FDA.reportPublic FDA data

Cephalexin

Product NDC
60687-163
11-digit product format
606870163
Labeler code
60687
Product ID
60687-163_297a2904-b417-5ef6-e063-6394a90a35cf
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Cephalexin
Dosage form
CAPSULE
Route
ORAL
Labeler
American Health Packaging
Application
ANDA090836
Marketing category
ANDA
Marketing start
2015-10-19
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
Rxcui309112, 309114

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
60687-163-01Cephalexin100 in 1 BOX, UNIT-DOSECAPSULE1007
60687-163-11Cephalexin1 in 1 BLISTER PACKCAPSULE17

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
60687-163CEPHALEXIN CAPSULE [AMERICAN HEALTH PACKAGING]7Current NDC, Legacy NDC, 2 package rows20241220_cb64cab2-5297-4ed2-a50a-2e5d5e14fa8d.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
309112cephalexin 250 MG Oral CapsulePSNcb64cab2-5297-4ed2-a50a-2e5d5e14fa8d7
309114cephalexin 500 MG Oral CapsulePSNcb64cab2-5297-4ed2-a50a-2e5d5e14fa8d7
309112cephalexin 250 MG Oral CapsuleSCDcb64cab2-5297-4ed2-a50a-2e5d5e14fa8d7
309114cephalexin 500 MG Oral CapsuleSCDcb64cab2-5297-4ed2-a50a-2e5d5e14fa8d7
309114cefalexin (as cefalexin monohydrate) 500 MG Oral CapsuleSYcb64cab2-5297-4ed2-a50a-2e5d5e14fa8d7
309112cephalexin (as cephalexin monohydrate) 250 MG Oral CapsuleSYcb64cab2-5297-4ed2-a50a-2e5d5e14fa8d7
309114cephalexin 500 MG Oral CapsulePSN3fcb3f88-9dfc-444d-952a-1d19677205254
309114cephalexin 500 MG Oral CapsulePSN712a6789-7aab-4114-ae92-d1c7686c6b964
309114cephalexin 500 MG Oral CapsuleSCD3fcb3f88-9dfc-444d-952a-1d19677205254
309114cephalexin 500 MG Oral CapsuleSCD712a6789-7aab-4114-ae92-d1c7686c6b964
309114cefalexin (as cefalexin monohydrate) 500 MG Oral CapsuleSY3fcb3f88-9dfc-444d-952a-1d19677205254
309114cefalexin (as cefalexin monohydrate) 500 MG Oral CapsuleSY712a6789-7aab-4114-ae92-d1c7686c6b964
309114cephalexin 500 MG Oral CapsulePSNab3fc544-3652-4de5-a7ff-e013adb69b5a1
309114cephalexin 500 MG Oral CapsuleSCDab3fc544-3652-4de5-a7ff-e013adb69b5a1
309114cefalexin (as cefalexin monohydrate) 500 MG Oral CapsuleSYab3fc544-3652-4de5-a7ff-e013adb69b5a1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
60687-163-0160687016301100 BLISTER PACK in 1 BOX, UNIT-DOSE (60687-163-01) / 1 CAPSULE in 1 BLISTER PACK (60687-163-11) 100 blister pack2015-10-190000-00-00NoNoCurrent
60687-163-11606870163111 in 1 BLISTER PACKHistorical