Cefadroxil

Product NDC
16714-388
11-digit product format
167140388
Labeler code
16714
Product ID
16714-388_f043b17c-7588-4594-904b-056efaea3446
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Cefadroxil
Dosage form
CAPSULE
Route
ORAL
Labeler
NorthStar Rx LLC
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
16714-388-01Cefadroxil50 in 1 BOTTLECAPSULE507
16714-388-02Cefadroxil100 in 1 BOTTLECAPSULE1007

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
16714-388-01EA - Each16714-388f4f78b8b-72ff-4951-8ff4-6402a34706b212013-03-03
16714-388-02EA - Each16714-38881177447-e096-4e34-9434-8f6493c7f32e12013-03-03

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
CEFADROXILACTIVE INGREDIENT280111G160CEFADROXIL CAPSULE [NORTHSTAR RX LLC]2
CEFADROXIL ANHYDROUSACTIVE MOIETYQ525PA8JJBCEFADROXIL CAPSULE [NORTHSTAR RX LLC]2
D&C RED NO. 28INACTIVE INGREDIENT767IP0Y5NHCEFADROXIL CAPSULE [NORTHSTAR RX LLC]2
FD&C BLUE NO. 1INACTIVE INGREDIENTH3R47K3TBDCEFADROXIL CAPSULE [NORTHSTAR RX LLC]2
FD&C RED NO. 40INACTIVE INGREDIENTWZB9127XOACEFADROXIL CAPSULE [NORTHSTAR RX LLC]2
FERROSOFERRIC OXIDEINACTIVE INGREDIENTXM0M87F357CEFADROXIL CAPSULE [NORTHSTAR RX LLC]2
GELATININACTIVE INGREDIENT2G86QN327LCEFADROXIL CAPSULE [NORTHSTAR RX LLC]2
LACTOSE MONOHYDRATEINACTIVE INGREDIENTEWQ57Q8I5XCEFADROXIL CAPSULE [NORTHSTAR RX LLC]2
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30CEFADROXIL CAPSULE [NORTHSTAR RX LLC]2
SODIUM LAURYL SULFATEINACTIVE INGREDIENT368GB5141JCEFADROXIL CAPSULE [NORTHSTAR RX LLC]2
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPCEFADROXIL CAPSULE [NORTHSTAR RX LLC]2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
16714-388CEFADROXIL CAPSULE [NORTHSTAR RX LLC]7Current NDC, Legacy NDC, 2 package rows20240131_17123057-58c7-401a-b87d-8c4c0764bbf6.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
309049cefadroxil 500 MG Oral CapsulePSN17123057-58c7-401a-b87d-8c4c0764bbf67
309049cefadroxil 500 MG Oral CapsuleSCD17123057-58c7-401a-b87d-8c4c0764bbf67
309049cefadroxil (as cefadroxil monohydrate) 500 MG Oral CapsuleSY17123057-58c7-401a-b87d-8c4c0764bbf67
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
309049cefadroxil 500 MG Oral CapsulePSN16f3dd01-650a-2426-e063-6394a90a1b4b1
309049cefadroxil 500 MG Oral CapsulePSN4fb524c1-f985-2a8f-e063-6394a90aab7f1
309049cefadroxil 500 MG Oral CapsulePSNe09261f8-e8e3-89cb-e053-2995a90a0cc01
309049cefadroxil 500 MG Oral CapsuleSCD16f3dd01-650a-2426-e063-6394a90a1b4b1
309049cefadroxil 500 MG Oral CapsuleSCD4fb524c1-f985-2a8f-e063-6394a90aab7f1
309049cefadroxil 500 MG Oral CapsuleSCDe09261f8-e8e3-89cb-e053-2995a90a0cc01
309049cefadroxil (as cefadroxil monohydrate) 500 MG Oral CapsuleSY16f3dd01-650a-2426-e063-6394a90a1b4b1
309049cefadroxil (as cefadroxil monohydrate) 500 MG Oral CapsuleSY4fb524c1-f985-2a8f-e063-6394a90aab7f1
309049cefadroxil (as cefadroxil monohydrate) 500 MG Oral CapsuleSYe09261f8-e8e3-89cb-e053-2995a90a0cc01

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
16714-388-011671403880150 CAPSULE in 1 BOTTLE (16714-388-01) 50 capsule2007-01-250000-00-00NoNoCurrent
16714-388-0216714038802100 CAPSULE in 1 BOTTLE (16714-388-02) 100 capsule2007-01-250000-00-00NoNoCurrent