Cefdinir

Product NDC
68071-3403
11-digit product format
680713403
Labeler code
68071
Product ID
68071-3403_2d540607-1806-4063-e063-6294a90a7159
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Cefdinir
Dosage form
POWDER, FOR SUSPENSION
Route
ORAL
Labeler
NuCare Pharmaceuticals,Inc.
Application
ANDA065259
Marketing category
ANDA
Marketing start
2007-05-07
Substance
CEFDINIR
Active strength
250 mg/5mL
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
CEFDINIR250 mg/5mL

Harmonized Identifiers#

Field, Values table
FieldValues
UniiCI0FAO63WC
Rxcui476576

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
68071-3403-12025-02-04C16284748780-12cef2736-80bc-d83d-e063-dadaa90ab31fCefdinir for Oral Suspension USP
68071-3403-12025-01-30C16284748780-12cef2736-80bc-d83d-e063-dadaa90ab31fCefdinir for Oral Suspension USP

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
68071-3403-1Cefdinir100 mL in 1 BOTTLEPOWDER, FOR SUSPENSION1002

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68071-3403CEFDINIR POWDER, FOR SUSPENSION [NUCARE PHARMACEUTICALS,INC.]2Current NDC, 1 package rows20250206_fbd76f8c-e6b8-52f4-e053-6394a90aa7ab.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
476576cefdinir 250 MG in 5 mL Oral SuspensionPSNfbd76f8c-e6b8-52f4-e053-6394a90aa7ab2
476576cefdinir 50 MG/ML Oral SuspensionSCDfbd76f8c-e6b8-52f4-e053-6394a90aa7ab2
476576cefdinir 250 MG per 5 ML Oral SuspensionSYfbd76f8c-e6b8-52f4-e053-6394a90aa7ab2

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
68071-3403-168071340301100 mL in 1 BOTTLE (68071-3403-1) 100 ml2023-05-16NoNoCurrent