FDA.reportPublic FDA data

Cefadroxil

Product NDC
80425-0400
11-digit product format
804250400
Labeler code
80425
Product ID
80425-0400_1a50a2bf-9704-4104-e063-6294a90af4df
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Cefadroxil
Dosage form
CAPSULE
Route
ORAL
Labeler
Advanced Rx Pharmacy of Tennessee, LLC
Application
ANDA065352
Marketing category
ANDA
Marketing start
2024-06-07
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
80425-0400-1Cefadroxil10 in 1 BOTTLECAPSULE101
80425-0400-2Cefadroxil20 in 1 BOTTLECAPSULE201
80425-0400-3Cefadroxil30 in 1 BOTTLECAPSULE301

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
80425-0400-1EA - Each80425-0400017e0ce6-33bd-48b8-a82f-67e5dc5db1a512024-08-12
80425-0400-2EA - Each80425-0400e275a2f5-81a5-430f-9b9b-39036c86092e12024-08-12
80425-0400-3EA - Each80425-04003719923e-f0dd-4207-b833-43d39f8d6e8212024-07-12

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
80425-0400CEFADROXIL CAPSULE [ADVANCED RX PHARMACY OF TENNESSEE, LLC]1Current NDC, 3 package rows20240612_1a50b564-b00f-58e4-e063-6294a90af2c6.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
309049cefadroxil 500 MG Oral CapsulePSN1a50b564-b00f-58e4-e063-6294a90af2c61
309049cefadroxil 500 MG Oral CapsuleSCD1a50b564-b00f-58e4-e063-6294a90af2c61
309049cefadroxil (as cefadroxil monohydrate) 500 MG Oral CapsuleSY1a50b564-b00f-58e4-e063-6294a90af2c61

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
80425-0400-18042504000110 CAPSULE in 1 BOTTLE (80425-0400-1) 10 capsule2024-06-07NoNoCurrent
80425-0400-28042504000220 CAPSULE in 1 BOTTLE (80425-0400-2) 20 capsule2024-06-07NoNoCurrent
80425-0400-38042504000330 CAPSULE in 1 BOTTLE (80425-0400-3) 30 capsule2024-06-07NoNoCurrent