CEFPODOXIME PROXETIL

Product NDC
69043-007
11-digit product format
690430007
Labeler code
69043
Product ID
69043-007_36f0759f-b50b-4a49-869b-d73f5ad7d8cf
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
CEFPODOXIME PROXETIL
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Cronus Pharma LLC
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
69043-007-01CEFPODOXIME PROXETIL100 in 1 BOTTLETABLET, FILM COATED1006
69043-007-25CEFPODOXIME PROXETIL250 in 1 BOTTLETABLET, FILM COATED2506

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
69043-007CEFPODOXIME PROXETIL TABLET, FILM COATED [CRONUS PHARMA LLC]6Current NDC, Legacy NDC, 2 package rows20240106_bc9c338c-1fc7-4bc2-a357-a78e433cbe9d.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
309076cefpodoxime proxetil 100 MG Oral TabletPSNbc9c338c-1fc7-4bc2-a357-a78e433cbe9d6
309078cefpodoxime proxetil 200 MG Oral TabletPSNbc9c338c-1fc7-4bc2-a357-a78e433cbe9d6
309076cefpodoxime 100 MG Oral TabletSCDbc9c338c-1fc7-4bc2-a357-a78e433cbe9d6
309078cefpodoxime 200 MG Oral TabletSCDbc9c338c-1fc7-4bc2-a357-a78e433cbe9d6

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
69043-007-0169043000701100 TABLET, FILM COATED in 1 BOTTLE (69043-007-01) 2007-06-110000-00-00NoNoCurrent
69043-007-2569043000725250 TABLET, FILM COATED in 1 BOTTLE (69043-007-25) 2023-10-06NoNoHistorical