FDA.reportPublic FDA data

NDC 66794-209-02 - Cefepime

This NDC is not currently matched to an FDA NDC product listing in FDA.report, but it is a valid NDC-form code. FDA.report is showing the available DailyMed label context for the product root.

Product NDC
66794-209
Requested NDC
66794-209-02
Package NDCs from labels
66794-209-02, 66794-209-41
Manufacturer
Piramal Critical Care Inc. | Piramal Critical Care Limited | Astral SteriTech Private Limited
Effective date
2022-12-24
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
Cefepime - Piramal Critical Care Inc. | Piramal Critical Care Limited | Astral SteriTech Private LimitedPiramal Critical Care Inc. | Piramal Critical Care Limited | Astral SteriTech Private Limited2022-12-24HUMAN PRESCRIPTION DRUG LABEL

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
66794-209-412024-02-20C16284748780-11030e365-1a98-111a-e063-dadaa90a10e2HIGHLIGHTS OF PRESCRIBING INFORMATION These highlights do not include all the information needed to use CEFEPIME FOR INJECTION safely and effectively. See full prescribing information for CEFEPIME FOR INJECTION. CEFEPIME for injection, for intravenous or intramuscular use Initial U.S. Approval: 1996
66794-209-412024-01-30C16284748780-11030e365-1a98-111a-e063-dadaa90a10e2HIGHLIGHTS OF PRESCRIBING INFORMATION These highlights do not include all the information needed to use CEFEPIME FOR INJECTION safely and effectively. See full prescribing information for CEFEPIME FOR INJECTION. CEFEPIME for injection, for intravenous or intramuscular use Initial U.S. Approval: 1996

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
66794-209-02EA - Each66794-209e4173dc2-52e0-4544-b0ee-4018114f0df812021-03-02
66794-209-41EA - Each66794-2093e8d6809-7bbc-4bc3-8798-b255d27ab1f612019-05-02

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 ยท 15 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
CefepimeCEFEPIMEBaxter Healthcare Corporationbe5f8ca6-7232-423a-a2d5-cccb7abe79212026-06-25Warnings, Adverse reactionsExact identifier
unii: I8X1O0607P
CefepimeCEFEPIMEWG Critical Care, LLC5fd857e5-591f-44ca-80cf-fd903660b03c2026-06-23Warnings, Adverse reactionsExact identifier
unii: I8X1O0607P
CefepimeCEFEPIMEWG Critical Care, LLCc654ef2e-1067-4026-8931-6a0dc2a17ad12026-06-23Warnings, Adverse reactionsExact identifier
unii: I8X1O0607P
ZAYNICHZIDEBACTAM DIHYDRATE AND CEFEPIME HYDROCHLORIDEWockhardt Suisse USA LLCc84e652e-5e76-4568-8812-bd5fa34803b62026-06-05Warnings, Adverse reactionsExact identifier
unii: I8X1O0607P
CEFEPIME HYDROCHLORIDE AND DEXTROSECEFEPIME HYDROCHLORIDEB. Braun Medical Inc.57517a0e-ec1b-4605-a7cc-7e3801158ec92026-04-07Warnings, Adverse reactionsExact identifier
unii: I8X1O0607P
Cefepime HydrochlorideCEFEPIME HYDROCHLORIDEHikma Pharmaceuticals USA Inc.b9914e7e-13f6-42d4-9cbb-8c7ed1ce7a012025-10-14Warnings, Adverse reactionsExact identifier
unii: I8X1O0607P
Cefepime HydrochlorideCEFEPIME HYDROCHLORIDEHikma Pharmaceuticals USA Inc.f64c181e-28c5-48ab-aa67-5ca0e3fd079c2025-06-30Warnings, Adverse reactionsExact identifier
unii: I8X1O0607P
CefepimeCEFEPIMEHospira, Inc.e80c27e2-164d-4836-ba24-c160d75dc5d32024-11-06Warnings, Adverse reactionsExact identifier
unii: I8X1O0607P
CEFEPIMECEFEPIMESAMSON MEDICAL TECHNOLOGIES LLCf776421b-bd46-4664-b9ff-533d805e12772024-03-11Warnings, Adverse reactionsExact identifier
unii: I8X1O0607P
114145c8-c49c-5a65-e063-6294a90a593d83d70378-012e-4ce3-e053-2991aa0a22be2024-02-13Warnings, Adverse reactionsExact identifier
spl set id: 83d70378-012e-4ce3-e053-2991aa0a22be
CefepimeCEFEPIMEFresenius Kabi USA, LLC5e1695e0-1310-4cd8-a5da-ad1a7dcd17922023-09-30Warnings, Adverse reactionsExact identifier
unii: I8X1O0607P
CefepimeCEFEPIMEApotex Corp.d63d360a-15ec-44a4-b80d-b2a5cb5759eb2023-05-10Warnings, Adverse reactionsExact identifier
unii: I8X1O0607P
CefepimeCEFEPIMEApotex Corp.02aa374f-37b4-456a-b5de-cfd3bbb6ce6e2023-05-10Warnings, Adverse reactionsExact identifier
unii: I8X1O0607P
CefepimeCEFEPIMEApotex Corp.dd641c7f-b857-48ff-bd9d-747e0c3cc89f2023-05-10Warnings, Adverse reactionsExact identifier
unii: I8X1O0607P
CefepimeCEFEPIME HYDROCHLORIDEQilu Pharmaceutical Co., Ltd.80b4c811-4a71-47fb-8565-85ce9d0f782c2021-11-15Warnings, Adverse reactionsExact identifier
unii: I8X1O0607P

Reported adverse events (FAERS/openFDA)#

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