Cephalexin

Product NDC
67877-892
11-digit product format
678770892
Labeler code
67877
Product ID
67877-892_779b70b9-d16c-4421-9e45-7800e947690d
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Cephalexin
Dosage form
TABLET
Route
ORAL
Labeler
Ascend Laboratories, LLC
Application
ANDA218947
Marketing category
ANDA
Marketing start
2024-10-21
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
Rxcui197454, 309115

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
67877-892-01Cephalexin100 in 1 BOTTLETABLET1003

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
67877-892-01EA - Each67877-892d95573b8-8bac-4d17-b030-7ef9c910dac512024-11-05

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
67877-892CEPHALEXIN TABLET [ASCEND LABORATORIES, LLC]3Current NDC, 1 package rows20241022_36882c6d-7b6f-41e3-8c54-e3b0073b8c07.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
309115cephalexin 250 MG Oral TabletPSN36882c6d-7b6f-41e3-8c54-e3b0073b8c073
197454cephalexin 500 MG Oral TabletPSN36882c6d-7b6f-41e3-8c54-e3b0073b8c073
309115cephalexin 250 MG Oral TabletSCD36882c6d-7b6f-41e3-8c54-e3b0073b8c073
197454cephalexin 500 MG Oral TabletSCD36882c6d-7b6f-41e3-8c54-e3b0073b8c073
309115cefalexin (as cefalexin monohydrate) 25 MG Oral TabletSY36882c6d-7b6f-41e3-8c54-e3b0073b8c073

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
67877-892-0167877089201100 TABLET in 1 BOTTLE (67877-892-01) 100 tablet2024-10-21NoNoCurrent