FDA.reportPublic FDA data

Cefdinir

Product NDC
71205-380
11-digit product format
712050380
Labeler code
71205
Product ID
71205-380_eb67d441-028c-49e6-93b4-2be3b6bc9acf
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Cefdinir
Dosage form
POWDER, FOR SUSPENSION
Route
ORAL
Labeler
Proficient Rx LP
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
e2db08c6-133f-4f4f-afb4-e90a2418d6f6Product name120230320
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
d5e51f11-ad28-caa4-4b49-4143974782adProduct name120150831

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
71205-380-00Cefdinir100 mL in 1 BOTTLEPOWDER, FOR SUSPENSION1003
71205-380-60Cefdinir60 mL in 1 BOTTLEPOWDER, FOR SUSPENSION603

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71205-380CEFDINIR POWDER, FOR SUSPENSION [PROFICIENT RX LP]3Current NDC, Legacy NDC, 2 package rows20220513_444cd2c4-836d-40d5-a307-d719fe83e763.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
476576cefdinir 250 MG in 5 mL Oral SuspensionPSN444cd2c4-836d-40d5-a307-d719fe83e7633
476576cefdinir 50 MG/ML Oral SuspensionSCD444cd2c4-836d-40d5-a307-d719fe83e7633
476576cefdinir 250 MG per 5 ML Oral SuspensionSY444cd2c4-836d-40d5-a307-d719fe83e7633

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
71205-380-0071205038000100 mL in 1 BOTTLE (71205-380-00) 100 ml2021-06-030000-00-00NoNoCurrent
71205-380-607120503806060 mL in 1 BOTTLE (71205-380-60) 60 ml2020-01-060000-00-00NoNoCurrent