Cephalexin

Product NDC
69043-008
11-digit product format
690430008
Labeler code
69043
Product ID
69043-008_c71c6d65-8fdd-496e-9338-c70276699886
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Cephalexin
Dosage form
CAPSULE
Route
ORAL
Labeler
Cronus Pharma LLC
Application
ANDA065253
Marketing category
ANDA
Marketing start
2005-11-16
Substance
CEPHALEXIN
Active strength
250 mg/1
Pharmacologic classes
Cephalosporin Antibacterial [EPC], Cephalosporins [CS]
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Cephalexin
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
CEPHALEXIN250 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiOBN7UDS42Y
Rxcui309112, 309114

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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
69043-008-01Cephalexin100 in 1 BOTTLECAPSULE1004
69043-008-05Cephalexin500 in 1 BOTTLECAPSULE5004

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
69043-008CEPHALEXIN CAPSULE [CRONUS PHARMA LLC]4Current NDC, Legacy NDC, 2 package rows20250117_a4e861e2-5803-4c4a-a962-92f5755e1ab5.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
309112cephalexin 250 MG Oral CapsulePSNa4e861e2-5803-4c4a-a962-92f5755e1ab54
309114cephalexin 500 MG Oral CapsulePSNa4e861e2-5803-4c4a-a962-92f5755e1ab54
309112cephalexin 250 MG Oral CapsuleSCDa4e861e2-5803-4c4a-a962-92f5755e1ab54
309114cephalexin 500 MG Oral CapsuleSCDa4e861e2-5803-4c4a-a962-92f5755e1ab54
309114cefalexin (as cefalexin monohydrate) 500 MG Oral CapsuleSYa4e861e2-5803-4c4a-a962-92f5755e1ab54
309112cephalexin (as cephalexin monohydrate) 250 MG Oral CapsuleSYa4e861e2-5803-4c4a-a962-92f5755e1ab54

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
69043-008-0169043000801100 CAPSULE in 1 BOTTLE (69043-008-01) 100 capsule2005-11-160000-00-00NoNoCurrent
69043-008-0569043000805500 CAPSULE in 1 BOTTLE (69043-008-05) 500 capsule2005-11-160000-00-00NoNoCurrent