FDA.reportPublic FDA data

Cefotan

Product NDC
0121-0976
11-digit product format
001210976
Labeler code
0121
Product ID
0121-0976_7e29cb53-c401-49b0-9b47-209601f7ec55
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Cefotetan
Dosage form
INJECTION, POWDER, FOR SOLUTION
Route
INTRAMUSCULAR; INTRAVENOUS
Labeler
PAI Holdings, LLC dba PAI Pharma
Application
NDA050588
Marketing category
NDA
Marketing start
2024-04-08
Substance
CEFOTETAN DISODIUM
Active strength
1 g/10mL
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
Cefotan
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
CEFOTETAN DISODIUM1 g/10mL

Harmonized Identifiers#

Field, Values table
FieldValues
Unii0GXP746VXB
Rxcui1722919, 1722921, 1731542, 1743557

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
0121-0976-10Cefotan10 in 1 TRAYINJECTION, POWDER, FOR SOLUTION106
0121-0976-55Cefotan10 mL in 1 VIALINJECTION, POWDER, FOR SOLUTION106

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0121-0976-10EA - Each0121-09768d9c3244-8e0d-4674-af43-10a9947422db12024-05-16
0121-0976-55EA - Each0121-0976ee8f929f-11f1-41ea-a482-7fc965c3aee612024-05-16

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0121-0976CEFOTAN (CEFOTETAN) INJECTION, POWDER, FOR SOLUTION [PAI HOLDINGS, LLC DBA PAI PHARMA]6Current NDC, 2 package rows20240410_f1510f5e-d001-44e0-accb-27cf79fd4f9a.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1731542Cefotan 1 GM InjectionPSNf1510f5e-d001-44e0-accb-27cf79fd4f9a6
1743557Cefotan 2 GM InjectionPSNf1510f5e-d001-44e0-accb-27cf79fd4f9a6
1722919cefoTEtan 1 GM InjectionPSNf1510f5e-d001-44e0-accb-27cf79fd4f9a6
1722921cefoTEtan 2 GM InjectionPSNf1510f5e-d001-44e0-accb-27cf79fd4f9a6
1731542cefotetan 1000 MG Injection [Cefotan]SBDf1510f5e-d001-44e0-accb-27cf79fd4f9a6
1743557cefotetan 2000 MG Injection [Cefotan]SBDf1510f5e-d001-44e0-accb-27cf79fd4f9a6
1722919cefotetan 1000 MG InjectionSCDf1510f5e-d001-44e0-accb-27cf79fd4f9a6
1722921cefotetan 2000 MG InjectionSCDf1510f5e-d001-44e0-accb-27cf79fd4f9a6
1731542Cefotan 1 GM InjectionSYf1510f5e-d001-44e0-accb-27cf79fd4f9a6
1731542Cefotan 1000 MG InjectionSYf1510f5e-d001-44e0-accb-27cf79fd4f9a6
1743557Cefotan 2 GM InjectionSYf1510f5e-d001-44e0-accb-27cf79fd4f9a6
1722919cefotetan (as disodium) 1 GM InjectionSYf1510f5e-d001-44e0-accb-27cf79fd4f9a6
1722921cefotetan (as disodium) 2 GM InjectionSYf1510f5e-d001-44e0-accb-27cf79fd4f9a6

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
0121-0976-100012109761010 VIAL in 1 TRAY (0121-0976-10) / 10 mL in 1 VIAL (0121-0976-55) 10 vial2024-04-08NoNoHistorical
0121-0976-550012109765510 mL in 1 VIAL10 mlHistorical