Last Updated: September 24, 2026

Details for New Drug Application (NDA): 209218

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NDA 209218 describes CEFTRIAXONE, which is a drug marketed by Acs Dobfar, Agila Speclts, Apotex, Aurobindo Pharma Ltd, Bedford, Facta Farma, Fresenius Kabi Usa, Hospira Inc, Lupin, Qilu Antibiotics, Samson Medcl, Sandoz, Sandoz Inc, Teva, Astral, Cephazone Pharma, Deva Holding As, Epic Pharma Llc, Hikma Farmaceutica, Teva Pharms Usa, Wockhardt Bio Ag, B Braun, Baxter Hlthcare, Anda Repository, and Hikma, and is included in thirty-seven NDAs. It is available from fifteen suppliers. Additional details are available on the CEFTRIAXONE profile page.

The generic ingredient in CEFTRIAXONE is ceftriaxone sodium. There is one drug master file entry for this compound. Seventeen suppliers are listed for this compound. Additional details are available on the ceftriaxone sodium profile page.

Summary for 209218

Tradename:	CEFTRIAXONE
Applicant:	Qilu Antibiotics
Ingredient:	ceftriaxone sodium
Patents:	0

Pharmacology for NDA: 209218

Medical Subject Heading (MeSH) Categories for 209218

Anti-Bacterial Agents

Suppliers and Packaging for NDA: 209218

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
CEFTRIAXONE	ceftriaxone sodium	INJECTABLE;INJECTION	209218	ANDA	Apotex Corp.	60505-6150	60505-6150-5	1 VIAL, PHARMACY BULK PACKAGE in 1 CARTON (60505-6150-5) / 1 INJECTION, POWDER, FOR SOLUTION in 1 VIAL, PHARMACY BULK PACKAGE

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	INJECTABLE;INJECTION			Strength	EQ 10GM BASE/VIAL
Approval Date:	Oct 17, 2018	TE:	AP	RLD:	No

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