FDA.reportPublic FDA data

Cephalexin

Product NDC
68071-4429
11-digit product format
680714429
Labeler code
68071
Product ID
68071-4429_1a8c402e-e2e2-a27c-e063-6294a90a9113
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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
68071-4429-3Cephalexin3 in 1 BOTTLECAPSULE310
68071-4429-4Cephalexin4 in 1 BOTTLECAPSULE410
68071-4429-6Cephalexin6 in 1 BOTTLECAPSULE610
68071-4429-8Cephalexin8 in 1 BOTTLECAPSULE810
68071-4429-9Cephalexin9 in 1 BOTTLECAPSULE910

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68071-4429CEPHALEXIN CAPSULE [NUCARE PHARMACEUTICALS,INC.]10Current NDC, Legacy NDC, 5 package rows20240612_6be20569-df34-04d9-e053-2991aa0a94fd.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
309114cephalexin 500 MG Oral CapsulePSN6be20569-df34-04d9-e053-2991aa0a94fd10
309114cephalexin 500 MG Oral CapsuleSCD6be20569-df34-04d9-e053-2991aa0a94fd10
309114cefalexin (as cefalexin monohydrate) 500 MG Oral CapsuleSY6be20569-df34-04d9-e053-2991aa0a94fd10

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
68071-4429-3680714429033 CAPSULE in 1 BOTTLE (68071-4429-3) 3 capsule2018-05-100000-00-00NoNoCurrent
68071-4429-4680714429044 CAPSULE in 1 BOTTLE (68071-4429-4) 4 capsule2018-05-100000-00-00NoNoCurrent
68071-4429-6680714429066 CAPSULE in 1 BOTTLE (68071-4429-6) 6 capsule2018-05-100000-00-00NoNoCurrent
68071-4429-8680714429088 CAPSULE in 1 BOTTLE (68071-4429-8) 8 capsule2018-05-100000-00-00NoNoCurrent
68071-4429-9680714429099 CAPSULE in 1 BOTTLE (68071-4429-9) 9 capsule2018-05-100000-00-00NoNoCurrent