FDA.reportPublic FDA data

Cefdinir

Product NDC
63187-835
11-digit product format
631870835
Labeler code
63187
Product ID
63187-835_5fcd955c-b46e-4949-b804-f81abe9d37b6
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Cefdinir
Dosage form
POWDER, FOR SUSPENSION
Route
ORAL
Labeler
Proficient Rx LP
Application
ANDA065473
Marketing category
ANDA
Marketing start
2007-12-14
Substance
CEFDINIR
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
CEFDINIR125 mg/5mL

Harmonized Identifiers#

Field, Values table
FieldValues
UniiCI0FAO63WC
Rxcui309054

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
63187-835-00Cefdinir1 in 1 CARTONPOWDER, FOR SUSPENSION15
63187-835-00Cefdinir100 mL in 1 BOTTLEPOWDER, FOR SUSPENSION1005
63187-835-60Cefdinir1 in 1 CARTONPOWDER, FOR SUSPENSION15
63187-835-60Cefdinir60 mL in 1 BOTTLEPOWDER, FOR SUSPENSION605

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
63187-835-00ML - Milliliter63187-83583352ca0-ce7c-47c3-a09c-2685dee95f2012017-06-15

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
63187-835CEFDINIR POWDER, FOR SUSPENSION [PROFICIENT RX LP]5Current NDC, Legacy NDC, 4 package rows20221012_be963e80-e298-49a0-a52f-3d4dcded7c8c.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
309054cefdinir 125 MG in 5 mL Oral SuspensionPSNbe963e80-e298-49a0-a52f-3d4dcded7c8c5
309054cefdinir 25 MG/ML Oral SuspensionSCDbe963e80-e298-49a0-a52f-3d4dcded7c8c5
309054cefdinir 125 MG per 5 ML Oral SuspensionSYbe963e80-e298-49a0-a52f-3d4dcded7c8c5

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
63187-835-00631870835001 BOTTLE in 1 CARTON (63187-835-00) / 100 mL in 1 BOTTLE1 bottle2017-05-010000-00-00NoNoCurrent
63187-835-60631870835601 BOTTLE in 1 CARTON (63187-835-60) / 60 mL in 1 BOTTLE1 bottle2017-05-010000-00-00NoNoCurrent