FDA.reportPublic FDA data

Cephalexin

Product NDC
80425-0004
11-digit product format
804250004
Labeler code
80425
Product ID
80425-0004_137a5de3-ab83-e2ab-e063-6294a90a6209
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Cephalexin
Dosage form
CAPSULE
Route
ORAL
Labeler
ADVANCED RX PHARMACY OF TENNESSEE, LLC
Application
ANDA065253
Marketing category
ANDA
Marketing start
2022-09-14
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
80425-0004-1Cephalexin28 in 1 BOTTLECAPSULE285
80425-0004-2Cephalexin40 in 1 BOTTLECAPSULE405
80425-0004-3Cephalexin6 in 1 BOTTLECAPSULE65
80425-0004-4Cephalexin5 in 1 BOTTLECAPSULE55
80425-0004-5Cephalexin14 in 1 BOTTLECAPSULE145
80425-0004-6Cephalexin20 in 1 BOTTLECAPSULE205
80425-0004-7Cephalexin30 in 1 BOTTLECAPSULE305

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
80425-0004-1EA - Each80425-0004568b0d95-e053-4078-9588-aae633aac1c812023-03-13
80425-0004-2EA - Each80425-000408cd35d1-2cad-40a7-91fb-fdb8337d9e6512023-03-13
80425-0004-3EA - Each80425-0004fbaf8b0f-38f5-4531-9f5b-26ccf9d8e76612024-06-10
80425-0004-4EA - Each80425-000449b4d903-13ce-40d3-89cf-31cd97d711e712024-04-05
80425-0004-5EA - Each80425-00041020912e-44d0-4ba7-bbbc-b3ce215a774812024-04-05
80425-0004-6EA - Each80425-000488fa8483-8c3b-4c86-bbfe-68a6da75564f12024-04-05
80425-0004-7EA - Each80425-00049246bd25-019c-471d-a5b0-e435a401b8e412024-04-05

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
80425-0004CEPHALEXIN CAPSULE [ADVANCED RX PHARMACY OF TENNESSEE, LLC]5Current NDC, Legacy NDC, 7 package rows20240314_af49507d-254f-296d-e053-2a95a90ad263.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
309114cephalexin 500 MG Oral CapsulePSNaf49507d-254f-296d-e053-2a95a90ad2635
309114cephalexin 500 MG Oral CapsuleSCDaf49507d-254f-296d-e053-2a95a90ad2635
309114cefalexin (as cefalexin monohydrate) 500 MG Oral CapsuleSYaf49507d-254f-296d-e053-2a95a90ad2635

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
80425-0004-18042500040128 CAPSULE in 1 BOTTLE (80425-0004-1) 28 capsule2022-09-140000-00-00NoNoCurrent
80425-0004-28042500040240 CAPSULE in 1 BOTTLE (80425-0004-2) 40 capsule2022-09-140000-00-00NoNoCurrent
80425-0004-3804250004036 CAPSULE in 1 BOTTLE (80425-0004-3) 6 capsule2024-01-18NoNoHistorical
80425-0004-4804250004045 CAPSULE in 1 BOTTLE (80425-0004-4) 5 capsule2024-01-18NoNoHistorical
80425-0004-58042500040514 CAPSULE in 1 BOTTLE (80425-0004-5) 14 capsule2024-01-18NoNoHistorical
80425-0004-68042500040620 CAPSULE in 1 BOTTLE (80425-0004-6) 20 capsule2024-01-18NoNoHistorical
80425-0004-78042500040730 CAPSULE in 1 BOTTLE (80425-0004-7) 30 capsule2024-01-18NoNoHistorical