FDA.reportPublic FDA data

Cefpodoxime Proxetil

Product NDC
64980-402
11-digit product format
649800402
Labeler code
64980
Product ID
64980-402_803b37ff-46c6-4dcb-9d9f-a118c4c4601b
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Cefpodoxime Proxetil
Dosage form
GRANULE, FOR SUSPENSION
Route
ORAL
Labeler
Rising Pharma Holdings, Inc.
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
64980-402-10Cefpodoxime Proxetil100 mL in 1 BOTTLEGRANULE, FOR SUSPENSION1007
64980-402-10Cefpodoxime Proxetil1 in 1 CARTONGRANULE, FOR SUSPENSION17
64980-402-50Cefpodoxime Proxetil1 in 1 CARTONGRANULE, FOR SUSPENSION17
64980-402-50Cefpodoxime Proxetil50 mL in 1 BOTTLEGRANULE, FOR SUSPENSION507

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
64980-402CEFPODOXIME PROXETIL GRANULE, FOR SUSPENSION [RISING PHARMA HOLDINGS, INC.]6Current NDC, Legacy NDC, 4 package rows20240105_edf589b2-f796-4522-a5e6-2bd0a833922f.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
309077cefpodoxime 100 MG in 5 mL Oral SuspensionPSNedf589b2-f796-4522-a5e6-2bd0a833922f7
309079cefpodoxime 50 MG in 5 mL Oral SuspensionPSNedf589b2-f796-4522-a5e6-2bd0a833922f7
309079cefpodoxime 10 MG/ML Oral SuspensionSCDedf589b2-f796-4522-a5e6-2bd0a833922f7
309077cefpodoxime 20 MG/ML Oral SuspensionSCDedf589b2-f796-4522-a5e6-2bd0a833922f7
309077cefpodoxime (as cefpodoxime proxetil) 100 MG per 5 ML Oral SuspensionSYedf589b2-f796-4522-a5e6-2bd0a833922f7
309079cefpodoxime (as cefpodoxime proxetil) 50 MG per 5 ML Oral SuspensionSYedf589b2-f796-4522-a5e6-2bd0a833922f7
309077cefpodoxime 100 MG per 5 ML Oral SuspensionSYedf589b2-f796-4522-a5e6-2bd0a833922f7
309079cefpodoxime 50 MG per 5 ML Oral SuspensionSYedf589b2-f796-4522-a5e6-2bd0a833922f7

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
64980-402-10649800402101 BOTTLE in 1 CARTON (64980-402-10) / 100 mL in 1 BOTTLE1 bottle2007-06-080000-00-00NoNoCurrent
64980-402-50649800402501 BOTTLE in 1 CARTON (64980-402-50) / 50 mL in 1 BOTTLE1 bottle2007-06-080000-00-00NoNoCurrent