Cefditoren Pivoxil

Product NDC
44009-802
11-digit product format
440090802
Labeler code
44009
Product ID
44009-802_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
2010-01-01
Marketing end
0000-00-00
Substance
CEFDITOREN PIVOXIL
Active strength
400 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
44009-802-202019-11-27C16284748780-19855d018-e114-cd31-e053-dbdaa90ab51aCefditoren Pivoxil Tablets 200 mg and 400 mg
44009-802-282019-11-27C16284748780-19855d018-e114-cd31-e053-dbdaa90ab51aCefditoren Pivoxil Tablets 200 mg and 400 mg

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
44009-802-20Cefditoren Pivoxil20 in 1 BLISTER PACKTABLET, FILM COATED202
44009-802-28Cefditoren Pivoxil28 in 1 BLISTER PACKTABLET, FILM COATED282

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
44009-802CEFDITOREN PIVOXIL TABLET, FILM COATED [PHARMA ROMLEV INC.]2Legacy NDC, 2 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
44009-802-204400908022020 in 1 BLISTER PACKHistorical
44009-802-284400908022828 in 1 BLISTER PACKHistorical