FDA.reportPublic FDA data

Cefdinir

Product NDC
67296-0469
11-digit product format
672960469
Labeler code
67296
Product ID
67296-0469_b8d03810-88c1-d272-e053-2a95a90aa617
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Cefdinir
Dosage form
CAPSULE
Route
ORAL
Labeler
RedPharm Drug, Inc.
Application
ANDA065264
Marketing category
ANDA
Marketing start
2007-05-01
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
d3e72f63-2c41-955f-f4ce-e90c6403e67cProduct name220210729
e8e66e64-d220-99cb-44eb-0f32dc8cbda1Product name220210729

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
67296-0469-12026-01-29C16284748780-1f386c649-bd5f-0266-e053-dadaa90a7c1aCednifir 300mg
67296-0469-22026-01-29C16284748780-1f386c649-bd5f-0266-e053-dadaa90a7c1aCednifir 300mg
67296-0469-32026-01-29C16284748780-1f386c649-bd5f-0266-e053-dadaa90a7c1aCednifir 300mg
67296-0469-12024-07-03C16284748780-1f386c649-bd5f-0266-e053-dadaa90a7c1aCednifir 300mg
67296-0469-22024-07-03C16284748780-1f386c649-bd5f-0266-e053-dadaa90a7c1aCednifir 300mg
67296-0469-32024-07-03C16284748780-1f386c649-bd5f-0266-e053-dadaa90a7c1aCednifir 300mg
67296-0469-12023-01-30C16284748780-1f386c649-bd5f-0266-e053-dadaa90a7c1aCednifir 300mg
67296-0469-22023-01-30C16284748780-1f386c649-bd5f-0266-e053-dadaa90a7c1aCednifir 300mg
67296-0469-32023-01-30C16284748780-1f386c649-bd5f-0266-e053-dadaa90a7c1aCednifir 300mg

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
67296-0469-1Cefdinir20 in 1 BOTTLECAPSULE2011
67296-0469-2Cefdinir14 in 1 BOTTLECAPSULE1411
67296-0469-3Cefdinir10 in 1 BOTTLECAPSULE1011

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
CEFDINIRACTIVE INGREDIENTCI0FAO63WCCEFDINIR CAPSULE [REDPHARM DRUG INC.]2
CEFDINIRACTIVE MOIETYCI0FAO63WCCEFDINIR CAPSULE [REDPHARM DRUG INC.]2
CARBOXYMETHYLCELLULOSE CALCIUMINACTIVE INGREDIENTUTY7PDF93LCEFDINIR CAPSULE [REDPHARM DRUG INC.]2
COLLOIDAL SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4CEFDINIR CAPSULE [REDPHARM DRUG INC.]2
D&C RED NO. 28INACTIVE INGREDIENT767IP0Y5NHCEFDINIR CAPSULE [REDPHARM DRUG INC.]2
FD&C BLUE NO. 1INACTIVE INGREDIENTH3R47K3TBDCEFDINIR CAPSULE [REDPHARM DRUG INC.]2
FD&C RED NO. 40INACTIVE INGREDIENTWZB9127XOACEFDINIR CAPSULE [REDPHARM DRUG INC.]2
GELATININACTIVE INGREDIENT2G86QN327LCEFDINIR CAPSULE [REDPHARM DRUG INC.]2
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30CEFDINIR CAPSULE [REDPHARM DRUG INC.]2
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPCEFDINIR CAPSULE [REDPHARM DRUG INC.]2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
67296-0469CEFDINIR CAPSULE [REDPHARM DRUG, INC.]11Legacy NDC, 3 package rows20240704_bcf04f49-8d0b-4563-9d0f-93939cdf6a6c.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
200346cefdinir 300 MG Oral CapsulePSNbcf04f49-8d0b-4563-9d0f-93939cdf6a6c11
200346cefdinir 300 MG Oral CapsuleSCDbcf04f49-8d0b-4563-9d0f-93939cdf6a6c11

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
67296-0469-16729604690120 CAPSULE in 1 BOTTLE (67296-0469-1) 20 capsule2011-06-240000-00-00NoNoCurrent
67296-0469-26729604690214 CAPSULE in 1 BOTTLE (67296-0469-2) 14 capsule2019-01-010000-00-00NoNoCurrent
67296-0469-36729604690310 CAPSULE in 1 BOTTLE (67296-0469-3) 10 capsule2019-01-010000-00-00NoNoCurrent