FDA.reportPublic FDA data

Cephalexin

Product NDC
68071-2889
11-digit product format
680712889
Labeler code
68071
Product ID
68071-2889_49a29add-94bf-b6b9-e063-6394a90aadc0
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Cephalexin
Dosage form
FOR SUSPENSION
Route
ORAL
Labeler
NuCare Pharmaceuticals,Inc.
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
2027-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Cephalexin
Listing expiration
2027-12-31

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
64bb7f1a-2c2e-4741-8301-dbfeda7239f6Product name120190628
398aa563-bb78-fe0f-46a8-757c40ef28bfProduct name120140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
68071-2889-22025-01-30C16284748780-12cef2736-764b-d83d-e063-dadaa90ab31fThese 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
68071-2889-2Cephalexin200 mL in 1 BOTTLEFOR SUSPENSION2002

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68071-2889CEPHALEXIN FOR SUSPENSION [NUCARE PHARMACEUTICALS,INC.]1Current NDC, Legacy NDC, 1 package rows20221124_ee278959-d321-d356-e053-2995a90a32c2.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
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

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
68071-2889-268071288902200 mL in 1 BOTTLE (68071-2889-2) 200 ml2022-11-230000-00-00NoNoCurrent