FDA.reportPublic FDA data

Cephalexin

Product NDC
50090-5196
11-digit product format
500905196
Labeler code
50090
Product ID
50090-5196_d53accce-79fa-48ff-ba91-88cbe796407d
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Cephalexin
Dosage form
FOR SUSPENSION
Route
ORAL
Labeler
A-S Medication Solutions
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
Rxcui309113

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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
50090-5196-02024-02-16C16284748780-1f386c649-d07b-0266-e053-dadaa90a7c1aThese highlights do not include all the information needed to use CEPHALEXIN FOR ORAL SUSPENSION safely and effectively. See full prescribing information for CEPHALEXIN FOR ORAL SUSPENSION CEPHALEXIN for oral suspension Initial U.S. Approval: 1971
50090-5196-02023-01-30C16284748780-1f386c649-d07b-0266-e053-dadaa90a7c1aThese highlights do not include all the information needed to use CEPHALEXIN FOR ORAL SUSPENSION safely and effectively. See full prescribing information for CEPHALEXIN FOR ORAL SUSPENSION CEPHALEXIN for oral suspension Initial U.S. Approval: 1971

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
50090-5196-0Cephalexin100 mL in 1 BOTTLEFOR SUSPENSION1003

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
50090-5196-0ML - Milliliter50090-519663498781-6132-4944-b987-b5c7fd0eb1e812021-04-08

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50090-5196CEPHALEXIN FOR SUSPENSION [A-S MEDICATION SOLUTIONS]3Current NDC, Legacy NDC, 1 package rows20240217_0edeb103-5e94-4f42-828f-c7336486c784.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
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

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
50090-5196-050090519600100 mL in 1 BOTTLE (50090-5196-0) 100 ml2020-09-300000-00-00NoNoCurrent