FDA.reportPublic FDA data

CEFPODOXIME PROXETIL

Product NDC
65862-096
11-digit product format
658620096
Labeler code
65862
Product ID
65862-096_12ee6554-adfc-4c3b-b87e-3568576359a6
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
CEFPODOXIME PROXETIL
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Aurobindo Pharma Limited
Application
ANDA065370
Marketing category
ANDA
Marketing start
2007-06-11
Substance
CEFPODOXIME PROXETIL
Active strength
200 mg/1
Pharmacologic classes
Cephalosporin Antibacterial [EPC], Cephalosporins [CS]
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
CEFPODOXIME PROXETIL
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
CEFPODOXIME PROXETIL200 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii2TB00A1Z7N
Rxcui309076, 309078

DailyMed Product Concepts#

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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
65862-096-01CEFPODOXIME PROXETIL100 in 1 BOTTLETABLET, FILM COATED10012
65862-096-20CEFPODOXIME PROXETIL20 in 1 BOTTLETABLET, FILM COATED2012
65862-096-25CEFPODOXIME PROXETIL250 in 1 BOTTLETABLET, FILM COATED25012
65862-096-99CEFPODOXIME PROXETIL1000 in 1 BOTTLETABLET, FILM COATED100012

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
65862-096-01EA - Each65862-0960eea6b6b-87da-4c5d-8823-ee2d0efa920312012-07-24
65862-096-20EA - Each65862-096410ff95a-2f49-4caa-952a-aa06a27ca47112012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
CEFPODOXIME PROXETILACTIVE INGREDIENT2TB00A1Z7NCEFPODOXIME PROXETIL TABLET, FILM COATED [AUROBINDO PHARMA LIMITED]5
CEFPODOXIMEACTIVE MOIETY7R4F94TVGYCEFPODOXIME PROXETIL TABLET, FILM COATED [AUROBINDO PHARMA LIMITED]5
CARBOXYMETHYLCELLULOSE CALCIUMINACTIVE INGREDIENTUTY7PDF93LCEFPODOXIME PROXETIL TABLET, FILM COATED [AUROBINDO PHARMA LIMITED]5
CROSPOVIDONEINACTIVE INGREDIENT68401960MKCEFPODOXIME PROXETIL TABLET, FILM COATED [AUROBINDO PHARMA LIMITED]5
FD&C RED NO. 40INACTIVE INGREDIENTWZB9127XOACEFPODOXIME PROXETIL TABLET, FILM COATED [AUROBINDO PHARMA LIMITED]5
FD&C YELLOW NO. 6INACTIVE INGREDIENTH77VEI93A8CEFPODOXIME PROXETIL TABLET, FILM COATED [AUROBINDO PHARMA LIMITED]5
FERRIC OXIDE YELLOWINACTIVE INGREDIENTEX438O2MRTCEFPODOXIME PROXETIL TABLET, FILM COATED [AUROBINDO PHARMA LIMITED]5
HYDROXYPROPYL CELLULOSEINACTIVE INGREDIENTRFW2ET671PCEFPODOXIME PROXETIL TABLET, FILM COATED [AUROBINDO PHARMA LIMITED]5
HYPROMELLOSE 2910 (6 MPA.S)INACTIVE INGREDIENT0WZ8WG20P6CEFPODOXIME PROXETIL TABLET, FILM COATED [AUROBINDO PHARMA LIMITED]5
LACTOSE MONOHYDRATEINACTIVE INGREDIENTEWQ57Q8I5XCEFPODOXIME PROXETIL TABLET, FILM COATED [AUROBINDO PHARMA LIMITED]5
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30CEFPODOXIME PROXETIL TABLET, FILM COATED [AUROBINDO PHARMA LIMITED]5
PROPYLENE GLYCOLINACTIVE INGREDIENT6DC9Q167V3CEFPODOXIME PROXETIL TABLET, FILM COATED [AUROBINDO PHARMA LIMITED]5
SODIUM LAURYL SULFATEINACTIVE INGREDIENT368GB5141JCEFPODOXIME PROXETIL TABLET, FILM COATED [AUROBINDO PHARMA LIMITED]5
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJCEFPODOXIME PROXETIL TABLET, FILM COATED [AUROBINDO PHARMA LIMITED]5
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPCEFPODOXIME PROXETIL TABLET, FILM COATED [AUROBINDO PHARMA LIMITED]5
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
65862-096CEFPODOXIME PROXETIL TABLET, FILM COATED [AUROBINDO PHARMA LIMITED]12Current NDC, Legacy NDC, 4 package rows20240104_c36f2137-98bb-4583-89f7-6bce9582c465.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
309076cefpodoxime proxetil 100 MG Oral TabletPSNc36f2137-98bb-4583-89f7-6bce9582c46512
309078cefpodoxime proxetil 200 MG Oral TabletPSNc36f2137-98bb-4583-89f7-6bce9582c46512
309076cefpodoxime 100 MG Oral TabletSCDc36f2137-98bb-4583-89f7-6bce9582c46512
309078cefpodoxime 200 MG Oral TabletSCDc36f2137-98bb-4583-89f7-6bce9582c46512

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
65862-096-0165862009601100 TABLET, FILM COATED in 1 BOTTLE (65862-096-01) 2007-06-110000-00-00NoNoCurrent
65862-096-206586200962020 TABLET, FILM COATED in 1 BOTTLE (65862-096-20) 2007-06-110000-00-00NoNoCurrent
65862-096-2565862009625250 TABLET, FILM COATED in 1 BOTTLE (65862-096-25) 2023-10-06NoNoHistorical
65862-096-99658620096991000 TABLET, FILM COATED in 1 BOTTLE (65862-096-99) 2007-06-110000-00-00NoNoCurrent