FDA.reportPublic FDA data

Cefadroxil

Product NDC
70518-3580
11-digit product format
705183580
Labeler code
70518
Product ID
70518-3580_4f5b7578-a0ce-82db-e063-6394a90a8426
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Cefadroxil
Dosage form
CAPSULE
Route
ORAL
Labeler
REMEDYREPACK INC.
Application
ANDA065392
Marketing category
ANDA
Marketing start
2022-11-22
Substance
CEFADROXIL
Active strength
500 mg/1
Pharmacologic classes
Cephalosporin Antibacterial [EPC], Cephalosporins [CS]
NDC exclude flag
No
Listing certified through
2027-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Cefadroxil
Listing expiration
2027-12-31

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
70518-3580-0Cefadroxil20 in 1 BLISTER PACKCAPSULE205
70518-3580-1Cefadroxil30 in 1 BLISTER PACKCAPSULE305

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
70518-3580CEFADROXIL CAPSULE [REMEDYREPACK INC.]3Current NDC, Legacy NDC, 2 package rows20240116_eb365f05-1c8f-4495-b443-abb0580b39fb.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
309049cefadroxil 500 MG Oral CapsulePSNeb365f05-1c8f-4495-b443-abb0580b39fb5
309049cefadroxil 500 MG Oral CapsuleSCDeb365f05-1c8f-4495-b443-abb0580b39fb5
309049cefadroxil (as cefadroxil monohydrate) 500 MG Oral CapsuleSYeb365f05-1c8f-4495-b443-abb0580b39fb5

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
70518-3580-07051835800020 CAPSULE in 1 BLISTER PACK (70518-3580-0) 20 capsule2022-11-220000-00-00NoNoCurrent
70518-3580-17051835800130 CAPSULE in 1 BLISTER PACK (70518-3580-1) 30 capsule2022-12-210000-00-00NoNoCurrent