Cefdinir

Product NDC
82868-059
11-digit product format
828680059
Labeler code
82868
Product ID
82868-059_47f9555a-fb69-3042-e063-6394a90aa6cb
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Cefdinir
Dosage form
CAPSULE
Route
ORAL
Labeler
Northwind Health Company, LLC
Application
ANDA210220
Marketing category
ANDA
Marketing start
2024-06-25
Substance
CEFDINIR
Active strength
300 mg/1
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
CEFDINIR300 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiCI0FAO63WC

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
82868-059-20Cefdinir20 in 1 BOTTLE, PLASTICCAPSULE202

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
82868-059CEFDINIR CAPSULE [NORTHWIND PHARMACEUTICALS, LLC]1Current NDC, 1 package rows20240713_1d0d50ba-8c2b-855c-e063-6394a90a5c7d.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
200346cefdinir 300 MG Oral CapsulePSN1d0d50ba-8c2b-855c-e063-6394a90a5c7d2
200346cefdinir 300 MG Oral CapsuleSCD1d0d50ba-8c2b-855c-e063-6394a90a5c7d2

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
82868-059-208286800592020 CAPSULE in 1 BOTTLE, PLASTIC (82868-059-20) 20 capsule2024-06-25NoNoHistorical