Cefdinir

Product NDC
68071-1645
11-digit product format
680711645
Labeler code
68071
Product ID
68071-1645_d57d9cf4-1a07-3cfa-e053-2a95a90aae6f
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Cefdinir
Dosage form
POWDER, FOR SUSPENSION
Route
ORAL
Labeler
NuCare Pharmaceuticals,Inc.
Application
ANDA065473
Marketing category
ANDA
Marketing start
2007-12-14
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
68071-1645-12025-01-30C16284748780-12cef2736-6f10-d83d-e063-dadaa90ab31fCefdinir for Oral Suspension, USP Rx only

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
68071-1645-1Cefdinir1 in 1 CARTONPOWDER, FOR SUSPENSION11
68071-1645-1Cefdinir100 mL in 1 BOTTLEPOWDER, FOR SUSPENSION1001

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68071-1645CEFDINIR POWDER, FOR SUSPENSION [NUCARE PHARMACEUTICALS,INC.]1Legacy NDC, 2 package rows20220114_d57d9cf4-1a06-3cfa-e053-2a95a90aae6f.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
476576cefdinir 250 MG in 5 mL Oral SuspensionPSNd57d9cf4-1a06-3cfa-e053-2a95a90aae6f1
476576cefdinir 50 MG/ML Oral SuspensionSCDd57d9cf4-1a06-3cfa-e053-2a95a90aae6f1
476576cefdinir 250 MG per 5 ML Oral SuspensionSYd57d9cf4-1a06-3cfa-e053-2a95a90aae6f1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
68071-1645-1680711645011 BOTTLE in 1 CARTON (68071-1645-1) > 100 mL in 1 BOTTLE1 bottle2022-01-130000-00-00NoNoCurrent