FDA.reportPublic FDA data

Cephalexin

Product NDC
68071-4516
11-digit product format
680714516
Labeler code
68071
Product ID
68071-4516_1a907bf9-f5a7-c98f-e063-6394a90a81b2
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Cephalexin
Dosage form
CAPSULE
Route
ORAL
Labeler
NuCare Pharmaceuticals,Inc.
Application
ANDA065229
Marketing category
ANDA
Marketing start
2006-01-11
Substance
CEPHALEXIN
Active strength
250 mg/1
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/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiOBN7UDS42Y
Rxcui309112

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
68071-4516-82022-02-07C16284748780-1d6a99b39-bb22-a426-e053-dadaa90af4c2HIGHLIGHTS OF PRESCRIBING INFORMATION These highlights do not include all the information needed to use CEPHALEXIN CAPSULES USP safely and effectively. See full prescribing information for CEPHALEXIN CAPSULES USP CEPHALEXIN capsules USP, for oral use Initial U.S. Approval: 1971
68071-4516-82022-01-28C16284748780-1d6a99b39-bb22-a426-e053-dadaa90af4c2HIGHLIGHTS OF PRESCRIBING INFORMATION These highlights do not include all the information needed to use CEPHALEXIN CAPSULES USP safely and effectively. See full prescribing information for CEPHALEXIN CAPSULES USP CEPHALEXIN capsules USP, for oral use Initial U.S. Approval: 1971

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
68071-4516-8Cephalexin28 in 1 BOTTLECAPSULE284

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68071-4516CEPHALEXIN CAPSULE [NUCARE PHARMACEUTICALS,INC.]4Current NDC, Legacy NDC, 1 package rows20240612_728c5212-dbd8-8df5-e053-2a91aa0a9579.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
309112cephalexin 250 MG Oral CapsulePSN728c5212-dbd8-8df5-e053-2a91aa0a95794
309112cephalexin 250 MG Oral CapsuleSCD728c5212-dbd8-8df5-e053-2a91aa0a95794
309112cephalexin (as cephalexin monohydrate) 250 MG Oral CapsuleSY728c5212-dbd8-8df5-e053-2a91aa0a95794

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
68071-4516-86807145160828 CAPSULE in 1 BOTTLE (68071-4516-8) 28 capsule2018-08-030000-00-00NoNoCurrent