FDA.reportPublic FDA data

Cefotetan

Product NDC
0143-9670
11-digit product format
001439670
Labeler code
0143
Product ID
0143-9670_239c7e32-be35-41ea-b466-2e15d3339398
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Cefotetan
Dosage form
INJECTION, POWDER, FOR SOLUTION
Route
INTRAMUSCULAR; INTRAVENOUS
Labeler
Hikma Pharmaceuticals USA Inc.
Application
ANDA091031
Marketing category
ANDA
Marketing start
2011-10-26
Substance
CEFOTETAN
Active strength
1 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
Cefotetan
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
CEFOTETAN1 g/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii48SPP0PA9Q
Rxcui1722919, 1722921

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
0cc1eec0-2b75-6316-520b-142bcbbb9bb7Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0143-9670-01Cefotetan1 in 1 VIALINJECTION, POWDER, FOR SOLUTION14
0143-9670-10Cefotetan10 in 1 CARTONINJECTION, POWDER, FOR SOLUTION104

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0143-9670-01EA - Each0143-9670f33c1e87-bd07-4ed7-8d2c-b73ebd9d5c9012018-02-20
0143-9670-10EA - Each0143-96708ff80fe7-365f-429c-b2bf-43976a7397aa12018-02-20

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0143-9670CEFOTETAN INJECTION, POWDER, FOR SOLUTION [HIKMA PHARMACEUTICALS USA INC.]4Current NDC, Legacy NDC, 2 package rows20240413_33b13b93-58ce-44c7-b9a2-af3b3a333f80.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1722919cefoTEtan 1 GM InjectionPSN33b13b93-58ce-44c7-b9a2-af3b3a333f804
1722921cefoTEtan 2 GM InjectionPSN33b13b93-58ce-44c7-b9a2-af3b3a333f804
1722919cefotetan 1000 MG InjectionSCD33b13b93-58ce-44c7-b9a2-af3b3a333f804
1722921cefotetan 2000 MG InjectionSCD33b13b93-58ce-44c7-b9a2-af3b3a333f804
1722919cefotetan (as disodium) 1 GM InjectionSY33b13b93-58ce-44c7-b9a2-af3b3a333f804
1722921cefotetan (as disodium) 2 GM InjectionSY33b13b93-58ce-44c7-b9a2-af3b3a333f804

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0143-9670-01001439670011 in 1 VIALHistorical
0143-9670-100014396701010 VIAL in 1 CARTON (0143-9670-10) / 1 INJECTION, POWDER, FOR SOLUTION in 1 VIAL (0143-9670-01) 10 vial2011-10-260000-00-00NoNoCurrent