CEFDINIR

Product NDC
76519-1172
11-digit product format
765191172
Labeler code
76519
Product ID
76519-1172_7640dd80-1a57-9805-e053-2991aa0acbb5
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
CEFDINIR
Dosage form
POWDER, FOR SUSPENSION
Route
ORAL
Labeler
H.J. Harkins Company, Inc.
Application
ANDA065332
Marketing category
ANDA
Marketing start
2018-03-26
Marketing end
0000-00-00
Substance
CEFDINIR MONOHYDRATE
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
76519-1172-62020-01-31C16284748780-19d75b9d0-3802-f424-e053-dadaa90a57ce1172/1214 CEFDINIR SUSP

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
76519-1172-6CEFDINIR60 mL in 1 BOTTLEPOWDER, FOR SUSPENSION601

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
76519-1172CEFDINIR POWDER, FOR SUSPENSION [H.J. HARKINS COMPANY, INC.]1Legacy NDC, 1 package rows20180921_7640dd80-1a56-9805-e053-2991aa0acbb5.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
309054cefdinir 125 MG in 5 mL Oral SuspensionPSN7640dd80-1a56-9805-e053-2991aa0acbb51
476576cefdinir 250 MG in 5 mL Oral SuspensionPSN7640dd80-1a56-9805-e053-2991aa0acbb51
309054cefdinir 25 MG/ML Oral SuspensionSCD7640dd80-1a56-9805-e053-2991aa0acbb51
476576cefdinir 50 MG/ML Oral SuspensionSCD7640dd80-1a56-9805-e053-2991aa0acbb51
309054cefdinir 125 MG per 5 ML Oral SuspensionSY7640dd80-1a56-9805-e053-2991aa0acbb51
476576cefdinir 250 MG per 5 ML Oral SuspensionSY7640dd80-1a56-9805-e053-2991aa0acbb51

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsStatus
76519-1172-67651911720660 mL in 1 BOTTLE60 mlHistorical