NDC 63323-596

Glucagon

Glucagon

Glucagon is a Intramuscular; Intravenous Injection, Powder, Lyophilized, For Solution in the Human Prescription Drug category. It is labeled and distributed by Fresenius Kabi Usa, Llc. The primary component is Glucagon Hydrochloride.

Product ID63323-596_3048a2b1-b1d6-426d-9946-60c2d12bb710
NDC63323-596
Product TypeHuman Prescription Drug
Proprietary NameGlucagon
Generic NameGlucagon
Dosage FormInjection, Powder, Lyophilized, For Solution
Route of AdministrationINTRAMUSCULAR; INTRAVENOUS
Marketing Start Date2015-05-08
Marketing CategoryNDA / NDA
Application NumberNDA201849
Labeler NameFresenius Kabi USA, LLC
Substance NameGLUCAGON HYDROCHLORIDE
Active Ingredient Strength1 mg/mL
Pharm ClassesAntihypoglycemic Agent [EPC],Gastrointestinal Motility Inhibitor [EPC],Increased Gluconeogenesis [PE],Increased Glycogenolysis [PE],Decreased GI Smooth Muscle Tone [PE],Decreased GI Motility [PE],Decreased Glycolysis [PE]
NDC Exclude FlagN
Listing Certified Through2021-12-31

Packaging

NDC 63323-596-13

10 VIAL, SINGLE-DOSE in 1 TRAY (63323-596-13) > 1 mL in 1 VIAL, SINGLE-DOSE (63323-596-11)
Marketing Start Date2015-05-08
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 63323-596-13 [63323059613]

Glucagon INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION
Marketing CategoryNDA
Application NumberNDA201849
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2015-05-08

NDC 63323-596-16 [63323059616]

Glucagon INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION
Marketing CategoryNDA
Application NumberNDA201849
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2015-05-08

NDC 63323-596-11 [63323059611]

Glucagon INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION
Marketing CategoryNDA
Application NumberNDA201849
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2020-01-24

NDC 63323-596-08 [63323059608]

Glucagon INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION
Marketing CategoryNDA
Application NumberNDA201849
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2019-05-24

Drug Details

Active Ingredients

IngredientStrength
GLUCAGON HYDROCHLORIDE1 mg/mL

OpenFDA Data

SPL SET ID:8c8acad6-44cc-43aa-966b-027e053be8f5
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 310497
  • Pharmacological Class

    • Antihypoglycemic Agent [EPC]
    • Gastrointestinal Motility Inhibitor [EPC]
    • Increased Gluconeogenesis [PE]
    • Increased Glycogenolysis [PE]
    • Decreased GI Smooth Muscle Tone [PE]
    • Decreased GI Motility [PE]
    • Decreased Glycolysis [PE]

    NDC Crossover Matching brand name "Glucagon" or generic name "Glucagon"

    NDCBrand NameGeneric Name
    0002-8031Glucagonglucagon
    0548-5850GlucagonGlucagon
    43742-0252GlucagonGlucagon
    43742-0734GlucagonGlucagon
    50090-0639Glucagonglucagon
    51662-1498GLUCAGONGLUCAGON
    63083-1555GlucagonGlucagon
    63323-582GlucagonGlucagon
    63323-593GlucagonGlucagon
    63323-594GlucagonGlucagon
    63323-596GlucagonGlucagon
    64725-8031Glucagonglucagon
    0002-6145Baqsimiglucagon

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