FDA.reportPublic FDA data

Cephalexin

Product NDC
85766-004
11-digit product format
857660004
Labeler code
85766
Product ID
85766-004_49ee7977-7bf4-f52f-e063-6294a90a579d
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Cephalexin
Dosage form
CAPSULE
Route
ORAL
Labeler
Sportpharm LLC
Application
ANDA065229
Marketing category
ANDA
Marketing start
2021-07-21
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
85766-004-14Cephalexin14 in 1 BOTTLE, PLASTICCAPSULE143
85766-004-20Cephalexin20 in 1 BOTTLE, PLASTICCAPSULE203
85766-004-21Cephalexin21 in 1 BOTTLE, PLASTICCAPSULE213
85766-004-28Cephalexin28 in 1 BOTTLE, PLASTICCAPSULE283
85766-004-30Cephalexin30 in 1 BOTTLE, PLASTICCAPSULE303

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
309114cephalexin 500 MG Oral CapsulePSN3d5a2665-65da-4b10-9e23-39fc88145da13
309114cephalexin 500 MG Oral CapsuleSCD3d5a2665-65da-4b10-9e23-39fc88145da13
309114cefalexin (as cefalexin monohydrate) 500 MG Oral CapsuleSY3d5a2665-65da-4b10-9e23-39fc88145da13

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
85766-004-148576600041414 CAPSULE in 1 BOTTLE, PLASTIC (85766-004-14) 14 capsule2025-06-18NoNoCurrent
85766-004-208576600042020 CAPSULE in 1 BOTTLE, PLASTIC (85766-004-20) 20 capsule2025-06-18NoNoCurrent
85766-004-218576600042121 CAPSULE in 1 BOTTLE, PLASTIC (85766-004-21) 21 capsule2025-06-18NoNoCurrent
85766-004-288576600042828 CAPSULE in 1 BOTTLE, PLASTIC (85766-004-28) 28 capsule2025-06-18NoNoCurrent
85766-004-308576600043030 CAPSULE in 1 BOTTLE, PLASTIC (85766-004-30) 30 capsule2025-06-18NoNoCurrent