FDA.reportPublic FDA data

Cefadroxil

Product NDC
50090-6050
11-digit product format
500906050
Labeler code
50090
Product ID
50090-6050_f7721758-c7eb-4d43-a1bf-59829a432f85
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Cefadroxil
Dosage form
CAPSULE
Route
ORAL
Labeler
A-S Medication Solutions
Application
ANDA065352
Marketing category
ANDA
Marketing start
2007-01-25
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
50090-6050-0Cefadroxil10 in 1 BOTTLECAPSULE105
50090-6050-1Cefadroxil14 in 1 BOTTLECAPSULE145
50090-6050-2Cefadroxil20 in 1 BOTTLECAPSULE205

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
50090-6050-0EA - Each50090-60508db07950-35b9-4cda-8956-45639ddfbb8c12022-09-12
50090-6050-1EA - Each50090-6050fc6e8996-0a3e-45f3-95c8-492f6790901d12024-06-10
50090-6050-2EA - Each50090-60507a978f5d-6bb1-465b-a0da-1cd601dbf6d812022-09-12

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50090-6050CEFADROXIL CAPSULE [A-S MEDICATION SOLUTIONS]5Current NDC, Legacy NDC, 3 package rows20240217_41ab333a-fafb-4647-844e-f3b2a76723cb.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
309049cefadroxil 500 MG Oral CapsulePSN41ab333a-fafb-4647-844e-f3b2a76723cb5
309049cefadroxil 500 MG Oral CapsuleSCD41ab333a-fafb-4647-844e-f3b2a76723cb5
309049cefadroxil (as cefadroxil monohydrate) 500 MG Oral CapsuleSY41ab333a-fafb-4647-844e-f3b2a76723cb5

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
50090-6050-05009060500010 CAPSULE in 1 BOTTLE (50090-6050-0) 10 capsule2022-08-040000-00-00NoNoCurrent
50090-6050-15009060500114 CAPSULE in 1 BOTTLE (50090-6050-1) 14 capsule2022-08-040000-00-00NoNoCurrent
50090-6050-25009060500220 CAPSULE in 1 BOTTLE (50090-6050-2) 20 capsule2022-08-040000-00-00NoNoCurrent