FDA.reportPublic FDA data

Cefadroxil

Product NDC
67296-1727
11-digit product format
672961727
Labeler code
67296
Product ID
67296-1727_490df962-55a6-ab63-e063-6294a90a56b2
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Cefadroxil
Dosage form
CAPSULE
Route
ORAL
Labeler
RedPharm Drug, Inc.
Application
ANDA065352
Marketing category
ANDA
Marketing start
2019-11-01
Substance
CEFADROXIL
Active strength
500 mg/1
Pharmacologic classes
Cephalosporin Antibacterial [EPC], Cephalosporins [CS]
NDC exclude flag
No
Listing certified through
2027-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Cefadroxil
Listing expiration
2027-12-31

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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
67296-1727-22024-08-02C16284748780-1f386c649-a951-0266-e053-dadaa90a7c1aCefadroxil 500mg
67296-1727-22023-01-30C16284748780-1f386c649-a951-0266-e053-dadaa90a7c1aCefadroxil 500mg

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
67296-1727-1Cefadroxil14 in 1 BOTTLECAPSULE144
67296-1727-2Cefadroxil20 in 1 BOTTLECAPSULE204

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
67296-1727CEFADROXIL CAPSULE [REDPHARM DRUG, INC.]3Current NDC, Legacy NDC, 2 package rows20240805_97193a92-12ff-cfab-e053-2a95a90a9f14.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
309049cefadroxil 500 MG Oral CapsulePSN97193a92-12ff-cfab-e053-2a95a90a9f144
309049cefadroxil 500 MG Oral CapsuleSCD97193a92-12ff-cfab-e053-2a95a90a9f144
309049cefadroxil (as cefadroxil monohydrate) 500 MG Oral CapsuleSY97193a92-12ff-cfab-e053-2a95a90a9f144

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
67296-1727-16729617270114 CAPSULE in 1 BOTTLE (67296-1727-1) 14 capsule2019-11-01NoNoHistorical
67296-1727-26729617270220 CAPSULE in 1 BOTTLE (67296-1727-2) 20 capsule2019-11-010000-00-00NoNoCurrent