Cefadroxil

Product NDC
68788-8479
11-digit product format
687888479
Labeler code
68788
Product ID
68788-8479_6da811af-e5a3-49cd-8b4a-f9b7f663dd75
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Cefadroxil
Dosage form
CAPSULE
Route
ORAL
Labeler
Preferred Pharmaceuticals Inc.
Application
ANDA065352
Marketing category
ANDA
Marketing start
2023-07-13
Substance
CEFADROXIL
Active strength
500 mg/1
Pharmacologic classes
Cephalosporin Antibacterial [EPC], Cephalosporins [CS]
NDC exclude flag
No
Listing certified through
2027-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Cefadroxil
Listing expiration
2027-12-31

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
68788-8479-2Cefadroxil20 in 1 BOTTLECAPSULE204
68788-8479-3Cefadroxil30 in 1 BOTTLECAPSULE304

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
68788-8479-2EA - Each68788-84796e2e2a85-e915-4e72-88aa-3d44bc8b82b312023-08-08
68788-8479-3EA - Each68788-84792d0cfab7-4be4-4452-ad85-00b168fa412412023-08-08

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68788-8479CEFADROXIL CAPSULE [PREFERRED PHARMACEUTICALS INC.]3Current NDC, 2 package rows20250217_41bc5f5a-5e1d-4cb6-a795-9f1756a8f074.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
309049cefadroxil 500 MG Oral CapsulePSN41bc5f5a-5e1d-4cb6-a795-9f1756a8f0744
309049cefadroxil 500 MG Oral CapsuleSCD41bc5f5a-5e1d-4cb6-a795-9f1756a8f0744
309049cefadroxil (as cefadroxil monohydrate) 500 MG Oral CapsuleSY41bc5f5a-5e1d-4cb6-a795-9f1756a8f0744

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
68788-8479-26878884790220 CAPSULE in 1 BOTTLE (68788-8479-2) 20 capsule2023-07-13NoNoHistorical
68788-8479-36878884790330 CAPSULE in 1 BOTTLE (68788-8479-3) 30 capsule2023-07-13NoNoHistorical