FDA.reportPublic FDA data

Cefdinir

Product NDC
68071-2503
11-digit product format
680712503
Labeler code
68071
Product ID
68071-2503_2badf51d-00cc-a56f-e063-6394a90a004d
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Cefdinir
Dosage form
CAPSULE
Route
ORAL
Labeler
NuCare Pharmaceuticals,Inc.
Application
ANDA210220
Marketing category
ANDA
Marketing start
2021-02-20
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
68071-2503-22024-10-09C16284748780-1f386c649-cf46-0266-e053-dadaa90a7c1aCEFDINIR CAPSULES, USP 300 mg Rx only To reduce the development of drug-resistant bacteria and maintain the effectiveness of cefdinir and other antibacterial drugs, cefdinir should be used only to treat or prevent infections that are proven or strongly suspected to be caused by bacteria.
68071-2503-22023-01-30C16284748780-1f386c649-cf46-0266-e053-dadaa90a7c1aCEFDINIR CAPSULES, USP 300 mg Rx only To reduce the development of drug-resistant bacteria and maintain the effectiveness of cefdinir and other antibacterial drugs, cefdinir should be used only to treat or prevent infections that are proven or strongly suspected to be caused by bacteria.

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
68071-2503-2Cefdinir20 in 1 BOTTLECAPSULE203
68071-2503-3Cefdinir30 in 1 BOTTLECAPSULE303

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68071-2503CEFDINIR CAPSULE [NUCARE PHARMACEUTICALS,INC.]3Current NDC, Legacy NDC, 2 package rows20250116_c974d975-8616-3551-e053-2995a90a65f3.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
200346cefdinir 300 MG Oral CapsulePSNc974d975-8616-3551-e053-2995a90a65f33
200346cefdinir 300 MG Oral CapsuleSCDc974d975-8616-3551-e053-2995a90a65f33

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
68071-2503-26807125030220 CAPSULE in 1 BOTTLE (68071-2503-2) 20 capsule2021-02-200000-00-00NoNoCurrent
68071-2503-36807125030330 CAPSULE in 1 BOTTLE (68071-2503-3) 30 capsule2025-01-14NoNoCurrent