FDA.reportPublic FDA data

CEFIXIME

Product NDC
68180-423
11-digit product format
681800423
Labeler code
68180
Product ID
68180-423_735f86f4-369c-4f5a-adbe-7dacea2e27b4
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
CEFIXIME
Dosage form
CAPSULE
Route
ORAL
Labeler
Lupin Pharmaceuticals, Inc.
Application
NDA203195
Marketing category
NDA AUTHORIZED GENERIC
Marketing start
2020-10-14
Substance
CEFIXIME
Active strength
400 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
CEFIXIME
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
CEFIXIME400 mg/1

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
a62a50ac-1535-4461-9768-8ae703e2e9fbProduct name120210525
9514609b-a2a9-f8ec-6ba6-3f8e5ee89877Product name120140508
bc07ef78-e82d-0c19-31f4-31f263780582Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
68180-423-08CEFIXIME50 in 1 BOTTLECAPSULE5014
68180-423-11CEFIXIME1 in 1 CARTONCAPSULE114
68180-423-11CEFIXIME10 in 1 BLISTER PACKCAPSULE1014

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
68180-423-08EA - Each68180-4230580def1-ac83-454a-971d-1ea15e45cbd012021-02-05
68180-423-11EA - Each68180-423687b1461-afcc-4f95-b409-d2f70ce2d7a712021-02-05

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
68180-423CEFIXIME POWDER, FOR SUSPENSION CEFIXIME CAPSULE [LUPIN PHARMACEUTICALS, INC.]12Current NDC, Legacy NDC, 3 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
409823cefixime 400 MG Oral CapsulePSN3194433c-c04e-442b-9668-fbeb0a15bac79
409823cefixime 400 MG Oral CapsuleSCD3194433c-c04e-442b-9668-fbeb0a15bac79

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
68180-423-086818004230850 CAPSULE in 1 BOTTLE (68180-423-08) 50 capsule2020-10-140000-00-00NoNoCurrent
68180-423-11681800423111 BLISTER PACK in 1 CARTON (68180-423-11) / 10 CAPSULE in 1 BLISTER PACK1 blister pack2020-10-140000-00-00NoNoCurrent