FDA.reportPublic FDA data

Cefdinir

Product NDC
65862-218
11-digit product format
658620218
Labeler code
65862
Product ID
65862-218_9cfbe4a1-045c-489f-8ca7-9d595997dab7
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Cefdinir
Dosage form
POWDER, FOR SUSPENSION
Route
ORAL
Labeler
Aurobindo Pharma Limited
Application
ANDA065473
Marketing category
ANDA
Marketing start
2007-12-14
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
65862-218-01Cefdinir100 mL in 1 BOTTLEPOWDER, FOR SUSPENSION10013
65862-218-01Cefdinir1 in 1 CARTONPOWDER, FOR SUSPENSION113
65862-218-60Cefdinir1 in 1 CARTONPOWDER, FOR SUSPENSION113
65862-218-60Cefdinir60 mL in 1 BOTTLEPOWDER, FOR SUSPENSION6013

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
65862-218-01ML - Milliliter65862-218bee220d9-acde-45d7-a2da-8af4c842352412012-07-24
65862-218-60ML - Milliliter65862-2186bf3851b-f1bc-4eab-be9d-5c947b38734f12012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
CEFDINIRACTIVE INGREDIENTCI0FAO63WCCEFDINIR POWDER, FOR SUSPENSION [AUROBINDO PHARMA LIMITED]7
CEFDINIRACTIVE MOIETYCI0FAO63WCCEFDINIR POWDER, FOR SUSPENSION [AUROBINDO PHARMA LIMITED]7
ANHYDROUS CITRIC ACIDINACTIVE INGREDIENTXF417D3PSLCEFDINIR POWDER, FOR SUSPENSION [AUROBINDO PHARMA LIMITED]7
GUAR GUMINACTIVE INGREDIENTE89I1637KECEFDINIR POWDER, FOR SUSPENSION [AUROBINDO PHARMA LIMITED]7
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30CEFDINIR POWDER, FOR SUSPENSION [AUROBINDO PHARMA LIMITED]7
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4CEFDINIR POWDER, FOR SUSPENSION [AUROBINDO PHARMA LIMITED]7
SODIUM BENZOATEINACTIVE INGREDIENTOJ245FE5EUCEFDINIR POWDER, FOR SUSPENSION [AUROBINDO PHARMA LIMITED]7
SUCROSEINACTIVE INGREDIENTC151H8M554CEFDINIR POWDER, FOR SUSPENSION [AUROBINDO PHARMA LIMITED]7
TRISODIUM CITRATE DIHYDRATEINACTIVE INGREDIENTB22547B95KCEFDINIR POWDER, FOR SUSPENSION [AUROBINDO PHARMA LIMITED]7
XANTHAN GUMINACTIVE INGREDIENTTTV12P4NEECEFDINIR POWDER, FOR SUSPENSION [AUROBINDO PHARMA LIMITED]7
CEFDINIRACTIVE INGREDIENTCI0FAO63WCCEFDINIR POWDER, FOR SUSPENSION [PHYSICIANS TOTAL CARE, INC.]1
CEFDINIRACTIVE MOIETYCI0FAO63WCCEFDINIR POWDER, FOR SUSPENSION [PHYSICIANS TOTAL CARE, INC.]1
ANHYDROUS CITRIC ACIDINACTIVE INGREDIENTXF417D3PSLCEFDINIR POWDER, FOR SUSPENSION [PHYSICIANS TOTAL CARE, INC.]1
GUAR GUMINACTIVE INGREDIENTE89I1637KECEFDINIR POWDER, FOR SUSPENSION [PHYSICIANS TOTAL CARE, INC.]1
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30CEFDINIR POWDER, FOR SUSPENSION [PHYSICIANS TOTAL CARE, INC.]1
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4CEFDINIR POWDER, FOR SUSPENSION [PHYSICIANS TOTAL CARE, INC.]1
SODIUM BENZOATEINACTIVE INGREDIENTOJ245FE5EUCEFDINIR POWDER, FOR SUSPENSION [PHYSICIANS TOTAL CARE, INC.]1
SUCROSEINACTIVE INGREDIENTC151H8M554CEFDINIR POWDER, FOR SUSPENSION [PHYSICIANS TOTAL CARE, INC.]1
TRISODIUM CITRATE DIHYDRATEINACTIVE INGREDIENTB22547B95KCEFDINIR POWDER, FOR SUSPENSION [PHYSICIANS TOTAL CARE, INC.]1
XANTHAN GUMINACTIVE INGREDIENTTTV12P4NEECEFDINIR POWDER, FOR SUSPENSION [PHYSICIANS TOTAL CARE, INC.]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
65862-218CEFDINIR POWDER, FOR SUSPENSION [AUROBINDO PHARMA LIMITED]13Current NDC, Legacy NDC, 4 package rows20240216_06fbdb63-d32f-4212-9962-f1de15597dda.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
309054cefdinir 125 MG in 5 mL Oral SuspensionPSN06fbdb63-d32f-4212-9962-f1de15597dda13
476576cefdinir 250 MG in 5 mL Oral SuspensionPSN06fbdb63-d32f-4212-9962-f1de15597dda13
309054cefdinir 25 MG/ML Oral SuspensionSCD06fbdb63-d32f-4212-9962-f1de15597dda13
476576cefdinir 50 MG/ML Oral SuspensionSCD06fbdb63-d32f-4212-9962-f1de15597dda13
309054cefdinir 125 MG per 5 ML Oral SuspensionSY06fbdb63-d32f-4212-9962-f1de15597dda13
476576cefdinir 250 MG per 5 ML Oral SuspensionSY06fbdb63-d32f-4212-9962-f1de15597dda13
309054cefdinir 125 MG in 5 mL Oral SuspensionPSNfb02aaab-d2a0-466e-8327-72e3df1e4e9d9
309054cefdinir 25 MG/ML Oral SuspensionSCDfb02aaab-d2a0-466e-8327-72e3df1e4e9d9
309054cefdinir 125 MG per 5 ML Oral SuspensionSYfb02aaab-d2a0-466e-8327-72e3df1e4e9d9
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
309054cefdinir 125 MG in 5 mL Oral SuspensionPSNbe963e80-e298-49a0-a52f-3d4dcded7c8c5
309054cefdinir 25 MG/ML Oral SuspensionSCDbe963e80-e298-49a0-a52f-3d4dcded7c8c5
309054cefdinir 125 MG per 5 ML Oral SuspensionSYbe963e80-e298-49a0-a52f-3d4dcded7c8c5
309054cefdinir 125 MG in 5 mL Oral SuspensionPSN8dfbad95-4dd8-01fd-e053-2a95a90a1de13
309054cefdinir 25 MG/ML Oral SuspensionSCD8dfbad95-4dd8-01fd-e053-2a95a90a1de13
309054cefdinir 125 MG per 5 ML Oral SuspensionSY8dfbad95-4dd8-01fd-e053-2a95a90a1de13
309054cefdinir 125 MG in 5 mL Oral SuspensionPSN3ab60dc3-c39c-4580-b418-1251a1b99c732
309054cefdinir 25 MG/ML Oral SuspensionSCD3ab60dc3-c39c-4580-b418-1251a1b99c732
309054cefdinir 125 MG per 5 ML Oral SuspensionSY3ab60dc3-c39c-4580-b418-1251a1b99c732
309054cefdinir 125 MG in 5 mL Oral SuspensionPSNd9243be5-bd27-4f37-ba8b-9f6f55f8b3e41
309054cefdinir 125 MG in 5 mL Oral SuspensionPSNee56347c-b61e-4648-ab88-d3af36f7dc8b1
476576cefdinir 250 MG in 5 mL Oral SuspensionPSNd9243be5-bd27-4f37-ba8b-9f6f55f8b3e41
309054cefdinir 25 MG/ML Oral SuspensionSCDee56347c-b61e-4648-ab88-d3af36f7dc8b1
309054cefdinir 25 MG/ML Oral SuspensionSCDd9243be5-bd27-4f37-ba8b-9f6f55f8b3e41
476576cefdinir 50 MG/ML Oral SuspensionSCDd9243be5-bd27-4f37-ba8b-9f6f55f8b3e41
309054cefdinir 125 MG per 5 ML Oral SuspensionSYd9243be5-bd27-4f37-ba8b-9f6f55f8b3e41
309054cefdinir 125 MG per 5 ML Oral SuspensionSYee56347c-b61e-4648-ab88-d3af36f7dc8b1
476576cefdinir 250 MG per 5 ML Oral SuspensionSYd9243be5-bd27-4f37-ba8b-9f6f55f8b3e41

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
65862-218-01658620218011 BOTTLE in 1 CARTON (65862-218-01) / 100 mL in 1 BOTTLE1 bottle2007-12-140000-00-00NoNoCurrent
65862-218-60658620218601 BOTTLE in 1 CARTON (65862-218-60) / 60 mL in 1 BOTTLE1 bottle2007-12-140000-00-00NoNoCurrent