Cefadroxil

Product NDC
33261-018
11-digit product format
332610018
Labeler code
33261
Product ID
33261-018_6b12226c-28cd-4448-9b95-242fd0cc761e
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Cefadroxil
Dosage form
CAPSULE
Route
ORAL
Labeler
Aidarex Pharmaceuticals LLC
Application
ANDA065392
Marketing category
ANDA
Marketing start
2008-04-23
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
2019-12-31
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

FDA-Initiated Inactive NDC Indexing#

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
33261-018-14Cefadroxil14 in 1 BOTTLECAPSULE141
33261-018-20Cefadroxil20 in 1 BOTTLECAPSULE201
33261-018-28Cefadroxil28 in 1 BOTTLECAPSULE281
33261-018-30Cefadroxil30 in 1 BOTTLECAPSULE301
33261-018-40Cefadroxil40 in 1 BOTTLECAPSULE401

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
33261-018-14EA - Each33261-01833e933e3-7c66-427f-aff7-acf1c5e9e62312017-06-15
33261-018-20EA - Each33261-018f0f1929e-2794-4db9-877f-0ee627a1574612017-06-15

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
CEFADROXILACTIVE INGREDIENT280111G160CEFADROXIL CAPSULE [AIDAREX PHARMACEUTICALS LLC]1
CEFADROXIL ANHYDROUSACTIVE MOIETYQ525PA8JJBCEFADROXIL CAPSULE [AIDAREX PHARMACEUTICALS LLC]1
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UCEFADROXIL CAPSULE [AIDAREX PHARMACEUTICALS LLC]1
CROSPOVIDONEINACTIVE INGREDIENT68401960MKCEFADROXIL CAPSULE [AIDAREX PHARMACEUTICALS LLC]1
D&C RED NO. 28INACTIVE INGREDIENT767IP0Y5NHCEFADROXIL CAPSULE [AIDAREX PHARMACEUTICALS LLC]1
FD&C BLUE NO. 1INACTIVE INGREDIENTH3R47K3TBDCEFADROXIL CAPSULE [AIDAREX PHARMACEUTICALS LLC]1
FD&C RED NO. 40INACTIVE INGREDIENTWZB9127XOACEFADROXIL CAPSULE [AIDAREX PHARMACEUTICALS LLC]1
FERROSOFERRIC OXIDEINACTIVE INGREDIENTXM0M87F357CEFADROXIL CAPSULE [AIDAREX PHARMACEUTICALS LLC]1
GELATININACTIVE INGREDIENT2G86QN327LCEFADROXIL CAPSULE [AIDAREX PHARMACEUTICALS LLC]1
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30CEFADROXIL CAPSULE [AIDAREX PHARMACEUTICALS LLC]1
POTASSIUM HYDROXIDEINACTIVE INGREDIENTWZH3C48M4TCEFADROXIL CAPSULE [AIDAREX PHARMACEUTICALS LLC]1
PROPYLENE GLYCOLINACTIVE INGREDIENT6DC9Q167V3CEFADROXIL CAPSULE [AIDAREX PHARMACEUTICALS LLC]1
SHELLACINACTIVE INGREDIENT46N107B71OCEFADROXIL CAPSULE [AIDAREX PHARMACEUTICALS LLC]1
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPCEFADROXIL CAPSULE [AIDAREX PHARMACEUTICALS LLC]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
33261-018CEFADROXIL CAPSULE [AIDAREX PHARMACEUTICALS LLC]1Legacy NDC, 5 package rows20140102_d433e4e8-9f38-405e-ac80-bc8dfcba0649.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
309049cefadroxil 500 MG Oral CapsulePSNd433e4e8-9f38-405e-ac80-bc8dfcba06491
309049cefadroxil 500 MG Oral CapsuleSCDd433e4e8-9f38-405e-ac80-bc8dfcba06491
309049cefadroxil (as cefadroxil monohydrate) 500 MG Oral CapsuleSYd433e4e8-9f38-405e-ac80-bc8dfcba06491

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionStatus
33261-018-143326100181414 in 1 BOTTLEHistorical
33261-018-203326100182020 in 1 BOTTLEHistorical
33261-018-283326100182828 in 1 BOTTLEHistorical
33261-018-303326100183030 in 1 BOTTLEHistorical
33261-018-403326100184040 in 1 BOTTLEHistorical