NDC 0597-0053

GlucaGen

Glucagon Hydrochloride

GlucaGen is a Intramuscular; Intravenous; Subcutaneous Injection, Powder, For Solution in the Human Prescription Drug category. It is labeled and distributed by Boehringer Ingelheim Pharmaceuticals, Inc.. The primary component is Glucagon Hydrochloride.

• Product ID: 0597-0053_0ff3a5b5-37eb-4bc4-a423-a218a0dbd8a2
• NDC: 0597-0053
• Product Type: Human Prescription Drug
• Proprietary Name: GlucaGen
• Generic Name: Glucagon Hydrochloride
• Dosage Form: Injection, Powder, For Solution
• Route of Administration: INTRAMUSCULAR; INTRAVENOUS; SUBCUTANEOUS
• Marketing Start Date: 2005-06-22
• Marketing Category: NDA / NDA
• Application Number: NDA020918
• Labeler Name: Boehringer Ingelheim Pharmaceuticals, Inc.
• Substance Name: GLUCAGON HYDROCHLORIDE
• Active Ingredient Strength: 1 mg/mL
• Pharm Classes: 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 Exclude Flag: N
• Listing Certified Through: 2021-12-31

Packaging

NDC 0597-0053-45

10 VIAL in 1 CARTON (0597-0053-45) > 1 mL in 1 VIAL

• Marketing Start Date: 2005-06-22
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 0597-0053-45 [00597005345]

GlucaGen INJECTION, POWDER, FOR SOLUTION

• Marketing Category: NDA
• Application Number: NDA020918
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: EA
• Marketing Start Date: 2005-06-22

Drug Details

Active Ingredients

Ingredient	Strength
GLUCAGON HYDROCHLORIDE	1 mg/mL

OpenFDA Data

• SPL SET ID: ff16e4b1-3668-4cb4-91a4-77ee509cd6f6
• Manufacturer:
  • Boehringer Ingelheim Pharmaceuticals, Inc.
• UNII:
  • 1H87NVF4DB
• RxNorm Concept Unique ID - RxCUI:
  • 153095
  • 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]
• 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 "GlucaGen" or generic name "Glucagon Hydrochloride"

NDC	Brand Name	Generic Name
0597-0053	GlucaGen	glucagon hydrochloride
0597-0260	GlucaGen	glucagon hydrochloride
0169-7065	GlucaGen HypoKit	glucagon hydrochloride