Cefdinir

Product NDC
68071-2683
11-digit product format
680712683
Labeler code
68071
Product ID
68071-2683_ddbdb94c-509f-d65b-e053-2a95a90afec7
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Cefdinir
Dosage form
POWDER, FOR SUSPENSION
Route
ORAL
Labeler
NuCare Pharmaceuticals,Inc.
Application
ANDA210534
Marketing category
ANDA
Marketing start
2021-02-20
Marketing end
0000-00-00
Substance
CEFDINIR
Active strength
250 mg/5mL
Pharmacologic classes
Cephalosporin Antibacterial [EPC], Cephalosporins [CS]
NDC exclude flag
No
Listing certified through
2023-12-31
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
68071-2683-12025-01-30C16284748780-12cef2736-75c8-d83d-e063-dadaa90ab31fCefdinir for Oral Suspension USP Rx only

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
68071-2683-1Cefdinir100 mL in 1 BOTTLEPOWDER, FOR SUSPENSION1001

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68071-2683CEFDINIR POWDER, FOR SUSPENSION [NUCARE PHARMACEUTICALS,INC.]1Legacy NDC, 1 package rows20220429_ddbdb94c-509e-d65b-e053-2a95a90afec7.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
476576cefdinir 250 MG in 5 mL Oral SuspensionPSNddbdb94c-509e-d65b-e053-2a95a90afec71
476576cefdinir 50 MG/ML Oral SuspensionSCDddbdb94c-509e-d65b-e053-2a95a90afec71
476576cefdinir 250 MG per 5 ML Oral SuspensionSYddbdb94c-509e-d65b-e053-2a95a90afec71

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
68071-2683-168071268301100 mL in 1 BOTTLE (68071-2683-1) 100 ml2022-04-280000-00-00NoNoCurrent