Cefdinir

Product NDC
68071-5106
11-digit product format
680715106
Labeler code
68071
Product ID
68071-5106_1b46ce4d-fa1c-4ce1-e063-6394a90a15f3
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Cefdinir
Dosage form
POWDER, FOR SUSPENSION
Route
ORAL
Labeler
NuCare Pharmaceuticals,Inc.
Application
ANDA065473
Marketing category
ANDA
Marketing start
2007-12-14
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#

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
68071-5106-6Cefdinir60 mL in 1 BOTTLEPOWDER, FOR SUSPENSION603

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68071-5106CEFDINIR POWDER, FOR SUSPENSION [NUCARE PHARMACEUTICALS,INC.]3Current NDC, Legacy NDC, 1 package rows20240621_96cad498-70d3-3089-e053-2995a90a9d19.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
476576cefdinir 250 MG in 5 mL Oral SuspensionPSN96cad498-70d3-3089-e053-2995a90a9d193
476576cefdinir 50 MG/ML Oral SuspensionSCD96cad498-70d3-3089-e053-2995a90a9d193
476576cefdinir 250 MG per 5 ML Oral SuspensionSY96cad498-70d3-3089-e053-2995a90a9d193

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
68071-5106-66807151060660 mL in 1 BOTTLE (68071-5106-6) 60 ml2019-11-070000-00-00NoNoCurrent