-593
11-digit product format
633230593
Labeler code
63323
Product ID
63323-593_eb37fc8a-a264-4ce9-a130-466e9b5f3a38
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Glucagon
Dosage form
KIT
Labeler
Fresenius Kabi USA, LLC
Application
NDA201849
Marketing category
NDA
Marketing start
2015-05-08
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 1mL7
63323-593-03Glucagon1 in 1 CARTONKIT17

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
63323-593-03EA - Each63323-59391035f6c-0468-45a6-bd86-945a848d3ddf12016-03-04

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
63323-593GLUCAGON INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION GLUCAGON KIT [FRESENIUS KABI USA, LLC]7Current NDC, Legacy NDC, 2 package rows20211118_e4be1c0e-0fe6-45a0-9229-5cde98434b84.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
310497glucagon (rDNA) 1 MG InjectionPSNe4be1c0e-0fe6-45a0-9229-5cde98434b847
310497glucagon (rDNA) 1 MG InjectionSCDe4be1c0e-0fe6-45a0-9229-5cde98434b847

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
63323-593-03633230593031 KIT in 1 CARTON (63323-593-03) * 1 mL in 1 VIAL, SINGLE-DOSE (63323-596-03) * 1 mL in 1 VIAL, SINGLE-DOSE (63323-185-03) 1 kit2015-05-080000-00-00NoNoCurrent