Orange Book product · Brand (NDA)
ZINACEF
CEFUROXIME SODIUM
At a glance
Oct 23, 1986
Approved
Brand (NDA)
Application
Not listed
TE code
None
Listed patents
Key dates
Approval
FDA approval date of this drug product.
Oct 23, 1986
40 yr 3 mo ago
Today
Pharmaceutical detail
Active ingredient
CEFUROXIME SODIUM
Strength
EQ 7.5GM BASE/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Dosage form
INJECTABLE
Route
INJECTION
TE code
Not listed
Application
NDA 050558
Product number
004
Marketing status
DISCN
Reference listed drug (RLD)
Yes
Reference standard (RS)
No
Active-ingredient family
View full familyThis is a reference-listed drug (RLD) — the basis for generic (ANDA) applications. Other products sharing this ingredient are listed below.
- 2001CEFUROXIME AND DEXTROSE IN DUPLEX CONTAINERBrand (NDA)
NDA 050780 · B BRAUN
- 1989ZINACEF IN PLASTIC CONTAINERBrand (NDA)
NDA 050643 · PAI HOLDINGS PHARM
- 2009CEFUROXIME SODIUM IN PLASTIC CONTAINERGeneric (ANDA)
ANDA 065251 · SAMSON MEDCL
- 2008CEFUROXIME SODIUMGeneric (ANDA)
ANDA 065483 · HOSPIRA INC
- 2008CEFUROXIME SODIUMGeneric (ANDA)
ANDA 065503 · HOSPIRA INC
- 2008CEFUROXIME SODIUMGeneric (ANDA)
ANDA 065484 · HOSPIRA INC
- 2004CEFUROXIME SODIUMGeneric (ANDA)
ANDA 065048 · HIKMA
- 2004CEFUROXIME SODIUMGeneric (ANDA)
ANDA 065046 · HIKMA
- 2001CEFUROXIME SODIUMGeneric (ANDA)
ANDA 065001 · FRESENIUS KABI USA
- 1998CEFUROXIME SODIUMGeneric (ANDA)
ANDA 065002 · FRESENIUS KABI USA
- 1998CEFUROXIME SODIUMGeneric (ANDA)
ANDA 064191 · TEVA PHARMS
- 1998CEFUROXIME SODIUMGeneric (ANDA)
ANDA 064192 · TEVA PHARMS
Listed patents
No patents are listed against this product in the Orange Book. Listed patents reflect those the NDA holder submits under 21 U.S.C. 355 and are not exhaustive.
