Cefdinir

Product NDC
53217-298
11-digit product format
532170298
Labeler code
53217
Product ID
53217-298_446675b3-5cf0-46eb-995a-a854c4a5a183
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Cefdinir
Dosage form
POWDER, FOR SUSPENSION
Route
ORAL
Labeler
Aidarex Pharmaceuticals LLC
Application
ANDA065473
Marketing category
ANDA
Marketing start
2007-12-14
Marketing end
0000-00-00
Substance
CEFDINIR
Active strength
125 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
53217-298-012020-01-31C16284748780-19d75b9d0-82f9-f424-e053-dadaa90a57ceCEFDINIR FOR ORAL SUSPENSION, USP Rx Only

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
53217-298-01Cefdinir60 mL in 1 BOTTLEPOWDER, FOR SUSPENSION601
53217-298-01Cefdinir1 in 1 CARTONPOWDER, FOR SUSPENSION11

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
53217-298-01ML - Milliliter53217-2983c3476dc-db40-4fd3-886b-10ffa708f8d212017-06-15

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
53217-298CEFDINIR POWDER, FOR SUSPENSION [AIDAREX PHARMACEUTICALS LLC]1Legacy NDC, 2 package rows20170518_ee56347c-b61e-4648-ab88-d3af36f7dc8b.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
309054cefdinir 125 MG in 5 mL Oral SuspensionPSNee56347c-b61e-4648-ab88-d3af36f7dc8b1
309054cefdinir 25 MG/ML Oral SuspensionSCDee56347c-b61e-4648-ab88-d3af36f7dc8b1
309054cefdinir 125 MG per 5 ML Oral SuspensionSYee56347c-b61e-4648-ab88-d3af36f7dc8b1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsStatus
53217-298-015321702980160 mL in 1 BOTTLE60 mlHistorical