FDA.reportPublic FDA data

Cefadroxil

Product NDC
68788-8261
11-digit product format
687888261
Labeler code
68788
Product ID
68788-8261_04451ec6-409d-40b1-b4a0-da3ca6bae328
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Cefadroxil
Dosage form
CAPSULE
Route
ORAL
Labeler
Preferred Pharmaceuticals, Inc.
Application
ANDA065392
Marketing category
ANDA
Marketing start
2022-09-19
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
68788-8261-2Cefadroxil50 in 1 BOTTLECAPSULE504
68788-8261-3Cefadroxil30 in 1 BOTTLECAPSULE304

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
68788-8261-2EA - Each68788-82615480c265-efdb-48e6-8f98-eacbf99e139612022-10-06
68788-8261-3EA - Each68788-8261fe8e4d27-50bc-4ce2-b51d-f72eb2400e3312022-10-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68788-8261CEFADROXIL CAPSULE [PREFERRED PHARMACEUTICALS, INC.]3Current NDC, Legacy NDC, 2 package rows20250112_485bc35b-637a-426b-aaa2-023c664914ae.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
309049cefadroxil 500 MG Oral CapsulePSN485bc35b-637a-426b-aaa2-023c664914ae4
309049cefadroxil 500 MG Oral CapsuleSCD485bc35b-637a-426b-aaa2-023c664914ae4
309049cefadroxil (as cefadroxil monohydrate) 500 MG Oral CapsuleSY485bc35b-637a-426b-aaa2-023c664914ae4

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
68788-8261-26878882610250 CAPSULE in 1 BOTTLE (68788-8261-2) 50 capsule2022-09-190000-00-00NoNoCurrent
68788-8261-36878882610330 CAPSULE in 1 BOTTLE (68788-8261-3) 30 capsule2022-09-190000-00-00NoNoCurrent