Cefadroxil

Product NDC
55289-589
11-digit product format
552890589
Labeler code
55289
Product ID
55289-589_da31fb95-ea07-1fd9-e053-2995a90ad99b
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Cefadroxil
Dosage form
CAPSULE
Route
ORAL
Labeler
PD-Rx Pharmaceuticals, Inc.
Application
ANDA065282
Marketing category
ANDA
Marketing start
2007-01-31
Marketing end
0000-00-00
Substance
CEFADROXIL
Active strength
500 mg/1
Pharmacologic classes
Cephalosporin Antibacterial [EPC], Cephalosporins [CS]
NDC exclude flag
No
Listing certified through
2023-12-31
Current FDA listing
Historical FDA.report record

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 Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
55289-589-10EA - Each55289-589718db34b-e6ae-40f1-a690-c76fcbb9215312012-07-24
55289-589-14EA - Each55289-589a875d68c-5867-4efc-aae5-90d987fcec9012012-07-24
55289-589-20EA - Each55289-5895d8358a6-8f9b-4c46-88bc-1308c8aa0b5212012-07-24
55289-589-28EA - Each55289-589269146ae-f7e1-4907-a578-b3edea00eba812015-02-02

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
CEFADROXILACTIVE INGREDIENT280111G160CEFADROXIL CAPSULE [PD-RX PHARMACEUTICALS, INC.]3
CEFADROXIL ANHYDROUSACTIVE MOIETYQ525PA8JJBCEFADROXIL CAPSULE [PD-RX PHARMACEUTICALS, INC.]3
ALUMINUM OXIDEINACTIVE INGREDIENTLMI26O6933CEFADROXIL CAPSULE [PD-RX PHARMACEUTICALS, INC.]3
CROSCARMELLOSE SODIUMINACTIVE INGREDIENTM28OL1HH48CEFADROXIL CAPSULE [PD-RX PHARMACEUTICALS, INC.]3
D&C YELLOW NO. 10INACTIVE INGREDIENT35SW5USQ3GCEFADROXIL CAPSULE [PD-RX PHARMACEUTICALS, INC.]3
FD&C BLUE NO. 1INACTIVE INGREDIENTH3R47K3TBDCEFADROXIL CAPSULE [PD-RX PHARMACEUTICALS, INC.]3
FD&C BLUE NO. 2INACTIVE INGREDIENTL06K8R7DQKCEFADROXIL CAPSULE [PD-RX PHARMACEUTICALS, INC.]3
FD&C RED NO. 40INACTIVE INGREDIENTWZB9127XOACEFADROXIL CAPSULE [PD-RX PHARMACEUTICALS, INC.]3
FERROSOFERRIC OXIDEINACTIVE INGREDIENTXM0M87F357CEFADROXIL CAPSULE [PD-RX PHARMACEUTICALS, INC.]3
GELATININACTIVE INGREDIENT2G86QN327LCEFADROXIL CAPSULE [PD-RX PHARMACEUTICALS, INC.]3
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30CEFADROXIL CAPSULE [PD-RX PHARMACEUTICALS, INC.]3
PROPYLENE GLYCOLINACTIVE INGREDIENT6DC9Q167V3CEFADROXIL CAPSULE [PD-RX PHARMACEUTICALS, INC.]3
SHELLACINACTIVE INGREDIENT46N107B71OCEFADROXIL CAPSULE [PD-RX PHARMACEUTICALS, INC.]3
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4CEFADROXIL CAPSULE [PD-RX PHARMACEUTICALS, INC.]3
SODIUM LAURYL SULFATEINACTIVE INGREDIENT368GB5141JCEFADROXIL CAPSULE [PD-RX PHARMACEUTICALS, INC.]3
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPCEFADROXIL CAPSULE [PD-RX PHARMACEUTICALS, INC.]3

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
55289-589CEFADROXIL CAPSULE [PD-RX PHARMACEUTICALS, INC.]17Legacy NDC20250322_88c7119e-404f-4718-b81f-d77d5eceb8f5.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
55289-589-105528905891010 CAPSULE in 1 BOTTLE, PLASTIC (55289-589-10) 10 capsule2010-09-210000-00-00NoNoCurrent
55289-589-145528905891414 CAPSULE in 1 BOTTLE, PLASTIC (55289-589-14) 14 capsule2010-09-210000-00-00NoNoCurrent
55289-589-205528905892020 CAPSULE in 1 BOTTLE, PLASTIC (55289-589-20) 20 capsule2010-09-210000-00-00NoNoCurrent
55289-589-285528905892828 CAPSULE in 1 BOTTLE, PLASTIC (55289-589-28) 28 capsule2010-09-210000-00-00NoNoCurrent