FDA.reportPublic FDA data

Cephalexin

Product NDC
68071-5038
11-digit product format
680715038
Labeler code
68071
Product ID
68071-5038_1b410dbc-8ddc-344b-e063-6294a90a840b
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
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
64bb7f1a-2c2e-4741-8301-dbfeda7239f6Product name120190628
398aa563-bb78-fe0f-46a8-757c40ef28bfProduct name120140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
68071-5038-02021-02-19C16284748780-1ba0f9c33-3306-a910-e053-dadaa90a0b85These 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
68071-5038-02021-01-29C16284748780-1ba0f9c33-3306-a910-e053-dadaa90a0b85These 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
68071-5038-0Cephalexin100 mL in 1 BOTTLEFOR SUSPENSION1004

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68071-5038CEPHALEXIN FOR SUSPENSION [NUCARE PHARMACEUTICALS,INC.]4Current NDC, Legacy NDC, 1 package rows20240620_90a76d24-e5a9-9000-e053-2a95a90ae8af.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
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

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
68071-5038-068071503800100 mL in 1 BOTTLE (68071-5038-0) 100 ml2019-08-210000-00-00NoNoCurrent