Cefadroxil

Product NDC
43063-553
11-digit product format
430630553
Labeler code
43063
Product ID
43063-553_2f3a95a9-25cd-d525-e063-6394a90a460f
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Cefadroxil
Dosage form
CAPSULE
Route
ORAL
Labeler
PD-Rx Pharmaceuticals, Inc.
Application
ANDA065392
Marketing category
ANDA
Marketing start
2008-04-23
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
43063-553-10Cefadroxil10 in 1 BOTTLE, PLASTICCAPSULE1020
43063-553-14Cefadroxil14 in 1 BOTTLE, PLASTICCAPSULE1420
43063-553-20Cefadroxil20 in 1 BOTTLE, PLASTICCAPSULE2020
43063-553-28Cefadroxil28 in 1 BOTTLE, PLASTICCAPSULE2820

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
43063-553-10EA - Each43063-55307829848-4208-4b6e-9a3a-ffb7ef14550a12015-04-03
43063-553-14EA - Each43063-553a4555d9f-cf5d-4840-8c6b-c808b842377a12015-03-03
43063-553-20EA - Each43063-553f404cae6-d8eb-43d7-9395-b2bea7e00ec812015-01-05
43063-553-28EA - Each43063-553e26e004c-1bbd-40ea-8910-84a961c5c43712015-03-03

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
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UCEFADROXIL CAPSULE [PD-RX PHARMACEUTICALS, INC.]8
CROSPOVIDONEINACTIVE INGREDIENT68401960MKCEFADROXIL 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
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30CEFADROXIL CAPSULE [PD-RX PHARMACEUTICALS, INC.]8
POTASSIUM HYDROXIDEINACTIVE INGREDIENTWZH3C48M4TCEFADROXIL CAPSULE [PD-RX PHARMACEUTICALS, INC.]8
PROPYLENE GLYCOLINACTIVE INGREDIENT6DC9Q167V3CEFADROXIL CAPSULE [PD-RX PHARMACEUTICALS, INC.]8
SHELLACINACTIVE INGREDIENT46N107B71OCEFADROXIL CAPSULE [PD-RX PHARMACEUTICALS, INC.]8
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPCEFADROXIL CAPSULE [PD-RX PHARMACEUTICALS, INC.]8

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
43063-553CEFADROXIL CAPSULE [PD-RX PHARMACEUTICALS, INC.]20Current NDC, Legacy NDC, 4 package rows20250303_f5bbbf87-f059-4bbd-aea9-27d31462654f.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
309049cefadroxil 500 MG Oral CapsulePSNf5bbbf87-f059-4bbd-aea9-27d31462654f20
309049cefadroxil 500 MG Oral CapsuleSCDf5bbbf87-f059-4bbd-aea9-27d31462654f20
309049cefadroxil (as cefadroxil monohydrate) 500 MG Oral CapsuleSYf5bbbf87-f059-4bbd-aea9-27d31462654f20

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
43063-553-104306305531010 CAPSULE in 1 BOTTLE, PLASTIC (43063-553-10) 10 capsule2012-09-110000-00-00NoNoCurrent
43063-553-144306305531414 CAPSULE in 1 BOTTLE, PLASTIC (43063-553-14) 14 capsule2012-09-110000-00-00NoNoCurrent
43063-553-204306305532020 CAPSULE in 1 BOTTLE, PLASTIC (43063-553-20) 20 capsule2012-09-110000-00-00NoNoCurrent
43063-553-284306305532828 CAPSULE in 1 BOTTLE, PLASTIC (43063-553-28) 28 capsule2012-09-110000-00-00NoNoCurrent