Cephalexin

Product NDC
42582-212
11-digit product format
425820212
Labeler code
42582
Product ID
42582-212_919700e3-a422-479c-b37a-9242275a31ac
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Cephalexin
Dosage form
CAPSULE
Route
ORAL
Labeler
Bi-Coastal Pharma International LLC
Application
ANDA062713
Marketing category
ANDA
Marketing start
2016-02-01
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
2023-12-31
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#

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
42582-212-10Cephalexin100 in 1 BOTTLECAPSULE1003
42582-212-18Cephalexin500 in 1 BOTTLECAPSULE5003

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
42582-212-10EA - Each42582-21216847488-57d6-45fd-8fa7-9b6d0676efa212016-11-08
42582-212-18EA - Each42582-21238315b90-86f9-4789-8c74-6acf081301d612016-11-08

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
42582-212CEPHALEXIN CAPSULE [BI-COASTAL PHARMA INTERNATIONAL LLC]3Legacy NDC, 2 package rows20220118_7b52fd9a-3cb6-4f0e-9e45-17a1eaec926d.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
309112cephalexin 250 MG Oral CapsulePSN7b52fd9a-3cb6-4f0e-9e45-17a1eaec926d3
309114cephalexin 500 MG Oral CapsulePSN7b52fd9a-3cb6-4f0e-9e45-17a1eaec926d3
309112cephalexin 250 MG Oral CapsuleSCD7b52fd9a-3cb6-4f0e-9e45-17a1eaec926d3
309114cephalexin 500 MG Oral CapsuleSCD7b52fd9a-3cb6-4f0e-9e45-17a1eaec926d3
309114cefalexin (as cefalexin monohydrate) 500 MG Oral CapsuleSY7b52fd9a-3cb6-4f0e-9e45-17a1eaec926d3
309112cephalexin (as cephalexin monohydrate) 250 MG Oral CapsuleSY7b52fd9a-3cb6-4f0e-9e45-17a1eaec926d3

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
42582-212-1042582021210100 CAPSULE in 1 BOTTLE (42582-212-10) 100 capsule2016-02-010000-00-00NoNoCurrent
42582-212-1842582021218500 CAPSULE in 1 BOTTLE (42582-212-18) 500 capsule2016-02-010000-00-00NoNoCurrent