Cephalexin

Product NDC
53808-0222
11-digit product format
538080222
Labeler code
53808
Product ID
53808-0222_ccd16e47-b47c-48e5-8281-f679ae506ddc
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
CEPHALEXIN
Dosage form
CAPSULE
Route
ORAL
Labeler
State of Florida DOH Central Pharmacy
Application
ANDA062702
Marketing category
ANDA
Marketing start
2009-07-01
Marketing end
0000-00-00
Substance
CEPHALEXIN
Active strength
500 mg/1
NDC exclude flag
E
Listing certified through
2017-12-31
Current FDA listing
Historical FDA.report record

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
dfa3f520-409c-432e-b6d3-9250d468c772Product name120250401
64bb7f1a-2c2e-4741-8301-dbfeda7239f6Product name120190628
398aa563-bb78-fe0f-46a8-757c40ef28bfProduct name120140508

FDA-Initiated Inactive NDC Indexing#

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
53808-0222-1Cephalexin30 in 1 BLISTER PACKCAPSULE301

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
CEPHALEXINACTIVE INGREDIENTOBN7UDS42YCEPHALEXIN CAPSULE [STATE OF FLORIDA DOH CENTRAL PHARMACY]1
CEPHALEXINACTIVE MOIETYOBN7UDS42YCEPHALEXIN CAPSULE [STATE OF FLORIDA DOH CENTRAL PHARMACY]1
CARBOXYMETHYLCELLULOSE SODIUMINACTIVE INGREDIENTK679OBS311CEPHALEXIN CAPSULE [STATE OF FLORIDA DOH CENTRAL PHARMACY]1
D&C YELLOW NO. 10INACTIVE INGREDIENT35SW5USQ3GCEPHALEXIN CAPSULE [STATE OF FLORIDA DOH CENTRAL PHARMACY]1
FD&C BLUE NO. 1INACTIVE INGREDIENTH3R47K3TBDCEPHALEXIN CAPSULE [STATE OF FLORIDA DOH CENTRAL PHARMACY]1
FD&C BLUE NO. 2INACTIVE INGREDIENTL06K8R7DQKCEPHALEXIN CAPSULE [STATE OF FLORIDA DOH CENTRAL PHARMACY]1
FD&C RED NO. 40INACTIVE INGREDIENTWZB9127XOACEPHALEXIN CAPSULE [STATE OF FLORIDA DOH CENTRAL PHARMACY]1
FERROSOFERRIC OXIDEINACTIVE INGREDIENTXM0M87F357CEPHALEXIN CAPSULE [STATE OF FLORIDA DOH CENTRAL PHARMACY]1
GELATININACTIVE INGREDIENT2G86QN327LCEPHALEXIN CAPSULE [STATE OF FLORIDA DOH CENTRAL PHARMACY]1
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30CEPHALEXIN CAPSULE [STATE OF FLORIDA DOH CENTRAL PHARMACY]1
PROPYLENE GLYCOLINACTIVE INGREDIENT6DC9Q167V3CEPHALEXIN CAPSULE [STATE OF FLORIDA DOH CENTRAL PHARMACY]1
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4CEPHALEXIN CAPSULE [STATE OF FLORIDA DOH CENTRAL PHARMACY]1
SODIUM LAURYL SULFATEINACTIVE INGREDIENT368GB5141JCEPHALEXIN CAPSULE [STATE OF FLORIDA DOH CENTRAL PHARMACY]1
SODIUM STARCH GLYCOLATE TYPE A POTATOINACTIVE INGREDIENT5856J3G2A2CEPHALEXIN CAPSULE [STATE OF FLORIDA DOH CENTRAL PHARMACY]1
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPCEPHALEXIN CAPSULE [STATE OF FLORIDA DOH CENTRAL PHARMACY]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
53808-0222CEPHALEXIN CAPSULE [STATE OF FLORIDA DOH CENTRAL PHARMACY]1Legacy NDC, 1 package rows20100806_704ed0b7-4ad3-4bb6-beac-221d20238216.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
309114cephalexin 500 MG Oral CapsulePSN704ed0b7-4ad3-4bb6-beac-221d202382161
309114cephalexin 500 MG Oral CapsuleSCD704ed0b7-4ad3-4bb6-beac-221d202382161
309114cefalexin (as cefalexin monohydrate) 500 MG Oral CapsuleSY704ed0b7-4ad3-4bb6-beac-221d202382161

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionStatus
53808-0222-15380802220130 in 1 BLISTER PACKHistorical