FDA.reportPublic FDA data

Cephalexin

Product NDC
59651-728
11-digit product format
596510728
Labeler code
59651
Product ID
59651-728_e52db116-14f2-437d-8097-0150193d4655
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Cephalexin
Dosage form
CAPSULE
Route
ORAL
Labeler
Aurobindo Pharma Limited
Application
ANDA065253
Marketing category
ANDA
Marketing start
2023-12-06
Substance
CEPHALEXIN
Active strength
750 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
CEPHALEXIN750 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiOBN7UDS42Y
Rxcui637173

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
59651-728-20Cephalexin20 in 1 BOTTLECAPSULE202
59651-728-50Cephalexin50 in 1 BOTTLECAPSULE502

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
59651-728-20EA - Each59651-7283854e611-037f-45c1-ba7b-8c020f8d11bc12024-01-04
59651-728-50EA - Each59651-728f303fc58-9da4-4e7a-bf1f-a52e71fb8f5712024-01-04

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
59651-728CEPHALEXIN CAPSULE [AUROBINDO PHARMA LIMITED]2Current NDC, 2 package rows20231229_f957ea27-2906-40c7-ac03-eb2f742473a0.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
637173cephalexin 750 MG Oral CapsulePSNf957ea27-2906-40c7-ac03-eb2f742473a02
637173cephalexin 750 MG Oral CapsuleSCDf957ea27-2906-40c7-ac03-eb2f742473a02

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
59651-728-11596510728111000 CAPSULE in 1 BAG (59651-728-11)1000 capsule06-DEC-23Current
59651-728-205965107282020 CAPSULE in 1 BOTTLE (59651-728-20) 20 capsule2023-12-06NoNoCurrent
59651-728-505965107285050 CAPSULE in 1 BOTTLE (59651-728-50) 50 capsule2023-12-06NoNoCurrent