FDA.reportPublic FDA data

Spectracef

Product NDC
44004-802
11-digit product format
440040802
Labeler code
44004
Product ID
44004-802_f99cc35f-6ffa-4f2e-bcdf-e51bb9a17c0d
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Cefditoren Pivoxil
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Vansen Pharma Inc.
Application
NDA021222
Marketing category
NDA
Marketing start
2013-02-05
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
a62a50ac-1535-4461-9768-8ae703e2e9fbProduct name120210525
735c6807-7b6d-31b0-8032-5eb0f5889757Product name120140508
9514609b-a2a9-f8ec-6ba6-3f8e5ee89877Product name120140508
bc07ef78-e82d-0c19-31f4-31f263780582Product name120140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
44004-802-202019-11-27C16284748780-19855d018-e309-cd31-e053-dbdaa90ab51aSpectracef® (cefditoren pivoxil) Tablets 200 mg and 400 mg
44004-802-282019-11-27C16284748780-19855d018-e309-cd31-e053-dbdaa90ab51aSpectracef® (cefditoren pivoxil) Tablets 200 mg and 400 mg

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
44004-802-20Spectracef20 in 1 BLISTER PACKTABLET, FILM COATED202
44004-802-28Spectracef28 in 1 BLISTER PACKTABLET, FILM COATED282

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
44004-802-20EA - Each44004-80248f051a0-6fbf-4737-8f16-855ee12d995912013-06-04
44004-802-28EA - Each44004-8021050f2cb-5a41-438e-9bf0-e8b6af7aa50c12013-06-04

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
CEFDITOREN PIVOXILACTIVE INGREDIENT78THA212DHSPECTRACEF (CEFDITOREN PIVOXIL) TABLET, FILM COATED SPECTRACEF (CEFDITOREN PIVOXIL) TABLET, FILM COATED [VANSEN PHARMA INC.]2
CEFDITORENACTIVE MOIETY81QS09V3YWSPECTRACEF (CEFDITOREN PIVOXIL) TABLET, FILM COATED SPECTRACEF (CEFDITOREN PIVOXIL) TABLET, FILM COATED [VANSEN PHARMA INC.]2
CARNAUBA WAXINACTIVE INGREDIENTR12CBM0EIZSPECTRACEF (CEFDITOREN PIVOXIL) TABLET, FILM COATED SPECTRACEF (CEFDITOREN PIVOXIL) TABLET, FILM COATED [VANSEN PHARMA INC.]2
CROSCARMELLOSE SODIUMINACTIVE INGREDIENTM28OL1HH48SPECTRACEF (CEFDITOREN PIVOXIL) TABLET, FILM COATED SPECTRACEF (CEFDITOREN PIVOXIL) TABLET, FILM COATED [VANSEN PHARMA INC.]2
D&C RED NO. 27INACTIVE INGREDIENT2LRS185U6KSPECTRACEF (CEFDITOREN PIVOXIL) TABLET, FILM COATED SPECTRACEF (CEFDITOREN PIVOXIL) TABLET, FILM COATED [VANSEN PHARMA INC.]2
FD&C BLUE NO. 1INACTIVE INGREDIENTH3R47K3TBDSPECTRACEF (CEFDITOREN PIVOXIL) TABLET, FILM COATED SPECTRACEF (CEFDITOREN PIVOXIL) TABLET, FILM COATED [VANSEN PHARMA INC.]2
HYDROXYPROPYL CELLULOSEINACTIVE INGREDIENTRFW2ET671PSPECTRACEF (CEFDITOREN PIVOXIL) TABLET, FILM COATED SPECTRACEF (CEFDITOREN PIVOXIL) TABLET, FILM COATED [VANSEN PHARMA INC.]2
HYPROMELLOSESINACTIVE INGREDIENT3NXW29V3WOSPECTRACEF (CEFDITOREN PIVOXIL) TABLET, FILM COATED SPECTRACEF (CEFDITOREN PIVOXIL) TABLET, FILM COATED [VANSEN PHARMA INC.]2
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30SPECTRACEF (CEFDITOREN PIVOXIL) TABLET, FILM COATED SPECTRACEF (CEFDITOREN PIVOXIL) TABLET, FILM COATED [VANSEN PHARMA INC.]2
MANNITOLINACTIVE INGREDIENT3OWL53L36ASPECTRACEF (CEFDITOREN PIVOXIL) TABLET, FILM COATED SPECTRACEF (CEFDITOREN PIVOXIL) TABLET, FILM COATED [VANSEN PHARMA INC.]2
POLYETHYLENE GLYCOLSINACTIVE INGREDIENT3WJQ0SDW1ASPECTRACEF (CEFDITOREN PIVOXIL) TABLET, FILM COATED SPECTRACEF (CEFDITOREN PIVOXIL) TABLET, FILM COATED [VANSEN PHARMA INC.]2
PROPYLENE GLYCOLINACTIVE INGREDIENT6DC9Q167V3SPECTRACEF (CEFDITOREN PIVOXIL) TABLET, FILM COATED SPECTRACEF (CEFDITOREN PIVOXIL) TABLET, FILM COATED [VANSEN PHARMA INC.]2
SHELLACINACTIVE INGREDIENT46N107B71OSPECTRACEF (CEFDITOREN PIVOXIL) TABLET, FILM COATED SPECTRACEF (CEFDITOREN PIVOXIL) TABLET, FILM COATED [VANSEN PHARMA INC.]2
SODIUM CASEINATEINACTIVE INGREDIENT7473P66J9ESPECTRACEF (CEFDITOREN PIVOXIL) TABLET, FILM COATED SPECTRACEF (CEFDITOREN PIVOXIL) TABLET, FILM COATED [VANSEN PHARMA INC.]2
SODIUM TRIPOLYPHOSPHATEINACTIVE INGREDIENT5HK03SA80JSPECTRACEF (CEFDITOREN PIVOXIL) TABLET, FILM COATED SPECTRACEF (CEFDITOREN PIVOXIL) TABLET, FILM COATED [VANSEN PHARMA INC.]2
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPSPECTRACEF (CEFDITOREN PIVOXIL) TABLET, FILM COATED SPECTRACEF (CEFDITOREN PIVOXIL) TABLET, FILM COATED [VANSEN PHARMA INC.]2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
44004-802SPECTRACEF (CEFDITOREN PIVOXIL) TABLET, FILM COATED SPECTRACEF (CEFDITOREN PIVOXIL) TABLET, FILM COATED [VANSEN PHARMA INC.]2Legacy NDC, 2 package rows20130605_1c90b649-5536-417c-82cb-89663137f14f.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
351127cefditoren pivoxil 200 MG Oral TabletPSN1c90b649-5536-417c-82cb-89663137f14f2
847360cefditoren pivoxil 400 MG Oral TabletPSN1c90b649-5536-417c-82cb-89663137f14f2
847365Spectracef 200 MG Oral TabletPSN1c90b649-5536-417c-82cb-89663137f14f2
847362Spectracef 400 MG Oral TabletPSN1c90b649-5536-417c-82cb-89663137f14f2
847365cefditoren pivoxil 200 MG Oral Tablet [Spectracef]SBD1c90b649-5536-417c-82cb-89663137f14f2
847362cefditoren pivoxil 400 MG Oral Tablet [Spectracef]SBD1c90b649-5536-417c-82cb-89663137f14f2
351127cefditoren pivoxil 200 MG Oral TabletSCD1c90b649-5536-417c-82cb-89663137f14f2
847360cefditoren pivoxil 400 MG Oral TabletSCD1c90b649-5536-417c-82cb-89663137f14f2
847365Spectracef 200 MG Oral TabletSY1c90b649-5536-417c-82cb-89663137f14f2
847362Spectracef 400 MG Oral TabletSY1c90b649-5536-417c-82cb-89663137f14f2

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionStatus
44004-802-204400408022020 in 1 BLISTER PACKHistorical
44004-802-284400408022828 in 1 BLISTER PACKHistorical