FDA.reportPublic FDA data

Cefadroxil

Product NDC
68071-4515
11-digit product format
680714515
Labeler code
68071
Product ID
68071-4515_1a906cf7-b91d-849f-e063-6294a90a0776
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Cefadroxil
Dosage form
CAPSULE
Route
ORAL
Labeler
NuCare Pharmaceuticals,Inc.
Application
ANDA065352
Marketing category
ANDA
Marketing start
2007-01-25
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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
68071-4515-12024-06-10C16284748780-1ba0f9c33-239c-a910-e053-dadaa90a0b85Cefadroxil Capsules, USP
68071-4515-22024-06-10C16284748780-1ba0f9c33-239c-a910-e053-dadaa90a0b85Cefadroxil Capsules, USP
68071-4515-12023-01-30C16284748780-1ba0f9c33-239c-a910-e053-dadaa90a0b85Cefadroxil Capsules, USP
68071-4515-22023-01-30C16284748780-1ba0f9c33-239c-a910-e053-dadaa90a0b85Cefadroxil Capsules, USP
68071-4515-12021-02-17C16284748780-1ba0f9c33-239c-a910-e053-dadaa90a0b85Cefadroxil Capsules, USP
68071-4515-22021-02-17C16284748780-1ba0f9c33-239c-a910-e053-dadaa90a0b85Cefadroxil Capsules, USP
68071-4515-12021-01-29C16284748780-1ba0f9c33-239c-a910-e053-dadaa90a0b85Cefadroxil Capsules, USP
68071-4515-22021-01-29C16284748780-1ba0f9c33-239c-a910-e053-dadaa90a0b85Cefadroxil Capsules, USP

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
68071-4515-1Cefadroxil10 in 1 BOTTLECAPSULE103
68071-4515-2Cefadroxil20 in 1 BOTTLECAPSULE203

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68071-4515CEFADROXIL CAPSULE [NUCARE PHARMACEUTICALS,INC.]3Current NDC, Legacy NDC, 2 package rows20240612_7278a39f-9de1-c9e2-e053-2a91aa0aea34.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
309049cefadroxil 500 MG Oral CapsulePSN7278a39f-9de1-c9e2-e053-2a91aa0aea343
309049cefadroxil 500 MG Oral CapsuleSCD7278a39f-9de1-c9e2-e053-2a91aa0aea343
309049cefadroxil (as cefadroxil monohydrate) 500 MG Oral CapsuleSY7278a39f-9de1-c9e2-e053-2a91aa0aea343

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
68071-4515-16807145150110 CAPSULE in 1 BOTTLE (68071-4515-1) 10 capsule2018-08-020000-00-00NoNoCurrent
68071-4515-26807145150220 CAPSULE in 1 BOTTLE (68071-4515-2) 20 capsule2018-08-020000-00-00NoNoCurrent