Cefpodoxime Proxetil

Product NDC
69292-516
11-digit product format
692920516
Labeler code
69292
Product ID
69292-516_157c18ee-7809-4e05-8caa-0359ef50142e
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Cefpodoxime Proxetil
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Amici Pharmaceuticals, LLC.
Application
ANDA210568
Marketing category
ANDA
Marketing start
2022-12-21
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
69292-516-01Cefpodoxime Proxetil100 in 1 BOTTLETABLET, FILM COATED1005
69292-516-50Cefpodoxime Proxetil500 in 1 BOTTLETABLET, FILM COATED5005

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
69292-516CEFPODOXIME PROXETIL TABLET, FILM COATED [AMICI PHARMACEUTICALS, LLC.]5Current NDC, Legacy NDC, 2 package rows20230714_9d6d7f50-9838-47e3-8214-53e2dbeeadea.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
309076cefpodoxime proxetil 100 MG Oral TabletPSN9d6d7f50-9838-47e3-8214-53e2dbeeadea5
309078cefpodoxime proxetil 200 MG Oral TabletPSN9d6d7f50-9838-47e3-8214-53e2dbeeadea5
309076cefpodoxime 100 MG Oral TabletSCD9d6d7f50-9838-47e3-8214-53e2dbeeadea5
309078cefpodoxime 200 MG Oral TabletSCD9d6d7f50-9838-47e3-8214-53e2dbeeadea5

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
69292-516-0169292051601100 TABLET, FILM COATED in 1 BOTTLE (69292-516-01) 2022-12-210000-00-00NoNoCurrent
69292-516-5069292051650500 TABLET, FILM COATED in 1 BOTTLE (69292-516-50) 2022-12-210000-00-00NoNoCurrent