Sold as Zinacef, Zinacef In Plastic Container, Cefuroxime And Dextrose In Duplex Container. Every FDA application for this active ingredient: 3 branded and 17 generic.
As of Nov 15, 2026, FDA lists 20 applications for Cefuroxime Sodium (sold as Zinacef, Zinacef In Plastic Container, Cefuroxime And Dextrose In Duplex Container), first approved Oct 19, 1983, with 0 new uses approved and 0 published complete response letters.
| Cefuroxime Sodium | Part D | $7K | +116% | 51 |
| Cefuroxime Sodium | Part B | $1K | +54% | 220 |
| Oct 19, 1983 | ZinacefNDA 50558 · New molecular entity | Pai Holdings Pharm | 53 | Discontinued |
| Jan 10, 1986 | Kefurox In Plastic ContainerANDA 62590 | Lilly | 5 | Discontinued |
| Jan 10, 1986 | KefuroxANDA 62591 | Acs Dobfar | 22 | Discontinued |
| Jan 10, 1986 | KefuroxANDA 62592 | Lilly | 18 | Discontinued |
| Apr 28, 1989 | Zinacef In Plastic ContainerNDA 50643 · New dosage form | Pai Holdings Pharm | 18 | Discontinued |
| Feb 26, 1993 | Cefuroxime SodiumANDA 64035 | Watson Labs Inc | 18 | Discontinued |
| Feb 26, 1993 | Cefuroxime SodiumANDA 64036 | Watson Labs Inc | 18 | Discontinued |
| May 30, 1997 | Cefuroxime SodiumANDA 64124 | Acs Dobfar Spa | 7 | Discontinued |
| May 30, 1997 | Cefuroxime SodiumANDA 64125 | Acs Dobfar Spa | 6 | Marketed |
| Apr 16, 1998 | Cefuroxime SodiumANDA 64191 | Teva Pharms | 1 | Discontinued |
| Apr 16, 1998 | Cefuroxime SodiumANDA 64192 | Teva Pharms | 1 | Discontinued |
| Sep 28, 1998 | Cefuroxime SodiumANDA 65002 | Fresenius Kabi USA | 6 | Discontinued |
| Feb 21, 2001 | Cefuroxime And Dextrose In Duplex ContainerNDA 50780 · New formulation or manufacturer | B Braun | 7 | Discontinued |
| May 30, 2001 | Cefuroxime SodiumANDA 65001 | Fresenius Kabi USA | 4 | Discontinued |
| Jan 9, 2004 | Cefuroxime SodiumANDA 65046 | Hikma | 5 | Discontinued |
| Jan 9, 2004 | Cefuroxime Sodium, CefuroximeANDA 65048 | Hikma | 5 | Marketed |
| Oct 15, 2008 | Cefuroxime SodiumANDA 65483 | Hospira Inc | 1 | Discontinued |
| Oct 15, 2008 | Cefuroxime SodiumANDA 65484 | Hospira Inc | 1 | Discontinued |
| Oct 15, 2008 | Cefuroxime SodiumANDA 65503 | Hospira Inc | 1 | Discontinued |
| Dec 30, 2009 | Cefuroxime Sodium In Plastic ContainerANDA 65251 | Samson Medcl | 0 | Discontinued |
Applications, approvals and products come from FDA's Drugs@FDA data files, refreshed weekly, grouped by active ingredient as FDA spells it. Complete response letters are FDA's published letters. Medicare spending is CMS's Part D and Part B dashboard, matched to this ingredient by generic name; shortages are FDA's shortage list, matched by application number; clinical trials are ClinicalTrials.gov studies naming the ingredient as an intervention, refreshed daily; safety programs are FDA's REMS list, matched by application number or, for shared programs, by ingredient. Drugs@FDA
Lilly
Fresenius Kabi USA
Hikma