FDA.reportPublic FDA data

CEFIXIME

Product NDC
68180-407
11-digit product format
681800407
Labeler code
68180
Product ID
68180-407_735f86f4-369c-4f5a-adbe-7dacea2e27b4
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
CEFIXIME
Dosage form
POWDER, FOR SUSPENSION
Route
ORAL
Labeler
Lupin Pharmaceuticals, Inc.
Application
ANDA065355
Marketing category
ANDA
Marketing start
2015-04-24
Substance
CEFIXIME
Active strength
200 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
CEFIXIME200 mg/5mL

Harmonized Identifiers#

Field, Values table
FieldValues
Unii97I1C92E55
Rxcui309058, 409823, 419849

DailyMed Product Concepts#

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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
68180-407-032020-10-27C16284748780-19d75b9d0-9127-f424-e053-dadaa90a57ceThese highlights do not include all the information needed to use CEFIXIME safely and effectively. See full prescribing information for CEFIXIME. CEFIXIME for oral suspension, 100 mg/5 mL CEFIXIME for oral suspension, 200 mg/5 mL CEFIXIME capsules, 400 mg For oral administration Initial U.S. Approval: 1986
68180-407-032020-10-27C16284748780-19d75b9d0-9127-f424-e053-dadaa90a57ceThese highlights do not include all the information needed to use CEFIXIME safely and effectively. See full prescribing information for CEFIXIME. CEFIXIME for oral suspension, 100 mg/5 mL CEFIXIME for oral suspension, 200 mg/5 mL CEFIXIME capsules, 400 mg For oral administration Initial U.S. Approval: 1986
68180-407-042020-10-27C16284748780-19d75b9d0-9127-f424-e053-dadaa90a57ceThese highlights do not include all the information needed to use CEFIXIME safely and effectively. See full prescribing information for CEFIXIME. CEFIXIME for oral suspension, 100 mg/5 mL CEFIXIME for oral suspension, 200 mg/5 mL CEFIXIME capsules, 400 mg For oral administration Initial U.S. Approval: 1986
68180-407-042020-10-27C16284748780-19d75b9d0-9127-f424-e053-dadaa90a57ceThese highlights do not include all the information needed to use CEFIXIME safely and effectively. See full prescribing information for CEFIXIME. CEFIXIME for oral suspension, 100 mg/5 mL CEFIXIME for oral suspension, 200 mg/5 mL CEFIXIME capsules, 400 mg For oral administration Initial U.S. Approval: 1986
68180-407-032020-01-31C16284748780-19d75b9d0-9127-f424-e053-dadaa90a57ceThese highlights do not include all the information needed to use CEFIXIME safely and effectively. See full prescribing information for CEFIXIME. CEFIXIME for oral suspension, 100 mg/5 mL CEFIXIME for oral suspension, 200 mg/5 mL CEFIXIME capsules, 400 mg For oral administration Initial U.S. Approval: 1986
68180-407-032020-01-31C16284748780-19d75b9d0-9127-f424-e053-dadaa90a57ceThese highlights do not include all the information needed to use CEFIXIME safely and effectively. See full prescribing information for CEFIXIME. CEFIXIME for oral suspension, 100 mg/5 mL CEFIXIME for oral suspension, 200 mg/5 mL CEFIXIME capsules, 400 mg For oral administration Initial U.S. Approval: 1986
68180-407-042020-01-31C16284748780-19d75b9d0-9127-f424-e053-dadaa90a57ceThese highlights do not include all the information needed to use CEFIXIME safely and effectively. See full prescribing information for CEFIXIME. CEFIXIME for oral suspension, 100 mg/5 mL CEFIXIME for oral suspension, 200 mg/5 mL CEFIXIME capsules, 400 mg For oral administration Initial U.S. Approval: 1986
68180-407-042020-01-31C16284748780-19d75b9d0-9127-f424-e053-dadaa90a57ceThese highlights do not include all the information needed to use CEFIXIME safely and effectively. See full prescribing information for CEFIXIME. CEFIXIME for oral suspension, 100 mg/5 mL CEFIXIME for oral suspension, 200 mg/5 mL CEFIXIME capsules, 400 mg For oral administration Initial U.S. Approval: 1986

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
68180-407-03CEFIXIME50 mL in 1 BOTTLEPOWDER, FOR SUSPENSION5014
68180-407-04CEFIXIME75 mL in 1 BOTTLEPOWDER, FOR SUSPENSION7514

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
68180-407-03ML - Milliliter68180-407503f12f5-873f-464e-9cc1-3fe516808f8e12015-05-05
68180-407-04ML - Milliliter68180-4071992ddcc-7dd3-450a-9ec9-1d9b75b1b7ef12015-05-05

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
CEFIXIMEACTIVE INGREDIENT97I1C92E55CEFIXIME POWDER, FOR SUSPENSION [LUPIN PHARMACEUTICALS, INC.]1
CEFIXIME ANHYDROUSACTIVE MOIETYXZ7BG04GJXCEFIXIME POWDER, FOR SUSPENSION [LUPIN PHARMACEUTICALS, INC.]1
COLLOIDAL SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4CEFIXIME POWDER, FOR SUSPENSION [LUPIN PHARMACEUTICALS, INC.]1
SODIUM BENZOATEINACTIVE INGREDIENTOJ245FE5EUCEFIXIME POWDER, FOR SUSPENSION [LUPIN PHARMACEUTICALS, INC.]1
STRAWBERRYINACTIVE INGREDIENT4J2TY8Y81VCEFIXIME POWDER, FOR SUSPENSION [LUPIN PHARMACEUTICALS, INC.]1
SUCROSEINACTIVE INGREDIENTC151H8M554CEFIXIME POWDER, FOR SUSPENSION [LUPIN PHARMACEUTICALS, INC.]1
XANTHAN GUMINACTIVE INGREDIENTTTV12P4NEECEFIXIME POWDER, FOR SUSPENSION [LUPIN PHARMACEUTICALS, INC.]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68180-407CEFIXIME POWDER, FOR SUSPENSION CEFIXIME CAPSULE [LUPIN PHARMACEUTICALS, INC.]12Current NDC, Legacy NDC, 2 package rows20250130_6d68dbd9-7d75-4ff1-91db-79ff8ae879ec.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
309058cefixime 100 MG in 5 mL Oral SuspensionPSN6d68dbd9-7d75-4ff1-91db-79ff8ae879ec14
419849cefixime 200 MG in 5 mL Oral SuspensionPSN6d68dbd9-7d75-4ff1-91db-79ff8ae879ec14
409823cefixime 400 MG Oral CapsulePSN6d68dbd9-7d75-4ff1-91db-79ff8ae879ec14
309058cefixime 20 MG/ML Oral SuspensionSCD6d68dbd9-7d75-4ff1-91db-79ff8ae879ec14
419849cefixime 40 MG/ML Oral SuspensionSCD6d68dbd9-7d75-4ff1-91db-79ff8ae879ec14
409823cefixime 400 MG Oral CapsuleSCD6d68dbd9-7d75-4ff1-91db-79ff8ae879ec14
309058cefixime 100 MG per 5 ML Oral SuspensionSY6d68dbd9-7d75-4ff1-91db-79ff8ae879ec14
419849cefixime 200 MG per 5 ML Oral SuspensionSY6d68dbd9-7d75-4ff1-91db-79ff8ae879ec14

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
68180-407-036818004070350 mL in 1 BOTTLE (68180-407-03) 50 ml2015-04-240000-00-00NoNoCurrent
68180-407-046818004070475 mL in 1 BOTTLE (68180-407-04) 75 ml2015-04-240000-00-00NoNoCurrent