FDA.reportPublic FDA data

Cephalexin

Product NDC
68071-4355
11-digit product format
680714355
Labeler code
68071
Product ID
68071-4355_1a55498c-d3ae-b7f7-e063-6394a90adb13
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Cephalexin
Dosage form
CAPSULE
Route
ORAL
Labeler
NuCare Pharmaceuticals,Inc.
Application
ANDA090836
Marketing category
ANDA
Marketing start
2011-01-19
Substance
CEPHALEXIN
Active strength
500 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
CEPHALEXIN500 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiOBN7UDS42Y
Rxcui309114

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
68071-4355-42021-02-16C16284748780-1ba0f9c33-431d-a910-e053-dadaa90a0b85These highlights do not include all the information needed to use CEPHALEXIN CAPSULES safely and effectively. See full prescribing information for CEPHALEXIN CAPSULES. CEPHALEXIN capsules, for oral use Initial U.S. Approval: 1971
68071-4355-42021-01-29C16284748780-1ba0f9c33-431d-a910-e053-dadaa90a0b85These highlights do not include all the information needed to use CEPHALEXIN CAPSULES safely and effectively. See full prescribing information for CEPHALEXIN CAPSULES. CEPHALEXIN capsules, for oral use Initial U.S. Approval: 1971

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
68071-4355-1Cephalexin21 in 1 BOTTLECAPSULE2110
68071-4355-3Cephalexin30 in 1 BOTTLECAPSULE3010
68071-4355-4Cephalexin14 in 1 BOTTLECAPSULE1410
68071-4355-7Cephalexin40 in 1 BOTTLECAPSULE4010
68071-4355-8Cephalexin28 in 1 BOTTLECAPSULE2810
68071-4355-9Cephalexin10 in 1 BOTTLECAPSULE1010

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
68071-4355-7EA - Each68071-4355fbeb737c-181b-4ead-a970-870d22983ef312021-04-08

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68071-4355CEPHALEXIN CAPSULE [NUCARE PHARMACEUTICALS,INC.]10Current NDC, Legacy NDC, 6 package rows20240608_681c235f-6dee-1401-e053-2991aa0addc0.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
309114cephalexin 500 MG Oral CapsulePSN681c235f-6dee-1401-e053-2991aa0addc010
309114cephalexin 500 MG Oral CapsuleSCD681c235f-6dee-1401-e053-2991aa0addc010
309114cefalexin (as cefalexin monohydrate) 500 MG Oral CapsuleSY681c235f-6dee-1401-e053-2991aa0addc010

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
68071-4355-16807143550121 CAPSULE in 1 BOTTLE (68071-4355-1) 21 capsule2018-03-230000-00-00NoNoCurrent
68071-4355-36807143550330 CAPSULE in 1 BOTTLE (68071-4355-3) 30 capsule2018-03-230000-00-00NoNoCurrent
68071-4355-46807143550414 CAPSULE in 1 BOTTLE (68071-4355-4) 14 capsule2018-03-230000-00-00NoNoCurrent
68071-4355-76807143550740 CAPSULE in 1 BOTTLE (68071-4355-7) 40 capsule2018-03-230000-00-00NoNoCurrent
68071-4355-86807143550828 CAPSULE in 1 BOTTLE (68071-4355-8) 28 capsule2018-03-230000-00-00NoNoCurrent
68071-4355-96807143550910 CAPSULE in 1 BOTTLE (68071-4355-9) 10 capsule2022-10-250000-00-00NoNoCurrent