FDA.reportPublic FDA data

Cefdinir

Product NDC
68071-5145
11-digit product format
680715145
Labeler code
68071
Product ID
68071-5145_45120ef3-e746-6c39-e063-6394a90ad638
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Cefdinir
Dosage form
CAPSULE
Route
ORAL
Labeler
NuCare Pharmaceuticals,Inc.
Application
ANDA065434
Marketing category
ANDA
Marketing start
2008-01-07
Substance
CEFDINIR
Active strength
300 mg/1
Pharmacologic classes
Cephalosporin Antibacterial [EPC], Cephalosporins [CS]
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Cefdinir
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
CEFDINIR300 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiCI0FAO63WC
Rxcui200346

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
68071-5145-22023-03-28C16284748780-1f386c649-fda4-0266-e053-dadaa90a7c1aCefdinir Capsules, USP Rx only
68071-5145-22023-01-30C16284748780-1f386c649-fda4-0266-e053-dadaa90a7c1aCefdinir Capsules, USP Rx only

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
68071-5145-2Cefdinir20 in 1 BOTTLECAPSULE205
68071-5145-7Cefdinir14 in 1 BOTTLECAPSULE145

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68071-5145CEFDINIR CAPSULE [NUCARE PHARMACEUTICALS,INC.]4Current NDC, Legacy NDC, 2 package rows20240621_9ba5cb2d-6272-27de-e053-2995a90a58c8.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
200346cefdinir 300 MG Oral CapsulePSN9ba5cb2d-6272-27de-e053-2995a90a58c85
200346cefdinir 300 MG Oral CapsuleSCD9ba5cb2d-6272-27de-e053-2995a90a58c85

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
68071-5145-26807151450220 CAPSULE in 1 BOTTLE (68071-5145-2) 20 capsule2020-01-080000-00-00NoNoCurrent
68071-5145-76807151450714 CAPSULE in 1 BOTTLE (68071-5145-7) 14 capsule2025-12-03NoNoCurrent