FDA.reportPublic FDA data

Cefadroxil

Product NDC
80425-0432
11-digit product format
804250432
Labeler code
80425
Product ID
80425-0432_205ca6df-b799-b6b1-e063-6294a90a6e5c
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Cefadroxil
Dosage form
CAPSULE
Route
ORAL
Labeler
Advanced Rx of Tennessee, LLC
Application
ANDA065392
Marketing category
ANDA
Marketing start
2024-08-23
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
80425-0432-1Cefadroxil10 in 1 BOTTLECAPSULE101
80425-0432-2Cefadroxil20 in 1 BOTTLECAPSULE201
80425-0432-3Cefadroxil30 in 1 BOTTLECAPSULE301

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
80425-0432-1EA - Each80425-0432570d22ac-8b6a-4eef-9ca5-76aa612723e912024-10-04
80425-0432-2EA - Each80425-0432b9b07b28-467d-4a99-8ab5-7273a3ff035912024-10-04
80425-0432-3EA - Each80425-043298d21e90-b894-4059-9e1f-f2849746128912024-10-04

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
80425-0432CEFADROXIL CAPSULE [ADVANCED RX OF TENNESSEE, LLC]1Current NDC, 3 package rows20240829_205cb17b-6fbf-e147-e063-6294a90a608e.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
309049cefadroxil 500 MG Oral CapsulePSN205cb17b-6fbf-e147-e063-6294a90a608e1
309049cefadroxil 500 MG Oral CapsuleSCD205cb17b-6fbf-e147-e063-6294a90a608e1
309049cefadroxil (as cefadroxil monohydrate) 500 MG Oral CapsuleSY205cb17b-6fbf-e147-e063-6294a90a608e1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
80425-0432-18042504320110 CAPSULE in 1 BOTTLE (80425-0432-1) 10 capsule2024-08-23NoNoCurrent
80425-0432-28042504320220 CAPSULE in 1 BOTTLE (80425-0432-2) 20 capsule2024-08-23NoNoCurrent
80425-0432-38042504320330 CAPSULE in 1 BOTTLE (80425-0432-3) 30 capsule2024-08-23NoNoCurrent