FDA.reportPublic FDA data

Cephalexin

Product NDC
61442-161
11-digit product format
614420161
Labeler code
61442
Product ID
61442-161_af92ea41-b5dd-433d-9c09-b103240f2853
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Cephalexin
Dosage form
CAPSULE
Route
ORAL
Labeler
Carlsbad Technology, Inc.
Application
ANDA065152
Marketing category
ANDA
Marketing start
2010-10-15
Marketing end
0000-00-00
Substance
CEPHALEXIN
Active strength
250 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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
61442-161-012020-01-31C16284748780-19d75b9d1-2b5c-f424-e053-dadaa90a57ce7ae019f7-ae75-4a5a-a7a7-38cb0992c127
61442-161-052020-01-31C16284748780-19d75b9d1-2b5c-f424-e053-dadaa90a57ce7ae019f7-ae75-4a5a-a7a7-38cb0992c127

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
61442-161-01EA - Each61442-16188a3517c-e41e-45bd-9548-95542f775d4712012-07-24
61442-161-05EA - Each61442-161a8020589-b0ad-4741-aa92-f3ae9801878c12012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
CephalexinACTIVE INGREDIENTOBN7UDS42YCEPHALEXIN CAPSULE [CARLSBAD TECHNOLOGY, INC.]8
Cephalexin AnhydrousACTIVE MOIETY5SFF1W6677CEPHALEXIN CAPSULE [CARLSBAD TECHNOLOGY, INC.]8
AlcoholINACTIVE INGREDIENT3K9958V90MCEPHALEXIN CAPSULE [CARLSBAD TECHNOLOGY, INC.]8
AmmoniaINACTIVE INGREDIENT5138Q19F1XCEPHALEXIN CAPSULE [CARLSBAD TECHNOLOGY, INC.]8
Butyl AlcoholINACTIVE INGREDIENT8PJ61P6TS3CEPHALEXIN CAPSULE [CARLSBAD TECHNOLOGY, INC.]8
Colloidal Silicon DioxideINACTIVE INGREDIENTETJ7Z6XBU4CEPHALEXIN CAPSULE [CARLSBAD TECHNOLOGY, INC.]8
FD&C Blue No. 1INACTIVE INGREDIENTH3R47K3TBDCEPHALEXIN CAPSULE [CARLSBAD TECHNOLOGY, INC.]8
FD&C Yellow No. 5INACTIVE INGREDIENTI753WB2F1MCEPHALEXIN CAPSULE [CARLSBAD TECHNOLOGY, INC.]8
Ferrosoferric OxideINACTIVE INGREDIENTXM0M87F357CEPHALEXIN CAPSULE [CARLSBAD TECHNOLOGY, INC.]8
GelatinINACTIVE INGREDIENT2G86QN327LCEPHALEXIN CAPSULE [CARLSBAD TECHNOLOGY, INC.]8
Isopropyl AlcoholINACTIVE INGREDIENTND2M416302CEPHALEXIN CAPSULE [CARLSBAD TECHNOLOGY, INC.]8
LactoseINACTIVE INGREDIENTJ2B2A4N98GCEPHALEXIN CAPSULE [CARLSBAD TECHNOLOGY, INC.]8
Magnesium StearateINACTIVE INGREDIENT70097M6I30CEPHALEXIN CAPSULE [CARLSBAD TECHNOLOGY, INC.]8
Potassium HydroxideINACTIVE INGREDIENTWZH3C48M4TCEPHALEXIN CAPSULE [CARLSBAD TECHNOLOGY, INC.]8
Propylene GlycolINACTIVE INGREDIENT6DC9Q167V3CEPHALEXIN CAPSULE [CARLSBAD TECHNOLOGY, INC.]8
ShellacINACTIVE INGREDIENT46N107B71OCEPHALEXIN CAPSULE [CARLSBAD TECHNOLOGY, INC.]8
Sodium Starch Glycolate Type A PotatoINACTIVE INGREDIENT5856J3G2A2CEPHALEXIN CAPSULE [CARLSBAD TECHNOLOGY, INC.]8
TalcINACTIVE INGREDIENT7SEV7J4R1UCEPHALEXIN CAPSULE [CARLSBAD TECHNOLOGY, INC.]8
Titanium DioxideINACTIVE INGREDIENT15FIX9V2JPCEPHALEXIN CAPSULE [CARLSBAD TECHNOLOGY, INC.]8
WaterINACTIVE INGREDIENT059QF0KO0RCEPHALEXIN CAPSULE [CARLSBAD TECHNOLOGY, INC.]8

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
61442-161CEPHALEXIN CAPSULE [CARLSBAD TECHNOLOGY, INC.]8Legacy NDC20140508_7ae019f7-ae75-4a5a-a7a7-38cb0992c127.zip