FDA.reportPublic FDA data

Cefadroxil

Product NDC
63187-883
11-digit product format
631870883
Labeler code
63187
Product ID
63187-883_da08672f-6155-4026-b283-a7738f7eb678
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Cefadroxil
Dosage form
CAPSULE
Route
ORAL
Labeler
Proficient Rx LP
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
63187-883-06Cefadroxil06 in 1 BOTTLECAPSULE065
63187-883-20Cefadroxil20 in 1 BOTTLECAPSULE205
63187-883-30Cefadroxil30 in 1 BOTTLECAPSULE305
63187-883-40Cefadroxil40 in 1 BOTTLECAPSULE405

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
63187-883CEFADROXIL CAPSULE [PROFICIENT RX LP]5Current NDC, Legacy NDC, 4 package rows20220626_57eebea5-28b6-44a3-888b-76950f6038f4.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
309049cefadroxil 500 MG Oral CapsulePSN57eebea5-28b6-44a3-888b-76950f6038f45
309049cefadroxil 500 MG Oral CapsuleSCD57eebea5-28b6-44a3-888b-76950f6038f45
309049cefadroxil (as cefadroxil monohydrate) 500 MG Oral CapsuleSY57eebea5-28b6-44a3-888b-76950f6038f45

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
63187-883-06631870883066 CAPSULE in 1 BOTTLE (63187-883-06) 6 capsule2017-10-020000-00-00NoNoCurrent
63187-883-206318708832020 CAPSULE in 1 BOTTLE (63187-883-20) 20 capsule2017-10-020000-00-00NoNoCurrent
63187-883-306318708833030 CAPSULE in 1 BOTTLE (63187-883-30) 30 capsule2017-10-020000-00-00NoNoCurrent
63187-883-406318708834040 CAPSULE in 1 BOTTLE (63187-883-40) 40 capsule2017-10-020000-00-00NoNoCurrent