FDA.reportPublic FDA data

Cephalexin

Product NDC
68071-3532
11-digit product format
680713532
Labeler code
68071
Product ID
68071-3532_44e6726a-ca3d-d488-e063-6294a90a3a33
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
68071-3532-1Cephalexin21 in 1 BOTTLECAPSULE217
68071-3532-2Cephalexin20 in 1 BOTTLECAPSULE207
68071-3532-3Cephalexin30 in 1 BOTTLECAPSULE307
68071-3532-4Cephalexin14 in 1 BOTTLECAPSULE147
68071-3532-6Cephalexin60 in 1 BOTTLECAPSULE607
68071-3532-7Cephalexin40 in 1 BOTTLECAPSULE407
68071-3532-8Cephalexin28 in 1 BOTTLECAPSULE287

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68071-3532CEPHALEXIN CAPSULE [NUCARE PHARMACEUTICALS,INC.]6Current NDC, 7 package rows20240815_0b3da88f-f513-cdf0-e063-6394a90a7205.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
309114cephalexin 500 MG Oral CapsulePSN0b3da88f-f513-cdf0-e063-6394a90a72057
309114cephalexin 500 MG Oral CapsuleSCD0b3da88f-f513-cdf0-e063-6394a90a72057
309114cefalexin (as cefalexin monohydrate) 500 MG Oral CapsuleSY0b3da88f-f513-cdf0-e063-6394a90a72057

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
68071-3532-16807135320121 CAPSULE in 1 BOTTLE (68071-3532-1) 21 capsule2023-11-28NoNoCurrent
68071-3532-26807135320220 CAPSULE in 1 BOTTLE (68071-3532-2) 20 capsule2023-11-28NoNoCurrent
68071-3532-36807135320330 CAPSULE in 1 BOTTLE (68071-3532-3) 30 capsule2023-11-28NoNoCurrent
68071-3532-46807135320414 CAPSULE in 1 BOTTLE (68071-3532-4) 14 capsule2023-11-28NoNoCurrent
68071-3532-66807135320660 CAPSULE in 1 BOTTLE (68071-3532-6) 60 capsule2025-12-01NoNoCurrent
68071-3532-76807135320740 CAPSULE in 1 BOTTLE (68071-3532-7) 40 capsule2023-11-28NoNoCurrent
68071-3532-86807135320828 CAPSULE in 1 BOTTLE (68071-3532-8) 28 capsule2023-11-28NoNoCurrent