Cefdinir

Product NDC
53217-406
11-digit product format
532170406
Labeler code
53217
Product ID
53217-406_5a197410-4559-472f-9a7f-3a3fdad4a0d0
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Cefdinir
Dosage form
POWDER, FOR SUSPENSION
Route
ORAL
Labeler
Aidarex Pharmaceuticals LLC
Application
ANDA065332
Marketing category
ANDA
Marketing start
2018-08-10
Marketing end
0000-00-00
Substance
CEFDINIR MONOHYDRATE
Active strength
250 mg/5mL
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
d3e72f63-2c41-955f-f4ce-e90c6403e67cProduct name220210729
e8e66e64-d220-99cb-44eb-0f32dc8cbda1Product name220210729

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
53217-406-012020-01-31C16284748780-19d75b9d1-1242-f424-e053-dadaa90a57ceCEFDINIR FOR ORAL SUSPENSION USP Rx only

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
53217-406-01Cefdinir100 mL in 1 BOTTLEPOWDER, FOR SUSPENSION1001

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
53217-406CEFDINIR POWDER, FOR SUSPENSION [AIDAREX PHARMACEUTICALS LLC]1Legacy NDC, 1 package rows20180825_be474782-045b-478f-a701-37976fb1b694.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
476576cefdinir 250 MG in 5 mL Oral SuspensionPSNbe474782-045b-478f-a701-37976fb1b6941
476576cefdinir 50 MG/ML Oral SuspensionSCDbe474782-045b-478f-a701-37976fb1b6941
476576cefdinir 250 MG per 5 ML Oral SuspensionSYbe474782-045b-478f-a701-37976fb1b6941

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsStatus
53217-406-0153217040601100 mL in 1 BOTTLE100 mlHistorical