Cefdinir

Product NDC
0093-3160
11-digit product format
000933160
Labeler code
0093
Product ID
0093-3160_588d0980-34a4-45b5-a1ca-a16ed3faa2be
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Cefdinir
Dosage form
CAPSULE
Route
ORAL
Labeler
Teva Pharmaceuticals USA, Inc.
Application
ANDA065368
Marketing category
ANDA
Marketing start
2007-05-09
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
351abe41-466c-4dd8-840a-0fdb68318bd5Product name120230316
d3e72f63-2c41-955f-f4ce-e90c6403e67cProduct name220210729
e8e66e64-d220-99cb-44eb-0f32dc8cbda1Product name220210729

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0093-3160-06Cefdinir60 in 1 BOTTLECAPSULE6016

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0093-3160-06EA - Each0093-316092cb0e77-c90c-4e76-877a-b2c4f7e4839c12012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
CEFDINIRACTIVE INGREDIENTCI0FAO63WCCEFDINIR CAPSULE [TEVA PHARMACEUTICALS USA INC]6
CEFDINIRACTIVE MOIETYCI0FAO63WCCEFDINIR CAPSULE [TEVA PHARMACEUTICALS USA INC]6
ALUMINUM OXIDEINACTIVE INGREDIENTLMI26O6933CEFDINIR CAPSULE [TEVA PHARMACEUTICALS USA INC]6
CARBOXYMETHYLCELLULOSE CALCIUMINACTIVE INGREDIENTUTY7PDF93LCEFDINIR CAPSULE [TEVA PHARMACEUTICALS USA INC]6
CROSCARMELLOSE SODIUMINACTIVE INGREDIENTM28OL1HH48CEFDINIR CAPSULE [TEVA PHARMACEUTICALS USA INC]6
D&C RED NO. 28INACTIVE INGREDIENT767IP0Y5NHCEFDINIR CAPSULE [TEVA PHARMACEUTICALS USA INC]6
D&C YELLOW NO. 10INACTIVE INGREDIENT35SW5USQ3GCEFDINIR CAPSULE [TEVA PHARMACEUTICALS USA INC]6
FD&C BLUE NO. 1INACTIVE INGREDIENTH3R47K3TBDCEFDINIR CAPSULE [TEVA PHARMACEUTICALS USA INC]6
FD&C BLUE NO. 2INACTIVE INGREDIENTL06K8R7DQKCEFDINIR CAPSULE [TEVA PHARMACEUTICALS USA INC]6
FD&C GREEN NO. 3INACTIVE INGREDIENT3P3ONR6O1SCEFDINIR CAPSULE [TEVA PHARMACEUTICALS USA INC]6
FD&C RED NO. 40INACTIVE INGREDIENTWZB9127XOACEFDINIR CAPSULE [TEVA PHARMACEUTICALS USA INC]6
FERROSOFERRIC OXIDEINACTIVE INGREDIENTXM0M87F357CEFDINIR CAPSULE [TEVA PHARMACEUTICALS USA INC]6
GELATININACTIVE INGREDIENT2G86QN327LCEFDINIR CAPSULE [TEVA PHARMACEUTICALS USA INC]6
INDIGOTINDISULFONATE SODIUMINACTIVE INGREDIENTD3741U8K7LCEFDINIR CAPSULE [TEVA PHARMACEUTICALS USA INC]6
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30CEFDINIR CAPSULE [TEVA PHARMACEUTICALS USA INC]6
POLYOXYL 40 STEARATEINACTIVE INGREDIENT13A4J4NH9ICEFDINIR CAPSULE [TEVA PHARMACEUTICALS USA INC]6
PROPYLENE GLYCOLINACTIVE INGREDIENT6DC9Q167V3CEFDINIR CAPSULE [TEVA PHARMACEUTICALS USA INC]6
SHELLACINACTIVE INGREDIENT46N107B71OCEFDINIR CAPSULE [TEVA PHARMACEUTICALS USA INC]6
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4CEFDINIR CAPSULE [TEVA PHARMACEUTICALS USA INC]6
SODIUM LAURYL SULFATEINACTIVE INGREDIENT368GB5141JCEFDINIR CAPSULE [TEVA PHARMACEUTICALS USA INC]6
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPCEFDINIR CAPSULE [TEVA PHARMACEUTICALS USA INC]6
CEFDINIRACTIVE INGREDIENTCI0FAO63WCCEFDINIR CAPSULE [REBEL DISTRIBUTORS CORP]1
CEFDINIRACTIVE MOIETYCI0FAO63WCCEFDINIR CAPSULE [REBEL DISTRIBUTORS CORP]1
ALUMINUM OXIDEINACTIVE INGREDIENTLMI26O6933CEFDINIR CAPSULE [REBEL DISTRIBUTORS CORP]1
CARBOXYMETHYLCELLULOSE CALCIUMINACTIVE INGREDIENTUTY7PDF93LCEFDINIR CAPSULE [REBEL DISTRIBUTORS CORP]1
CROSCARMELLOSE SODIUMINACTIVE INGREDIENTM28OL1HH48CEFDINIR CAPSULE [REBEL DISTRIBUTORS CORP]1
D&C RED NO. 28INACTIVE INGREDIENT767IP0Y5NHCEFDINIR CAPSULE [REBEL DISTRIBUTORS CORP]1
D&C YELLOW NO. 10INACTIVE INGREDIENT35SW5USQ3GCEFDINIR CAPSULE [REBEL DISTRIBUTORS CORP]1
FD&C BLUE NO. 1INACTIVE INGREDIENTH3R47K3TBDCEFDINIR CAPSULE [REBEL DISTRIBUTORS CORP]1
FD&C BLUE NO. 2INACTIVE INGREDIENTL06K8R7DQKCEFDINIR CAPSULE [REBEL DISTRIBUTORS CORP]1
FD&C GREEN NO. 3INACTIVE INGREDIENT3P3ONR6O1SCEFDINIR CAPSULE [REBEL DISTRIBUTORS CORP]1
FD&C RED NO. 40INACTIVE INGREDIENTWZB9127XOACEFDINIR CAPSULE [REBEL DISTRIBUTORS CORP]1
FERROSOFERRIC OXIDEINACTIVE INGREDIENTXM0M87F357CEFDINIR CAPSULE [REBEL DISTRIBUTORS CORP]1
GELATININACTIVE INGREDIENT2G86QN327LCEFDINIR CAPSULE [REBEL DISTRIBUTORS CORP]1
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30CEFDINIR CAPSULE [REBEL DISTRIBUTORS CORP]1
POLYOXYL 40 STEARATEINACTIVE INGREDIENT13A4J4NH9ICEFDINIR CAPSULE [REBEL DISTRIBUTORS CORP]1
PROPYLENE GLYCOLINACTIVE INGREDIENT6DC9Q167V3CEFDINIR CAPSULE [REBEL DISTRIBUTORS CORP]1
SHELLACINACTIVE INGREDIENT46N107B71OCEFDINIR CAPSULE [REBEL DISTRIBUTORS CORP]1
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4CEFDINIR CAPSULE [REBEL DISTRIBUTORS CORP]1
SODIUM LAURYL SULFATEINACTIVE INGREDIENT368GB5141JCEFDINIR CAPSULE [REBEL DISTRIBUTORS CORP]1
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPCEFDINIR CAPSULE [REBEL DISTRIBUTORS CORP]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0093-3160CEFDINIR CAPSULE [TEVA PHARMACEUTICALS USA, INC.]16Current NDC, Legacy NDC, 1 package rows20240209_de3441e3-7fd2-4d29-a8b7-0f9b66e35c9c.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
200346cefdinir 300 MG Oral CapsulePSNde3441e3-7fd2-4d29-a8b7-0f9b66e35c9c16
200346cefdinir 300 MG Oral CapsuleSCDde3441e3-7fd2-4d29-a8b7-0f9b66e35c9c16
200346cefdinir 300 MG Oral CapsulePSN9249fe25-dff8-43ef-addf-4e5e5385ca334
200346cefdinir 300 MG Oral CapsuleSCD9249fe25-dff8-43ef-addf-4e5e5385ca334
200346cefdinir 300 MG Oral CapsulePSN1acc5d17-10a4-e23d-e063-6394a90a52c32
200346cefdinir 300 MG Oral CapsulePSNbd5caea8-56e7-7279-e053-2995a90aa1a12
200346cefdinir 300 MG Oral CapsuleSCD1acc5d17-10a4-e23d-e063-6394a90a52c32
200346cefdinir 300 MG Oral CapsuleSCDbd5caea8-56e7-7279-e053-2995a90aa1a12
200346cefdinir 300 MG Oral CapsulePSNf910ec1a-3896-45b9-b8b2-df50a50064a11
200346cefdinir 300 MG Oral CapsuleSCDf910ec1a-3896-45b9-b8b2-df50a50064a11

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0093-3160-060009331600660 CAPSULE in 1 BOTTLE (0093-3160-06) 60 capsule2007-05-090000-00-00NoNoCurrent