Orange Book product · Brand (NDA)
ROCEPHIN W/ DEXTROSE IN PLASTIC CONTAINER
CEFTRIAXONE SODIUM
At a glance
Feb 11, 1987
Approved
Brand (NDA)
Application
Not listed
TE code
None
Listed patents
Key dates
Approval
FDA approval date of this drug product.
Feb 11, 1987
39 yr 11 mo ago
Today
Pharmaceutical detail
Active ingredient
CEFTRIAXONE SODIUM
Strength
EQ 10MG BASE/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**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 050624
Product number
001
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.
- 2005CEFTRIAXONE AND DEXTROSE IN DUPLEX CONTAINERBrand (NDA)
NDA 050796 · B BRAUN
- 1984ROCEPHINBrand (NDA)
NDA 050585 · HOFFMANN LA ROCHE
- 2024CEFTRIAXONEGeneric (ANDA)
ANDA 210197 · DEVA HOLDING AS
- 2018CEFTRIAXONEGeneric (ANDA)
ANDA 209218 · QILU ANTIBIOTICS
- 2018CEFTRIAXONEGeneric (ANDA)
ANDA 091049 · ASTRAL
- 2017CEFTRIAXONE SODIUMGeneric (ANDA)
ANDA 090701 · HIKMA
- 2017CEFTRIAXONE SODIUMGeneric (ANDA)
ANDA 091117 · ANDA REPOSITORY
- 2016CEFTRIAXONEGeneric (ANDA)
ANDA 203702 · QILU ANTIBIOTICS
- 2014CEFTRIAXONEGeneric (ANDA)
ANDA 090057 · SAMSON MEDCL
- 2013CEFTRIAXONEGeneric (ANDA)
ANDA 091068 · AGILA SPECLTS
- 2012CEFTRIAXONEGeneric (ANDA)
ANDA 202563 · HOSPIRA INC
- 2008CEFTRIAXONEGeneric (ANDA)
ANDA 065475 · BEDFORD
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.
