Cephalexin

Product NDC
67046-1533
11-digit product format
670461533
Labeler code
67046
Product ID
67046-1533_30b709d6-c43d-c721-e063-6294a90abd61
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Cephalexin
Dosage form
CAPSULE
Route
ORAL
Labeler
Coupler, LLC
Application
ANDA065253
Marketing category
ANDA
Marketing start
2025-03-19
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

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
67046-1533-3Cephalexin30 in 1 BLISTER PACKCAPSULE301

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
67046-1533CEPHALEXIN CAPSULE [COUPLER, LLC]1Current NDC, 1 package rows20250322_30b7071e-cef1-bd41-e063-6394a90ad48e.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
309112cephalexin 250 MG Oral CapsulePSN30b7071e-cef1-bd41-e063-6394a90ad48e1
309112cephalexin 250 MG Oral CapsuleSCD30b7071e-cef1-bd41-e063-6394a90ad48e1
309112cephalexin (as cephalexin monohydrate) 250 MG Oral CapsuleSY30b7071e-cef1-bd41-e063-6394a90ad48e1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
67046-1533-36704615330330 CAPSULE in 1 BLISTER PACK (67046-1533-3) 30 capsule2025-03-19NoNoHistorical