Cefdinir

Product NDC
68071-3156
11-digit product format
680713156
Labeler code
68071
Product ID
68071-3156_2d53fd8c-5f3f-8b3f-e063-6394a90a3ea0
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Cefdinir
Dosage form
POWDER, FOR SUSPENSION
Route
ORAL
Labeler
NuCare Pharmaceuticals, Inc.
Application
ANDA065332
Marketing category
ANDA
Marketing start
2007-05-08
Substance
CEFDINIR MONOHYDRATE
Active strength
125 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
CEFDINIR MONOHYDRATE125 mg/5mL

Harmonized Identifiers#

Field, Values table
FieldValues
Unii6E7SN358SE
Rxcui309054

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
68071-3156-6Cefdinir60 mL in 1 BOTTLEPOWDER, FOR SUSPENSION606

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68071-3156CEFDINIR POWDER, FOR SUSPENSION [NUCARE PHARMACEUTICALS, INC.]6Current NDC, Legacy NDC, 1 package rows20250206_4ade94bb-6c39-13cd-e054-00144ff8d46c.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
309054cefdinir 125 MG in 5 mL Oral SuspensionPSN4ade94bb-6c39-13cd-e054-00144ff8d46c6
309054cefdinir 25 MG/ML Oral SuspensionSCD4ade94bb-6c39-13cd-e054-00144ff8d46c6
309054cefdinir 125 MG per 5 ML Oral SuspensionSY4ade94bb-6c39-13cd-e054-00144ff8d46c6

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
68071-3156-66807131560660 mL in 1 BOTTLE (68071-3156-6) 60 ml2017-03-160000-00-00NoNoCurrent