FDA.reportPublic FDA data

Cephalexin

Product NDC
67877-544
11-digit product format
678770544
Labeler code
67877
Product ID
67877-544_84f07b4a-a15e-41cb-af85-e110c5cf342e
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Cephalexin
Dosage form
FOR SUSPENSION
Route
ORAL
Labeler
Ascend Laboratories, LLC
Application
ANDA210221
Marketing category
ANDA
Marketing start
2019-03-28
Substance
CEPHALEXIN
Active strength
125 mg/5mL
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
CEPHALEXIN125 mg/5mL

Harmonized Identifiers#

Field, Values table
FieldValues
UniiOBN7UDS42Y
Rxcui309110, 309113

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
67877-544-68Cephalexin200 mL in 1 BOTTLEFOR SUSPENSION2007
67877-544-88Cephalexin100 mL in 1 BOTTLEFOR SUSPENSION1007

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
67877-544-68ML - Milliliter67877-544ea3c109f-4b5d-48c1-8062-66c6f0cdaac812019-06-19
67877-544-88ML - Milliliter67877-544a5ba1e94-590d-45d4-af90-039ac884fa8612019-06-19

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
67877-544CEPHALEXIN FOR SUSPENSION [ASCEND LABORATORIES, LLC]7Current NDC, Legacy NDC, 2 package rows20220708_bb28751c-bd1b-4e7f-8271-a14c1b4314e3.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
309110cephalexin 125 MG in 5 mL Oral SuspensionPSNa8f14231-5d43-46f7-ba1f-d6de8162d5e7113
309110cephalexin 25 MG/ML Oral SuspensionSCDa8f14231-5d43-46f7-ba1f-d6de8162d5e7113
309110cefalexin 25 MG/ML Oral SuspensionSYa8f14231-5d43-46f7-ba1f-d6de8162d5e7113
309110cephalexin 125 MG per 5 ML Oral SuspensionSYa8f14231-5d43-46f7-ba1f-d6de8162d5e7113
309110cephalexin 125 MG in 5 mL Oral SuspensionPSNf4ced8c7-a276-4a44-a60c-f8d1689a2bdf110
309110cephalexin 25 MG/ML Oral SuspensionSCDf4ced8c7-a276-4a44-a60c-f8d1689a2bdf110
309110cefalexin 25 MG/ML Oral SuspensionSYf4ced8c7-a276-4a44-a60c-f8d1689a2bdf110
309110cephalexin 125 MG per 5 ML Oral SuspensionSYf4ced8c7-a276-4a44-a60c-f8d1689a2bdf110
309110cephalexin 125 MG in 5 mL Oral SuspensionPSN92be9844-0775-4808-bdeb-dccb09647d91100
309110cephalexin 25 MG/ML Oral SuspensionSCD92be9844-0775-4808-bdeb-dccb09647d91100
309110cefalexin 25 MG/ML Oral SuspensionSY92be9844-0775-4808-bdeb-dccb09647d91100
309110cephalexin 125 MG per 5 ML Oral SuspensionSY92be9844-0775-4808-bdeb-dccb09647d91100
309110cephalexin 125 MG in 5 mL Oral SuspensionPSNfbf5fcdf-40fc-40e5-b784-308032fff0e57
309110cephalexin 125 MG in 5 mL Oral SuspensionPSNbb28751c-bd1b-4e7f-8271-a14c1b4314e37
309113cephalexin 250 MG in 5 mL Oral SuspensionPSNbb28751c-bd1b-4e7f-8271-a14c1b4314e37
309110cephalexin 25 MG/ML Oral SuspensionSCDfbf5fcdf-40fc-40e5-b784-308032fff0e57
309110cephalexin 25 MG/ML Oral SuspensionSCDbb28751c-bd1b-4e7f-8271-a14c1b4314e37
309113cephalexin 50 MG/ML Oral SuspensionSCDbb28751c-bd1b-4e7f-8271-a14c1b4314e37
309110cefalexin 25 MG/ML Oral SuspensionSYbb28751c-bd1b-4e7f-8271-a14c1b4314e37
309110cefalexin 25 MG/ML Oral SuspensionSYfbf5fcdf-40fc-40e5-b784-308032fff0e57
309113cefalexin 50 MG/ML Oral SuspensionSYbb28751c-bd1b-4e7f-8271-a14c1b4314e37
309110cephalexin 125 MG per 5 ML Oral SuspensionSYbb28751c-bd1b-4e7f-8271-a14c1b4314e37
309110cephalexin 125 MG per 5 ML Oral SuspensionSYfbf5fcdf-40fc-40e5-b784-308032fff0e57
309113cephalexin 250 MG per 5 ML Oral SuspensionSYbb28751c-bd1b-4e7f-8271-a14c1b4314e37
309110cephalexin 125 MG in 5 mL Oral SuspensionPSNada33464-b416-9ac6-e053-2a95a90af7873
309110cephalexin 25 MG/ML Oral SuspensionSCDada33464-b416-9ac6-e053-2a95a90af7873
309110cefalexin 25 MG/ML Oral SuspensionSYada33464-b416-9ac6-e053-2a95a90af7873
309110cephalexin 125 MG per 5 ML Oral SuspensionSYada33464-b416-9ac6-e053-2a95a90af7873

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
67877-544-6867877054468200 mL in 1 BOTTLE (67877-544-68) 200 ml2019-03-280000-00-00NoNoCurrent
67877-544-8867877054488100 mL in 1 BOTTLE (67877-544-88) 100 ml2019-03-280000-00-00NoNoCurrent