Cefdinir

Product NDC
63187-616
11-digit product format
631870616
Labeler code
63187
Product ID
63187-616_aec22cad-186d-4dac-9fe3-c3b4d6075b2c
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Cefdinir
Dosage form
POWDER, FOR SUSPENSION
Route
ORAL
Labeler
Proficient Rx LP
Application
ANDA065332
Marketing category
ANDA
Marketing start
2007-05-08
Substance
CEFDINIR MONOHYDRATE
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
CEFDINIR MONOHYDRATE250 mg/5mL

Harmonized Identifiers#

Field, Values table
FieldValues
Unii6E7SN358SE
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
63187-616-00Cefdinir100 mL in 1 BOTTLEPOWDER, FOR SUSPENSION1004
63187-616-60Cefdinir60 mL in 1 BOTTLEPOWDER, FOR SUSPENSION604

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
63187-616CEFDINIR POWDER, FOR SUSPENSION [PROFICIENT RX LP]4Current NDC, Legacy NDC, 2 package rows20220402_f22acd90-5dc4-406d-af78-5f9c3a674647.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
476576cefdinir 250 MG in 5 mL Oral SuspensionPSNf22acd90-5dc4-406d-af78-5f9c3a6746474
476576cefdinir 50 MG/ML Oral SuspensionSCDf22acd90-5dc4-406d-af78-5f9c3a6746474
476576cefdinir 250 MG per 5 ML Oral SuspensionSYf22acd90-5dc4-406d-af78-5f9c3a6746474

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
63187-616-0063187061600100 mL in 1 BOTTLE (63187-616-00) 100 ml2007-05-080000-00-00NoNoCurrent
63187-616-606318706166060 mL in 1 BOTTLE (63187-616-60) 60 ml2007-05-080000-00-00NoNoCurrent