FDA.reportPublic FDA data

NDC 0143-9876-01 - Cefoxitin

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
0143-9876
Requested NDC
0143-9876-01
Package NDCs from labels
0143-9876-01, 0143-9876-10
Manufacturer
Hikma Pharmaceuticals USA Inc. | HIKMA FARMACEUTICA (PORTUGAL), S.A
Effective date
2025-03-03
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
Cefoxitin - Hikma Pharmaceuticals USA Inc. | HIKMA FARMACEUTICA (PORTUGAL), S.AHikma Pharmaceuticals USA Inc. | HIKMA FARMACEUTICA (PORTUGAL), S.A2025-03-03HUMAN PRESCRIPTION DRUG LABEL

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
0143-9876-102021-01-09C16284748780-1956f9ecf-d314-621f-e053-dbdaa90a74adCEFOXITIN FOR INJECTION, USP
0143-9876-102019-10-21C16284748780-1956f9ecf-d314-621f-e053-dbdaa90a74adCEFOXITIN FOR INJECTION, USP

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0143-9876-01Cefoxitin1 in 1 BOTTLEINJECTION, POWDER, FOR SOLUTION113
0143-9876-10Cefoxitin10 in 1 CARTONINJECTION, POWDER, FOR SOLUTION1013

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0143-9876CEFOXITIN INJECTION, POWDER, FOR SOLUTION [HIKMA PHARMACEUTICALS USA INC.]13Current NDC, Legacy NDC, 2 package rows20250305_6a4a2afa-4f00-41d4-bd6d-baa0a95f6929.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0143-9876-10EA - Each0143-9876b117093c-dbb7-4e2d-8252-be614fa260e212012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
CEFOXITIN SODIUMACTIVE INGREDIENTQ68050H03TCEFOXITIN INJECTION, POWDER, FOR SOLUTION [WEST-WARD PHARMACEUTICAL CORP]2
CEFOXITINACTIVE MOIETY6OEV9DX57YCEFOXITIN INJECTION, POWDER, FOR SOLUTION [WEST-WARD PHARMACEUTICAL CORP]2

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 11 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
CefoxitinCEFOXITINWG Critical Care, LLC658a0dc6-6da5-44dc-94f2-1211619297f72026-08-24Warnings, Adverse reactionsExact identifier
unii: Q68050H03T
CefoxitinCEFOXITINWG Critical Care, LLC91ac4c14-8dd8-4efe-a462-d1c488a6184f2025-11-12Warnings, Adverse reactionsExact identifier
unii: Q68050H03T
CefoxitinCEFOXITINHikma Pharmaceuticals USA Inc.6a4a2afa-4f00-41d4-bd6d-baa0a95f69292025-03-03Warnings, Adverse reactionsExact identifier
application number: ANDA065239
ndc (package): 0143-9876-10
ndc (package): 0143-9876-01
ndc (product): 0143-9876
ndc11 (package): 00143987601
rxcui: 309072
spl id: 3de36693-e566-4f2a-b9fe-8b777b275fa4
spl set id: 6a4a2afa-4f00-41d4-bd6d-baa0a95f6929
unii: Q68050H03T
CefoxitinCEFOXITINHikma Pharmaceuticals USA Inc.d2c449b9-5624-4166-95b1-d7813b3d04452024-04-11Warnings, Adverse reactionsExact identifier
unii: Q68050H03T
CefoxitinCEFOXITINSagent Pharmaceuticalsb272ef9c-4d83-4ee2-b9cc-477440822cca2024-01-03Warnings, Adverse reactionsExact identifier
unii: Q68050H03T
CefoxitinCEFOXITINWG Critical Care, LLCf5288962-caee-4771-8229-df9cdefcfa672023-10-16Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 309072
unii: Q68050H03T
CefoxitinCEFOXITIN SODIUMFresenius Kabi USA, LLC2a9d1e7b-96ee-4e6c-a1e8-47b76b9244222023-07-10Warnings, Adverse reactionsExact identifier
unii: Q68050H03T
CefoxitinCEFOXITIN SODIUMFresenius Kabi USA, LLCd02170ff-65aa-48b8-a922-94271c46ffa72022-09-23Warnings, Adverse reactionsExact identifier
unii: Q68050H03T
CefoxitinCEFOXITINSAMSON MEDICAL TECHNOLOGIES LLCea6dba56-5d9c-463a-b1d9-f7af5b602ed92020-11-16Boxed warning, Warnings, Adverse reactionsExact identifier
unii: Q68050H03T
CefoxitinCEFOXITINSagent Pharmaceuticals4c6f7665-204f-6c69-7669-61204d756e6e2020-06-09Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 309072
unii: Q68050H03T
Cefoxitin and DextroseCEFOXITIN SODIUMB. Braun Medical Inc.6c7e9485-1ede-411c-8c46-9114393328642019-07-29Warnings, Adverse reactionsExact identifier
unii: Q68050H03T

Reported adverse events (FAERS/openFDA)#

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