Cephalexin

Product NDC
63874-112
11-digit product format
638740112
Labeler code
63874
Product ID
63874-112_b4cebeeb-b014-4e9d-a865-4f09e4473c36
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Cephalexin
Dosage form
CAPSULE
Route
ORAL
Labeler
Altura Pharmaceuticals, Inc.
Application
ANDA065215
Marketing category
ANDA
Marketing start
2010-01-01
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
63874-112-01Cephalexin100 in 1 BOTTLE, PLASTICCAPSULE1001
63874-112-14Cephalexin14 in 1 BOTTLE, PLASTICCAPSULE141
63874-112-28Cephalexin28 in 1 BOTTLE, PLASTICCAPSULE281
63874-112-30Cephalexin30 in 1 BOTTLE, PLASTICCAPSULE301
63874-112-40Cephalexin40 in 1 BOTTLE, PLASTICCAPSULE401

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
63874-112-01EA - Each63874-1123c1e4b45-904f-430e-9e0b-7620d5b1ab5b12012-07-24
63874-112-14EA - Each63874-112c41765e3-7b71-4230-9bf7-7d83fd0a948012012-07-24
63874-112-28EA - Each63874-1121fe7ae99-3751-4cfc-96fc-3367df43f3d112012-07-24
63874-112-30EA - Each63874-112aec3109e-fcfc-4f29-8345-c58066bb1c7d12012-07-24
63874-112-40EA - Each63874-11264c80916-1de1-4815-a139-658b9cc5b64712012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
CEPHALEXINACTIVE INGREDIENTOBN7UDS42YCEPHALEXIN CAPSULE [ALTURA PHARMACEUTICALS, INC.]1
CEPHALEXINACTIVE MOIETYOBN7UDS42YCEPHALEXIN CAPSULE [ALTURA PHARMACEUTICALS, INC.]1
COLLOIDAL SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4CEPHALEXIN CAPSULE [ALTURA PHARMACEUTICALS, INC.]1
D&C YELLOW NO. 10INACTIVE INGREDIENT35SW5USQ3GCEPHALEXIN CAPSULE [ALTURA PHARMACEUTICALS, INC.]1
FD&C BLUE NO. 2INACTIVE INGREDIENTL06K8R7DQKCEPHALEXIN CAPSULE [ALTURA PHARMACEUTICALS, INC.]1
GELATININACTIVE INGREDIENT2G86QN327LCEPHALEXIN CAPSULE [ALTURA PHARMACEUTICALS, INC.]1
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30CEPHALEXIN CAPSULE [ALTURA PHARMACEUTICALS, INC.]1
SODIUM STARCH GLYCOLATE TYPE A POTATOINACTIVE INGREDIENT5856J3G2A2CEPHALEXIN CAPSULE [ALTURA PHARMACEUTICALS, INC.]1
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPCEPHALEXIN CAPSULE [ALTURA PHARMACEUTICALS, INC.]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
63874-112CEPHALEXIN CAPSULE [ALTURA PHARMACEUTICALS, INC.]1Legacy NDC, 5 package rows20100429_27f5aa5b-28ca-4154-b37e-18a931bf3398.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
309112cephalexin 250 MG Oral CapsulePSN27f5aa5b-28ca-4154-b37e-18a931bf33981
309114cephalexin 500 MG Oral CapsulePSN27f5aa5b-28ca-4154-b37e-18a931bf33981
309112cephalexin 250 MG Oral CapsuleSCD27f5aa5b-28ca-4154-b37e-18a931bf33981
309114cephalexin 500 MG Oral CapsuleSCD27f5aa5b-28ca-4154-b37e-18a931bf33981
309114cefalexin (as cefalexin monohydrate) 500 MG Oral CapsuleSY27f5aa5b-28ca-4154-b37e-18a931bf33981
309112cephalexin (as cephalexin monohydrate) 250 MG Oral CapsuleSY27f5aa5b-28ca-4154-b37e-18a931bf33981

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionStatus
63874-112-0163874011201100 in 1 BOTTLE, PLASTICHistorical
63874-112-146387401121414 in 1 BOTTLE, PLASTICHistorical
63874-112-286387401122828 in 1 BOTTLE, PLASTICHistorical
63874-112-306387401123030 in 1 BOTTLE, PLASTICHistorical
63874-112-406387401124040 in 1 BOTTLE, PLASTICHistorical