FDA.reportPublic FDA data

CEFIXIME

Product NDC
67877-584
11-digit product format
678770584
Labeler code
67877
Product ID
67877-584_30690cba-b831-45c1-b799-a013d6cfc2db
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
CEFIXIME
Dosage form
CAPSULE
Route
ORAL
Labeler
Ascend Laboratories, LLC
Application
ANDA210574
Marketing category
ANDA
Marketing start
2018-10-12
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
Rxcui409823

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
67877-584-01CEFIXIME100 in 1 BOTTLECAPSULE10010
67877-584-05CEFIXIME500 in 1 BOTTLECAPSULE50010
67877-584-33CEFIXIME10 in 1 CARTONCAPSULE1010
67877-584-33CEFIXIME10 in 1 BLISTER PACKCAPSULE1010
67877-584-50CEFIXIME50 in 1 BOTTLECAPSULE5010

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
67877-584-33EA - Each67877-5849f550001-4269-46be-a036-b433f8e1d45112022-06-06
67877-584-50EA - Each67877-584bb2b527a-0cde-43fa-85ab-e7fe797afd7812019-06-19

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
67877-584CEFIXIME CAPSULE [ASCEND LABORATORIES, LLC]10Current NDC, Legacy NDC, 5 package rows20220603_6f1df975-f825-4301-87da-d7eba56a6890.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
409823cefixime 400 MG Oral CapsulePSNd6718f02-8eea-4c2f-9aa2-65121d9a6e4c13
409823cefixime 400 MG Oral CapsuleSCDd6718f02-8eea-4c2f-9aa2-65121d9a6e4c13
409823cefixime 400 MG Oral CapsulePSN6f1df975-f825-4301-87da-d7eba56a689010
409823cefixime 400 MG Oral CapsuleSCD6f1df975-f825-4301-87da-d7eba56a689010
409823cefixime 400 MG Oral CapsulePSNf0fdb14b-e4fb-707e-e053-2a95a90a90493
409823cefixime 400 MG Oral CapsuleSCDf0fdb14b-e4fb-707e-e053-2a95a90a90493

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
67877-584-0167877058401100 CAPSULE in 1 BOTTLE (67877-584-01) 100 capsule2018-10-120000-00-00NoNoCurrent
67877-584-0567877058405500 CAPSULE in 1 BOTTLE (67877-584-05) 500 capsule2018-10-120000-00-00NoNoCurrent
67877-584-336787705843310 BLISTER PACK in 1 CARTON (67877-584-33) / 10 CAPSULE in 1 BLISTER PACK10 blister pack2020-11-260000-00-00NoNoCurrent
67877-584-506787705845050 CAPSULE in 1 BOTTLE (67877-584-50) 50 capsule2018-10-120000-00-00NoNoCurrent