FDA.reportPublic FDA data

Glucagon

Product NDC
63323-596
11-digit product format
633230596
Labeler code
63323
Product ID
63323-596_9e17207f-b348-4be8-8416-2f0aa1392390
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Glucagon
Dosage form
INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION
Route
INTRAMUSCULAR; INTRAVENOUS
Labeler
Fresenius Kabi USA, LLC
Application
NDA201849
Marketing category
NDA
Marketing start
2015-05-08
Substance
GLUCAGON HYDROCHLORIDE
Active strength
1 mg/mL
Pharmacologic classes
Antihypoglycemic Agent [EPC], Decreased GI Motility [PE], Decreased GI Smooth Muscle Tone [PE], Decreased Glycolysis [PE], Gastrointestinal Motility Inhibitor [EPC], Increased Gluconeogenesis [PE], 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
Glucagon
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
GLUCAGON HYDROCHLORIDE1 mg/mL

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
63323-596-11Glucagon1 mL in 1 VIAL, SINGLE-DOSEINJECTION, POWDER, LYOPHILIZED,17
63323-596-13Glucagon10 in 1 TRAYINJECTION, POWDER, LYOPHILIZED,107
63323-596-08Glucagon1 mL in 1 VIAL, SINGLE-DOSEINJECTION, POWDER, LYOPHILIZED,16
63323-596-16Glucagon10 in 1 TRAYINJECTION, POWDER, LYOPHILIZED,106

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
63323-596-08EA - Each63323-596fe2f13d2-b25a-41e9-8f9e-0bb3462b9d6812022-10-06
63323-596-11EA - Each63323-596037fd4b8-d779-4b81-9b86-3e6be92e457812023-03-13
63323-596-13EA - Each63323-596eb692baf-7a37-49d4-83dc-af1f928cbe4d12015-06-09
63323-596-16EA - Each63323-5965cb3c2fe-c644-4772-975f-ef574abc9f1e12015-12-02

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
GLUCAGON HYDROCHLORIDEACTIVE INGREDIENT1H87NVF4DBGLUCAGON INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [FRESENIUS KABI USA, LLC]1
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
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
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
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
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
63323-596GLUCAGON INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION GLUCAGON KIT [FRESENIUS KABI USA, LLC]7Current NDC, Legacy NDC, 2 package rows20211118_e4be1c0e-0fe6-45a0-9229-5cde98434b84.zip
63323-596GLUCAGON 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 InjectionPSNe4be1c0e-0fe6-45a0-9229-5cde98434b847
310497glucagon (rDNA) 1 MG InjectionSCDe4be1c0e-0fe6-45a0-9229-5cde98434b847
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
63323-596-08633230596081 mL in 1 VIAL, SINGLE-DOSE1 mlHistorical
63323-596-11633230596111 mL in 1 VIAL, SINGLE-DOSE1 mlHistorical
63323-596-136332305961310 VIAL, SINGLE-DOSE in 1 TRAY (63323-596-13) / 1 mL in 1 VIAL, SINGLE-DOSE (63323-596-11) 2015-05-080000-00-00NoNoCurrent
63323-596-166332305961610 VIAL, SINGLE-DOSE in 1 TRAY (63323-596-16) / 1 mL in 1 VIAL, SINGLE-DOSE (63323-596-08) 2015-05-080000-00-00NoNoCurrent