FDA.reportPublic FDA data

Cefdinir

Product NDC
50090-1033
11-digit product format
500901033
Labeler code
50090
Product ID
50090-1033_2b8b8acc-40d9-4992-9c3b-e5f145951211
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Cefdinir
Dosage form
CAPSULE
Route
ORAL
Labeler
A-S Medication Solutions
Application
ANDA065264
Marketing category
ANDA
Marketing start
2006-05-30
Substance
CEFDINIR
Active strength
300 mg/1
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
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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
50090-1033-02023-02-07C16284748780-1f386c649-e35a-0266-e053-dadaa90a7c1aCEFDINIR CAPSULES USP
50090-1033-12023-02-07C16284748780-1f386c649-e35a-0266-e053-dadaa90a7c1aCEFDINIR CAPSULES USP
50090-1033-22023-02-07C16284748780-1f386c649-e35a-0266-e053-dadaa90a7c1aCEFDINIR CAPSULES USP
50090-1033-32023-02-07C16284748780-1f386c649-e35a-0266-e053-dadaa90a7c1aCEFDINIR CAPSULES USP
50090-1033-02023-01-30C16284748780-1f386c649-e35a-0266-e053-dadaa90a7c1aCEFDINIR CAPSULES USP
50090-1033-12023-01-30C16284748780-1f386c649-e35a-0266-e053-dadaa90a7c1aCEFDINIR CAPSULES USP
50090-1033-22023-01-30C16284748780-1f386c649-e35a-0266-e053-dadaa90a7c1aCEFDINIR CAPSULES USP
50090-1033-32023-01-30C16284748780-1f386c649-e35a-0266-e053-dadaa90a7c1aCEFDINIR CAPSULES USP

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
50090-1033-0Cefdinir10 in 1 BOTTLECAPSULE1011
50090-1033-1Cefdinir20 in 1 BOTTLECAPSULE2011
50090-1033-2Cefdinir14 in 1 BOTTLECAPSULE1411
50090-1033-3Cefdinir30 in 1 BOTTLECAPSULE3011

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
50090-1033-0EA - Each50090-1033cb6fc725-99fd-4002-ba74-c8d6f9b2fe4312023-06-06
50090-1033-1EA - Each50090-1033e81f6577-53ed-483c-a97b-82ea31d1e72e12021-08-05
50090-1033-2EA - Each50090-1033c419610d-de77-4035-8be5-0168ac7c30ab12021-08-05
50090-1033-3EA - Each50090-103379bd886d-ae44-4894-af7b-c828115578d112023-06-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50090-1033CEFDINIR CAPSULE [A-S MEDICATION SOLUTIONS]11Current NDC, Legacy NDC, 4 package rows20250403_12e89d69-7ef8-4dd6-ab64-a7fc3f1f8e70.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
200346cefdinir 300 MG Oral CapsulePSN12e89d69-7ef8-4dd6-ab64-a7fc3f1f8e7011
200346cefdinir 300 MG Oral CapsuleSCD12e89d69-7ef8-4dd6-ab64-a7fc3f1f8e7011

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
50090-1033-05009010330010 CAPSULE in 1 BOTTLE (50090-1033-0) 10 capsule2019-10-090000-00-00NoNoCurrent
50090-1033-15009010330120 CAPSULE in 1 BOTTLE (50090-1033-1) 20 capsule2014-11-280000-00-00NoNoCurrent
50090-1033-25009010330214 CAPSULE in 1 BOTTLE (50090-1033-2) 14 capsule2019-10-090000-00-00NoNoCurrent
50090-1033-35009010330330 CAPSULE in 1 BOTTLE (50090-1033-3) 30 capsule2019-10-090000-00-00NoNoCurrent