FDA.reportPublic FDA data

Cephalexin

Product NDC
21695-317
11-digit product format
216950317
Labeler code
21695
Product ID
21695-317_8bae9b61-3264-4cba-ad32-dfdec9259af3
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Cephalexin
Dosage form
CAPSULE
Route
ORAL
Labeler
Rebel Distributors Corp.
Application
ANDA065253
Marketing category
ANDA
Marketing start
2005-11-16
Marketing end
0000-00-00
Substance
CEPHALEXIN
Active strength
500 mg/1
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
21695-317-122019-09-24C16284748780-1934fe258-4734-48b1-e053-8cdaa90a720aCephalexin Capsules, USP
21695-317-142019-09-24C16284748780-1934fe258-4734-48b1-e053-8cdaa90a720aCephalexin Capsules, USP
21695-317-202019-09-24C16284748780-1934fe258-4734-48b1-e053-8cdaa90a720aCephalexin Capsules, USP
21695-317-282019-09-24C16284748780-1934fe258-4734-48b1-e053-8cdaa90a720aCephalexin Capsules, USP
21695-317-302019-09-24C16284748780-1934fe258-4734-48b1-e053-8cdaa90a720aCephalexin Capsules, USP
21695-317-402019-09-24C16284748780-1934fe258-4734-48b1-e053-8cdaa90a720aCephalexin Capsules, USP
21695-317-602019-09-24C16284748780-1934fe258-4734-48b1-e053-8cdaa90a720aCephalexin Capsules, USP

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
21695-317-12Cephalexin12 in 1 BOTTLECAPSULE121
21695-317-14Cephalexin14 in 1 BOTTLECAPSULE141
21695-317-20Cephalexin20 in 1 BOTTLECAPSULE201
21695-317-28Cephalexin28 in 1 BOTTLECAPSULE281
21695-317-30Cephalexin30 in 1 BOTTLECAPSULE301
21695-317-40Cephalexin40 in 1 BOTTLECAPSULE401
21695-317-60Cephalexin60 in 1 BOTTLECAPSULE601

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
21695-317CEPHALEXIN CAPSULE [REBEL DISTRIBUTORS CORP.]1Legacy NDC, 7 package rows20100202_12cdaf8c-06d1-45f2-b008-2ec33791bbe9.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
309112cephalexin 250 MG Oral CapsulePSN12cdaf8c-06d1-45f2-b008-2ec33791bbe91
309114cephalexin 500 MG Oral CapsulePSN12cdaf8c-06d1-45f2-b008-2ec33791bbe91
309112cephalexin 250 MG Oral CapsuleSCD12cdaf8c-06d1-45f2-b008-2ec33791bbe91
309114cephalexin 500 MG Oral CapsuleSCD12cdaf8c-06d1-45f2-b008-2ec33791bbe91
309114cefalexin (as cefalexin monohydrate) 500 MG Oral CapsuleSY12cdaf8c-06d1-45f2-b008-2ec33791bbe91
309112cephalexin (as cephalexin monohydrate) 250 MG Oral CapsuleSY12cdaf8c-06d1-45f2-b008-2ec33791bbe91

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionStatus
21695-317-122169503171212 in 1 BOTTLEHistorical
21695-317-142169503171414 in 1 BOTTLEHistorical
21695-317-202169503172020 in 1 BOTTLEHistorical
21695-317-282169503172828 in 1 BOTTLEHistorical
21695-317-302169503173030 in 1 BOTTLEHistorical
21695-317-402169503174040 in 1 BOTTLEHistorical
21695-317-602169503176060 in 1 BOTTLEHistorical