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Last Updated: December 12, 2025

Details for New Drug Application (NDA): 218813

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NDA 218813 describes GLUCAGON, which is a drug marketed by Amphastar Pharms Inc, Cipla, Lilly, Lupin Ltd, Mylan Labs Ltd, and Fresenius Kabi Usa, and is included in seven NDAs. It is available from eight suppliers. Additional details are available on the GLUCAGON profile page.

The generic ingredient in GLUCAGON is glucagon hydrochloride. There are twelve drug master file entries for this compound. Two suppliers are listed for this compound. Additional details are available on the glucagon hydrochloride profile page.

Summary for 218813

Tradename:	GLUCAGON
Applicant:	Cipla
Ingredient:	glucagon
Patents:	0

Medical Subject Heading (MeSH) Categories for 218813

Gastrointestinal Agents
Hormones

Suppliers and Packaging for NDA: 218813

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
GLUCAGON	glucagon	INJECTABLE;INJECTION	218813	ANDA	Cipla USA Inc.	69097-027	69097-027-50	1 KIT in 1 CARTON (69097-027-50) * 1 mL in 1 VIAL, GLASS (69097-028-32) * 1 mL in 1 SYRINGE, GLASS (69097-029-31)

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	INJECTABLE;INJECTION			Strength	1MG/VIAL
Approval Date:	Sep 15, 2025	TE:	AP	RLD:	No
Regulatory Exclusivity Expiration:	Apr 18, 2026
Regulatory Exclusivity Use:	COMPETITIVE GENERIC THERAPY

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