FDA.reportPublic FDA data

Cephalexin

Product NDC
67296-0037
11-digit product format
672960037
Labeler code
67296
Product ID
67296-0037_b8d03810-88bd-d272-e053-2a95a90aa617
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Cephalexin
Dosage form
CAPSULE
Route
ORAL
Labeler
RedPharm Drug, Inc.
Application
ANDA062702
Marketing category
ANDA
Marketing start
1990-09-30
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
2022-12-31
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
67296-0037-12024-07-10C16284748780-1f386c64a-22c1-0266-e053-dadaa90a7c1aCephalexin 500mg
67296-0037-22024-07-10C16284748780-1f386c64a-22c1-0266-e053-dadaa90a7c1aCephalexin 500mg
67296-0037-32024-07-10C16284748780-1f386c64a-22c1-0266-e053-dadaa90a7c1aCephalexin 500mg
67296-0037-42024-07-10C16284748780-1f386c64a-22c1-0266-e053-dadaa90a7c1aCephalexin 500mg
67296-0037-72024-07-10C16284748780-1f386c64a-22c1-0266-e053-dadaa90a7c1aCephalexin 500mg
67296-0037-12023-01-30C16284748780-1f386c64a-22c1-0266-e053-dadaa90a7c1aCephalexin 500mg
67296-0037-22023-01-30C16284748780-1f386c64a-22c1-0266-e053-dadaa90a7c1aCephalexin 500mg
67296-0037-32023-01-30C16284748780-1f386c64a-22c1-0266-e053-dadaa90a7c1aCephalexin 500mg
67296-0037-42023-01-30C16284748780-1f386c64a-22c1-0266-e053-dadaa90a7c1aCephalexin 500mg
67296-0037-72023-01-30C16284748780-1f386c64a-22c1-0266-e053-dadaa90a7c1aCephalexin 500mg

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
67296-0037-1Cephalexin20 in 1 BOTTLECAPSULE2010
67296-0037-2Cephalexin30 in 1 BOTTLECAPSULE3010
67296-0037-3Cephalexin40 in 1 BOTTLECAPSULE4010
67296-0037-4Cephalexin14 in 1 BOTTLECAPSULE1410
67296-0037-7Cephalexin28 in 1 BOTTLECAPSULE2810
67296-0037-5Cephalexin21 in 1 BOTTLECAPSULE212

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
67296-0037CEPHALEXIN CAPSULE [REDPHARM DRUG, INC.]10Legacy NDC, 5 package rows20240711_925f69c9-5d03-b73e-e053-2995a90a417f.zip
67296-0037CEPHALEXIN CAPSULE [REDPHARM DRUG INC.]2Legacy NDC, 1 package rows20240711_f4c288b6-237f-6d10-e053-2995a90a78f0.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
309114cephalexin 500 MG Oral CapsulePSN925f69c9-5d03-b73e-e053-2995a90a417f10
309114cephalexin 500 MG Oral CapsuleSCD925f69c9-5d03-b73e-e053-2995a90a417f10
309114cefalexin (as cefalexin monohydrate) 500 MG Oral CapsuleSY925f69c9-5d03-b73e-e053-2995a90a417f10
309114cephalexin 500 MG Oral CapsulePSNf4c288b6-237f-6d10-e053-2995a90a78f02
309114cephalexin 500 MG Oral CapsuleSCDf4c288b6-237f-6d10-e053-2995a90a78f02
309114cefalexin (as cefalexin monohydrate) 500 MG Oral CapsuleSYf4c288b6-237f-6d10-e053-2995a90a78f02

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
67296-0037-16729600370120 CAPSULE in 1 BOTTLE (67296-0037-1) 20 capsule2019-01-010000-00-00NoNoCurrent
67296-0037-26729600370230 CAPSULE in 1 BOTTLE (67296-0037-2) 30 capsule2019-01-010000-00-00NoNoCurrent
67296-0037-36729600370340 CAPSULE in 1 BOTTLE (67296-0037-3) 40 capsule2019-01-010000-00-00NoNoCurrent
67296-0037-46729600370414 CAPSULE in 1 BOTTLE (67296-0037-4) 14 capsule2019-01-010000-00-00NoNoCurrent
67296-0037-56729600370521 in 1 BOTTLEHistorical
67296-0037-76729600370728 CAPSULE in 1 BOTTLE (67296-0037-7) 28 capsule2019-01-010000-00-00NoNoCurrent