Cephalexin

Product NDC
69778-931
11-digit product format
697780931
Labeler code
69778
Product ID
69778-931_5f2379e6-9041-4de6-83a2-f63fa36db0d9
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Cephalexin
Dosage form
CAPSULE
Route
ORAL
Labeler
Pharma-C, Inc.
Application
ANDA065152
Marketing category
ANDA
Marketing start
2010-10-15
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
Rxcui309112, 309114

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
69778-931-04Cephalexin500 in 1 BOTTLE, PLASTICCAPSULE5002

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
69778-931CEPHALEXIN CAPSULE [PHARMA-C, INC.]2Current NDC, Legacy NDC, 1 package rows20161209_bf9a6c06-11fd-4fb7-9cf5-e8e787758c1c.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
309112cephalexin 250 MG Oral CapsulePSNbf9a6c06-11fd-4fb7-9cf5-e8e787758c1c2
309114cephalexin 500 MG Oral CapsulePSNbf9a6c06-11fd-4fb7-9cf5-e8e787758c1c2
309112cephalexin 250 MG Oral CapsuleSCDbf9a6c06-11fd-4fb7-9cf5-e8e787758c1c2
309114cephalexin 500 MG Oral CapsuleSCDbf9a6c06-11fd-4fb7-9cf5-e8e787758c1c2
309114cefalexin (as cefalexin monohydrate) 500 MG Oral CapsuleSYbf9a6c06-11fd-4fb7-9cf5-e8e787758c1c2
309112cephalexin (as cephalexin monohydrate) 250 MG Oral CapsuleSYbf9a6c06-11fd-4fb7-9cf5-e8e787758c1c2

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
69778-931-0469778093104500 CAPSULE in 1 BOTTLE, PLASTIC (69778-931-04) 500 capsule2016-10-110000-00-00NoNoCurrent