FDA.reportPublic FDA data

Cephalexin

Product NDC
68071-3538
11-digit product format
680713538
Labeler code
68071
Product ID
68071-3538_39731b80-e276-057e-e063-6394a90a4142
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Cephalexin
Dosage form
CAPSULE
Route
ORAL
Labeler
NuCare Pharmaceuticals,Inc.
Application
ANDA065253
Marketing category
ANDA
Marketing start
2005-11-16
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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
68071-3538-3Cephalexin30 in 1 BOTTLECAPSULE305
68071-3538-4Cephalexin4 in 1 BOTTLECAPSULE45
68071-3538-6Cephalexin6 in 1 BOTTLECAPSULE65
68071-3538-8Cephalexin8 in 1 BOTTLECAPSULE85
68071-3538-9Cephalexin9 in 1 BOTTLECAPSULE95

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68071-3538CEPHALEXIN CAPSULE [NUCARE PHARMACEUTICALS,INC.]4Current NDC, 5 package rows20240820_0aad51b4-86d5-e312-e063-6394a90a250d.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
309114cephalexin 500 MG Oral CapsulePSN0aad51b4-86d5-e312-e063-6394a90a250d5
309114cephalexin 500 MG Oral CapsuleSCD0aad51b4-86d5-e312-e063-6394a90a250d5
309114cefalexin (as cefalexin monohydrate) 500 MG Oral CapsuleSY0aad51b4-86d5-e312-e063-6394a90a250d5

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
68071-3538-36807135380330 CAPSULE in 1 BOTTLE (68071-3538-3) 30 capsule2024-01-15NoNoHistorical
68071-3538-4680713538044 CAPSULE in 1 BOTTLE (68071-3538-4) 4 capsule2024-01-15NoNoHistorical
68071-3538-6680713538066 CAPSULE in 1 BOTTLE (68071-3538-6) 6 capsule2023-11-21NoNoHistorical
68071-3538-8680713538088 CAPSULE in 1 BOTTLE (68071-3538-8) 8 capsule2023-11-21NoNoHistorical
68071-3538-9680713538099 CAPSULE in 1 BOTTLE (68071-3538-9) 9 capsule2025-07-08NoNoHistorical