FDA.reportPublic FDA data

cefdinir

Product NDC
67877-547
11-digit product format
678770547
Labeler code
67877
Product ID
67877-547_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
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, 476576

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
e2db08c6-133f-4f4f-afb4-e90a2418d6f6Product name120230320
c6f86816-7da6-43ea-8c25-ac9758311cc5Product name120220118
d3e72f63-2c41-955f-f4ce-e90c6403e67cProduct name220210729
e8e66e64-d220-99cb-44eb-0f32dc8cbda1Product name220210729
ce6d5c06-3ae0-18a6-d5b3-8cd3cc0f8906Product name720210625
f52be47f-7aa7-46c0-b1fa-50c18dd50206Product name120201029
11ed6f83-cdd2-4637-8379-b1a1d3ae3cdeProduct name120181101
86c45a79-b9f0-4476-a27c-6e10db098497Product name120180125
252e11b6-1a9a-4283-a242-df2c129c496dProduct name320170717
d5e51f11-ad28-caa4-4b49-4143974782adProduct name120150831

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
67877-547-88cefdinir100 mL in 1 BOTTLEPOWDER, FOR SUSPENSION1006
67877-547-98cefdinir60 mL in 1 BOTTLEPOWDER, FOR SUSPENSION606

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
67877-547-88ML - Milliliter67877-5476549f19e-9f14-46bf-bf22-41c3155e26d212021-04-08
67877-547-98ML - Milliliter67877-5471caa8866-c6d1-42c2-838f-141271ec6dbf12021-04-08

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
67877-547CEFDINIR 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 SuspensionPSN2bd2101c-511d-45a9-b1d8-a45ed40c5b808
309054cefdinir 25 MG/ML Oral SuspensionSCD2bd2101c-511d-45a9-b1d8-a45ed40c5b808
309054cefdinir 125 MG per 5 ML Oral SuspensionSY2bd2101c-511d-45a9-b1d8-a45ed40c5b808
309054cefdinir 125 MG in 5 mL Oral SuspensionPSN2e384d98-642e-4841-9f62-fcea4c242f4e7
309054cefdinir 25 MG/ML Oral SuspensionSCD2e384d98-642e-4841-9f62-fcea4c242f4e7
309054cefdinir 125 MG per 5 ML Oral SuspensionSY2e384d98-642e-4841-9f62-fcea4c242f4e7
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
309054cefdinir 125 MG in 5 mL Oral SuspensionPSNc8c34c9a-baab-1f0f-e053-2a95a90a26352
309054cefdinir 25 MG/ML Oral SuspensionSCDc8c34c9a-baab-1f0f-e053-2a95a90a26352
309054cefdinir 125 MG per 5 ML Oral SuspensionSYc8c34c9a-baab-1f0f-e053-2a95a90a26352

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
67877-547-8867877054788100 mL in 1 BOTTLE (67877-547-88) 100 ml2021-02-200000-00-00NoNoCurrent
67877-547-986787705479860 mL in 1 BOTTLE (67877-547-98) 60 ml2021-02-200000-00-00NoNoCurrent