FDA.reportPublic FDA data

Cefpodoxime Proxetil

Product NDC
67877-878
11-digit product format
678770878
Labeler code
67877
Product ID
67877-878_1a9e47ee-3f6f-4be0-9b06-9430d2a5f1bd
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Cefpodoxime Proxetil
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Ascend Laboratories, LLC
Application
ANDA210568
Marketing category
ANDA
Marketing start
2023-03-01
Substance
CEFPODOXIME PROXETIL
Active strength
100 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 PROXETIL100 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
67877-878-01Cefpodoxime Proxetil100 in 1 BOTTLETABLET, FILM COATED1002
67877-878-05Cefpodoxime Proxetil500 in 1 BOTTLETABLET, FILM COATED5002
67877-878-20Cefpodoxime Proxetil20 in 1 BOTTLETABLET, FILM COATED202

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
67877-878-20EA - Each67877-878b8aafce6-48fd-4994-9f3c-1ec8694588bb12023-03-13

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
67877-878CEFPODOXIME PROXETIL TABLET, FILM COATED [ASCEND LABORATORIES, LLC]2Current NDC, 3 package rows20230419_ce5646cb-a450-4c2c-8499-6ecf71b12b0e.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
309076cefpodoxime proxetil 100 MG Oral TabletPSNce5646cb-a450-4c2c-8499-6ecf71b12b0e2
309078cefpodoxime proxetil 200 MG Oral TabletPSNce5646cb-a450-4c2c-8499-6ecf71b12b0e2
309076cefpodoxime 100 MG Oral TabletSCDce5646cb-a450-4c2c-8499-6ecf71b12b0e2
309078cefpodoxime 200 MG Oral TabletSCDce5646cb-a450-4c2c-8499-6ecf71b12b0e2
309076cefpodoxime proxetil 100 MG Oral TabletPSN1b405104-650b-c8e3-e063-6294a90a9e8a1
309076cefpodoxime 100 MG Oral TabletSCD1b405104-650b-c8e3-e063-6294a90a9e8a1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
67877-878-0167877087801100 TABLET, FILM COATED in 1 BOTTLE (67877-878-01) 2023-03-01NoNoHistorical
67877-878-0567877087805500 TABLET, FILM COATED in 1 BOTTLE (67877-878-05) 2023-03-01NoNoHistorical
67877-878-206787708782020 TABLET, FILM COATED in 1 BOTTLE (67877-878-20) 2023-03-01NoNoHistorical