FDA.reportPublic FDA data

Cephalexin

Product NDC
82804-106
11-digit product format
828040106
Labeler code
82804
Product ID
82804-106_88347743-e869-4266-835f-599e7c957d00
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Cephalexin
Dosage form
CAPSULE
Route
ORAL
Labeler
Proficient Rx LP
Application
ANDA065253
Marketing category
ANDA
Marketing start
2005-11-16
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
82804-106-14Cephalexin14 in 1 BOTTLECAPSULE144
82804-106-15Cephalexin15 in 1 BOTTLECAPSULE154
82804-106-20Cephalexin20 in 1 BOTTLECAPSULE204
82804-106-28Cephalexin28 in 1 BOTTLECAPSULE284
82804-106-30Cephalexin30 in 1 BOTTLECAPSULE304
82804-106-40Cephalexin40 in 1 BOTTLECAPSULE404

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
82804-106-14EA - Each82804-106da64cf11-dffd-43bf-8c94-d719b219042e12024-08-12
82804-106-15EA - Each82804-106dbe26bca-fa79-4e0d-910b-087550602cae12024-08-12
82804-106-20EA - Each82804-106bc6cb677-b6cb-46b2-949d-2f149b3098a212024-10-04
82804-106-28EA - Each82804-10616be4c6e-910b-4813-b7db-08a1a4bb72c412024-08-12
82804-106-30EA - Each82804-1066c33ca3e-6f44-4b77-9193-0ca75c04f51b12024-08-12
82804-106-40EA - Each82804-1061c573c6c-80b3-4b01-9d06-707265b0fffc12024-08-12

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
82804-106CEPHALEXIN CAPSULE [PROFICIENT RX LP]4Current NDC, 6 package rows20240731_e43271ef-c145-4145-b7f0-a02c237de2b5.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
309114cephalexin 500 MG Oral CapsulePSNe43271ef-c145-4145-b7f0-a02c237de2b54
309114cephalexin 500 MG Oral CapsuleSCDe43271ef-c145-4145-b7f0-a02c237de2b54
309114cefalexin (as cefalexin monohydrate) 500 MG Oral CapsuleSYe43271ef-c145-4145-b7f0-a02c237de2b54

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
82804-106-148280401061414 CAPSULE in 1 BOTTLE (82804-106-14) 14 capsule2024-07-01NoNoCurrent
82804-106-158280401061515 CAPSULE in 1 BOTTLE (82804-106-15) 15 capsule2024-07-25NoNoCurrent
82804-106-208280401062020 CAPSULE in 1 BOTTLE (82804-106-20) 20 capsule2024-07-25NoNoCurrent
82804-106-288280401062828 CAPSULE in 1 BOTTLE (82804-106-28) 28 capsule2024-05-16NoNoCurrent
82804-106-308280401063030 CAPSULE in 1 BOTTLE (82804-106-30) 30 capsule2024-06-27NoNoCurrent
82804-106-408280401064040 CAPSULE in 1 BOTTLE (82804-106-40) 40 capsule2024-05-16NoNoCurrent