Orange Book product · Brand (NDA)
ROCEPHIN
CEFTRIAXONE SODIUM
At a glance
Dec 21, 1984
Approved
Brand (NDA)
Application
Not listed
TE code
None
Listed patents
Key dates
Approval
FDA approval date of this drug product.
Dec 21, 1984
42 yr 1 mo ago
Today
Pharmaceutical detail
Active ingredient
CEFTRIAXONE SODIUM
Strength
EQ 500MG BASE/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Dosage form
INJECTABLE
Route
INTRAMUSCULAR, INTRAVENOUS
TE code
Not listed
Application
NDA 050585
Product number
002
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
- 1987ROCEPHIN W/ DEXTROSE IN PLASTIC CONTAINERBrand (NDA)
NDA 050624 · 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.
