FDA.reportPublic FDA data

Cefadroxil

Product NDC
66267-045
11-digit product format
662670045
Labeler code
66267
Product ID
66267-045_b8a5f55c-bca1-3e4b-e053-2995a90ab901
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Cefadroxil
Dosage form
CAPSULE
Route
ORAL
Labeler
NuCare Pharmaceuticals, Inc.
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
2022-12-31
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
66267-045-102025-01-30C16284748780-1f386c64a-4424-0266-e053-dadaa90a7c1aCefadroxil Capsules USP 500 mg
66267-045-142025-01-30C16284748780-1f386c64a-4424-0266-e053-dadaa90a7c1aCefadroxil Capsules USP 500 mg
66267-045-202025-01-30C16284748780-1f386c64a-4424-0266-e053-dadaa90a7c1aCefadroxil Capsules USP 500 mg
66267-045-302025-01-30C16284748780-1f386c64a-4424-0266-e053-dadaa90a7c1aCefadroxil Capsules USP 500 mg
66267-045-142023-03-10C16284748780-1f386c64a-4424-0266-e053-dadaa90a7c1aCefadroxil Capsules USP 500 mg
66267-045-202023-03-10C16284748780-1f386c64a-4424-0266-e053-dadaa90a7c1aCefadroxil Capsules USP 500 mg
66267-045-302023-03-10C16284748780-1f386c64a-4424-0266-e053-dadaa90a7c1aCefadroxil Capsules USP 500 mg
66267-045-142023-01-30C16284748780-1f386c64a-4424-0266-e053-dadaa90a7c1aCefadroxil Capsules USP 500 mg
66267-045-202023-01-30C16284748780-1f386c64a-4424-0266-e053-dadaa90a7c1aCefadroxil Capsules USP 500 mg
66267-045-302023-01-30C16284748780-1f386c64a-4424-0266-e053-dadaa90a7c1aCefadroxil Capsules USP 500 mg

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
66267-045-10Cefadroxil10 in 1 BOTTLECAPSULE104
66267-045-14Cefadroxil14 in 1 BOTTLECAPSULE144
66267-045-20Cefadroxil20 in 1 BOTTLECAPSULE204
66267-045-30Cefadroxil30 in 1 BOTTLECAPSULE304

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
66267-045-10EA - Each66267-045bc85dbf5-b3c8-4e94-8708-3e49b335635212023-03-13
66267-045-14EA - Each66267-045df3ebaaf-1ab9-4f42-904b-59d81bdc581912016-10-06
66267-045-20EA - Each66267-0452ee88f18-886e-4b00-a31b-e4997a2cb1b012016-10-06
66267-045-30EA - Each66267-04546b51160-91bb-45e4-9930-9cfc56e35d3a12016-10-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
66267-045CEFADROXIL CAPSULE [NUCARE PHARMACEUTICALS, INC.]4Legacy NDC, 4 package rows20230312_3d958dea-aed7-1ef7-e054-00144ff8d46c.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
309049cefadroxil 500 MG Oral CapsulePSN3d958dea-aed7-1ef7-e054-00144ff8d46c4
309049cefadroxil 500 MG Oral CapsuleSCD3d958dea-aed7-1ef7-e054-00144ff8d46c4
309049cefadroxil (as cefadroxil monohydrate) 500 MG Oral CapsuleSY3d958dea-aed7-1ef7-e054-00144ff8d46c4

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
66267-045-106626700451010 in 1 BOTTLEHistorical
66267-045-146626700451414 CAPSULE in 1 BOTTLE (66267-045-14) 14 capsule2016-09-280000-00-00NoNoCurrent
66267-045-206626700452020 CAPSULE in 1 BOTTLE (66267-045-20) 20 capsule2016-09-280000-00-00NoNoCurrent
66267-045-306626700453030 CAPSULE in 1 BOTTLE (66267-045-30) 30 capsule2016-09-280000-00-00NoNoCurrent