FDA.reportPublic FDA data

Cephalexin

Product NDC
68071-2249
11-digit product format
680712249
Labeler code
68071
Product ID
68071-2249_1d76830d-a699-9442-e063-6294a90a51b8
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Cephalexin
Dosage form
CAPSULE
Route
ORAL
Labeler
NuCare Pharmaceuticals,Inc.
Application
ANDA062702
Marketing category
ANDA
Marketing start
1990-09-30
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
68071-2249-32022-02-07C16284748780-1d6a99b39-ae97-a426-e053-dadaa90af4c2These highlights do not include all the information needed to use CEPHALEXIN safely and effectively. See full prescribing information for CEPHALEXIN. CEPHALEXIN capsules, CEPHALEXIN for oral suspension, and CEPHALEXIN tablets, for oral use Initial U.S. Approval: 1971
68071-2249-32022-01-28C16284748780-1d6a99b39-ae97-a426-e053-dadaa90af4c2These highlights do not include all the information needed to use CEPHALEXIN safely and effectively. See full prescribing information for CEPHALEXIN. CEPHALEXIN capsules, CEPHALEXIN for oral suspension, and CEPHALEXIN tablets, for oral use Initial U.S. Approval: 1971

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
68071-2249-3Cephalexin30 in 1 BOTTLECAPSULE304
68071-2249-4Cephalexin14 in 1 BOTTLECAPSULE144

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68071-2249CEPHALEXIN CAPSULE [NUCARE PHARMACEUTICALS,INC.]4Current NDC, Legacy NDC, 2 package rows20240719_ade02343-3e4b-b1f1-e053-2995a90ac5fe.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
309114cephalexin 500 MG Oral CapsulePSNade02343-3e4b-b1f1-e053-2995a90ac5fe4
309114cephalexin 500 MG Oral CapsuleSCDade02343-3e4b-b1f1-e053-2995a90ac5fe4
309114cefalexin (as cefalexin monohydrate) 500 MG Oral CapsuleSYade02343-3e4b-b1f1-e053-2995a90ac5fe4

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
68071-2249-36807122490330 CAPSULE in 1 BOTTLE (68071-2249-3) 30 capsule2020-08-270000-00-00NoNoCurrent
68071-2249-46807122490414 CAPSULE in 1 BOTTLE (68071-2249-4) 14 capsule2023-07-26NoNoCurrent