FDA.reportPublic FDA data

Cephalexin

Product NDC
76420-754
11-digit product format
764200754
Labeler code
76420
Product ID
76420-754_1bb09c78-f794-4b3b-e063-6394a90a8936
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Cephalexin
Dosage form
CAPSULE
Route
ORAL
Labeler
Asclemed USA, Inc.
Application
ANDA090836
Marketing category
ANDA
Marketing start
2019-08-19
Substance
CEPHALEXIN
Active strength
250 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
CEPHALEXIN250 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiOBN7UDS42Y
Rxcui309112

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
76420-754-28Cephalexin28 in 1 BOTTLE, PLASTICCAPSULE281
76420-754-30Cephalexin30 in 1 BOTTLE, PLASTICCAPSULE301
76420-754-40Cephalexin40 in 1 BOTTLE, PLASTICCAPSULE401

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
76420-754-28EA - Each76420-75463d14173-492d-4391-b248-c3662920d83812024-08-12
76420-754-30EA - Each76420-7548e59151a-9605-4a5e-9934-da63886d53fe12024-08-12
76420-754-40EA - Each76420-7542ed8428e-ec52-49c4-99b2-2e2fa01dd12512024-08-12

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
76420-754CEPHALEXIN CAPSULE [ASCLEMED USA, INC.]1Current NDC, 3 package rows20240626_4eb58a7e-1c92-4be3-b702-e522e0fbf425.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
309112cephalexin 250 MG Oral CapsulePSN4eb58a7e-1c92-4be3-b702-e522e0fbf4251
309112cephalexin 250 MG Oral CapsuleSCD4eb58a7e-1c92-4be3-b702-e522e0fbf4251
309112cephalexin (as cephalexin monohydrate) 250 MG Oral CapsuleSY4eb58a7e-1c92-4be3-b702-e522e0fbf4251

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
76420-754-287642007542828 CAPSULE in 1 BOTTLE, PLASTIC (76420-754-28) 28 capsule2024-06-21NoNoCurrent
76420-754-307642007543030 CAPSULE in 1 BOTTLE, PLASTIC (76420-754-30) 30 capsule2024-06-21NoNoCurrent
76420-754-407642007544040 CAPSULE in 1 BOTTLE, PLASTIC (76420-754-40) 40 capsule2024-06-21NoNoCurrent