FDA.reportPublic FDA data

Cefixime 400 mg

Product NDC
83112-400
11-digit product format
831120400
Labeler code
83112
Product ID
83112-400_466300ca-f48d-6568-e063-6294a90ac2a0
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Cefixime
Dosage form
CAPSULE
Route
ORAL
Labeler
Health Department, Oklahoma State
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 400 mg
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
83112-400-00Cefixime 400 mg2 in 1 PACKETCAPSULE23
83112-400-02Cefixime 400 mg2 in 1 PACKETCAPSULE23

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
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 startSampleExclude flagStatus
83112-400-00831120400002 CAPSULE in 1 PACKET (83112-400-00) 2 capsule2018-10-12NoNoCurrent
83112-400-02831120400022 CAPSULE in 1 PACKET (83112-400-02) 2 capsule2018-10-12NoNoCurrent