FDA.reportPublic FDA data

Cephalexin

Product NDC
80425-0005
11-digit product format
804250005
Labeler code
80425
Product ID
80425-0005_0f3ed48b-be43-1ecb-e063-6294a90a6eb0
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Cephalexin
Dosage form
CAPSULE
Route
ORAL
Labeler
ADVANCED RX PHARMACY OF TENNESSEE, LLC
Application
ANDA065229
Marketing category
ANDA
Marketing start
2006-01-11
Substance
CEPHALEXIN
Active strength
500 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
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
80425-0005-1Cephalexin28 in 1 BOTTLECAPSULE2812
80425-0005-2Cephalexin40 in 1 BOTTLECAPSULE4012
80425-0005-3Cephalexin6 in 1 BOTTLECAPSULE612

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
80425-0005-1EA - Each80425-00055d189a3a-c1ea-4245-9fec-cff214bed77212023-03-13
80425-0005-2EA - Each80425-0005001f864f-ac0b-45c7-a2a7-a1a3f313f11212023-03-13
80425-0005-3EA - Each80425-000565a1e74d-0909-429a-8f2d-3fb01a84f6f812024-06-10

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
80425-0005CEPHALEXIN CAPSULE [ADVANCED RX PHARMACY OF TENNESSEE, LLC]12Current NDC, Legacy NDC, 3 package rows20240119_af10128f-021a-14b7-e053-2a95a90a4365.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
309114cephalexin 500 MG Oral CapsulePSNaf10128f-021a-14b7-e053-2a95a90a436512
309114cephalexin 500 MG Oral CapsuleSCDaf10128f-021a-14b7-e053-2a95a90a436512
309114cefalexin (as cefalexin monohydrate) 500 MG Oral CapsuleSYaf10128f-021a-14b7-e053-2a95a90a436512

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
80425-0005-18042500050128 CAPSULE in 1 BOTTLE (80425-0005-1) 28 capsule2006-01-110000-00-00NoNoCurrent
80425-0005-28042500050240 CAPSULE in 1 BOTTLE (80425-0005-2) 40 capsule2006-01-110000-00-00NoNoCurrent
80425-0005-3804250005036 CAPSULE in 1 BOTTLE (80425-0005-3) 6 capsule2024-01-18NoNoHistorical