FDA.reportPublic FDA data

Cefpodoxime Proxetil

Product NDC
65862-140
11-digit product format
658620140
Labeler code
65862
Product ID
65862-140_95331369-8343-4244-8d82-03a1bc4af0c0
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Cefpodoxime Proxetil
Dosage form
GRANULE, FOR SUSPENSION
Route
ORAL
Labeler
Aurobindo Pharma Limited
Application
ANDA065409
Marketing category
ANDA
Marketing start
2007-06-08
Substance
CEFPODOXIME PROXETIL
Active strength
50 mg/5mL
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 PROXETIL50 mg/5mL

Harmonized Identifiers#

Field, Values table
FieldValues
Unii2TB00A1Z7N
Rxcui309077, 309079

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
65862-140-01Cefpodoxime Proxetil100 mL in 1 BOTTLEGRANULE, FOR SUSPENSION10011
65862-140-01Cefpodoxime Proxetil1 in 1 CARTONGRANULE, FOR SUSPENSION111
65862-140-50Cefpodoxime Proxetil50 mL in 1 BOTTLEGRANULE, FOR SUSPENSION5011
65862-140-50Cefpodoxime Proxetil1 in 1 CARTONGRANULE, FOR SUSPENSION111
65862-140-75Cefpodoxime Proxetil75 mL in 1 BOTTLEGRANULE, FOR SUSPENSION7511
65862-140-75Cefpodoxime Proxetil1 in 1 CARTONGRANULE, FOR SUSPENSION111

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
65862-140-01ML - Milliliter65862-14051beec75-9a0e-4afd-82a9-9facd2de492312012-07-24
65862-140-50ML - Milliliter65862-14098425837-0ee2-44e2-880b-c7aec1da893212012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
CEFPODOXIME PROXETILACTIVE INGREDIENT2TB00A1Z7NCEFPODOXIME PROXETIL GRANULE, FOR SUSPENSION [AUROBINDO PHARMA LIMITED]6
CEFPODOXIMEACTIVE MOIETY7R4F94TVGYCEFPODOXIME PROXETIL GRANULE, FOR SUSPENSION [AUROBINDO PHARMA LIMITED]6
ANHYDROUS CITRIC ACIDINACTIVE INGREDIENTXF417D3PSLCEFPODOXIME PROXETIL GRANULE, FOR SUSPENSION [AUROBINDO PHARMA LIMITED]6
CARBOXYMETHYLCELLULOSE SODIUMINACTIVE INGREDIENTK679OBS311CEFPODOXIME PROXETIL GRANULE, FOR SUSPENSION [AUROBINDO PHARMA LIMITED]6
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UCEFPODOXIME PROXETIL GRANULE, FOR SUSPENSION [AUROBINDO PHARMA LIMITED]6
CROSCARMELLOSE SODIUMINACTIVE INGREDIENTM28OL1HH48CEFPODOXIME PROXETIL GRANULE, FOR SUSPENSION [AUROBINDO PHARMA LIMITED]6
FERRIC OXIDE YELLOWINACTIVE INGREDIENTEX438O2MRTCEFPODOXIME PROXETIL GRANULE, FOR SUSPENSION [AUROBINDO PHARMA LIMITED]6
HYDROXYPROPYL CELLULOSEINACTIVE INGREDIENTRFW2ET671PCEFPODOXIME PROXETIL GRANULE, FOR SUSPENSION [AUROBINDO PHARMA LIMITED]6
LACTOSE MONOHYDRATEINACTIVE INGREDIENTEWQ57Q8I5XCEFPODOXIME PROXETIL GRANULE, FOR SUSPENSION [AUROBINDO PHARMA LIMITED]6
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4CEFPODOXIME PROXETIL GRANULE, FOR SUSPENSION [AUROBINDO PHARMA LIMITED]6
SODIUM BENZOATEINACTIVE INGREDIENTOJ245FE5EUCEFPODOXIME PROXETIL GRANULE, FOR SUSPENSION [AUROBINDO PHARMA LIMITED]6
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJCEFPODOXIME PROXETIL GRANULE, FOR SUSPENSION [AUROBINDO PHARMA LIMITED]6
SUCROSEINACTIVE INGREDIENTC151H8M554CEFPODOXIME PROXETIL GRANULE, FOR SUSPENSION [AUROBINDO PHARMA LIMITED]6
TRISODIUM CITRATE DIHYDRATEINACTIVE INGREDIENTB22547B95KCEFPODOXIME PROXETIL GRANULE, FOR SUSPENSION [AUROBINDO PHARMA LIMITED]6

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
65862-140CEFPODOXIME PROXETIL GRANULE, FOR SUSPENSION [AUROBINDO PHARMA LIMITED]11Current NDC, Legacy NDC, 6 package rows20240105_63777889-d306-4fc3-88da-b24859040ef4.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
309077cefpodoxime 100 MG in 5 mL Oral SuspensionPSN63777889-d306-4fc3-88da-b24859040ef411
309079cefpodoxime 50 MG in 5 mL Oral SuspensionPSN63777889-d306-4fc3-88da-b24859040ef411
309079cefpodoxime 10 MG/ML Oral SuspensionSCD63777889-d306-4fc3-88da-b24859040ef411
309077cefpodoxime 20 MG/ML Oral SuspensionSCD63777889-d306-4fc3-88da-b24859040ef411
309077cefpodoxime (as cefpodoxime proxetil) 100 MG per 5 ML Oral SuspensionSY63777889-d306-4fc3-88da-b24859040ef411
309079cefpodoxime (as cefpodoxime proxetil) 50 MG per 5 ML Oral SuspensionSY63777889-d306-4fc3-88da-b24859040ef411
309077cefpodoxime 100 MG per 5 ML Oral SuspensionSY63777889-d306-4fc3-88da-b24859040ef411
309079cefpodoxime 50 MG per 5 ML Oral SuspensionSY63777889-d306-4fc3-88da-b24859040ef411

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
65862-140-01658620140011 BOTTLE in 1 CARTON (65862-140-01) / 100 mL in 1 BOTTLE1 bottle2007-06-080000-00-00NoNoCurrent
65862-140-50658620140501 BOTTLE in 1 CARTON (65862-140-50) / 50 mL in 1 BOTTLE1 bottle2007-06-080000-00-00NoNoCurrent
65862-140-75658620140751 BOTTLE in 1 CARTON (65862-140-75) / 75 mL in 1 BOTTLE1 bottle2007-06-080000-00-00NoNoCurrent