Cefpodoxime Proxetil

Product NDC
68071-3441
11-digit product format
680713441
Labeler code
68071
Product ID
68071-3441_2d80b340-7ddc-adf0-e063-6294a90af485
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Cefpodoxime Proxetil
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
NuCare Pharmaceuticals,Inc.
Application
ANDA210568
Marketing category
ANDA
Marketing start
2023-02-13
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
Rxcui309078

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
e28aad34-15f4-8358-f1eb-20900c754318Product name220230125
bd926630-c211-e651-84da-4ef72dbed2c5Product name120140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
68071-3441-22025-02-06C16284748780-12cef2736-9c88-d83d-e063-dadaa90ab31ffe827f61-9336-72e7-e053-6394a90af75f
68071-3441-22025-01-30C16284748780-12cef2736-9c88-d83d-e063-dadaa90ab31ffe827f61-9336-72e7-e053-6394a90af75f

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
68071-3441-2Cefpodoxime Proxetil20 in 1 BOTTLETABLET, FILM COATED202

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68071-3441CEFPODOXIME PROXETIL TABLET, FILM COATED [NUCARE PHARMACEUTICALS,INC.]2Current NDC, 1 package rows20250209_fe827f61-9336-72e7-e053-6394a90af75f.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
309078cefpodoxime proxetil 200 MG Oral TabletPSNfe827f61-9336-72e7-e053-6394a90af75f2
309078cefpodoxime 200 MG Oral TabletSCDfe827f61-9336-72e7-e053-6394a90af75f2

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
68071-3441-26807134410220 TABLET, FILM COATED in 1 BOTTLE (68071-3441-2) 2023-06-19NoNoHistorical