FDA.reportPublic FDA data

Cefadroxil

Product NDC
65862-085
11-digit product format
658620085
Labeler code
65862
Product ID
65862-085_58128541-059d-4ef1-9dbf-98fa1befdcf0
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Cefadroxil
Dosage form
CAPSULE
Route
ORAL
Labeler
Aurobindo Pharma Limited
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
65862-085-01Cefadroxil100 in 1 BOTTLECAPSULE10013
65862-085-50Cefadroxil50 in 1 BOTTLECAPSULE5013

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
65862-085-01EA - Each65862-0857cbc1705-36ff-4b50-be46-092e20f672f312012-07-24
65862-085-50EA - Each65862-0857881118d-3ef6-486a-aedd-8fb7f986cc0b12012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
CEFADROXILACTIVE INGREDIENT280111G160CEFADROXIL CAPSULE [PD-RX PHARMACEUTICALS, INC.]8
CEFADROXIL ANHYDROUSACTIVE MOIETYQ525PA8JJBCEFADROXIL CAPSULE [PD-RX PHARMACEUTICALS, INC.]8
D&C RED NO. 28INACTIVE INGREDIENT767IP0Y5NHCEFADROXIL CAPSULE [PD-RX PHARMACEUTICALS, INC.]8
FD&C BLUE NO. 1INACTIVE INGREDIENTH3R47K3TBDCEFADROXIL CAPSULE [PD-RX PHARMACEUTICALS, INC.]8
FD&C RED NO. 40INACTIVE INGREDIENTWZB9127XOACEFADROXIL CAPSULE [PD-RX PHARMACEUTICALS, INC.]8
FERROSOFERRIC OXIDEINACTIVE INGREDIENTXM0M87F357CEFADROXIL CAPSULE [PD-RX PHARMACEUTICALS, INC.]8
GELATININACTIVE INGREDIENT2G86QN327LCEFADROXIL CAPSULE [PD-RX PHARMACEUTICALS, INC.]8
LACTOSE MONOHYDRATEINACTIVE INGREDIENTEWQ57Q8I5XCEFADROXIL CAPSULE [PD-RX PHARMACEUTICALS, INC.]8
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30CEFADROXIL CAPSULE [PD-RX PHARMACEUTICALS, INC.]8
SODIUM LAURYL SULFATEINACTIVE INGREDIENT368GB5141JCEFADROXIL CAPSULE [PD-RX PHARMACEUTICALS, INC.]8
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPCEFADROXIL CAPSULE [PD-RX PHARMACEUTICALS, INC.]8
CEFADROXILACTIVE INGREDIENT280111G160CEFADROXIL CAPSULE [AUROBINDO PHARMA LIMITED]7
CEFADROXIL ANHYDROUSACTIVE MOIETYQ525PA8JJBCEFADROXIL CAPSULE [AUROBINDO PHARMA LIMITED]7
D&C RED NO. 28INACTIVE INGREDIENT767IP0Y5NHCEFADROXIL CAPSULE [AUROBINDO PHARMA LIMITED]7
FD&C BLUE NO. 1INACTIVE INGREDIENTH3R47K3TBDCEFADROXIL CAPSULE [AUROBINDO PHARMA LIMITED]7
FD&C RED NO. 40INACTIVE INGREDIENTWZB9127XOACEFADROXIL CAPSULE [AUROBINDO PHARMA LIMITED]7
FERROSOFERRIC OXIDEINACTIVE INGREDIENTXM0M87F357CEFADROXIL CAPSULE [AUROBINDO PHARMA LIMITED]7
GELATININACTIVE INGREDIENT2G86QN327LCEFADROXIL CAPSULE [AUROBINDO PHARMA LIMITED]7
LACTOSE MONOHYDRATEINACTIVE INGREDIENTEWQ57Q8I5XCEFADROXIL CAPSULE [AUROBINDO PHARMA LIMITED]7
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30CEFADROXIL CAPSULE [AUROBINDO PHARMA LIMITED]7
SODIUM LAURYL SULFATEINACTIVE INGREDIENT368GB5141JCEFADROXIL CAPSULE [AUROBINDO PHARMA LIMITED]7
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPCEFADROXIL CAPSULE [AUROBINDO PHARMA LIMITED]7
CEFADROXILACTIVE INGREDIENT280111G160CEFADROXIL CAPSULE [STAT RX USA LLC]1
CEFADROXILACTIVE MOIETY280111G160CEFADROXIL CAPSULE [STAT RX USA LLC]1
D&C RED NO. 28INACTIVE INGREDIENT767IP0Y5NHCEFADROXIL CAPSULE [STAT RX USA LLC]1
FD&C BLUE NO. 1INACTIVE INGREDIENTH3R47K3TBDCEFADROXIL CAPSULE [STAT RX USA LLC]1
FD&C RED NO. 40INACTIVE INGREDIENTWZB9127XOACEFADROXIL CAPSULE [STAT RX USA LLC]1
FERROSOFERRIC OXIDEINACTIVE INGREDIENTXM0M87F357CEFADROXIL CAPSULE [STAT RX USA LLC]1
GELATININACTIVE INGREDIENT2G86QN327LCEFADROXIL CAPSULE [STAT RX USA LLC]1
LACTOSE MONOHYDRATEINACTIVE INGREDIENTEWQ57Q8I5XCEFADROXIL CAPSULE [STAT RX USA LLC]1
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30CEFADROXIL CAPSULE [STAT RX USA LLC]1
SODIUM LAURYL SULFATEINACTIVE INGREDIENT368GB5141JCEFADROXIL CAPSULE [STAT RX USA LLC]1
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPCEFADROXIL CAPSULE [STAT RX USA LLC]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
65862-085CEFADROXIL CAPSULE [AUROBINDO PHARMA LIMITED]13Current NDC, Legacy NDC, 2 package rows20240131_7bb90096-14d3-400e-94d3-048bff6b1292.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
309049cefadroxil 500 MG Oral CapsulePSNab9cf28c-7c16-4bfa-879d-c360b4d1d5a624
309049cefadroxil 500 MG Oral CapsuleSCDab9cf28c-7c16-4bfa-879d-c360b4d1d5a624
309049cefadroxil (as cefadroxil monohydrate) 500 MG Oral CapsuleSYab9cf28c-7c16-4bfa-879d-c360b4d1d5a624
309049cefadroxil 500 MG Oral CapsulePSN7bb90096-14d3-400e-94d3-048bff6b129213
309049cefadroxil 500 MG Oral CapsuleSCD7bb90096-14d3-400e-94d3-048bff6b129213
309049cefadroxil (as cefadroxil monohydrate) 500 MG Oral CapsuleSY7bb90096-14d3-400e-94d3-048bff6b129213
309049cefadroxil 500 MG Oral CapsulePSNbc0c3f88-a7ed-4147-b92a-456abc82835b6
309049cefadroxil 500 MG Oral CapsuleSCDbc0c3f88-a7ed-4147-b92a-456abc82835b6
309049cefadroxil (as cefadroxil monohydrate) 500 MG Oral CapsuleSYbc0c3f88-a7ed-4147-b92a-456abc82835b6
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
309049cefadroxil 500 MG Oral CapsulePSN7278a39f-9de1-c9e2-e053-2a91aa0aea343
309049cefadroxil 500 MG Oral CapsulePSN78ec0be1-b770-e670-e053-2991aa0af1e33
309049cefadroxil 500 MG Oral CapsuleSCD7278a39f-9de1-c9e2-e053-2a91aa0aea343
309049cefadroxil 500 MG Oral CapsuleSCD78ec0be1-b770-e670-e053-2991aa0af1e33
309049cefadroxil (as cefadroxil monohydrate) 500 MG Oral CapsuleSY78ec0be1-b770-e670-e053-2991aa0af1e33
309049cefadroxil (as cefadroxil monohydrate) 500 MG Oral CapsuleSY7278a39f-9de1-c9e2-e053-2a91aa0aea343
309049cefadroxil 500 MG Oral CapsulePSN02566385-46f3-255a-e063-6294a90a1d1c2
309049cefadroxil 500 MG Oral CapsuleSCD02566385-46f3-255a-e063-6294a90a1d1c2
309049cefadroxil (as cefadroxil monohydrate) 500 MG Oral CapsuleSY02566385-46f3-255a-e063-6294a90a1d1c2
309049cefadroxil 500 MG Oral CapsulePSN8cf65b07-115e-4499-92c4-5f16792a954d1
309049cefadroxil 500 MG Oral CapsulePSN1a50b564-b00f-58e4-e063-6294a90af2c61
309049cefadroxil 500 MG Oral CapsuleSCD8cf65b07-115e-4499-92c4-5f16792a954d1
309049cefadroxil 500 MG Oral CapsuleSCD1a50b564-b00f-58e4-e063-6294a90af2c61
309049cefadroxil (as cefadroxil monohydrate) 500 MG Oral CapsuleSY8cf65b07-115e-4499-92c4-5f16792a954d1
309049cefadroxil (as cefadroxil monohydrate) 500 MG Oral CapsuleSY1a50b564-b00f-58e4-e063-6294a90af2c61

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
65862-085-0165862008501100 CAPSULE in 1 BOTTLE (65862-085-01) 100 capsule2007-01-250000-00-00NoNoCurrent
65862-085-12658620085121200 CAPSULE in 1 BAG (65862-085-12)1200 capsule25-JAN-07Current
65862-085-506586200855050 CAPSULE in 1 BOTTLE (65862-085-50) 50 capsule2007-01-250000-00-00NoNoCurrent