FDA.reportPublic FDA data

Cefadroxil

Product NDC
80425-0198
11-digit product format
804250198
Labeler code
80425
Product ID
80425-0198_10f671c2-e1e0-da2f-e063-6394a90a8724
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
2022-11-02
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
80425-0198-1Cefadroxil10 in 1 BOTTLECAPSULE106
80425-0198-2Cefadroxil30 in 1 BOTTLECAPSULE306
80425-0198-3Cefadroxil20 in 1 BOTTLECAPSULE206

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
80425-0198-1EA - Each80425-0198fa6bd022-72c2-49de-bfe1-dfbaf2458edb12023-06-06
80425-0198-2EA - Each80425-019860265ca7-1c82-4fa4-9812-67a2a18e68ac12023-06-06
80425-0198-3EA - Each80425-019888c9d8eb-6a94-4384-b6a3-712df226078912024-03-12

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
80425-0198CEFADROXIL CAPSULE [ADVANCED RX PHARMACY OF TENNESSEE, LLC]6Current NDC, Legacy NDC, 3 package rows20240210_ec836a53-7ed1-79b9-e053-2a95a90a9c36.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
309049cefadroxil 500 MG Oral CapsulePSNec836a53-7ed1-79b9-e053-2a95a90a9c366
309049cefadroxil 500 MG Oral CapsuleSCDec836a53-7ed1-79b9-e053-2a95a90a9c366
309049cefadroxil (as cefadroxil monohydrate) 500 MG Oral CapsuleSYec836a53-7ed1-79b9-e053-2a95a90a9c366

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
80425-0198-18042501980110 CAPSULE in 1 BOTTLE (80425-0198-1) 10 capsule2023-11-02NoNoCurrent
80425-0198-28042501980230 CAPSULE in 1 BOTTLE (80425-0198-2) 30 capsule2023-11-02NoNoCurrent
80425-0198-38042501980320 CAPSULE in 1 BOTTLE (80425-0198-3) 20 capsule2024-02-09NoNoCurrent