Orange Book product · Brand (NDA)
ANCEF
CEFAZOLIN SODIUM
At a glance
Approved Prior to Jan 1, 1982
Approved
Brand (NDA)
Application
Not listed
TE code
None
Listed patents
Key dates
No patent or exclusivity dates are listed for this product.
Pharmaceutical detail
Active ingredient
CEFAZOLIN SODIUM
Strength
EQ 5GM BASE/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**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 050461
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.
- 2023CEFAZOLIN SODIUMBrand (NDA)
NDA 211413 · HQ SPCLT PHARMA
- 2022CEFAZOLIN SODIUMBrand (NDA)
NDA 216109 · HIKMA
- 2021CEFAZOLIN IN DEXTROSEBrand (NDA)
NDA 207131 · BAXTER HLTHCARE CORP
- 2000CEFAZOLIN AND DEXTROSEBrand (NDA)
NDA 050779 · B BRAUN
- 1983ANCEF IN DEXTROSE 5% IN PLASTIC CONTAINERBrand (NDA)
NDA 050566 · BAXTER HLTHCARE
- 2018CEFAZOLIN SODIUMGeneric (ANDA)
ANDA 209217 · QILU ANTIBIOTICS
- 2016CEFAZOLIN SODIUMGeneric (ANDA)
ANDA 201654 · HOSPIRA
- 2015CEFAZOLIN SODIUMGeneric (ANDA)
ANDA 203661 · QILU ANTIBIOTICS
- 2009CEFAZOLIN SODIUMGeneric (ANDA)
ANDA 065280 · CEPHAZONE PHARMA
- 2009CEFAZOLIN SODIUMGeneric (ANDA)
ANDA 065295 · CEPHAZONE PHARMA
- 2009CEFAZOLIN SODIUMGeneric (ANDA)
ANDA 065296 · CEPHAZONE PHARMA
- 2008CEFAZOLIN SODIUMGeneric (ANDA)
ANDA 065303 · ACS DOBFAR
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.
