FDA.reportPublic FDA data

Cefdinir

Product NDC
70518-4169
11-digit product format
705184169
Labeler code
70518
Product ID
70518-4169_51dfcdb4-b2fb-80a3-e063-6394a90a1ebb
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Cefdinir
Dosage form
CAPSULE
Route
ORAL
Labeler
REMEDYREPACK INC.
Application
ANDA210220
Marketing category
ANDA
Marketing start
2024-08-27
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
Rxcui200346

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
70518-4169-0Cefdinir20 in 1 BOTTLE, PLASTICCAPSULE205
70518-4169-1Cefdinir30 in 1 BLISTER PACKCAPSULE305
70518-4169-2Cefdinir14 in 1 BOTTLE, PLASTICCAPSULE145
70518-4169-3Cefdinir10 in 1 BOTTLE, PLASTICCAPSULE105

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
70518-4169CEFDINIR CAPSULE [REMEDYREPACK INC.]3Current NDC, 4 package rows20250316_a8029f7c-6353-46db-8c8c-c86a9485a14f.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
200346cefdinir 300 MG Oral CapsulePSNa8029f7c-6353-46db-8c8c-c86a9485a14f5
200346cefdinir 300 MG Oral CapsuleSCDa8029f7c-6353-46db-8c8c-c86a9485a14f5

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
70518-4169-07051841690020 CAPSULE in 1 BOTTLE, PLASTIC (70518-4169-0) 20 capsule2024-08-27NoNoCurrent
70518-4169-17051841690130 CAPSULE in 1 BLISTER PACK (70518-4169-1) 30 capsule2024-12-23NoNoCurrent
70518-4169-27051841690214 CAPSULE in 1 BOTTLE, PLASTIC (70518-4169-2) 14 capsule2025-03-12NoNoCurrent
70518-4169-37051841690310 CAPSULE in 1 BOTTLE, PLASTIC (70518-4169-3) 10 capsule2026-05-14NoNoCurrent