FDA.reportPublic FDA data

CEFADROXIL

Product NDC
63304-973
11-digit product format
633040973
Labeler code
63304
Product ID
63304-973_a95b07d7-65c1-438d-91e0-0eaca684eccf
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
cefadroxil monohydrate
Dosage form
POWDER, FOR SUSPENSION
Route
ORAL
Labeler
Ranbaxy Pharmaceuticals Inc.
Application
ANDA065115
Marketing category
ANDA
Marketing start
2005-08-30
Marketing end
0000-00-00
Substance
CEFADROXIL
Active strength
250 mg/5mL
Pharmacologic classes
Cephalosporin Antibacterial [EPC],Cephalosporins [CS]
NDC exclude flag
E
Listing certified through
2017-12-31
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#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
63304-973-032019-11-27C16284748780-19855d018-d2a7-cd31-e053-dbdaa90ab51aCEFADROXIL FOR ORAL SUSPENSION, USP Rx only
63304-973-042019-11-27C16284748780-19855d018-d2a7-cd31-e053-dbdaa90ab51aCEFADROXIL FOR ORAL SUSPENSION, USP Rx only

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
63304-973-03CEFADROXIL50 mL in 1 BOTTLEPOWDER, FOR SUSPENSION502
63304-973-04CEFADROXIL100 mL in 1 BOTTLEPOWDER, FOR SUSPENSION1002

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
63304-973-04ML - Milliliter63304-9734989c659-971d-44e0-ba00-0a0f8d17568c12013-02-13

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
CEFADROXILACTIVE INGREDIENT280111G160CEFADROXIL (CEFADROXIL MONOHYDRATE) POWDER, FOR SUSPENSION [RANBAXY PHARMACEUTICALS INC.]2
CEFADROXIL ANHYDROUSACTIVE MOIETYQ525PA8JJBCEFADROXIL (CEFADROXIL MONOHYDRATE) POWDER, FOR SUSPENSION [RANBAXY PHARMACEUTICALS INC.]2
FD&C YELLOW NO. 6INACTIVE INGREDIENTH77VEI93A8CEFADROXIL (CEFADROXIL MONOHYDRATE) POWDER, FOR SUSPENSION [RANBAXY PHARMACEUTICALS INC.]2
FRUITINACTIVE INGREDIENTC2AIY4ERZCCEFADROXIL (CEFADROXIL MONOHYDRATE) POWDER, FOR SUSPENSION [RANBAXY PHARMACEUTICALS INC.]2
POLYSORBATE 80INACTIVE INGREDIENT6OZP39ZG8HCEFADROXIL (CEFADROXIL MONOHYDRATE) POWDER, FOR SUSPENSION [RANBAXY PHARMACEUTICALS INC.]2
RASPBERRYINACTIVE INGREDIENT4N14V5R27WCEFADROXIL (CEFADROXIL MONOHYDRATE) POWDER, FOR SUSPENSION [RANBAXY PHARMACEUTICALS INC.]2
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4CEFADROXIL (CEFADROXIL MONOHYDRATE) POWDER, FOR SUSPENSION [RANBAXY PHARMACEUTICALS INC.]2
SODIUM BENZOATEINACTIVE INGREDIENTOJ245FE5EUCEFADROXIL (CEFADROXIL MONOHYDRATE) POWDER, FOR SUSPENSION [RANBAXY PHARMACEUTICALS INC.]2
SUCROSEINACTIVE INGREDIENTC151H8M554CEFADROXIL (CEFADROXIL MONOHYDRATE) POWDER, FOR SUSPENSION [RANBAXY PHARMACEUTICALS INC.]2
XANTHAN GUMINACTIVE INGREDIENTTTV12P4NEECEFADROXIL (CEFADROXIL MONOHYDRATE) POWDER, FOR SUSPENSION [RANBAXY PHARMACEUTICALS INC.]2
CEFADROXILACTIVE INGREDIENT280111G160CEFADROXIL (CEFADROXIL MONOHYDRATE) POWDER, FOR SUSPENSION [PHYSICIANS TOTAL CARE, INC.]1
CEFADROXILACTIVE MOIETY280111G160CEFADROXIL (CEFADROXIL MONOHYDRATE) POWDER, FOR SUSPENSION [PHYSICIANS TOTAL CARE, INC.]1
FD&C YELLOW NO. 6INACTIVE INGREDIENTH77VEI93A8CEFADROXIL (CEFADROXIL MONOHYDRATE) POWDER, FOR SUSPENSION [PHYSICIANS TOTAL CARE, INC.]1
POLYSORBATE 80INACTIVE INGREDIENT6OZP39ZG8HCEFADROXIL (CEFADROXIL MONOHYDRATE) POWDER, FOR SUSPENSION [PHYSICIANS TOTAL CARE, INC.]1
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4CEFADROXIL (CEFADROXIL MONOHYDRATE) POWDER, FOR SUSPENSION [PHYSICIANS TOTAL CARE, INC.]1
SODIUM BENZOATEINACTIVE INGREDIENTOJ245FE5EUCEFADROXIL (CEFADROXIL MONOHYDRATE) POWDER, FOR SUSPENSION [PHYSICIANS TOTAL CARE, INC.]1
SUCROSEINACTIVE INGREDIENTC151H8M554CEFADROXIL (CEFADROXIL MONOHYDRATE) POWDER, FOR SUSPENSION [PHYSICIANS TOTAL CARE, INC.]1
XANTHAN GUMINACTIVE INGREDIENTTTV12P4NEECEFADROXIL (CEFADROXIL MONOHYDRATE) POWDER, FOR SUSPENSION [PHYSICIANS TOTAL CARE, INC.]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
63304-973CEFADROXIL (CEFADROXIL MONOHYDRATE) POWDER, FOR SUSPENSION [RANBAXY PHARMACEUTICALS INC.]2Legacy NDC, 2 package rows20130321_5fc4f89c-cf94-4e7a-bf31-d3d86a242efa.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
309048cefadroxil 250 MG in 5 mL Oral SuspensionPSN5fc4f89c-cf94-4e7a-bf31-d3d86a242efa2
105171cefadroxil 500 MG in 5 mL Oral SuspensionPSN5fc4f89c-cf94-4e7a-bf31-d3d86a242efa2
105171cefadroxil 100 MG/ML Oral SuspensionSCD5fc4f89c-cf94-4e7a-bf31-d3d86a242efa2
105170cefadroxil 25 MG/ML Oral SuspensionSCD5fc4f89c-cf94-4e7a-bf31-d3d86a242efa2
309048cefadroxil 50 MG/ML Oral SuspensionSCD5fc4f89c-cf94-4e7a-bf31-d3d86a242efa2
105171cefadroxil (as cefadroxil monohydrate) 100 MG/ML Oral SuspensionSY5fc4f89c-cf94-4e7a-bf31-d3d86a242efa2
105170cefadroxil (as cefadroxil monohydrate) 25 MG/ML Oral SuspensionSY5fc4f89c-cf94-4e7a-bf31-d3d86a242efa2
309048cefadroxil (as cefadroxil monohydrate) 50 MG/ML Oral SuspensionSY5fc4f89c-cf94-4e7a-bf31-d3d86a242efa2
105170cefadroxil 125 MG per 5 ML Oral SuspensionSY5fc4f89c-cf94-4e7a-bf31-d3d86a242efa2
309048cefadroxil 250 MG per 5 ML Powder for Oral SuspensionSY5fc4f89c-cf94-4e7a-bf31-d3d86a242efa2
105171cefadroxil 500 MG per 5 ML Powder for Oral SuspensionSY5fc4f89c-cf94-4e7a-bf31-d3d86a242efa2
309048cefadroxil 250 MG in 5 mL Oral SuspensionPSN4306730b-e894-45ca-b4e9-3fe7f65b7b1d1
105171cefadroxil 500 MG in 5 mL Oral SuspensionPSN4306730b-e894-45ca-b4e9-3fe7f65b7b1d1
105171cefadroxil 100 MG/ML Oral SuspensionSCD4306730b-e894-45ca-b4e9-3fe7f65b7b1d1
309048cefadroxil 50 MG/ML Oral SuspensionSCD4306730b-e894-45ca-b4e9-3fe7f65b7b1d1
105171cefadroxil (as cefadroxil monohydrate) 100 MG/ML Oral SuspensionSY4306730b-e894-45ca-b4e9-3fe7f65b7b1d1
309048cefadroxil (as cefadroxil monohydrate) 50 MG/ML Oral SuspensionSY4306730b-e894-45ca-b4e9-3fe7f65b7b1d1
309048cefadroxil 250 MG per 5 ML Powder for Oral SuspensionSY4306730b-e894-45ca-b4e9-3fe7f65b7b1d1
105171cefadroxil 500 MG per 5 ML Powder for Oral SuspensionSY4306730b-e894-45ca-b4e9-3fe7f65b7b1d1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsStatus
63304-973-036330409730350 mL in 1 BOTTLE50 mlHistorical
63304-973-0463304097304100 mL in 1 BOTTLE100 mlHistorical