Cefdinir

Product NDC
68788-8655
11-digit product format
687888655
Labeler code
68788
Product ID
68788-8655_a1224216-2592-4f61-b9b5-6406cf43c0eb
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Cefdinir
Dosage form
POWDER, FOR SUSPENSION
Route
ORAL
Labeler
Preferred Pharmaceuticals Inc.
Application
ANDA065332
Marketing category
ANDA
Marketing start
2024-05-09
Substance
CEFDINIR MONOHYDRATE
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
CEFDINIR MONOHYDRATE250 mg/5mL

Harmonized Identifiers#

Field, Values table
FieldValues
Unii6E7SN358SE
Rxcui476576

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
e2db08c6-133f-4f4f-afb4-e90a2418d6f6Product name120230320
c6f86816-7da6-43ea-8c25-ac9758311cc5Product name120220118
d3e72f63-2c41-955f-f4ce-e90c6403e67cProduct name220210729
e8e66e64-d220-99cb-44eb-0f32dc8cbda1Product name220210729
ce6d5c06-3ae0-18a6-d5b3-8cd3cc0f8906Product name720210625
f52be47f-7aa7-46c0-b1fa-50c18dd50206Product name120201029
11ed6f83-cdd2-4637-8379-b1a1d3ae3cdeProduct name120181101
86c45a79-b9f0-4476-a27c-6e10db098497Product name120180125
252e11b6-1a9a-4283-a242-df2c129c496dProduct name320170717
d5e51f11-ad28-caa4-4b49-4143974782adProduct name120150831

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
68788-8655-1Cefdinir100 mL in 1 BOTTLEPOWDER, FOR SUSPENSION1003

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
68788-8655-1ML - Milliliter68788-8655546b1395-d050-4b23-837f-615654d90d2e12024-06-10

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68788-8655CEFDINIR POWDER, FOR SUSPENSION [PREFERRED PHARMACEUTICALS INC.]2Current NDC, 1 package rows20250221_0d1212c9-604f-4999-8f7d-e7cf300705ef.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
476576cefdinir 250 MG in 5 mL Oral SuspensionPSN0d1212c9-604f-4999-8f7d-e7cf300705ef3
476576cefdinir 50 MG/ML Oral SuspensionSCD0d1212c9-604f-4999-8f7d-e7cf300705ef3
476576cefdinir 250 MG per 5 ML Oral SuspensionSY0d1212c9-604f-4999-8f7d-e7cf300705ef3

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
68788-8655-168788865501100 mL in 1 BOTTLE (68788-8655-1) 100 ml2024-05-09NoNoHistorical