FDA.reportPublic FDA data

Cephalexin

Product NDC
68071-5241
11-digit product format
680715241
Labeler code
68071
Product ID
68071-5241_1d78c026-b1a3-0461-e063-6294a90ab4e5
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
68071-5241-42022-02-07C16284748780-1d6a99b39-6ead-a426-e053-dadaa90af4c2These 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
68071-5241-42022-01-28C16284748780-1d6a99b39-6ead-a426-e053-dadaa90af4c2These 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
68071-5241-4Cephalexin4 in 1 BOTTLECAPSULE43

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68071-5241CEPHALEXIN CAPSULE [NUCARE PHARMACEUTICALS,INC.]3Current NDC, Legacy NDC, 1 package rows20240719_a33280d4-7caf-f74b-e053-2a95a90a90c3.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
309112cephalexin 250 MG Oral CapsulePSNa33280d4-7caf-f74b-e053-2a95a90a90c33
309112cephalexin 250 MG Oral CapsuleSCDa33280d4-7caf-f74b-e053-2a95a90a90c33
309112cephalexin (as cephalexin monohydrate) 250 MG Oral CapsuleSYa33280d4-7caf-f74b-e053-2a95a90a90c33

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
68071-5241-4680715241044 CAPSULE in 1 BOTTLE (68071-5241-4) 4 capsule2020-04-130000-00-00NoNoCurrent