FDA.reportPublic FDA data

Cefadroxil

Product NDC
57237-096
11-digit product format
572370096
Labeler code
57237
Product ID
57237-096_15dc4c1d-6a9a-4c87-a037-e6fc34d84ad9
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Cefadroxil
Dosage form
CAPSULE
Route
ORAL
Labeler
Rising Pharma Holdings, Inc.
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
57237-096-01Cefadroxil100 in 1 BOTTLECAPSULE1006
57237-096-50Cefadroxil50 in 1 BOTTLECAPSULE506

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
57237-096-01EA - Each57237-096dcdb0008-6902-48a0-ba60-0bae6c7ed9b712015-01-05
57237-096-50EA - Each57237-096ccbed19b-1f33-4823-a21d-fa842479c27b12015-01-05

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
CEFADROXILACTIVE INGREDIENT280111G160CEFADROXIL CAPSULE [CITRON PHARMA LLC]1
CEFADROXIL ANHYDROUSACTIVE MOIETYQ525PA8JJBCEFADROXIL CAPSULE [CITRON PHARMA LLC]1
D&C RED NO. 28INACTIVE INGREDIENT767IP0Y5NHCEFADROXIL CAPSULE [CITRON PHARMA LLC]1
FD&C BLUE NO. 1INACTIVE INGREDIENTH3R47K3TBDCEFADROXIL CAPSULE [CITRON PHARMA LLC]1
FD&C RED NO. 40INACTIVE INGREDIENTWZB9127XOACEFADROXIL CAPSULE [CITRON PHARMA LLC]1
FERROSOFERRIC OXIDEINACTIVE INGREDIENTXM0M87F357CEFADROXIL CAPSULE [CITRON PHARMA LLC]1
GELATININACTIVE INGREDIENT2G86QN327LCEFADROXIL CAPSULE [CITRON PHARMA LLC]1
LACTOSE MONOHYDRATEINACTIVE INGREDIENTEWQ57Q8I5XCEFADROXIL CAPSULE [CITRON PHARMA LLC]1
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30CEFADROXIL CAPSULE [CITRON PHARMA LLC]1
SODIUM LAURYL SULFATEINACTIVE INGREDIENT368GB5141JCEFADROXIL CAPSULE [CITRON PHARMA LLC]1
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPCEFADROXIL CAPSULE [CITRON PHARMA LLC]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
57237-096CEFADROXIL CAPSULE [RISING PHARMA HOLDINGS, INC.]6Current NDC, Legacy NDC, 2 package rows20240202_74c99fd8-16d1-4d2c-9158-42ff5eed2b7c.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
309049cefadroxil 500 MG Oral CapsulePSN672519a7-11a1-4d8e-b2ca-dc9598c2f179102
309049cefadroxil 500 MG Oral CapsulePSN9c3bed82-6df0-4643-944a-a826f7dc018f102
309049cefadroxil 500 MG Oral CapsulePSN8cdaac56-b84a-4b6b-b94d-cab15d5961c5102
309049cefadroxil 500 MG Oral CapsuleSCD672519a7-11a1-4d8e-b2ca-dc9598c2f179102
309049cefadroxil 500 MG Oral CapsuleSCD8cdaac56-b84a-4b6b-b94d-cab15d5961c5102
309049cefadroxil 500 MG Oral CapsuleSCD9c3bed82-6df0-4643-944a-a826f7dc018f102
309049cefadroxil (as cefadroxil monohydrate) 500 MG Oral CapsuleSY672519a7-11a1-4d8e-b2ca-dc9598c2f179102
309049cefadroxil (as cefadroxil monohydrate) 500 MG Oral CapsuleSY8cdaac56-b84a-4b6b-b94d-cab15d5961c5102
309049cefadroxil (as cefadroxil monohydrate) 500 MG Oral CapsuleSY9c3bed82-6df0-4643-944a-a826f7dc018f102
309049cefadroxil 500 MG Oral CapsulePSN74c99fd8-16d1-4d2c-9158-42ff5eed2b7c6
309049cefadroxil 500 MG Oral CapsulePSNec836a53-7ed1-79b9-e053-2a95a90a9c366
309049cefadroxil 500 MG Oral CapsuleSCD74c99fd8-16d1-4d2c-9158-42ff5eed2b7c6
309049cefadroxil 500 MG Oral CapsuleSCDec836a53-7ed1-79b9-e053-2a95a90a9c366
309049cefadroxil (as cefadroxil monohydrate) 500 MG Oral CapsuleSYec836a53-7ed1-79b9-e053-2a95a90a9c366
309049cefadroxil (as cefadroxil monohydrate) 500 MG Oral CapsuleSY74c99fd8-16d1-4d2c-9158-42ff5eed2b7c6
309049cefadroxil 500 MG Oral CapsulePSN97193a92-12ff-cfab-e053-2a95a90a9f144
309049cefadroxil 500 MG Oral CapsulePSNa7e74b63-9d5c-7baa-e053-2a95a90a98b24
309049cefadroxil 500 MG Oral CapsuleSCD97193a92-12ff-cfab-e053-2a95a90a9f144
309049cefadroxil 500 MG Oral CapsuleSCDa7e74b63-9d5c-7baa-e053-2a95a90a98b24
309049cefadroxil (as cefadroxil monohydrate) 500 MG Oral CapsuleSY97193a92-12ff-cfab-e053-2a95a90a9f144
309049cefadroxil (as cefadroxil monohydrate) 500 MG Oral CapsuleSYa7e74b63-9d5c-7baa-e053-2a95a90a98b24
309049cefadroxil 500 MG Oral CapsulePSNa218d8d3-af90-4599-e053-2995a90a0ede3
309049cefadroxil 500 MG Oral CapsulePSN8bdd68a4-4e2e-0170-e053-2a95a90adb783
309049cefadroxil 500 MG Oral CapsuleSCDa218d8d3-af90-4599-e053-2995a90a0ede3
309049cefadroxil 500 MG Oral CapsuleSCD8bdd68a4-4e2e-0170-e053-2a95a90adb783
309049cefadroxil (as cefadroxil monohydrate) 500 MG Oral CapsuleSY8bdd68a4-4e2e-0170-e053-2a95a90adb783
309049cefadroxil (as cefadroxil monohydrate) 500 MG Oral CapsuleSYa218d8d3-af90-4599-e053-2995a90a0ede3

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
57237-096-0157237009601100 CAPSULE in 1 BOTTLE (57237-096-01) 100 capsule2007-01-250000-00-00NoNoCurrent
57237-096-505723700965050 CAPSULE in 1 BOTTLE (57237-096-50) 50 capsule2007-01-250000-00-00NoNoCurrent