Cefdinir

Product NDC
57237-099
11-digit product format
572370099
Labeler code
57237
Product ID
57237-099_084623a7-ebe0-4468-9a4b-9fd016e96c3c
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Cefdinir
Dosage form
CAPSULE
Route
ORAL
Labeler
Rising Pharma Holdings, Inc.
Application
ANDA065434
Marketing category
ANDA
Marketing start
2008-01-07
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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
57237-099-60Cefdinir60 in 1 BOTTLECAPSULE609

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
57237-099-60EA - Each57237-0996d684f7c-85f4-46fc-9878-cc7450d8f1d112015-01-05

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
CEFDINIRACTIVE INGREDIENTCI0FAO63WCCEFDINIR CAPSULE [CITRON PHARMA LLC]1
CEFDINIRACTIVE MOIETYCI0FAO63WCCEFDINIR CAPSULE [CITRON PHARMA LLC]1
CARBOXYMETHYLCELLULOSE CALCIUMINACTIVE INGREDIENTUTY7PDF93LCEFDINIR CAPSULE [CITRON PHARMA LLC]1
D&C RED NO. 28INACTIVE INGREDIENT767IP0Y5NHCEFDINIR CAPSULE [CITRON PHARMA LLC]1
FD&C BLUE NO. 1INACTIVE INGREDIENTH3R47K3TBDCEFDINIR CAPSULE [CITRON PHARMA LLC]1
FERROSOFERRIC OXIDEINACTIVE INGREDIENTXM0M87F357CEFDINIR CAPSULE [CITRON PHARMA LLC]1
GELATININACTIVE INGREDIENT2G86QN327LCEFDINIR CAPSULE [CITRON PHARMA LLC]1
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30CEFDINIR CAPSULE [CITRON PHARMA LLC]1
SHELLACINACTIVE INGREDIENT46N107B71OCEFDINIR CAPSULE [CITRON PHARMA LLC]1
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4CEFDINIR CAPSULE [CITRON PHARMA LLC]1
SODIUM LAURYL SULFATEINACTIVE INGREDIENT368GB5141JCEFDINIR CAPSULE [CITRON PHARMA LLC]1
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPCEFDINIR CAPSULE [CITRON PHARMA LLC]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
57237-099CEFDINIR CAPSULE [RISING PHARMA HOLDINGS, INC.]9Current NDC, Legacy NDC, 1 package rows20240215_a5594006-8e37-459e-8e85-7e2a83d7a57e.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
200346cefdinir 300 MG Oral CapsulePSN463084e5-908d-4bbc-b542-10b98211e28e14
200346cefdinir 300 MG Oral CapsulePSN7c25ae35-61f4-4aef-a8d9-8de77b02ab8014
200346cefdinir 300 MG Oral CapsuleSCD463084e5-908d-4bbc-b542-10b98211e28e14
200346cefdinir 300 MG Oral CapsuleSCD7c25ae35-61f4-4aef-a8d9-8de77b02ab8014
200346cefdinir 300 MG Oral CapsulePSN3c2130f9-a0d8-4a4e-bcad-36379202b7bb13
200346cefdinir 300 MG Oral CapsuleSCD3c2130f9-a0d8-4a4e-bcad-36379202b7bb13
200346cefdinir 300 MG Oral CapsulePSNa5594006-8e37-459e-8e85-7e2a83d7a57e9
200346cefdinir 300 MG Oral CapsuleSCDa5594006-8e37-459e-8e85-7e2a83d7a57e9
200346cefdinir 300 MG Oral CapsulePSNc3892cd7-0e98-4ba3-a845-4aedf6c2a8308
200346cefdinir 300 MG Oral CapsuleSCDc3892cd7-0e98-4ba3-a845-4aedf6c2a8308
200346cefdinir 300 MG Oral CapsulePSNeb354221-c476-41cb-ad87-52423f81d6987
200346cefdinir 300 MG Oral CapsulePSN54b06071-f3cb-5627-e054-00144ff8d46c7
200346cefdinir 300 MG Oral CapsuleSCDeb354221-c476-41cb-ad87-52423f81d6987
200346cefdinir 300 MG Oral CapsuleSCD54b06071-f3cb-5627-e054-00144ff8d46c7
200346cefdinir 300 MG Oral CapsulePSN506bcf51-3b7e-4fc0-b22e-a5b726471e3a5
200346cefdinir 300 MG Oral CapsulePSN4f1be4f6-9fb2-5c19-e054-00144ff8d46c5
200346cefdinir 300 MG Oral CapsulePSN064e3f74-9644-49bd-abef-20e1dd97794e5
200346cefdinir 300 MG Oral CapsuleSCD506bcf51-3b7e-4fc0-b22e-a5b726471e3a5
200346cefdinir 300 MG Oral CapsuleSCD4f1be4f6-9fb2-5c19-e054-00144ff8d46c5
200346cefdinir 300 MG Oral CapsuleSCD064e3f74-9644-49bd-abef-20e1dd97794e5
200346cefdinir 300 MG Oral CapsulePSN87af716a-6564-ceee-e053-2a95a90a66793
200346cefdinir 300 MG Oral CapsulePSN8c3b89a9-cb3f-5960-e053-2995a90aaeee3
200346cefdinir 300 MG Oral CapsuleSCD87af716a-6564-ceee-e053-2a95a90a66793
200346cefdinir 300 MG Oral CapsuleSCD8c3b89a9-cb3f-5960-e053-2995a90aaeee3

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
57237-099-605723700996060 CAPSULE in 1 BOTTLE (57237-099-60) 60 capsule2008-01-070000-00-00NoNoCurrent