Cephalexin

Product NDC
66116-398
11-digit product format
661160398
Labeler code
66116
Product ID
66116-398_9ef147ae-fcc5-4fd1-b65c-7a37dae89b91
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Cephalexin
Dosage form
CAPSULE
Route
ORAL
Labeler
MedVantx, Inc.
Application
ANDA065215
Marketing category
ANDA
Marketing start
2006-02-01
Marketing end
0000-00-00
Substance
CEPHALEXIN
Active strength
500 mg/1
Pharmacologic classes
Cephalosporin Antibacterial [EPC],Cephalosporins [CS]
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#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
66116-398-282019-11-27C16284748780-19855d018-e222-cd31-e053-dbdaa90ab51aCEPHALEXIN CAPSULES, USP

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
66116-398-28Cephalexin28 in 1 BOTTLE, PLASTICCAPSULE281

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
CEPHALEXINACTIVE INGREDIENTOBN7UDS42YCEPHALEXIN CAPSULE [MEDVANTX, INC.]1
CEPHALEXIN ANHYDROUSACTIVE MOIETY5SFF1W6677CEPHALEXIN CAPSULE [MEDVANTX, INC.]1
D&C YELLOW NO. 10INACTIVE INGREDIENT35SW5USQ3GCEPHALEXIN CAPSULE [MEDVANTX, INC.]1
FD&C BLUE NO. 2INACTIVE INGREDIENTL06K8R7DQKCEPHALEXIN CAPSULE [MEDVANTX, INC.]1
GELATININACTIVE INGREDIENT2G86QN327LCEPHALEXIN CAPSULE [MEDVANTX, INC.]1
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30CEPHALEXIN CAPSULE [MEDVANTX, INC.]1
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4CEPHALEXIN CAPSULE [MEDVANTX, INC.]1
SODIUM STARCH GLYCOLATE TYPE A POTATOINACTIVE INGREDIENT5856J3G2A2CEPHALEXIN CAPSULE [MEDVANTX, INC.]1
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPCEPHALEXIN CAPSULE [MEDVANTX, INC.]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
66116-398CEPHALEXIN CAPSULE [MEDVANTX, INC.]1Legacy NDC, 1 package rows20130823_9ef147ae-fcc5-4fd1-b65c-7a37dae89b91.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
309114cephalexin 500 MG Oral CapsulePSN9ef147ae-fcc5-4fd1-b65c-7a37dae89b911
309114cephalexin 500 MG Oral CapsuleSCD9ef147ae-fcc5-4fd1-b65c-7a37dae89b911
309114cefalexin (as cefalexin monohydrate) 500 MG Oral CapsuleSY9ef147ae-fcc5-4fd1-b65c-7a37dae89b911

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionStatus
66116-398-286611603982828 in 1 BOTTLE, PLASTICHistorical