Cefdinir

Product NDC
50090-5583
11-digit product format
500905583
Labeler code
50090
Product ID
50090-5583_ba627e74-603c-4e79-a70a-cd3951bbdb68
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Cefdinir
Dosage form
POWDER, FOR SUSPENSION
Route
ORAL
Labeler
A-S Medication Solutions
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
2022-12-31
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
50090-5583-02023-01-30C16284748780-1f386c64a-042c-0266-e053-dadaa90a7c1aCefdinir for Oral Suspension, USP Rx only

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
50090-5583-0Cefdinir1 in 1 CARTONPOWDER, FOR SUSPENSION11
50090-5583-0Cefdinir100 mL in 1 BOTTLEPOWDER, FOR SUSPENSION1001

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
50090-5583-0ML - Milliliter50090-5583020e0936-3ca2-47f8-907e-246abfd8416012023-02-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50090-5583CEFDINIR POWDER, FOR SUSPENSION [A-S MEDICATION SOLUTIONS]1Legacy NDC, 2 package rows20210713_8b86e279-8948-44b1-9c51-37afc11b827d.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
476576cefdinir 250 MG in 5 mL Oral SuspensionPSN8b86e279-8948-44b1-9c51-37afc11b827d1
476576cefdinir 50 MG/ML Oral SuspensionSCD8b86e279-8948-44b1-9c51-37afc11b827d1
476576cefdinir 250 MG per 5 ML Oral SuspensionSY8b86e279-8948-44b1-9c51-37afc11b827d1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
50090-5583-0500905583001 BOTTLE in 1 CARTON (50090-5583-0) > 100 mL in 1 BOTTLE1 bottle2021-07-080000-00-00NoNoCurrent