cephalexin

Product NDC
50436-0117
11-digit product format
504360117
Labeler code
50436
Product ID
50436-0117_51a8f729-cedf-4974-b630-4528f2222f5a
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
cephalexin
Dosage form
CAPSULE
Route
ORAL
Labeler
Unit Dose Services
Application
ANDA062791
Marketing category
ANDA
Marketing start
2010-06-21
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
2019-12-31
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
50436-0117-12020-01-31C16284748780-19d75b9d0-2f6e-f424-e053-dadaa90a57ceCephalexin Capsules, USP To reduce the development of drug-resistant bacteria and maintain the effectiveness of cephalexin capsules, USP and other antibacterial drugs, cephalexin capsule, USP should be used only to treat or prevent infections that are proven or strongly suspected to be caused by bacteria.
50436-0117-22020-01-31C16284748780-19d75b9d0-2f6e-f424-e053-dadaa90a57ceCephalexin Capsules, USP To reduce the development of drug-resistant bacteria and maintain the effectiveness of cephalexin capsules, USP and other antibacterial drugs, cephalexin capsule, USP should be used only to treat or prevent infections that are proven or strongly suspected to be caused by bacteria.
50436-0117-32020-01-31C16284748780-19d75b9d0-2f6e-f424-e053-dadaa90a57ceCephalexin Capsules, USP To reduce the development of drug-resistant bacteria and maintain the effectiveness of cephalexin capsules, USP and other antibacterial drugs, cephalexin capsule, USP should be used only to treat or prevent infections that are proven or strongly suspected to be caused by bacteria.
50436-0117-42020-01-31C16284748780-19d75b9d0-2f6e-f424-e053-dadaa90a57ceCephalexin Capsules, USP To reduce the development of drug-resistant bacteria and maintain the effectiveness of cephalexin capsules, USP and other antibacterial drugs, cephalexin capsule, USP should be used only to treat or prevent infections that are proven or strongly suspected to be caused by bacteria.
50436-0117-52020-01-31C16284748780-19d75b9d0-2f6e-f424-e053-dadaa90a57ceCephalexin Capsules, USP To reduce the development of drug-resistant bacteria and maintain the effectiveness of cephalexin capsules, USP and other antibacterial drugs, cephalexin capsule, USP should be used only to treat or prevent infections that are proven or strongly suspected to be caused by bacteria.
50436-0117-82020-01-31C16284748780-19d75b9d0-2f6e-f424-e053-dadaa90a57ceCephalexin Capsules, USP To reduce the development of drug-resistant bacteria and maintain the effectiveness of cephalexin capsules, USP and other antibacterial drugs, cephalexin capsule, USP should be used only to treat or prevent infections that are proven or strongly suspected to be caused by bacteria.

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
50436-0117-1cephalexin28 in 1 BOTTLECAPSULE284
50436-0117-2cephalexin30 in 1 BOTTLECAPSULE304
50436-0117-3cephalexin40 in 1 BOTTLECAPSULE404
50436-0117-4cephalexin14 in 1 BOTTLECAPSULE144
50436-0117-5cephalexin20 in 1 BOTTLECAPSULE204
50436-0117-8cephalexin21 in 1 BOTTLECAPSULE214

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
50436-0117-1EA - Each50436-01179453d61b-2597-4e4b-8c91-d21900a4bbd812013-04-01
50436-0117-2EA - Each50436-01170bbf8647-75c2-4002-80de-27fcb4d558da12013-06-04
50436-0117-3EA - Each50436-0117cfb537ae-0fb6-45ba-9fa4-e3274f42cd6812013-04-01
50436-0117-4EA - Each50436-01178a47bbe1-f28f-4164-ad24-52405c73f2d712013-06-04
50436-0117-5EA - Each50436-01174133aa72-d663-440c-83bf-cfd12405bafb12013-04-01
50436-0117-8EA - Each50436-01175d258e1f-f8f0-4589-86a5-3c283d585af312013-04-01

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
CEPHALEXINACTIVE INGREDIENTOBN7UDS42YCEPHALEXIN CAPSULE [UNIT DOSE SERVICES]4
CEPHALEXIN ANHYDROUSACTIVE MOIETY5SFF1W6677CEPHALEXIN CAPSULE [UNIT DOSE SERVICES]4
D&C YELLOW NO. 10INACTIVE INGREDIENT35SW5USQ3GCEPHALEXIN CAPSULE [UNIT DOSE SERVICES]4
FD&C BLUE NO. 1INACTIVE INGREDIENTH3R47K3TBDCEPHALEXIN CAPSULE [UNIT DOSE SERVICES]4
FD&C GREEN NO. 3INACTIVE INGREDIENT3P3ONR6O1SCEPHALEXIN CAPSULE [UNIT DOSE SERVICES]4
FD&C YELLOW NO. 6INACTIVE INGREDIENTH77VEI93A8CEPHALEXIN CAPSULE [UNIT DOSE SERVICES]4
GELATININACTIVE INGREDIENT2G86QN327LCEPHALEXIN CAPSULE [UNIT DOSE SERVICES]4
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30CEPHALEXIN CAPSULE [UNIT DOSE SERVICES]4
SODIUM LAURYL SULFATEINACTIVE INGREDIENT368GB5141JCEPHALEXIN CAPSULE [UNIT DOSE SERVICES]4
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPCEPHALEXIN CAPSULE [UNIT DOSE SERVICES]4

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50436-0117CEPHALEXIN CAPSULE [UNIT DOSE SERVICES]4Legacy NDC, 6 package rows20130502_6abc40af-be15-405e-845c-c31866b3d6f6.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
309114cephalexin 500 MG Oral CapsulePSN6abc40af-be15-405e-845c-c31866b3d6f64
309114cephalexin 500 MG Oral CapsuleSCD6abc40af-be15-405e-845c-c31866b3d6f64
309114cefalexin (as cefalexin monohydrate) 500 MG Oral CapsuleSY6abc40af-be15-405e-845c-c31866b3d6f64

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionStatus
50436-0117-15043601170128 in 1 BOTTLEHistorical
50436-0117-25043601170230 in 1 BOTTLEHistorical
50436-0117-35043601170340 in 1 BOTTLEHistorical
50436-0117-45043601170414 in 1 BOTTLEHistorical
50436-0117-55043601170520 in 1 BOTTLEHistorical
50436-0117-85043601170821 in 1 BOTTLEHistorical