cephalexin

Product NDC
42254-080
11-digit product format
422540080
Labeler code
42254
Product ID
42254-080_4511cefb-084b-4191-899c-f500091f589c
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
cephalexin
Dosage form
CAPSULE
Route
ORAL
Labeler
Rebel Distributors Corp
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
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
42254-080-062019-09-24C16284748780-19350213a-3caa-c013-e053-90daa90a1393Cephalexin 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.
42254-080-122019-09-24C16284748780-19350213a-3caa-c013-e053-90daa90a1393Cephalexin 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.
42254-080-142019-09-24C16284748780-19350213a-3caa-c013-e053-90daa90a1393Cephalexin 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.
42254-080-202019-09-24C16284748780-19350213a-3caa-c013-e053-90daa90a1393Cephalexin 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.
42254-080-212019-09-24C16284748780-19350213a-3caa-c013-e053-90daa90a1393Cephalexin 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.
42254-080-282019-09-24C16284748780-19350213a-3caa-c013-e053-90daa90a1393Cephalexin 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.
42254-080-302019-09-24C16284748780-19350213a-3caa-c013-e053-90daa90a1393Cephalexin 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.
42254-080-402019-09-24C16284748780-19350213a-3caa-c013-e053-90daa90a1393Cephalexin 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
42254-080-06cephalexin6 in 1 BOTTLECAPSULE62
42254-080-12cephalexin12 in 1 BOTTLECAPSULE122
42254-080-14cephalexin14 in 1 BOTTLECAPSULE142
42254-080-20cephalexin20 in 1 BOTTLECAPSULE202
42254-080-21cephalexin21 in 1 BOTTLECAPSULE212
42254-080-28cephalexin28 in 1 BOTTLECAPSULE282
42254-080-30cephalexin30 in 1 BOTTLECAPSULE302
42254-080-40cephalexin40 in 1 BOTTLECAPSULE402

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
42254-080-06EA - Each42254-080f9c78d29-7c44-4779-893e-022e86d1cb0412012-07-24
42254-080-12EA - Each42254-0807b1283de-d965-4e5a-9f02-a08944bc32a112012-07-24
42254-080-14EA - Each42254-080384c157e-ebf7-4b27-9786-72671da80dad12013-04-01
42254-080-20EA - Each42254-080a5168a9c-50f0-4ea4-8f9a-1a250c03f04012012-07-24
42254-080-21EA - Each42254-080c80a2d91-a1b0-4a6e-8d7f-9a2ec34aaba012013-04-01
42254-080-28EA - Each42254-080d0f98feb-8d98-4e05-9e68-aebd48fe893712012-07-24
42254-080-30EA - Each42254-080efa85219-04b0-4956-9a47-075de8ea6e9812012-07-24
42254-080-40EA - Each42254-080d143188e-b321-42a1-a781-94ad6cfae52412012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
CEPHALEXINACTIVE INGREDIENTOBN7UDS42YCEPHALEXIN CAPSULE [REBEL DISTRIBUTORS CORP]2
CEPHALEXIN ANHYDROUSACTIVE MOIETY5SFF1W6677CEPHALEXIN CAPSULE [REBEL DISTRIBUTORS CORP]2
D&C YELLOW NO. 10INACTIVE INGREDIENT35SW5USQ3GCEPHALEXIN CAPSULE [REBEL DISTRIBUTORS CORP]2
FD&C BLUE NO. 1INACTIVE INGREDIENTH3R47K3TBDCEPHALEXIN CAPSULE [REBEL DISTRIBUTORS CORP]2
FD&C GREEN NO. 3INACTIVE INGREDIENT3P3ONR6O1SCEPHALEXIN CAPSULE [REBEL DISTRIBUTORS CORP]2
FD&C YELLOW NO. 6INACTIVE INGREDIENTH77VEI93A8CEPHALEXIN CAPSULE [REBEL DISTRIBUTORS CORP]2
GELATININACTIVE INGREDIENT2G86QN327LCEPHALEXIN CAPSULE [REBEL DISTRIBUTORS CORP]2
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30CEPHALEXIN CAPSULE [REBEL DISTRIBUTORS CORP]2
SODIUM LAURYL SULFATEINACTIVE INGREDIENT368GB5141JCEPHALEXIN CAPSULE [REBEL DISTRIBUTORS CORP]2
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPCEPHALEXIN CAPSULE [REBEL DISTRIBUTORS CORP]2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
42254-080CEPHALEXIN CAPSULE [REBEL DISTRIBUTORS CORP]2Legacy NDC, 8 package rows20130329_c5604b48-d58f-45ac-8602-72241ed4b906.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
309114cephalexin 500 MG Oral CapsulePSNc5604b48-d58f-45ac-8602-72241ed4b9062
309114cephalexin 500 MG Oral CapsuleSCDc5604b48-d58f-45ac-8602-72241ed4b9062
309114cefalexin (as cefalexin monohydrate) 500 MG Oral CapsuleSYc5604b48-d58f-45ac-8602-72241ed4b9062

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionStatus
42254-080-06422540080066 in 1 BOTTLEHistorical
42254-080-124225400801212 in 1 BOTTLEHistorical
42254-080-144225400801414 in 1 BOTTLEHistorical
42254-080-204225400802020 in 1 BOTTLEHistorical
42254-080-214225400802121 in 1 BOTTLEHistorical
42254-080-284225400802828 in 1 BOTTLEHistorical
42254-080-304225400803030 in 1 BOTTLEHistorical
42254-080-404225400804040 in 1 BOTTLEHistorical