FDA.reportPublic FDA data

Application 050585

Type
NDA
Sponsor
HOFFMANN LA ROCHE

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001ROCEPHINCEFTRIAXONE SODIUMINJECTABLE;INTRAMUSCULAR, INTRAVENOUSEQ 250MG BASE/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**YesNo
002ROCEPHINCEFTRIAXONE SODIUMINJECTABLE;INTRAMUSCULAR, INTRAVENOUSEQ 500MG BASE/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**YesNo
003ROCEPHINCEFTRIAXONE SODIUMINJECTABLE;INTRAMUSCULAR, INTRAVENOUSEQ 1GM BASE/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**YesNo
004ROCEPHINCEFTRIAXONE SODIUMINJECTABLE;INTRAMUSCULAR, INTRAVENOUSEQ 2GM BASE/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**YesNo
005ROCEPHINCEFTRIAXONE SODIUMINJECTABLE;INJECTIONEQ 10GM BASE/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**YesNo
006ROCEPHIN KITCEFTRIAXONE SODIUM; LIDOCAINEINJECTABLE;INJECTIONEQ 1GM BASE/VIAL,N/A;N/A,1%NoNo
007ROCEPHIN KITCEFTRIAXONE SODIUM; LIDOCAINEINJECTABLE;INJECTIONEQ 500MG BASE/VIAL,N/A;N/A,1%NoNo

Source provenance: Browse the complete Orange Book source catalog · source snapshot 43.

Orange Book products#

Current product rows page 1 of 1 · 7 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
N050585-001ROCEPHINCEFTRIAXONE SODIUMEQ 250MG BASE/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**INJECTABLE / INTRAMUSCULAR, INTRAVENOUSRLD1984-12-21
N050585-002ROCEPHINCEFTRIAXONE SODIUMEQ 500MG BASE/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**INJECTABLE / INTRAMUSCULAR, INTRAVENOUSRLD1984-12-21
N050585-003ROCEPHINCEFTRIAXONE SODIUMEQ 1GM BASE/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**INJECTABLE / INTRAMUSCULAR, INTRAVENOUSRLD1984-12-21
N050585-004ROCEPHINCEFTRIAXONE SODIUMEQ 2GM BASE/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**INJECTABLE / INTRAMUSCULAR, INTRAVENOUSRLD1984-12-21
N050585-005ROCEPHINCEFTRIAXONE SODIUMEQ 10GM BASE/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**INJECTABLE / INJECTIONRLD1984-12-21
N050585-006ROCEPHIN KITCEFTRIAXONE SODIUM; LIDOCAINEEQ 1GM BASE/VIAL,N/A;N/A,1%INJECTABLE / INJECTION1996-05-08
N050585-007ROCEPHIN KITCEFTRIAXONE SODIUM; LIDOCAINEEQ 500MG BASE/VIAL,N/A;N/A,1%INJECTABLE / INJECTION1996-05-08

Observed Orange Book product history#

Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.

Product history page 1 of 8 · 301 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-09-14 22:38:342026-08N050585-001ROCEPHINEQ 250MG BASE/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**INJECTABLE / INTRAMUSCULAR, INTRAVENOUSRLD1984-12-2184e616aacf4f…
2026-09-14 22:38:342026-08N050585-002ROCEPHINEQ 500MG BASE/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**INJECTABLE / INTRAMUSCULAR, INTRAVENOUSRLD1984-12-2184e616aacf4f…
2026-09-14 22:38:342026-08N050585-003ROCEPHINEQ 1GM BASE/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**INJECTABLE / INTRAMUSCULAR, INTRAVENOUSRLD1984-12-2184e616aacf4f…
2026-09-14 22:38:342026-08N050585-004ROCEPHINEQ 2GM BASE/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**INJECTABLE / INTRAMUSCULAR, INTRAVENOUSRLD1984-12-2184e616aacf4f…
2026-09-14 22:38:342026-08N050585-005ROCEPHINEQ 10GM BASE/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**INJECTABLE / INJECTIONRLD1984-12-2184e616aacf4f…
2026-09-14 22:38:342026-08N050585-006ROCEPHIN KITEQ 1GM BASE/VIAL,N/A;N/A,1%INJECTABLE / INJECTION1996-05-0884e616aacf4f…
2026-09-14 22:38:342026-08N050585-007ROCEPHIN KITEQ 500MG BASE/VIAL,N/A;N/A,1%INJECTABLE / INJECTION1996-05-0884e616aacf4f…
2026-08-18 06:07:402026-07N050585-001ROCEPHINEQ 250MG BASE/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**INJECTABLE / INTRAMUSCULAR, INTRAVENOUSRLD1984-12-21caaa826d4ba7…
2026-08-18 06:07:402026-07N050585-002ROCEPHINEQ 500MG BASE/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**INJECTABLE / INTRAMUSCULAR, INTRAVENOUSRLD1984-12-21caaa826d4ba7…
2026-08-18 06:07:402026-07N050585-003ROCEPHINEQ 1GM BASE/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**INJECTABLE / INTRAMUSCULAR, INTRAVENOUSRLD1984-12-21caaa826d4ba7…
2026-08-18 06:07:402026-07N050585-004ROCEPHINEQ 2GM BASE/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**INJECTABLE / INTRAMUSCULAR, INTRAVENOUSRLD1984-12-21caaa826d4ba7…
2026-08-18 06:07:402026-07N050585-005ROCEPHINEQ 10GM BASE/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**INJECTABLE / INJECTIONRLD1984-12-21caaa826d4ba7…
2026-08-18 06:07:402026-07N050585-006ROCEPHIN KITEQ 1GM BASE/VIAL,N/A;N/A,1%INJECTABLE / INJECTION1996-05-08caaa826d4ba7…
2026-08-18 06:07:402026-07N050585-007ROCEPHIN KITEQ 500MG BASE/VIAL,N/A;N/A,1%INJECTABLE / INJECTION1996-05-08caaa826d4ba7…
2026-02-19 14:30 UTC2026-02N050585-001ROCEPHINEQ 250MG BASE/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**INJECTABLE / INTRAMUSCULAR, INTRAVENOUSRLD1984-12-21011fe1cb6892…
2026-02-19 14:30 UTC2026-02N050585-002ROCEPHINEQ 500MG BASE/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**INJECTABLE / INTRAMUSCULAR, INTRAVENOUSRLD1984-12-21011fe1cb6892…
2026-02-19 14:30 UTC2026-02N050585-003ROCEPHINEQ 1GM BASE/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**INJECTABLE / INTRAMUSCULAR, INTRAVENOUSRLD1984-12-21011fe1cb6892…
2026-02-19 14:30 UTC2026-02N050585-004ROCEPHINEQ 2GM BASE/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**INJECTABLE / INTRAMUSCULAR, INTRAVENOUSRLD1984-12-21011fe1cb6892…
2026-02-19 14:30 UTC2026-02N050585-005ROCEPHINEQ 10GM BASE/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**INJECTABLE / INJECTIONRLD1984-12-21011fe1cb6892…
2026-02-19 14:30 UTC2026-02N050585-006ROCEPHIN KITEQ 1GM BASE/VIAL,N/A;N/A,1%INJECTABLE / INJECTION1996-05-08011fe1cb6892…
2026-02-19 14:30 UTC2026-02N050585-007ROCEPHIN KITEQ 500MG BASE/VIAL,N/A;N/A,1%INJECTABLE / INJECTION1996-05-08011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N050585-001ROCEPHINEQ 250MG BASE/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**INJECTABLE / INTRAMUSCULAR, INTRAVENOUSRLD1984-12-2131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N050585-002ROCEPHINEQ 500MG BASE/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**INJECTABLE / INTRAMUSCULAR, INTRAVENOUSRLD1984-12-2131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N050585-003ROCEPHINEQ 1GM BASE/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**INJECTABLE / INTRAMUSCULAR, INTRAVENOUSRLD1984-12-2131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N050585-004ROCEPHINEQ 2GM BASE/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**INJECTABLE / INTRAMUSCULAR, INTRAVENOUSRLD1984-12-2131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N050585-005ROCEPHINEQ 10GM BASE/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**INJECTABLE / INJECTIONRLD1984-12-2131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N050585-006ROCEPHIN KITEQ 1GM BASE/VIAL,N/A;N/A,1%INJECTABLE / INJECTION1996-05-0831067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N050585-007ROCEPHIN KITEQ 500MG BASE/VIAL,N/A;N/A,1%INJECTABLE / INJECTION1996-05-0831067a03dcf5…
2025-08-23 18:47 UTC2025-08N050585-001ROCEPHINEQ 250MG BASE/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**INJECTABLE / INTRAMUSCULAR, INTRAVENOUSRLD1984-12-216a471c1ec25d…
2025-08-23 18:47 UTC2025-08N050585-002ROCEPHINEQ 500MG BASE/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**INJECTABLE / INTRAMUSCULAR, INTRAVENOUSRLD1984-12-216a471c1ec25d…
2025-08-23 18:47 UTC2025-08N050585-003ROCEPHINEQ 1GM BASE/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**INJECTABLE / INTRAMUSCULAR, INTRAVENOUSRLD1984-12-216a471c1ec25d…
2025-08-23 18:47 UTC2025-08N050585-004ROCEPHINEQ 2GM BASE/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**INJECTABLE / INTRAMUSCULAR, INTRAVENOUSRLD1984-12-216a471c1ec25d…
2025-08-23 18:47 UTC2025-08N050585-005ROCEPHINEQ 10GM BASE/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**INJECTABLE / INJECTIONRLD1984-12-216a471c1ec25d…
2025-08-23 18:47 UTC2025-08N050585-006ROCEPHIN KITEQ 1GM BASE/VIAL,N/A;N/A,1%INJECTABLE / INJECTION1996-05-086a471c1ec25d…
2025-08-23 18:47 UTC2025-08N050585-007ROCEPHIN KITEQ 500MG BASE/VIAL,N/A;N/A,1%INJECTABLE / INJECTION1996-05-086a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N050585-001ROCEPHINEQ 250MG BASE/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**INJECTABLE / INTRAMUSCULAR, INTRAVENOUSRLD1984-12-21fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N050585-002ROCEPHINEQ 500MG BASE/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**INJECTABLE / INTRAMUSCULAR, INTRAVENOUSRLD1984-12-21fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N050585-003ROCEPHINEQ 1GM BASE/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**INJECTABLE / INTRAMUSCULAR, INTRAVENOUSRLD1984-12-21fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N050585-004ROCEPHINEQ 2GM BASE/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**INJECTABLE / INTRAMUSCULAR, INTRAVENOUSRLD1984-12-21fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N050585-005ROCEPHINEQ 10GM BASE/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**INJECTABLE / INJECTIONRLD1984-12-21fd3edfee7708…

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 2 of 2 · 25 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Ceftriaxone SodiumCEFTRIAXONE SODIUMApotex Corp.ac03a72c-0e35-40f9-b7fc-081badb5f19c2023-01-28Warnings, Adverse reactionsName fallback
generic name: CEFTRIAXONE SODIUM
CeftriaxoneCEFTRIAXONE SODIUMSamson Medical Technologies, LLC5cd2d96f-83e5-4326-ae87-d0ede4ba493a2023-01-15Warnings, Adverse reactionsName fallback
generic name: CEFTRIAXONE SODIUM
Ceftriaxone SodiumCEFTRIAXONE SODIUMProficient Rx LPa25ab5ea-c46d-4562-8f7e-0ccffc2ab0692022-10-01Warnings, Adverse reactionsName fallback
generic name: CEFTRIAXONE SODIUM
Ceftriaxone SodiumCEFTRIAXONE SODIUMProficient Rx LP42ba7a9d-7d2b-4eac-af59-897151a8c9242022-05-02Warnings, Adverse reactionsName fallback
generic name: CEFTRIAXONE SODIUM
Ceftriaxone SodiumCEFTRIAXONE SODIUMHospira, Inc9d1f630b-e759-4395-9d01-ddc90e4fea752022-03-09Warnings, Adverse reactionsName fallback
generic name: CEFTRIAXONE SODIUM

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
54905SUPPL2018-07-16
54879SUPPL2018-07-13
7848SUPPL2015-07-08
39008SUPPL2015-07-01
7847SUPPL2015-03-24
17903SUPPL2015-03-23
30121SUPPL2013-04-16
17902SUPPL2013-04-16
30118SUPPL2010-11-18
17900SUPPL2010-11-17
30120SUPPL2010-03-04
17901SUPPL2010-03-03
30119SUPPL2009-06-16
39007SUPPL2009-06-10
17899SUPPL2009-04-03
30117SUPPL2009-03-13
39003SUPPL2008-08-26
17898SUPPL2008-08-26
30116SUPPL2008-08-20
44200ORIG2007-09-11
17897SUPPL2007-07-24
7846SUPPL2007-07-24
39006SUPPL2007-05-16
30115SUPPL2007-05-16
39005SUPPL2004-09-15
30114SUPPL2004-09-15
39004SUPPL2004-09-03
30113SUPPL2004-09-03
7845SUPPL2004-04-07
17896SUPPL2004-04-05