FDA.reportPublic FDA data

Cephalexin

Product NDC
67877-545
11-digit product format
678770545
Labeler code
67877
Product ID
67877-545_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
250 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
CEPHALEXIN250 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
c6f86816-7da6-43ea-8c25-ac9758311cc5Product name120220118
64bb7f1a-2c2e-4741-8301-dbfeda7239f6Product name120190628
252e11b6-1a9a-4283-a242-df2c129c496dProduct name320170717
398aa563-bb78-fe0f-46a8-757c40ef28bfProduct name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
67877-545-68Cephalexin200 mL in 1 BOTTLEFOR SUSPENSION2007
67877-545-88Cephalexin100 mL in 1 BOTTLEFOR SUSPENSION1007

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
67877-545-68ML - Milliliter67877-545359b41ac-c726-4030-824e-4ace50e8570d12019-06-19
67877-545-88ML - Milliliter67877-54586d98301-4141-47bf-af78-75da718f60c712019-06-19

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
67877-545CEPHALEXIN 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
309113cephalexin 250 MG in 5 mL Oral SuspensionPSN06c2fb2e-0539-4f16-bac4-e15a575ca802108
309113cephalexin 50 MG/ML Oral SuspensionSCD06c2fb2e-0539-4f16-bac4-e15a575ca802108
309113cefalexin 50 MG/ML Oral SuspensionSY06c2fb2e-0539-4f16-bac4-e15a575ca802108
309113cephalexin 250 MG per 5 ML Oral SuspensionSY06c2fb2e-0539-4f16-bac4-e15a575ca802108
309113cephalexin 250 MG in 5 mL Oral SuspensionPSNe186afb5-7531-45ea-b785-c230483a7747107
309113cephalexin 250 MG in 5 mL Oral SuspensionPSNdf6bb893-e3d7-4c8f-8cec-35b4d2fa33b3107
309113cephalexin 50 MG/ML Oral SuspensionSCDe186afb5-7531-45ea-b785-c230483a7747107
309113cephalexin 50 MG/ML Oral SuspensionSCDdf6bb893-e3d7-4c8f-8cec-35b4d2fa33b3107
309113cefalexin 50 MG/ML Oral SuspensionSYe186afb5-7531-45ea-b785-c230483a7747107
309113cefalexin 50 MG/ML Oral SuspensionSYdf6bb893-e3d7-4c8f-8cec-35b4d2fa33b3107
309113cephalexin 250 MG per 5 ML Oral SuspensionSYe186afb5-7531-45ea-b785-c230483a7747107
309113cephalexin 250 MG per 5 ML Oral SuspensionSYdf6bb893-e3d7-4c8f-8cec-35b4d2fa33b3107
309113cephalexin 250 MG in 5 mL Oral SuspensionPSN8d7f247a-3b42-4823-96fb-5f5c1bd94d49106
309113cephalexin 50 MG/ML Oral SuspensionSCD8d7f247a-3b42-4823-96fb-5f5c1bd94d49106
309113cefalexin 50 MG/ML Oral SuspensionSY8d7f247a-3b42-4823-96fb-5f5c1bd94d49106
309113cephalexin 250 MG per 5 ML Oral SuspensionSY8d7f247a-3b42-4823-96fb-5f5c1bd94d49106
309113cephalexin 250 MG in 5 mL Oral SuspensionPSNf1439d25-3d3d-4fe5-b6e7-d76e62892969103
309113cephalexin 50 MG/ML Oral SuspensionSCDf1439d25-3d3d-4fe5-b6e7-d76e62892969103
309113cefalexin 50 MG/ML Oral SuspensionSYf1439d25-3d3d-4fe5-b6e7-d76e62892969103
309113cephalexin 250 MG per 5 ML Oral SuspensionSYf1439d25-3d3d-4fe5-b6e7-d76e62892969103
309113cephalexin 250 MG in 5 mL Oral SuspensionPSN5f867aa3-ea64-4a14-a63b-979b8ff8d80c100
309113cephalexin 250 MG in 5 mL Oral SuspensionPSNc7028200-b141-496b-89e9-491558d4c879100
309113cephalexin 250 MG in 5 mL Oral SuspensionPSN1bfa8744-24ee-4c70-845c-c532b8084433100
309113cephalexin 50 MG/ML Oral SuspensionSCD5f867aa3-ea64-4a14-a63b-979b8ff8d80c100
309113cephalexin 50 MG/ML Oral SuspensionSCDc7028200-b141-496b-89e9-491558d4c879100
309113cephalexin 50 MG/ML Oral SuspensionSCD1bfa8744-24ee-4c70-845c-c532b8084433100
309113cefalexin 50 MG/ML Oral SuspensionSY1bfa8744-24ee-4c70-845c-c532b8084433100
309113cefalexin 50 MG/ML Oral SuspensionSYc7028200-b141-496b-89e9-491558d4c879100
309113cefalexin 50 MG/ML Oral SuspensionSY5f867aa3-ea64-4a14-a63b-979b8ff8d80c100
309113cephalexin 250 MG per 5 ML Oral SuspensionSY1bfa8744-24ee-4c70-845c-c532b8084433100
309113cephalexin 250 MG per 5 ML Oral SuspensionSYc7028200-b141-496b-89e9-491558d4c879100
309113cephalexin 250 MG per 5 ML Oral SuspensionSY5f867aa3-ea64-4a14-a63b-979b8ff8d80c100
309110cephalexin 125 MG in 5 mL Oral SuspensionPSNbb28751c-bd1b-4e7f-8271-a14c1b4314e37
309113cephalexin 250 MG in 5 mL Oral SuspensionPSN6c7bfa58-2d38-4607-8c33-485ba4931c687
309113cephalexin 250 MG in 5 mL Oral SuspensionPSNbb28751c-bd1b-4e7f-8271-a14c1b4314e37
309110cephalexin 25 MG/ML Oral SuspensionSCDbb28751c-bd1b-4e7f-8271-a14c1b4314e37
309113cephalexin 50 MG/ML Oral SuspensionSCD6c7bfa58-2d38-4607-8c33-485ba4931c687
309113cephalexin 50 MG/ML Oral SuspensionSCDbb28751c-bd1b-4e7f-8271-a14c1b4314e37
309110cefalexin 25 MG/ML Oral SuspensionSYbb28751c-bd1b-4e7f-8271-a14c1b4314e37
309113cefalexin 50 MG/ML Oral SuspensionSY6c7bfa58-2d38-4607-8c33-485ba4931c687
309113cefalexin 50 MG/ML Oral SuspensionSYbb28751c-bd1b-4e7f-8271-a14c1b4314e37
309110cephalexin 125 MG per 5 ML Oral SuspensionSYbb28751c-bd1b-4e7f-8271-a14c1b4314e37
309113cephalexin 250 MG per 5 ML Oral SuspensionSYbb28751c-bd1b-4e7f-8271-a14c1b4314e37
309113cephalexin 250 MG per 5 ML Oral SuspensionSY6c7bfa58-2d38-4607-8c33-485ba4931c687
309113cephalexin 250 MG in 5 mL Oral SuspensionPSN28fec572-e3b9-448c-8626-5c0920f38eeb5
309113cephalexin 50 MG/ML Oral SuspensionSCD28fec572-e3b9-448c-8626-5c0920f38eeb5
309113cefalexin 50 MG/ML Oral SuspensionSY28fec572-e3b9-448c-8626-5c0920f38eeb5
309113cephalexin 250 MG per 5 ML Oral SuspensionSY28fec572-e3b9-448c-8626-5c0920f38eeb5
309113cephalexin 250 MG in 5 mL Oral SuspensionPSN90a76d24-e5a9-9000-e053-2a95a90ae8af4
309113cephalexin 50 MG/ML Oral SuspensionSCD90a76d24-e5a9-9000-e053-2a95a90ae8af4
309113cefalexin 50 MG/ML Oral SuspensionSY90a76d24-e5a9-9000-e053-2a95a90ae8af4
309113cephalexin 250 MG per 5 ML Oral SuspensionSY90a76d24-e5a9-9000-e053-2a95a90ae8af4
309113cephalexin 250 MG in 5 mL Oral SuspensionPSN0edeb103-5e94-4f42-828f-c7336486c7843
309113cephalexin 50 MG/ML Oral SuspensionSCD0edeb103-5e94-4f42-828f-c7336486c7843
309113cefalexin 50 MG/ML Oral SuspensionSY0edeb103-5e94-4f42-828f-c7336486c7843
309113cephalexin 250 MG per 5 ML Oral SuspensionSY0edeb103-5e94-4f42-828f-c7336486c7843
309113cephalexin 250 MG in 5 mL Oral SuspensionPSNee278959-d321-d356-e053-2995a90a32c22
309113cephalexin 50 MG/ML Oral SuspensionSCDee278959-d321-d356-e053-2995a90a32c22
309113cefalexin 50 MG/ML Oral SuspensionSYee278959-d321-d356-e053-2995a90a32c22
309113cephalexin 250 MG per 5 ML Oral SuspensionSYee278959-d321-d356-e053-2995a90a32c22
309113cephalexin 250 MG in 5 mL Oral SuspensionPSN9fc5cfb0-7ba0-4669-b79c-270b6a9ff5731
309113cephalexin 50 MG/ML Oral SuspensionSCD9fc5cfb0-7ba0-4669-b79c-270b6a9ff5731
309113cefalexin 50 MG/ML Oral SuspensionSY9fc5cfb0-7ba0-4669-b79c-270b6a9ff5731
309113cephalexin 250 MG per 5 ML Oral SuspensionSY9fc5cfb0-7ba0-4669-b79c-270b6a9ff5731

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
67877-545-6867877054568200 mL in 1 BOTTLE (67877-545-68) 200 ml2019-03-280000-00-00NoNoCurrent
67877-545-8867877054588100 mL in 1 BOTTLE (67877-545-88) 100 ml2019-03-280000-00-00NoNoCurrent