FDA.reportPublic FDA data

Cefdinir

Product NDC
67296-0868
11-digit product format
672960868
Labeler code
67296
Product ID
67296-0868_bd5caea8-56e8-7279-e053-2995a90aa1a1
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Cefdinir
Dosage form
CAPSULE
Route
ORAL
Labeler
EPM Packaging, Inc.
Application
ANDA065368
Marketing category
ANDA
Marketing start
2007-05-09
Marketing end
0000-00-00
Substance
CEFDINIR
Active strength
300 mg/1
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
351abe41-466c-4dd8-840a-0fdb68318bd5Product name120230316
d3e72f63-2c41-955f-f4ce-e90c6403e67cProduct name220210729
e8e66e64-d220-99cb-44eb-0f32dc8cbda1Product name220210729

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
67296-0868-12024-07-11C16284748780-1f386c649-c798-0266-e053-dadaa90a7c1aCefdinir 300mg capsules
67296-0868-22024-07-11C16284748780-1f386c649-c798-0266-e053-dadaa90a7c1aCefdinir 300mg capsules
67296-0868-32024-07-11C16284748780-1f386c649-c798-0266-e053-dadaa90a7c1aCefdinir 300mg capsules
67296-0868-42024-07-11C16284748780-1f386c649-c798-0266-e053-dadaa90a7c1aCefdinir 300mg capsules
67296-0868-12023-01-30C16284748780-1f386c649-c798-0266-e053-dadaa90a7c1aCefdinir 300mg capsules
67296-0868-22023-01-30C16284748780-1f386c649-c798-0266-e053-dadaa90a7c1aCefdinir 300mg capsules
67296-0868-32023-01-30C16284748780-1f386c649-c798-0266-e053-dadaa90a7c1aCefdinir 300mg capsules
67296-0868-42023-01-30C16284748780-1f386c649-c798-0266-e053-dadaa90a7c1aCefdinir 300mg capsules

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
67296-0868-1Cefdinir20 in 1 BOTTLECAPSULE202
67296-0868-2Cefdinir14 in 1 BOTTLECAPSULE142
67296-0868-3Cefdinir28 in 1 BOTTLECAPSULE282
67296-0868-4Cefdinir10 in 1 BOTTLECAPSULE102

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
67296-0868CEFDINIR CAPSULE [REDPHARM DRUG]2Legacy NDC, 4 package rows20240712_bd5caea8-56e7-7279-e053-2995a90aa1a1.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
200346cefdinir 300 MG Oral CapsulePSNbd5caea8-56e7-7279-e053-2995a90aa1a12
200346cefdinir 300 MG Oral CapsuleSCDbd5caea8-56e7-7279-e053-2995a90aa1a12

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
67296-0868-16729608680120 CAPSULE in 1 BOTTLE (67296-0868-1) 20 capsule2021-03-010000-00-00NoNoCurrent
67296-0868-26729608680214 CAPSULE in 1 BOTTLE (67296-0868-2) 14 capsule2021-03-010000-00-00NoNoCurrent
67296-0868-36729608680328 CAPSULE in 1 BOTTLE (67296-0868-3) 28 capsule2021-03-010000-00-00NoNoCurrent
67296-0868-46729608680410 CAPSULE in 1 BOTTLE (67296-0868-4) 10 capsule2021-03-010000-00-00NoNoCurrent