FDA.reportPublic FDA data

CEFIXIME

Product NDC
70518-3221
11-digit product format
705183221
Labeler code
70518
Product ID
70518-3221_4ecf7772-70f8-92cf-e063-6294a90a99b0
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
CEFIXIME
Dosage form
CAPSULE
Route
ORAL
Labeler
REMEDYREPACK INC.
Application
NDA203195
Marketing category
NDA AUTHORIZED GENERIC
Marketing start
2021-09-14
Substance
CEFIXIME
Active strength
400 mg/1
Pharmacologic classes
Cephalosporin Antibacterial [EPC], Cephalosporins [CS]
NDC exclude flag
No
Listing certified through
2027-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
CEFIXIME
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
CEFIXIME400 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii97I1C92E55
Rxcui409823

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
70518-3221-0CEFIXIME2 in 1 BOXCAPSULE29
70518-3221-1CEFIXIME1 in 1 POUCHCAPSULE19
70518-3221-2CEFIXIME2 in 1 BOXCAPSULE29
70518-3221-3CEFIXIME1 in 1 POUCHCAPSULE19
70518-3221-4CEFIXIME2 in 1 BOTTLE, PLASTICCAPSULE29
70518-3221-5CEFIXIME2 in 1 BOTTLE, PLASTICCAPSULE29

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
70518-3221-1EA - Each70518-32218a439962-d641-437a-bfd5-b222341aa8cc12024-04-05
70518-3221-2EA - Each70518-32210135676c-0db8-4f7e-b938-bdd3e657c6d412024-04-05
70518-3221-3EA - Each70518-3221841e4149-5df0-4e2c-b485-fcc15beefced12026-02-05
70518-3221-4EA - Each70518-3221d121acf6-3c3c-4f23-85e3-e7aaf525406212024-04-05

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
70518-3221CEFIXIME CAPSULE [REMEDYREPACK INC.]6Current NDC, Legacy NDC, 6 package rows20240927_3194433c-c04e-442b-9668-fbeb0a15bac7.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
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
70518-3221-0705183221002 POUCH in 1 BOX (70518-3221-0) > 1 CAPSULE in 1 POUCH (70518-3221-1) 2 pouch2021-09-140000-00-00NoNoCurrent
70518-3221-1705183221011 in 1 POUCHHistorical
70518-3221-2705183221022 POUCH in 1 BOX (70518-3221-2) / 1 CAPSULE in 1 POUCH (70518-3221-3) 2 pouch2021-11-040000-00-00NoNoCurrent
70518-3221-3705183221031 in 1 POUCHHistorical
70518-3221-4705183221042 CAPSULE in 1 BOTTLE, PLASTIC (70518-3221-4) 2 capsule2022-03-020000-00-00NoNoCurrent
70518-3221-5705183221052 CAPSULE in 1 BOTTLE, PLASTIC (70518-3221-5) 2 capsule2022-06-060000-00-00NoNoCurrent