FDA.reportPublic FDA data

Cephalexin

Product NDC
82868-057
11-digit product format
828680057
Labeler code
82868
Product ID
82868-057_47f921ac-95c2-eee7-e063-6394a90a02a3
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Cephalexin
Dosage form
CAPSULE
Route
ORAL
Labeler
Northwind Health Company, LLC
Application
ANDA065253
Marketing category
ANDA
Marketing start
2024-06-11
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
82868-057-10Cephalexin10 in 1 BOTTLE, PLASTICCAPSULE104
82868-057-14Cephalexin14 in 1 BOTTLE, PLASTICCAPSULE144
82868-057-20Cephalexin20 in 1 BOTTLE, PLASTICCAPSULE204
82868-057-21Cephalexin21 in 1 BOTTLE, PLASTICCAPSULE214
82868-057-28Cephalexin28 in 1 BOTTLE, PLASTICCAPSULE284
82868-057-30Cephalexin30 in 1 BOTTLE, PLASTICCAPSULE304
82868-057-40Cephalexin40 in 1 BOTTLE, PLASTICCAPSULE404

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
82868-057CEPHALEXIN CAPSULE [NORTHWIND PHARMACEUTICALS, LLC]2Current NDC, 7 package rows20241116_1d0d50ba-8c2c-855c-e063-6394a90a5c7d.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
309114cephalexin 500 MG Oral CapsulePSN1d0d50ba-8c2c-855c-e063-6394a90a5c7d4
309114cephalexin 500 MG Oral CapsuleSCD1d0d50ba-8c2c-855c-e063-6394a90a5c7d4
309114cefalexin (as cefalexin monohydrate) 500 MG Oral CapsuleSY1d0d50ba-8c2c-855c-e063-6394a90a5c7d4

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
82868-057-108286800571010 CAPSULE in 1 BOTTLE, PLASTIC (82868-057-10) 10 capsule2024-06-11NoNoHistorical
82868-057-148286800571414 CAPSULE in 1 BOTTLE, PLASTIC (82868-057-14) 14 capsule2024-06-11NoNoHistorical
82868-057-208286800572020 CAPSULE in 1 BOTTLE, PLASTIC (82868-057-20) 20 capsule2024-07-17NoNoHistorical
82868-057-218286800572121 CAPSULE in 1 BOTTLE, PLASTIC (82868-057-21) 21 capsule2024-11-27NoNoHistorical
82868-057-288286800572828 CAPSULE in 1 BOTTLE, PLASTIC (82868-057-28) 28 capsule2025-07-16NoNoHistorical
82868-057-308286800573030 CAPSULE in 1 BOTTLE, PLASTIC (82868-057-30) 30 capsule2024-10-07NoNoHistorical
82868-057-408286800574040 CAPSULE in 1 BOTTLE, PLASTIC (82868-057-40) 40 capsule2025-02-04NoNoHistorical