Cefadroxil

Product NDC
43063-595
11-digit product format
430630595
Labeler code
43063
Product ID
43063-595_41399346-37b8-2396-e063-6394a90ae471
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Cefadroxil
Dosage form
CAPSULE
Route
ORAL
Labeler
PD-Rx 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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
43063-595-20Cefadroxil20 in 1 BOTTLE, PLASTICCAPSULE2024
43063-595-28Cefadroxil28 in 1 BOTTLE, PLASTICCAPSULE2824

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
43063-595CEFADROXIL CAPSULE [PD-RX PHARMACEUTICALS, INC.]23Current NDC, Legacy NDC, 2 package rows20240509_ab9cf28c-7c16-4bfa-879d-c360b4d1d5a6.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
309049cefadroxil 500 MG Oral CapsulePSNab9cf28c-7c16-4bfa-879d-c360b4d1d5a624
309049cefadroxil 500 MG Oral CapsuleSCDab9cf28c-7c16-4bfa-879d-c360b4d1d5a624
309049cefadroxil (as cefadroxil monohydrate) 500 MG Oral CapsuleSYab9cf28c-7c16-4bfa-879d-c360b4d1d5a624

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
43063-595-204306305952020 CAPSULE in 1 BOTTLE, PLASTIC (43063-595-20) 20 capsule2015-08-170000-00-00NoNoCurrent
43063-595-284306305952828 CAPSULE in 1 BOTTLE, PLASTIC (43063-595-28) 28 capsule2016-07-210000-00-00NoNoCurrent