FDA.reportPublic FDA data

cefdinir

Product NDC
67877-548
11-digit product format
678770548
Labeler code
67877
Product ID
67877-548_662007e2-462e-4513-b5b0-efd5dcdc2421
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
cefdinir
Dosage form
POWDER, FOR SUSPENSION
Route
ORAL
Labeler
Ascend Laboratories, LLC
Application
ANDA210534
Marketing category
ANDA
Marketing start
2021-02-20
Substance
CEFDINIR
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
CEFDINIR250 mg/5mL

Harmonized Identifiers#

Field, Values table
FieldValues
UniiCI0FAO63WC
Rxcui309054, 476576

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
d3e72f63-2c41-955f-f4ce-e90c6403e67cProduct name220210729
e8e66e64-d220-99cb-44eb-0f32dc8cbda1Product name220210729
d5e51f11-ad28-caa4-4b49-4143974782adProduct name120150831

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
67877-548-88cefdinir100 mL in 1 BOTTLEPOWDER, FOR SUSPENSION1006
67877-548-98cefdinir60 mL in 1 BOTTLEPOWDER, FOR SUSPENSION606

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
67877-548-88ML - Milliliter67877-548a1a8fb45-eafe-4178-a517-7420d1f8345612021-04-08
67877-548-98ML - Milliliter67877-5489662ad26-8bff-4dc2-8346-6654484e87c412021-04-08

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
67877-548CEFDINIR POWDER, FOR SUSPENSION [ASCEND LABORATORIES, LLC]6Current NDC, Legacy NDC, 2 package rows20220702_efb5a975-75ec-46e1-ba84-f68d0b9bf36f.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
309054cefdinir 125 MG in 5 mL Oral SuspensionPSN982d0f53-20bc-1cb4-e053-2995a90ad33c8
476576cefdinir 250 MG in 5 mL Oral SuspensionPSN982d0f53-20bc-1cb4-e053-2995a90ad33c8
309054cefdinir 25 MG/ML Oral SuspensionSCD982d0f53-20bc-1cb4-e053-2995a90ad33c8
476576cefdinir 50 MG/ML Oral SuspensionSCD982d0f53-20bc-1cb4-e053-2995a90ad33c8
309054cefdinir 125 MG per 5 ML Oral SuspensionSY982d0f53-20bc-1cb4-e053-2995a90ad33c8
476576cefdinir 250 MG per 5 ML Oral SuspensionSY982d0f53-20bc-1cb4-e053-2995a90ad33c8
476576cefdinir 250 MG in 5 mL Oral SuspensionPSN7bbcc4ac-c964-4c6b-88c0-11c0ba9933db7
476576cefdinir 50 MG/ML Oral SuspensionSCD7bbcc4ac-c964-4c6b-88c0-11c0ba9933db7
476576cefdinir 250 MG per 5 ML Oral SuspensionSY7bbcc4ac-c964-4c6b-88c0-11c0ba9933db7
309054cefdinir 125 MG in 5 mL Oral SuspensionPSNefb5a975-75ec-46e1-ba84-f68d0b9bf36f6
476576cefdinir 250 MG in 5 mL Oral SuspensionPSNefb5a975-75ec-46e1-ba84-f68d0b9bf36f6
309054cefdinir 25 MG/ML Oral SuspensionSCDefb5a975-75ec-46e1-ba84-f68d0b9bf36f6
476576cefdinir 50 MG/ML Oral SuspensionSCDefb5a975-75ec-46e1-ba84-f68d0b9bf36f6
309054cefdinir 125 MG per 5 ML Oral SuspensionSYefb5a975-75ec-46e1-ba84-f68d0b9bf36f6
476576cefdinir 250 MG per 5 ML Oral SuspensionSYefb5a975-75ec-46e1-ba84-f68d0b9bf36f6
476576cefdinir 250 MG in 5 mL Oral SuspensionPSNddbdb94c-509e-d65b-e053-2a95a90afec71
476576cefdinir 50 MG/ML Oral SuspensionSCDddbdb94c-509e-d65b-e053-2a95a90afec71
476576cefdinir 250 MG per 5 ML Oral SuspensionSYddbdb94c-509e-d65b-e053-2a95a90afec71

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
67877-548-8867877054888100 mL in 1 BOTTLE (67877-548-88) 100 ml2021-02-200000-00-00NoNoCurrent
67877-548-986787705489860 mL in 1 BOTTLE (67877-548-98) 60 ml2021-02-200000-00-00NoNoCurrent