CEFPODOXIME PROXETIL

Product NDC
16714-395
11-digit product format
167140395
Labeler code
16714
Product ID
16714-395_518e9779-a683-436e-a032-c6a0df0a0de2
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
CEFPODOXIME PROXETIL
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
NorthStar Rx 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
16714-395-01CEFPODOXIME PROXETIL20 in 1 BOTTLETABLET, FILM COATED209

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
16714-395-01EA - Each16714-395ff140a51-d7a7-43d6-b17b-6a7b571e63f912013-03-03

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
CEFPODOXIME PROXETILACTIVE INGREDIENT2TB00A1Z7NCEFPODOXIME PROXETIL TABLET, FILM COATED [NORTHSTAR RX LLC]2
CEFPODOXIMEACTIVE MOIETY7R4F94TVGYCEFPODOXIME PROXETIL TABLET, FILM COATED [NORTHSTAR RX LLC]2
CARBOXYMETHYLCELLULOSE CALCIUMINACTIVE INGREDIENTUTY7PDF93LCEFPODOXIME PROXETIL TABLET, FILM COATED [NORTHSTAR RX LLC]2
CROSPOVIDONEINACTIVE INGREDIENT68401960MKCEFPODOXIME PROXETIL TABLET, FILM COATED [NORTHSTAR RX LLC]2
FD&C RED NO. 40INACTIVE INGREDIENTWZB9127XOACEFPODOXIME PROXETIL TABLET, FILM COATED [NORTHSTAR RX LLC]2
FD&C YELLOW NO. 6INACTIVE INGREDIENTH77VEI93A8CEFPODOXIME PROXETIL TABLET, FILM COATED [NORTHSTAR RX LLC]2
FERRIC OXIDE YELLOWINACTIVE INGREDIENTEX438O2MRTCEFPODOXIME PROXETIL TABLET, FILM COATED [NORTHSTAR RX LLC]2
HYDROXYPROPYL CELLULOSEINACTIVE INGREDIENTRFW2ET671PCEFPODOXIME PROXETIL TABLET, FILM COATED [NORTHSTAR RX LLC]2
HYPROMELLOSE 2910 (6 MPA.S)INACTIVE INGREDIENT0WZ8WG20P6CEFPODOXIME PROXETIL TABLET, FILM COATED [NORTHSTAR RX LLC]2
LACTOSE MONOHYDRATEINACTIVE INGREDIENTEWQ57Q8I5XCEFPODOXIME PROXETIL TABLET, FILM COATED [NORTHSTAR RX LLC]2
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30CEFPODOXIME PROXETIL TABLET, FILM COATED [NORTHSTAR RX LLC]2
PROPYLENE GLYCOLINACTIVE INGREDIENT6DC9Q167V3CEFPODOXIME PROXETIL TABLET, FILM COATED [NORTHSTAR RX LLC]2
SODIUM LAURYL SULFATEINACTIVE INGREDIENT368GB5141JCEFPODOXIME PROXETIL TABLET, FILM COATED [NORTHSTAR RX LLC]2
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJCEFPODOXIME PROXETIL TABLET, FILM COATED [NORTHSTAR RX LLC]2
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPCEFPODOXIME PROXETIL TABLET, FILM COATED [NORTHSTAR RX LLC]2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
16714-395CEFPODOXIME PROXETIL TABLET, FILM COATED [NORTHSTAR RX LLC]9Current NDC, Legacy NDC, 1 package rows20240104_4587a7c1-cd6c-4946-a0dd-fcfe0c8504b9.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
309076cefpodoxime proxetil 100 MG Oral TabletPSN4587a7c1-cd6c-4946-a0dd-fcfe0c8504b99
309078cefpodoxime proxetil 200 MG Oral TabletPSN4587a7c1-cd6c-4946-a0dd-fcfe0c8504b99
309076cefpodoxime 100 MG Oral TabletSCD4587a7c1-cd6c-4946-a0dd-fcfe0c8504b99
309078cefpodoxime 200 MG Oral TabletSCD4587a7c1-cd6c-4946-a0dd-fcfe0c8504b99

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
16714-395-011671403950120 TABLET, FILM COATED in 1 BOTTLE (16714-395-01) 2007-06-110000-00-00NoNoCurrent