CEFPODOXIME PROXETIL

Product NDC
55289-393
11-digit product format
552890393
Labeler code
55289
Product ID
55289-393_dd0401d5-c552-7684-e053-2995a90aafbe
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
CEFPODOXIME PROXETIL
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
PD-Rx Pharmaceuticals, Inc.
Application
ANDA065370
Marketing category
ANDA
Marketing start
2007-06-11
Marketing end
0000-00-00
Substance
CEFPODOXIME PROXETIL
Active strength
200 mg/1
Pharmacologic classes
Cephalosporin Antibacterial [EPC], Cephalosporins [CS]
NDC exclude flag
No
Listing certified through
2023-12-31
Current FDA listing
Historical FDA.report record

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
e28aad34-15f4-8358-f1eb-20900c754318Product name220230125
bd926630-c211-e651-84da-4ef72dbed2c5Product name120140508

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
55289-393-02EA - Each55289-393dc09623b-695b-4101-b57e-4410b716f93812012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
CEFPODOXIME PROXETILACTIVE INGREDIENT2TB00A1Z7NCEFPODOXIME PROXETIL TABLET, FILM COATED [PD-RX PHARMACEUTICALS, INC.]3
CEFPODOXIMEACTIVE MOIETY7R4F94TVGYCEFPODOXIME PROXETIL TABLET, FILM COATED [PD-RX PHARMACEUTICALS, INC.]3
CARBOXYMETHYLCELLULOSE CALCIUMINACTIVE INGREDIENTUTY7PDF93LCEFPODOXIME PROXETIL TABLET, FILM COATED [PD-RX PHARMACEUTICALS, INC.]3
CROSPOVIDONEINACTIVE INGREDIENT68401960MKCEFPODOXIME PROXETIL TABLET, FILM COATED [PD-RX PHARMACEUTICALS, INC.]3
FD&C RED NO. 40INACTIVE INGREDIENTWZB9127XOACEFPODOXIME PROXETIL TABLET, FILM COATED [PD-RX PHARMACEUTICALS, INC.]3
FD&C YELLOW NO. 6INACTIVE INGREDIENTH77VEI93A8CEFPODOXIME PROXETIL TABLET, FILM COATED [PD-RX PHARMACEUTICALS, INC.]3
HYDROXYPROPYL CELLULOSEINACTIVE INGREDIENTRFW2ET671PCEFPODOXIME PROXETIL TABLET, FILM COATED [PD-RX PHARMACEUTICALS, INC.]3
HYPROMELLOSE 2910 (6 MPA.S)INACTIVE INGREDIENT0WZ8WG20P6CEFPODOXIME PROXETIL TABLET, FILM COATED [PD-RX PHARMACEUTICALS, INC.]3
LACTOSE MONOHYDRATEINACTIVE INGREDIENTEWQ57Q8I5XCEFPODOXIME PROXETIL TABLET, FILM COATED [PD-RX PHARMACEUTICALS, INC.]3
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30CEFPODOXIME PROXETIL TABLET, FILM COATED [PD-RX PHARMACEUTICALS, INC.]3
PROPYLENE GLYCOLINACTIVE INGREDIENT6DC9Q167V3CEFPODOXIME PROXETIL TABLET, FILM COATED [PD-RX PHARMACEUTICALS, INC.]3
SODIUM LAURYL SULFATEINACTIVE INGREDIENT368GB5141JCEFPODOXIME PROXETIL TABLET, FILM COATED [PD-RX PHARMACEUTICALS, INC.]3
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJCEFPODOXIME PROXETIL TABLET, FILM COATED [PD-RX PHARMACEUTICALS, INC.]3
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPCEFPODOXIME PROXETIL TABLET, FILM COATED [PD-RX PHARMACEUTICALS, INC.]3

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
55289-393CEFPODOXIME PROXETIL TABLET, FILM COATED [PD-RX PHARMACEUTICALS, INC.]16Legacy NDC20241012_8b7f7043-5bfb-47a5-80cb-4f3f65358dff.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
55289-393-02552890393022 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (55289-393-02) 2010-06-230000-00-00NoNoCurrent