FDA.reportPublic FDA data

Cephalexin

Product NDC
61442-162
11-digit product format
614420162
Labeler code
61442
Product ID
61442-162_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
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
61442-162-012020-01-31C16284748780-19d75b9d1-2b5c-f424-e053-dadaa90a57ce7ae019f7-ae75-4a5a-a7a7-38cb0992c127
61442-162-052020-01-31C16284748780-19d75b9d1-2b5c-f424-e053-dadaa90a57ce7ae019f7-ae75-4a5a-a7a7-38cb0992c127

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
61442-162-01EA - Each61442-162d58aefb0-7f0a-4ad2-bb6d-e92d06a7927812012-07-24
61442-162-05EA - Each61442-1621803ea32-ce3c-4e49-b813-1154e62cd05712012-07-24

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

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
61442-162CEPHALEXIN CAPSULE [CARLSBAD TECHNOLOGY, INC.]8Legacy NDC20140508_7ae019f7-ae75-4a5a-a7a7-38cb0992c127.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
309114cephalexin 500 MG Oral CapsulePSN5399cebf-caf8-40f8-a1fa-a2e547a2b8171
309114cephalexin 500 MG Oral CapsuleSCD5399cebf-caf8-40f8-a1fa-a2e547a2b8171
309114cefalexin (as cefalexin monohydrate) 500 MG Oral CapsuleSY5399cebf-caf8-40f8-a1fa-a2e547a2b8171