FDA.reportPublic FDA data

CEFIXIME

Product NDC
70518-2749
11-digit product format
705182749
Labeler code
70518
Product ID
70518-2749_4a8d83f6-006d-5ac4-e063-6294a90abe49
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
CEFIXIME
Dosage form
CAPSULE
Route
ORAL
Labeler
REMEDYREPACK INC.
Application
ANDA210574
Marketing category
ANDA
Marketing start
2020-05-21
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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
70518-2749-02023-03-13C16284748780-1f386c649-fc63-0266-e053-dadaa90a7c1aThese highlights do not include all the information needed to use CEFIXIME CAPSULES safely and effectively. See full prescribing information for CEFIXIME CAPSULES. CEFIXIME capsules, for oral use. Initial U.S. Approval: 1986
70518-2749-12023-03-13C16284748780-1f386c649-fc63-0266-e053-dadaa90a7c1aThese highlights do not include all the information needed to use CEFIXIME CAPSULES safely and effectively. See full prescribing information for CEFIXIME CAPSULES. CEFIXIME capsules, for oral use. Initial U.S. Approval: 1986
70518-2749-22023-03-13C16284748780-1f386c649-fc63-0266-e053-dadaa90a7c1aThese highlights do not include all the information needed to use CEFIXIME CAPSULES safely and effectively. See full prescribing information for CEFIXIME CAPSULES. CEFIXIME capsules, for oral use. Initial U.S. Approval: 1986
70518-2749-32023-03-13C16284748780-1f386c649-fc63-0266-e053-dadaa90a7c1aThese highlights do not include all the information needed to use CEFIXIME CAPSULES safely and effectively. See full prescribing information for CEFIXIME CAPSULES. CEFIXIME capsules, for oral use. Initial U.S. Approval: 1986
70518-2749-02023-01-30C16284748780-1f386c649-fc63-0266-e053-dadaa90a7c1aThese highlights do not include all the information needed to use CEFIXIME CAPSULES safely and effectively. See full prescribing information for CEFIXIME CAPSULES. CEFIXIME capsules, for oral use. Initial U.S. Approval: 1986
70518-2749-12023-01-30C16284748780-1f386c649-fc63-0266-e053-dadaa90a7c1aThese highlights do not include all the information needed to use CEFIXIME CAPSULES safely and effectively. See full prescribing information for CEFIXIME CAPSULES. CEFIXIME capsules, for oral use. Initial U.S. Approval: 1986
70518-2749-22023-01-30C16284748780-1f386c649-fc63-0266-e053-dadaa90a7c1aThese highlights do not include all the information needed to use CEFIXIME CAPSULES safely and effectively. See full prescribing information for CEFIXIME CAPSULES. CEFIXIME capsules, for oral use. Initial U.S. Approval: 1986
70518-2749-32023-01-30C16284748780-1f386c649-fc63-0266-e053-dadaa90a7c1aThese highlights do not include all the information needed to use CEFIXIME CAPSULES safely and effectively. See full prescribing information for CEFIXIME CAPSULES. CEFIXIME capsules, for oral use. Initial U.S. Approval: 1986

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
70518-2749-0CEFIXIME10 in 1 BOTTLE, PLASTICCAPSULE1013
70518-2749-1CEFIXIME1 in 1 BOTTLE, PLASTICCAPSULE113
70518-2749-2CEFIXIME2 in 1 BOTTLE, PLASTICCAPSULE213
70518-2749-3CEFIXIME2 in 1 BLISTER PACKCAPSULE213
70518-2749-4CEFIXIME1 in 1 POUCHCAPSULE113
70518-2749-5CEFIXIME2 in 1 BOXCAPSULE213

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
70518-2749-0EA - Each70518-27494a2a2e63-140b-49ca-97f8-6e6e6609a03f12024-04-05
70518-2749-2EA - Each70518-274912246bc9-96d6-4c1a-b009-828e4663cc0812026-01-08
70518-2749-4EA - Each70518-27491480d406-dd5f-4c3f-b2c2-d6d51763e98112026-01-08

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
70518-2749CEFIXIME CAPSULE [REMEDYREPACK INC.]11Current NDC, Legacy NDC, 6 package rows20250125_d6718f02-8eea-4c2f-9aa2-65121d9a6e4c.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

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
70518-2749-07051827490010 CAPSULE in 1 BOTTLE, PLASTIC (70518-2749-0) 10 capsule2020-05-210000-00-00NoNoCurrent
70518-2749-1705182749011 CAPSULE in 1 BOTTLE, PLASTIC (70518-2749-1) 1 capsule2020-06-020000-00-00NoNoCurrent
70518-2749-2705182749022 CAPSULE in 1 BOTTLE, PLASTIC (70518-2749-2) 2 capsule2021-01-260000-00-00NoNoCurrent
70518-2749-3705182749032 CAPSULE in 1 BLISTER PACK (70518-2749-3) 2 capsule2021-03-090000-00-00NoNoCurrent
70518-2749-4705182749041 in 1 POUCHHistorical
70518-2749-5705182749052 POUCH in 1 BOX (70518-2749-5) / 1 CAPSULE in 1 POUCH (70518-2749-4) 2 pouch2023-07-07NoNoHistorical