FDA.reportPublic FDA data

Cefixime

Product NDC
65862-751
11-digit product format
658620751
Labeler code
65862
Product ID
65862-751_141b12c3-31de-4ca7-ac89-d864975846ab
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
cefixime
Dosage form
POWDER, FOR SUSPENSION
Route
ORAL
Labeler
Aurobindo Pharma Limited
Application
ANDA204835
Marketing category
ANDA
Marketing start
2015-04-14
Substance
CEFIXIME
Active strength
100 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
Cefixime
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
CEFIXIME100 mg/5mL

Harmonized Identifiers#

Field, Values table
FieldValues
Unii97I1C92E55
Rxcui309058, 419849

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
3b2162c7-9766-84dc-4509-6d61a89e78a5Product name520210729
7953affb-a49b-11df-6839-b5f62ce45d92Product name620210729

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
65862-751-01Cefixime100 mL in 1 BOTTLEPOWDER, FOR SUSPENSION1009
65862-751-50Cefixime50 mL in 1 BOTTLEPOWDER, FOR SUSPENSION509

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
65862-751-50ML - Milliliter65862-751e718dd90-0bf2-4ab0-bf52-2340bbca041412015-05-05

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
CEFIXIMEACTIVE INGREDIENT97I1C92E55CEFIXIME POWDER, FOR SUSPENSION [AUROBINDO PHARMA LIMITED]1
CEFIXIME ANHYDROUSACTIVE MOIETYXZ7BG04GJXCEFIXIME POWDER, FOR SUSPENSION [AUROBINDO PHARMA LIMITED]1
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4CEFIXIME POWDER, FOR SUSPENSION [AUROBINDO PHARMA LIMITED]1
STRAWBERRYINACTIVE INGREDIENT4J2TY8Y81VCEFIXIME POWDER, FOR SUSPENSION [AUROBINDO PHARMA LIMITED]1
SUCROSEINACTIVE INGREDIENTC151H8M554CEFIXIME POWDER, FOR SUSPENSION [AUROBINDO PHARMA LIMITED]1
XANTHAN GUMINACTIVE INGREDIENTTTV12P4NEECEFIXIME POWDER, FOR SUSPENSION [AUROBINDO PHARMA LIMITED]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
65862-751CEFIXIME POWDER, FOR SUSPENSION [AUROBINDO PHARMA LIMITED]9Current NDC, Legacy NDC, 2 package rows20240216_068e6edd-a5fe-40d8-8dcf-ac82b78dced4.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
309058cefixime 100 MG in 5 mL Oral SuspensionPSN068e6edd-a5fe-40d8-8dcf-ac82b78dced49
419849cefixime 200 MG in 5 mL Oral SuspensionPSN068e6edd-a5fe-40d8-8dcf-ac82b78dced49
309058cefixime 20 MG/ML Oral SuspensionSCD068e6edd-a5fe-40d8-8dcf-ac82b78dced49
419849cefixime 40 MG/ML Oral SuspensionSCD068e6edd-a5fe-40d8-8dcf-ac82b78dced49
309058cefixime 100 MG per 5 ML Oral SuspensionSY068e6edd-a5fe-40d8-8dcf-ac82b78dced49
419849cefixime 200 MG per 5 ML Oral SuspensionSY068e6edd-a5fe-40d8-8dcf-ac82b78dced49

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
65862-751-0165862075101100 mL in 1 BOTTLE (65862-751-01) 100 ml2015-04-140000-00-00NoNoCurrent
65862-751-506586207515050 mL in 1 BOTTLE (65862-751-50) 50 ml2015-04-140000-00-00NoNoCurrent