FDA.reportPublic FDA data

Cephalexin

Product NDC
70934-109
11-digit product format
709340109
Labeler code
70934
Product ID
70934-109_9a6689a3-639f-2b1f-e053-2995a90a64b0
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Cephalexin
Dosage form
CAPSULE
Route
ORAL
Labeler
Denton Pharma, Inc. DBA Northwind Pharmaceuticals
Application
ANDA065253
Marketing category
ANDA
Marketing start
2018-04-30
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
2020-12-31
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
70934-109-102021-01-29C16284748780-1ba0f9c33-21aa-a910-e053-dadaa90a0b85These highlights do not include all the information needed to use CEPHALEXIN CAPSULES safely and effectively. See full prescribing information for CEPHALEXIN CAPSULES CEPHALEXIN capsules, for oral use Initial U.S. Approval: 1971
70934-109-282021-01-29C16284748780-1ba0f9c33-21aa-a910-e053-dadaa90a0b85These highlights do not include all the information needed to use CEPHALEXIN CAPSULES safely and effectively. See full prescribing information for CEPHALEXIN CAPSULES CEPHALEXIN capsules, for oral use Initial U.S. Approval: 1971

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
70934-109-10Cephalexin10 in 1 BOTTLE, PLASTICCAPSULE102
70934-109-28Cephalexin28 in 1 BOTTLE, PLASTICCAPSULE282

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
70934-109-10EA - Each70934-109e5350298-e921-44b6-9cbe-41d2305a6a3812018-09-05
70934-109-28EA - Each70934-109c91fa7d2-0519-4b2c-9bea-ffc3a82c878412018-09-05

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
70934-109CEPHALEXIN CAPSULE [DENTON PHARMA, INC. DBA NORTHWIND PHARMACEUTICALS]2Legacy NDC, 2 package rows20191225_6d6db2d0-8af2-bfc5-e053-2991aa0ada40.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
309114cephalexin 500 MG Oral CapsulePSN6d6db2d0-8af2-bfc5-e053-2991aa0ada402
309114cephalexin 500 MG Oral CapsuleSCD6d6db2d0-8af2-bfc5-e053-2991aa0ada402
309114cefalexin (as cefalexin monohydrate) 500 MG Oral CapsuleSY6d6db2d0-8af2-bfc5-e053-2991aa0ada402

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionStatus
70934-109-107093401091010 in 1 BOTTLE, PLASTICHistorical
70934-109-287093401092828 in 1 BOTTLE, PLASTICHistorical