FDA.reportPublic FDA data

Cefdinir

Product NDC
68180-723
11-digit product format
681800723
Labeler code
68180
Product ID
68180-723_b32b7bfb-4770-4da0-8c48-684233cd10c9
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Cefdinir
Dosage form
POWDER, FOR SUSPENSION
Route
ORAL
Labeler
Lupin Pharmaceuticals, Inc.
Application
ANDA065259
Marketing category
ANDA
Marketing start
2007-05-07
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
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
68180-723-04Cefdinir60 mL in 1 BOTTLEPOWDER, FOR SUSPENSION609
68180-723-05Cefdinir100 mL in 1 BOTTLEPOWDER, FOR SUSPENSION1009
68180-723-10Cefdinir100 mL in 1 BOTTLEPOWDER, FOR SUSPENSION1009
68180-723-20Cefdinir60 mL in 1 BOTTLEPOWDER, FOR SUSPENSION609

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
68180-723-04ML - Milliliter68180-7231172b959-611a-4ea5-9252-0eff149dea6b12020-07-13
68180-723-05ML - Milliliter68180-72367b0c16d-a74f-4d56-b743-7f2ba607dea412020-07-13
68180-723-10ML - Milliliter68180-723930a24c2-9387-456e-8134-1be8427bf2a412012-07-24
68180-723-20ML - Milliliter68180-723cd52e6af-139b-4dd7-97b4-c9db56878ab912012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
CEFDINIRACTIVE INGREDIENTCI0FAO63WCCEFDINIR POWDER, FOR SUSPENSION [AIDAREX PHARMACEUTICALS LLC]2
CEFDINIRACTIVE MOIETYCI0FAO63WCCEFDINIR POWDER, FOR SUSPENSION [AIDAREX PHARMACEUTICALS LLC]2
CITRIC ACID MONOHYDRATEINACTIVE INGREDIENT2968PHW8QPCEFDINIR POWDER, FOR SUSPENSION [AIDAREX PHARMACEUTICALS LLC]2
GUAR GUMINACTIVE INGREDIENTE89I1637KECEFDINIR POWDER, FOR SUSPENSION [AIDAREX PHARMACEUTICALS LLC]2
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4CEFDINIR POWDER, FOR SUSPENSION [AIDAREX PHARMACEUTICALS LLC]2
SODIUM BENZOATEINACTIVE INGREDIENTOJ245FE5EUCEFDINIR POWDER, FOR SUSPENSION [AIDAREX PHARMACEUTICALS LLC]2
SODIUM CITRATEINACTIVE INGREDIENT1Q73Q2JULRCEFDINIR POWDER, FOR SUSPENSION [AIDAREX PHARMACEUTICALS LLC]2
STRAWBERRYINACTIVE INGREDIENT4J2TY8Y81VCEFDINIR POWDER, FOR SUSPENSION [AIDAREX PHARMACEUTICALS LLC]2
SUCROSEINACTIVE INGREDIENTC151H8M554CEFDINIR POWDER, FOR SUSPENSION [AIDAREX PHARMACEUTICALS LLC]2
XANTHAN GUMINACTIVE INGREDIENTTTV12P4NEECEFDINIR POWDER, FOR SUSPENSION [AIDAREX PHARMACEUTICALS LLC]2
CEFDINIRACTIVE INGREDIENTCI0FAO63WCCEFDINIR (CEFDINIR) POWDER, FOR SUSPENSION [LUPIN PHARMACEUTICALS INC]1
CEFDINIRACTIVE INGREDIENTCI0FAO63WCCEFDINIR POWDER, FOR SUSPENSION [REBEL DISTRIBUTORS CORP]1
CEFDINIRACTIVE INGREDIENTCI0FAO63WCCEFDINIR POWDER, FOR SUSPENSION [DISPENSING SOLUTIONS, INC.]1
CEFDINIRACTIVE MOIETYCI0FAO63WCCEFDINIR (CEFDINIR) POWDER, FOR SUSPENSION [LUPIN PHARMACEUTICALS INC]1
CEFDINIRACTIVE MOIETYCI0FAO63WCCEFDINIR POWDER, FOR SUSPENSION [DISPENSING SOLUTIONS, INC.]1
CEFDINIRACTIVE MOIETYCI0FAO63WCCEFDINIR POWDER, FOR SUSPENSION [REBEL DISTRIBUTORS CORP]1
CITRIC ACIDINACTIVE INGREDIENT2968PHW8QPCEFDINIR (CEFDINIR) POWDER, FOR SUSPENSION [LUPIN PHARMACEUTICALS INC]1
CITRIC ACID MONOHYDRATEINACTIVE INGREDIENT2968PHW8QPCEFDINIR POWDER, FOR SUSPENSION [DISPENSING SOLUTIONS, INC.]1
CITRIC ACID MONOHYDRATEINACTIVE INGREDIENT2968PHW8QPCEFDINIR POWDER, FOR SUSPENSION [REBEL DISTRIBUTORS CORP]1
COLLOIDAL SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4CEFDINIR (CEFDINIR) POWDER, FOR SUSPENSION [LUPIN PHARMACEUTICALS INC]1
COLLOIDAL SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4CEFDINIR POWDER, FOR SUSPENSION [DISPENSING SOLUTIONS, INC.]1
GUAR GUMINACTIVE INGREDIENTE89I1637KECEFDINIR (CEFDINIR) POWDER, FOR SUSPENSION [LUPIN PHARMACEUTICALS INC]1
GUAR GUMINACTIVE INGREDIENTE89I1637KECEFDINIR POWDER, FOR SUSPENSION [REBEL DISTRIBUTORS CORP]1
GUAR GUMINACTIVE INGREDIENTE89I1637KECEFDINIR POWDER, FOR SUSPENSION [DISPENSING SOLUTIONS, INC.]1
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4CEFDINIR POWDER, FOR SUSPENSION [REBEL DISTRIBUTORS CORP]1
SODIUM BENZOATEINACTIVE INGREDIENTOJ245FE5EUCEFDINIR POWDER, FOR SUSPENSION [REBEL DISTRIBUTORS CORP]1
SODIUM BENZOATEINACTIVE INGREDIENTOJ245FE5EUCEFDINIR (CEFDINIR) POWDER, FOR SUSPENSION [LUPIN PHARMACEUTICALS INC]1
SODIUM BENZOATEINACTIVE INGREDIENTOJ245FE5EUCEFDINIR POWDER, FOR SUSPENSION [DISPENSING SOLUTIONS, INC.]1
SODIUM CITRATEINACTIVE INGREDIENT1Q73Q2JULRCEFDINIR (CEFDINIR) POWDER, FOR SUSPENSION [LUPIN PHARMACEUTICALS INC]1
SODIUM CITRATEINACTIVE INGREDIENT1Q73Q2JULRCEFDINIR POWDER, FOR SUSPENSION [REBEL DISTRIBUTORS CORP]1
SODIUM CITRATEINACTIVE INGREDIENT1Q73Q2JULRCEFDINIR POWDER, FOR SUSPENSION [DISPENSING SOLUTIONS, INC.]1
STRAWBERRYINACTIVE INGREDIENT4J2TY8Y81VCEFDINIR POWDER, FOR SUSPENSION [REBEL DISTRIBUTORS CORP]1
STRAWBERRYINACTIVE INGREDIENT4J2TY8Y81VCEFDINIR (CEFDINIR) POWDER, FOR SUSPENSION [LUPIN PHARMACEUTICALS INC]1
STRAWBERRYINACTIVE INGREDIENT4J2TY8Y81VCEFDINIR POWDER, FOR SUSPENSION [DISPENSING SOLUTIONS, INC.]1
SUCROSEINACTIVE INGREDIENTC151H8M554CEFDINIR POWDER, FOR SUSPENSION [REBEL DISTRIBUTORS CORP]1
SUCROSEINACTIVE INGREDIENTC151H8M554CEFDINIR (CEFDINIR) POWDER, FOR SUSPENSION [LUPIN PHARMACEUTICALS INC]1
SUCROSEINACTIVE INGREDIENTC151H8M554CEFDINIR POWDER, FOR SUSPENSION [DISPENSING SOLUTIONS, INC.]1
XANTHAN GUMINACTIVE INGREDIENTTTV12P4NEECEFDINIR (CEFDINIR) POWDER, FOR SUSPENSION [LUPIN PHARMACEUTICALS INC]1
XANTHAN GUMINACTIVE INGREDIENTTTV12P4NEECEFDINIR POWDER, FOR SUSPENSION [DISPENSING SOLUTIONS, INC.]1
XANTHAN GUMINACTIVE INGREDIENTTTV12P4NEECEFDINIR POWDER, FOR SUSPENSION [REBEL DISTRIBUTORS CORP]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68180-723CEFDINIR POWDER, FOR SUSPENSION [LUPIN PHARMACEUTICALS, INC.]8Current NDC, Legacy NDC, 4 package rows20250130_7490df67-56c0-4a1c-8533-2107f3e8aea5.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
476576cefdinir 250 MG in 5 mL Oral SuspensionPSN17b4e82f-4169-4ab9-bd4a-79781a71e16016
476576cefdinir 50 MG/ML Oral SuspensionSCD17b4e82f-4169-4ab9-bd4a-79781a71e16016
476576cefdinir 250 MG per 5 ML Oral SuspensionSY17b4e82f-4169-4ab9-bd4a-79781a71e16016
309054cefdinir 125 MG in 5 mL Oral SuspensionPSN7490df67-56c0-4a1c-8533-2107f3e8aea59
476576cefdinir 250 MG in 5 mL Oral SuspensionPSN7490df67-56c0-4a1c-8533-2107f3e8aea59
309054cefdinir 25 MG/ML Oral SuspensionSCD7490df67-56c0-4a1c-8533-2107f3e8aea59
476576cefdinir 50 MG/ML Oral SuspensionSCD7490df67-56c0-4a1c-8533-2107f3e8aea59
309054cefdinir 125 MG per 5 ML Oral SuspensionSY7490df67-56c0-4a1c-8533-2107f3e8aea59
476576cefdinir 250 MG per 5 ML Oral SuspensionSY7490df67-56c0-4a1c-8533-2107f3e8aea59
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 SuspensionPSN37b5d000-db9e-4b6e-8208-6361e98fb55d3
476576cefdinir 250 MG in 5 mL Oral SuspensionPSN3bf75b93-b42d-44f2-8cce-70ad3ca77cd53
476576cefdinir 250 MG in 5 mL Oral SuspensionPSN444cd2c4-836d-40d5-a307-d719fe83e7633
476576cefdinir 50 MG/ML Oral SuspensionSCD3bf75b93-b42d-44f2-8cce-70ad3ca77cd53
476576cefdinir 50 MG/ML Oral SuspensionSCD444cd2c4-836d-40d5-a307-d719fe83e7633
476576cefdinir 50 MG/ML Oral SuspensionSCD37b5d000-db9e-4b6e-8208-6361e98fb55d3
476576cefdinir 250 MG per 5 ML Oral SuspensionSY3bf75b93-b42d-44f2-8cce-70ad3ca77cd53
476576cefdinir 250 MG per 5 ML Oral SuspensionSY444cd2c4-836d-40d5-a307-d719fe83e7633
476576cefdinir 250 MG per 5 ML Oral SuspensionSY37b5d000-db9e-4b6e-8208-6361e98fb55d3
476576cefdinir 250 MG in 5 mL Oral SuspensionPSNfbd76f8c-e6b8-52f4-e053-6394a90aa7ab2
476576cefdinir 250 MG in 5 mL Oral SuspensionPSN8640931e-317a-42b4-806a-146f00ddf2a62
476576cefdinir 50 MG/ML Oral SuspensionSCD8640931e-317a-42b4-806a-146f00ddf2a62
476576cefdinir 50 MG/ML Oral SuspensionSCDfbd76f8c-e6b8-52f4-e053-6394a90aa7ab2
476576cefdinir 250 MG per 5 ML Oral SuspensionSY8640931e-317a-42b4-806a-146f00ddf2a62
476576cefdinir 250 MG per 5 ML Oral SuspensionSYfbd76f8c-e6b8-52f4-e053-6394a90aa7ab2
309054cefdinir 125 MG in 5 mL Oral SuspensionPSNe90660c8-2714-4592-aeaa-bc9ceb26057c1
476576cefdinir 250 MG in 5 mL Oral SuspensionPSN2c3705f2-0b44-4d38-a7f9-4b392d0a1a451
476576cefdinir 250 MG in 5 mL Oral SuspensionPSNa4587ea9-c06b-4603-beea-1ef926a4d0be1
476576cefdinir 250 MG in 5 mL Oral SuspensionPSNe90660c8-2714-4592-aeaa-bc9ceb26057c1
476576cefdinir 250 MG in 5 mL Oral SuspensionPSN3714d558-cbaa-42e8-831b-ffbbc951ebf21
309054cefdinir 25 MG/ML Oral SuspensionSCDe90660c8-2714-4592-aeaa-bc9ceb26057c1
476576cefdinir 50 MG/ML Oral SuspensionSCD3714d558-cbaa-42e8-831b-ffbbc951ebf21
476576cefdinir 50 MG/ML Oral SuspensionSCDa4587ea9-c06b-4603-beea-1ef926a4d0be1
476576cefdinir 50 MG/ML Oral SuspensionSCDe90660c8-2714-4592-aeaa-bc9ceb26057c1
476576cefdinir 50 MG/ML Oral SuspensionSCD2c3705f2-0b44-4d38-a7f9-4b392d0a1a451
309054cefdinir 125 MG per 5 ML Oral SuspensionSYe90660c8-2714-4592-aeaa-bc9ceb26057c1
476576cefdinir 250 MG per 5 ML Oral SuspensionSY2c3705f2-0b44-4d38-a7f9-4b392d0a1a451
476576cefdinir 250 MG per 5 ML Oral SuspensionSYa4587ea9-c06b-4603-beea-1ef926a4d0be1
476576cefdinir 250 MG per 5 ML Oral SuspensionSYe90660c8-2714-4592-aeaa-bc9ceb26057c1
476576cefdinir 250 MG per 5 ML Oral SuspensionSY3714d558-cbaa-42e8-831b-ffbbc951ebf21

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
68180-723-046818007230460 mL in 1 BOTTLE (68180-723-04) 60 ml2020-05-220000-00-00NoNoCurrent
68180-723-0568180072305100 mL in 1 BOTTLE (68180-723-05) 100 ml2020-05-220000-00-00NoNoCurrent
68180-723-1068180072310100 mL in 1 BOTTLE (68180-723-10) 100 ml2007-05-072022-01-31NoNoCurrent
68180-723-206818007232060 mL in 1 BOTTLE (68180-723-20) 60 ml2007-05-072022-01-31NoNoCurrent