Cefotan

Product NDC
52565-052
11-digit product format
525650052
Labeler code
52565
Product ID
52565-052_675e1e86-13c2-4287-b4ed-cc60d01b9acc
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Cefotetan Disodium
Dosage form
INJECTION, POWDER, FOR SOLUTION
Route
INTRAMUSCULAR; INTRAVENOUS
Labeler
Teligent Pharma, Inc.
Application
NDA050588
Marketing category
NDA
Marketing start
2015-10-01
Marketing end
0000-00-00
Substance
CEFOTETAN DISODIUM
Active strength
1 g/10mL
Pharmacologic classes
Cephalosporin Antibacterial [EPC],Cephalosporins [CS]
NDC exclude flag
No
Listing certified through
2020-12-31
Current FDA listing
Historical FDA.report record

DailyMed Product Concepts#

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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
52565-052-102022-01-28C16284748780-1d6a99b39-d1a9-a426-e053-dadaa90af4c2CEFOTAN ® (Cefotetan for injection, USP)

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
52565-052-10Cefotan10 in 1 TRAYINJECTION, POWDER, FOR SOLUTION105
52565-052-10Cefotan10 mL in 1 VIALINJECTION, POWDER, FOR SOLUTION105

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
52565-052-10EA - Each52565-05201aefb2c-da86-4367-ab7b-744dbd0386eb12016-03-04

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
52565-052CEFOTAN (CEFOTETAN DISODIUM) INJECTION, POWDER, FOR SOLUTION CEFOTAN (CEFOTETAN DISODIUM) INJECTION, POWDER, FOR SOLUTION [TELIGENT PHARMA, INC.]5Legacy NDC, 2 package rows20190207_0860bfe0-da3e-4460-da57-2411db14c426.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1731542Cefotan 1 GM InjectionPSN0860bfe0-da3e-4460-da57-2411db14c4265
1743557Cefotan 2 GM InjectionPSN0860bfe0-da3e-4460-da57-2411db14c4265
1722919cefoTEtan 1 GM InjectionPSN0860bfe0-da3e-4460-da57-2411db14c4265
1722921cefoTEtan 2 GM InjectionPSN0860bfe0-da3e-4460-da57-2411db14c4265
1731542cefotetan 1000 MG Injection [Cefotan]SBD0860bfe0-da3e-4460-da57-2411db14c4265
1743557cefotetan 2000 MG Injection [Cefotan]SBD0860bfe0-da3e-4460-da57-2411db14c4265
1722919cefotetan 1000 MG InjectionSCD0860bfe0-da3e-4460-da57-2411db14c4265
1722921cefotetan 2000 MG InjectionSCD0860bfe0-da3e-4460-da57-2411db14c4265
1731542Cefotan 1 GM InjectionSY0860bfe0-da3e-4460-da57-2411db14c4265
1731542Cefotan 1000 MG InjectionSY0860bfe0-da3e-4460-da57-2411db14c4265
1743557Cefotan 2 GM InjectionSY0860bfe0-da3e-4460-da57-2411db14c4265
1722919cefotetan (as disodium) 1 GM InjectionSY0860bfe0-da3e-4460-da57-2411db14c4265
1722921cefotetan (as disodium) 2 GM InjectionSY0860bfe0-da3e-4460-da57-2411db14c4265

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
52565-052-105256500521010 VIAL in 1 TRAY (52565-052-10) > 10 mL in 1 VIAL10 vial2015-10-010000-00-00NoNoCurrent