Cefdinir

Product NDC
68788-7844
11-digit product format
687887844
Labeler code
68788
Product ID
68788-7844_4a9cc651-518c-411a-956e-77213d2d1336
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Cefdinir
Dosage form
POWDER, FOR SUSPENSION
Route
ORAL
Labeler
Preferred Pharmaceuticals Inc.
Application
ANDA065473
Marketing category
ANDA
Marketing start
2021-01-20
Substance
CEFDINIR
Active strength
250 mg/5mL
Pharmacologic classes
Cephalosporin Antibacterial [EPC], Cephalosporins [CS]
NDC exclude flag
No
Listing certified through
2027-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Cefdinir
Listing expiration
2027-12-31

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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
68788-7844-1Cefdinir1 in 1 CARTONPOWDER, FOR SUSPENSION16
68788-7844-1Cefdinir100 mL in 1 BOTTLEPOWDER, FOR SUSPENSION1006

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
68788-7844-1ML - Milliliter68788-784447a96ea4-1a2f-46dd-825d-54643472af6712021-03-02

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68788-7844CEFDINIR POWDER, FOR SUSPENSION [PREFERRED PHARMACEUTICALS INC.]5Current NDC, Legacy NDC, 2 package rows20250221_5b6c1b5d-a1d5-4e08-9077-2af3f38fea4e.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
476576cefdinir 250 MG in 5 mL Oral SuspensionPSN5b6c1b5d-a1d5-4e08-9077-2af3f38fea4e6
476576cefdinir 50 MG/ML Oral SuspensionSCD5b6c1b5d-a1d5-4e08-9077-2af3f38fea4e6
476576cefdinir 250 MG per 5 ML Oral SuspensionSY5b6c1b5d-a1d5-4e08-9077-2af3f38fea4e6

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
68788-7844-1687887844011 BOTTLE in 1 CARTON (68788-7844-1) > 100 mL in 1 BOTTLE1 bottle2021-01-200000-00-00NoNoCurrent