FDA.reportPublic FDA data

Cefoxitin

Product NDC
0143-9876
11-digit product format
001439876
Labeler code
0143
Product ID
0143-9876_3de36693-e566-4f2a-b9fe-8b777b275fa4
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Cefoxitin
Dosage form
INJECTION, POWDER, FOR SOLUTION
Route
INTRAVENOUS
Labeler
Hikma Pharmaceuticals USA Inc.
Application
ANDA065239
Marketing category
ANDA
Marketing start
2010-02-26
Substance
CEFOXITIN SODIUM
Active strength
10 g/1
Pharmacologic classes
Cephalosporin Antibacterial [EPC], Cephalosporins [CS]
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Cefoxitin
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
CEFOXITIN SODIUM10 g/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiQ68050H03T
Rxcui309072

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
674c093f-2e56-4442-b936-d876c9ac5966Product name120160111
33228014-863e-d9a4-2fc1-b5fe1bf2d490Product name120140508
cd1ea622-6dd0-ac04-3600-f4b6f14160ccProduct name120140508

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 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

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 RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
309072cefOXitin 200 MG/ML Injectable SolutionPSN6a4a2afa-4f00-41d4-bd6d-baa0a95f692913
309072cefoxitin 200 MG/ML Injectable SolutionSCD6a4a2afa-4f00-41d4-bd6d-baa0a95f692913
309072cefoxitin (as cefoxitin sodium) 200 MG/ML Injectable SolutionSY6a4a2afa-4f00-41d4-bd6d-baa0a95f692913

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0143-9876-01001439876011 in 1 BOTTLEHistorical
0143-9876-100014398761010 BOTTLE in 1 CARTON (0143-9876-10) / 1 INJECTION, POWDER, FOR SOLUTION in 1 BOTTLE (0143-9876-01) 10 bottle2010-02-260000-00-00NoNoCurrent