FDA.reportPublic FDA data

Cefadroxil

Product NDC
67296-0491
11-digit product format
672960491
Labeler code
67296
Product ID
67296-0491_46c0f244-d678-1f91-e063-6394a90afc5f
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Cefadroxil
Dosage form
CAPSULE
Route
ORAL
Labeler
Redpharm Drug
Application
ANDA065392
Marketing category
ANDA
Marketing start
2008-04-23
Substance
CEFADROXIL
Active strength
500 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
Cefadroxil
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
CEFADROXIL500 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii280111G160
Rxcui309049

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
560bed03-0257-a1db-0638-2c46fc35054cProduct name220170824
34f1b9ee-0673-df8c-ddae-36eaf4c48382Product name120140508
3793572a-4958-68b2-f923-8cf695ec1cc1Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
67296-0491-1Cefadroxil20 in 1 BOTTLECAPSULE202
67296-0491-2Cefadroxil14 in 1 BOTTLECAPSULE142
67296-0491-4Cefadroxil40 in 1 BOTTLECAPSULE402

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
67296-0491CEFADROXIL CAPSULE [REDPHARM DRUG]1Current NDC, 3 package rows20240704_1c50c0db-ca03-6217-e063-6294a90a89fa.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
309049cefadroxil 500 MG Oral CapsulePSN1c50c0db-ca03-6217-e063-6294a90a89fa2
309049cefadroxil 500 MG Oral CapsuleSCD1c50c0db-ca03-6217-e063-6294a90a89fa2
309049cefadroxil (as cefadroxil monohydrate) 500 MG Oral CapsuleSY1c50c0db-ca03-6217-e063-6294a90a89fa2

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
67296-0491-16729604910120 CAPSULE in 1 BOTTLE (67296-0491-1) 20 capsule2008-04-23NoNoHistorical
67296-0491-26729604910214 CAPSULE in 1 BOTTLE (67296-0491-2) 14 capsule2008-04-23NoNoHistorical
67296-0491-46729604910440 CAPSULE in 1 BOTTLE (67296-0491-4) 40 capsule2008-04-23NoNoHistorical