Cefditoren Pivoxil

Product NDC
44009-801
11-digit product format
440090801
Labeler code
44009
Product ID
44009-801_edeaf75d-92f5-4fef-a127-ad200561aa71
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
cefditoren pivoxil
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Pharma RomLev Inc.
Application
NDA021222
Marketing category
NDA
Marketing start
2013-02-12
Marketing end
0000-00-00
Substance
CEFDITOREN PIVOXIL
Active strength
200 mg/1
Pharmacologic classes
Cephalosporin Antibacterial [EPC],Cephalosporins [CS]
NDC exclude flag
E
Listing certified through
2017-12-31
Current FDA listing
Historical FDA.report record

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
735c6807-7b6d-31b0-8032-5eb0f5889757Product name120140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
44009-801-202019-11-27C16284748780-19855d018-e114-cd31-e053-dbdaa90ab51aCefditoren Pivoxil Tablets 200 mg and 400 mg

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
44009-801-20Cefditoren Pivoxil20 in 1 BLISTER PACKTABLET, FILM COATED202

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
44009-801CEFDITOREN PIVOXIL TABLET, FILM COATED [PHARMA ROMLEV INC.]2Legacy NDC, 1 package rows20130606_d5050d0e-81d1-4707-a38a-e80de2aebf09.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
351127cefditoren pivoxil 200 MG Oral TabletPSNd5050d0e-81d1-4707-a38a-e80de2aebf092
847360cefditoren pivoxil 400 MG Oral TabletPSNd5050d0e-81d1-4707-a38a-e80de2aebf092
351127cefditoren pivoxil 200 MG Oral TabletSCDd5050d0e-81d1-4707-a38a-e80de2aebf092
847360cefditoren pivoxil 400 MG Oral TabletSCDd5050d0e-81d1-4707-a38a-e80de2aebf092

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionStatus
44009-801-204400908012020 in 1 BLISTER PACKHistorical