FDA.reportPublic FDA data

Application 050817

Type
NDA
Sponsor
BAXTER HLTHCARE

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001CEFEPIME IN PLASTIC CONTAINERCEFEPIME HYDROCHLORIDEINJECTABLE;INJECTIONEQ 1GM BASE/50ML (EQ 20MG BASE/ML)YesYes
002CEFEPIME IN PLASTIC CONTAINERCEFEPIME HYDROCHLORIDEINJECTABLE;INJECTIONEQ 2GM BASE/100ML (EQ 20MG BASE/ML)YesYes

Source provenance: Browse the complete Orange Book source catalog · source snapshot 44.

Orange Book products#

Current product rows page 1 of 1 · 2 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
N050817-001CEFEPIME IN PLASTIC CONTAINERCEFEPIME HYDROCHLORIDEEQ 1GM BASE/50ML (EQ 20MG BASE/ML)INJECTABLE / INJECTIONRLD, RS2008-08-05
N050817-002CEFEPIME IN PLASTIC CONTAINERCEFEPIME HYDROCHLORIDEEQ 2GM BASE/100ML (EQ 20MG BASE/ML)INJECTABLE / INJECTIONRLD, RS2008-08-05

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 3 of 3 · 88 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2022-10-28 04:53 UTC2022-10N050817-001CEFEPIME IN PLASTIC CONTAINEREQ 1GM BASE/50ML (EQ 20MG BASE/ML)INJECTABLE / INJECTIONRLD, RS2008-08-05f41ea6bd6efb…
2022-10-28 04:53 UTC2022-10N050817-002CEFEPIME IN PLASTIC CONTAINEREQ 2GM BASE/100ML (EQ 20MG BASE/ML)INJECTABLE / INJECTIONRLD, RS2008-08-05f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09N050817-001CEFEPIME IN PLASTIC CONTAINEREQ 1GM BASE/50ML (EQ 20MG BASE/ML)INJECTABLE / INJECTIONRLD, RS2008-08-05e64feba35796…
2022-09-29 23:25 UTC2022-09N050817-002CEFEPIME IN PLASTIC CONTAINEREQ 2GM BASE/100ML (EQ 20MG BASE/ML)INJECTABLE / INJECTIONRLD, RS2008-08-05e64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07N050817-001CEFEPIME IN PLASTIC CONTAINEREQ 1GM BASE/50ML (EQ 20MG BASE/ML)INJECTABLE / INJECTIONRLD, RS2008-08-05cb3db0bc1861…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07N050817-002CEFEPIME IN PLASTIC CONTAINEREQ 2GM BASE/100ML (EQ 20MG BASE/ML)INJECTABLE / INJECTIONRLD, RS2008-08-05cb3db0bc1861…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06N050817-001CEFEPIME IN PLASTIC CONTAINEREQ 1GM BASE/50ML (EQ 20MG BASE/ML)INJECTABLE / INJECTIONRLD, RS2008-08-05a50c72e98297…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06N050817-002CEFEPIME IN PLASTIC CONTAINEREQ 2GM BASE/100ML (EQ 20MG BASE/ML)INJECTABLE / INJECTIONRLD, RS2008-08-05a50c72e98297…

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 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
CefepimeCEFEPIMEBaxter Healthcare Corporationbe5f8ca6-7232-423a-a2d5-cccb7abe79212026-06-25Warnings, Adverse reactionsExact identifier
application applno (NDA): 050817
application number: NDA050817
ndc (product): 0338-1301

Reported adverse events (FAERS/openFDA)#

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

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 6 matching rows.

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0338-1301CefepimecefepimeBaxter Healthcare CorporationNDACurrent
0338-1301CefepimecefepimeBaxter Healthcare CorporationNDACurrent
0338-1301CefepimecefepimeBaxter Healthcare CorporationNDACurrent
0338-1301CefepimecefepimeBaxter Healthcare CorporationNDACurrent
0338-1301CefepimecefepimeBaxter Healthcare CorporationNDACurrent
0338-1301CefepimecefepimeBaxter Healthcare CorporationNDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
82994SUPPL 2025-07-31
82987SUPPL 2025-07-30
62820SUPPL2020-05-05
62814SUPPL2020-05-04
39384SUPPL2016-05-11
30607SUPPL2016-05-10
39383SUPPL2014-06-10
8337SUPPL2014-06-05
18296SUPPL2012-09-11
8338SUPPL2012-09-10
18295SUPPL2010-07-06
30606SUPPL2010-07-02
44789ORIG2009-12-31
42752ORIG2009-12-31
23729ORIG2008-09-19
30605ORIG2008-08-12