Cephalexin

Product NDC
67046-1245
11-digit product format
670461245
Labeler code
67046
Product ID
67046-1245_508a337c-b7a1-b3c7-e063-6394a90a91ba
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Cephalexin
Dosage form
CAPSULE
Route
ORAL
Labeler
Coupler LLC
Application
ANDA065229
Marketing category
ANDA
Marketing start
2026-04-28
Substance
CEPHALEXIN
Active strength
500 mg/1
Pharmacologic classes
Cephalosporin Antibacterial [EPC], Cephalosporins [CS]
NDC exclude flag
No
Listing certified through
2027-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Cephalexin
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
CEPHALEXIN500 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiOBN7UDS42Y
Rxcui309114

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
67046-1245-3Cephalexin30 in 1 BLISTER PACKCAPSULE301

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
309114cephalexin 500 MG Oral CapsulePSN508a3401-df0b-0555-e063-6294a90a155a1
309114cephalexin 500 MG Oral CapsuleSCD508a3401-df0b-0555-e063-6294a90a155a1
309114cefalexin (as cefalexin monohydrate) 500 MG Oral CapsuleSY508a3401-df0b-0555-e063-6294a90a155a1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
67046-1245-36704612450330 CAPSULE in 1 BLISTER PACK (67046-1245-3) 30 capsule2026-04-28NoNoHistorical