FDA.reportPublic FDA data

Cefoxitin

Product NDC
0143-9877
11-digit product format
001439877
Labeler code
0143
Product ID
0143-9877_4638263b-1c03-4a32-ba82-70270cf42490
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Cefoxitin
Dosage form
INJECTION, POWDER, FOR SOLUTION
Route
INTRAVENOUS
Labeler
Hikma Pharmaceuticals USA Inc.
Application
ANDA065238
Marketing category
ANDA
Marketing start
2010-03-12
Substance
CEFOXITIN SODIUM
Active strength
2 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 SODIUM2 g/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiQ68050H03T
Rxcui1665102, 1665107

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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0143-9877-01Cefoxitin1 in 1 VIALINJECTION, POWDER, FOR SOLUTION19
0143-9877-25Cefoxitin25 in 1 CARTONINJECTION, POWDER, FOR SOLUTION259

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0143-9877-01EA - Each0143-98773596b5ec-b9b0-4fe5-bd18-0f13574516e312018-07-03
0143-9877-25EA - Each0143-98776fe6b04b-f505-43b6-8594-2a75e00c0f7612012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
CEFOXITIN SODIUMACTIVE INGREDIENTQ68050H03TCEFOXITIN INJECTION, POWDER, FOR SOLUTION [WEST-WARD PHARMACEUTICAL CORP]1
CEFOXITINACTIVE MOIETY6OEV9DX57YCEFOXITIN INJECTION, POWDER, FOR SOLUTION [WEST-WARD PHARMACEUTICAL CORP]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0143-9877CEFOXITIN INJECTION, POWDER, FOR SOLUTION [HIKMA PHARMACEUTICALS USA INC.]9Current NDC, Legacy NDC, 2 package rows20240413_d2c449b9-5624-4166-95b1-d7813b3d0445.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1665102cefOXitin 1 GM InjectionPSNd2c449b9-5624-4166-95b1-d7813b3d04459
1665107cefOXitin 2 GM InjectionPSNd2c449b9-5624-4166-95b1-d7813b3d04459
1665102cefoxitin 1000 MG InjectionSCDd2c449b9-5624-4166-95b1-d7813b3d04459
1665107cefoxitin 2000 MG InjectionSCDd2c449b9-5624-4166-95b1-d7813b3d04459
1665102cefoxitin (as cefoxitin sodium) 1000 MG InjectionSYd2c449b9-5624-4166-95b1-d7813b3d04459
1665107cefoxitin (as cefoxitin sodium) 2000 MG InjectionSYd2c449b9-5624-4166-95b1-d7813b3d04459
1665102cefoxitin 1 GM InjectionSYd2c449b9-5624-4166-95b1-d7813b3d04459
1665107cefoxitin 2 GM InjectionSYd2c449b9-5624-4166-95b1-d7813b3d04459

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0143-9877-01001439877011 in 1 VIALHistorical
0143-9877-250014398772525 VIAL in 1 CARTON (0143-9877-25) / 1 INJECTION, POWDER, FOR SOLUTION in 1 VIAL (0143-9877-01) 25 vial2010-03-120000-00-00NoNoCurrent