Cefpodoxime Proxetil

Product NDC
0781-5439
11-digit product format
007815439
Labeler code
0781
Product ID
0781-5439_6878b572-5711-43a8-9972-1410927f1f14
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Cefpodoxime Proxetil
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Sandoz Inc
Application
ANDA065462
Marketing category
ANDA
Marketing start
2008-05-28
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
0781-5439-01Cefpodoxime Proxetil100 in 1 BOTTLETABLET, FILM COATED10017
0781-5439-20Cefpodoxime Proxetil20 in 1 BOTTLETABLET, FILM COATED2017

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0781-5439-01EA - Each0781-54394e9c5c7f-8b63-4be7-9c13-7e626ffcb3f012012-07-24
0781-5439-20EA - Each0781-543905fa2b43-4790-4b5f-a8af-cd2a193a044312012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
CEFPODOXIME PROXETILACTIVE INGREDIENT2TB00A1Z7NCEFPODOXIME PROXETIL TABLET, FILM COATED [SANDOZ INC]14
CEFPODOXIMEACTIVE MOIETY7R4F94TVGYCEFPODOXIME PROXETIL TABLET, FILM COATED [SANDOZ INC]14
CARBOXYMETHYLCELLULOSE CALCIUMINACTIVE INGREDIENTUTY7PDF93LCEFPODOXIME PROXETIL TABLET, FILM COATED [SANDOZ INC]14
CROSPOVIDONEINACTIVE INGREDIENT68401960MKCEFPODOXIME PROXETIL TABLET, FILM COATED [SANDOZ INC]14
FD&C YELLOW NO. 6INACTIVE INGREDIENTH77VEI93A8CEFPODOXIME PROXETIL TABLET, FILM COATED [SANDOZ INC]14
HYDROXYPROPYL CELLULOSE (TYPE H)INACTIVE INGREDIENTRFW2ET671PCEFPODOXIME PROXETIL TABLET, FILM COATED [SANDOZ INC]14
HYPROMELLOSESINACTIVE INGREDIENT3NXW29V3WOCEFPODOXIME PROXETIL TABLET, FILM COATED [SANDOZ INC]14
LACTOSE MONOHYDRATEINACTIVE INGREDIENTEWQ57Q8I5XCEFPODOXIME PROXETIL TABLET, FILM COATED [SANDOZ INC]14
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30CEFPODOXIME PROXETIL TABLET, FILM COATED [SANDOZ INC]14
SODIUM LAURYL SULFATEINACTIVE INGREDIENT368GB5141JCEFPODOXIME PROXETIL TABLET, FILM COATED [SANDOZ INC]14
TALCINACTIVE INGREDIENT7SEV7J4R1UCEFPODOXIME PROXETIL TABLET, FILM COATED [SANDOZ INC]14
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPCEFPODOXIME PROXETIL TABLET, FILM COATED [SANDOZ INC]14

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0781-5439CEFPODOXIME PROXETIL TABLET, FILM COATED [SANDOZ INC]17Current NDC, Legacy NDC, 2 package rows20210402_8519a9d8-7106-4545-bc58-859ee9a6708e.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
309076cefpodoxime proxetil 100 MG Oral TabletPSN8519a9d8-7106-4545-bc58-859ee9a6708e17
309078cefpodoxime proxetil 200 MG Oral TabletPSN8519a9d8-7106-4545-bc58-859ee9a6708e17
309076cefpodoxime 100 MG Oral TabletSCD8519a9d8-7106-4545-bc58-859ee9a6708e17
309078cefpodoxime 200 MG Oral TabletSCD8519a9d8-7106-4545-bc58-859ee9a6708e17

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
0781-5439-0100781543901100 TABLET, FILM COATED in 1 BOTTLE (0781-5439-01) 2008-05-280000-00-00NoNoCurrent
0781-5439-200078154392020 TABLET, FILM COATED in 1 BOTTLE (0781-5439-20) 2008-05-280000-00-00NoNoCurrent