Cephalexin

Product NDC
45865-428
11-digit product format
458650428
Labeler code
45865
Product ID
45865-428_9ab1fdd1-ec80-6939-e053-2a95a90ad46f
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Cephalexin
Dosage form
CAPSULE
Route
ORAL
Labeler
Medsource Pharmaceuticals
Application
ANDA065253
Marketing category
ANDA
Marketing start
2005-11-16
Marketing end
0000-00-00
Substance
CEPHALEXIN
Active strength
500 mg/1
Pharmacologic classes
Cephalosporin Antibacterial [EPC],Cephalosporins [CS]
NDC exclude flag
No
Listing certified through
2020-12-31
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
45865-428-282025-01-30C16284748780-12cef2736-5e6b-d83d-e063-dadaa90ab31f1d73e25f-6a61-3845-e054-00144ff8d46c
45865-428-302025-01-30C16284748780-12cef2736-5e6b-d83d-e063-dadaa90ab31f1d73e25f-6a61-3845-e054-00144ff8d46c

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
45865-428-28Cephalexin28 in 1 BOTTLECAPSULE282
45865-428-30Cephalexin30 in 1 BOTTLECAPSULE302

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
CEPHALEXINACTIVE INGREDIENTOBN7UDS42YCEPHALEXIN CAPSULE [MEDSOURCE PHARMACEUTICALS]1
CEPHALEXIN ANHYDROUSACTIVE MOIETY5SFF1W6677CEPHALEXIN CAPSULE [MEDSOURCE PHARMACEUTICALS]1
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UCEPHALEXIN CAPSULE [MEDSOURCE PHARMACEUTICALS]1
CROSCARMELLOSE SODIUMINACTIVE INGREDIENTM28OL1HH48CEPHALEXIN CAPSULE [MEDSOURCE PHARMACEUTICALS]1
D&C YELLOW NO. 10INACTIVE INGREDIENT35SW5USQ3GCEPHALEXIN CAPSULE [MEDSOURCE PHARMACEUTICALS]1
FD&C BLUE NO. 1INACTIVE INGREDIENTH3R47K3TBDCEPHALEXIN CAPSULE [MEDSOURCE PHARMACEUTICALS]1
FD&C YELLOW NO. 6INACTIVE INGREDIENTH77VEI93A8CEPHALEXIN CAPSULE [MEDSOURCE PHARMACEUTICALS]1
GELATININACTIVE INGREDIENT2G86QN327LCEPHALEXIN CAPSULE [MEDSOURCE PHARMACEUTICALS]1
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30CEPHALEXIN CAPSULE [MEDSOURCE PHARMACEUTICALS]1
SODIUM LAURYL SULFATEINACTIVE INGREDIENT368GB5141JCEPHALEXIN CAPSULE [MEDSOURCE PHARMACEUTICALS]1
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPCEPHALEXIN CAPSULE [MEDSOURCE PHARMACEUTICALS]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
45865-428CEPHALEXIN CAPSULE [MEDSOURCE PHARMACEUTICALS]2Legacy NDC, 2 package rows20191228_1d73e25f-6a61-3845-e054-00144ff8d46c.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
309114cephalexin 500 MG Oral CapsulePSN1d73e25f-6a61-3845-e054-00144ff8d46c2
309114cephalexin 500 MG Oral CapsuleSCD1d73e25f-6a61-3845-e054-00144ff8d46c2
309114cefalexin (as cefalexin monohydrate) 500 MG Oral CapsuleSY1d73e25f-6a61-3845-e054-00144ff8d46c2

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
45865-428-284586504282828 CAPSULE in 1 BOTTLE (45865-428-28) 28 capsule2015-08-260000-00-00NoNoCurrent
45865-428-304586504283030 CAPSULE in 1 BOTTLE (45865-428-30) 30 capsule2015-08-260000-00-00NoNoCurrent