FDA.reportPublic FDA data

Cephalexin

Product NDC
76420-736
11-digit product format
764200736
Labeler code
76420
Product ID
76420-736_1b62bc14-7a3a-dd94-e063-6294a90a84ba
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Cephalexin
Dosage form
CAPSULE
Route
ORAL
Labeler
Asclemed USA, Inc.
Application
ANDA065229
Marketing category
ANDA
Marketing start
2021-07-20
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
76420-736-00Cephalexin100 in 1 BOXCAPSULE1001
76420-736-01Cephalexin1 in 1 POUCHCAPSULE11
76420-736-14Cephalexin14 in 1 BOTTLE, PLASTICCAPSULE141
76420-736-20Cephalexin20 in 1 BOTTLE, PLASTICCAPSULE201
76420-736-21Cephalexin21 in 1 BOTTLE, PLASTICCAPSULE211
76420-736-28Cephalexin28 in 1 BOTTLE, PLASTICCAPSULE281
76420-736-30Cephalexin30 in 1 BOTTLE, PLASTICCAPSULE301
76420-736-40Cephalexin40 in 1 BOTTLE, PLASTICCAPSULE401

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
76420-736-00EA - Each76420-7369ca9d13b-5d39-4582-872b-a71f314980e212024-08-12
76420-736-01EA - Each76420-7368a679989-e109-432d-a2b7-42d531f1c17312024-08-12
76420-736-14EA - Each76420-736346ee191-74e0-4256-9c85-8b5da825fe9312024-08-12
76420-736-20EA - Each76420-736acba3473-64dd-4dac-96e6-facad652e70712024-08-12
76420-736-21EA - Each76420-736cdcf1359-3655-43fa-b2e5-0267a5c7eb9a12024-08-12
76420-736-28EA - Each76420-736dafea01b-148f-4777-81d2-cd4a29076db412024-08-12
76420-736-30EA - Each76420-7360329ea8d-edbe-45fc-b6f3-599acd5fecf812024-08-12
76420-736-40EA - Each76420-7363079b84f-91da-427b-83d7-705c084bbf0012024-08-12

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
76420-736CEPHALEXIN CAPSULE [ASCLEMED USA, INC.]1Current NDC, 8 package rows20240626_20f8cc57-231c-4d36-a209-ff9e5735d65c.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
309114cephalexin 500 MG Oral CapsulePSN20f8cc57-231c-4d36-a209-ff9e5735d65c1
309114cephalexin 500 MG Oral CapsuleSCD20f8cc57-231c-4d36-a209-ff9e5735d65c1
309114cefalexin (as cefalexin monohydrate) 500 MG Oral CapsuleSY20f8cc57-231c-4d36-a209-ff9e5735d65c1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
76420-736-0076420073600100 CAPSULE in 1 BOX (76420-736-00) 100 capsule2024-06-20NoNoHistorical
76420-736-01764200736011 CAPSULE in 1 POUCH (76420-736-01) 1 capsule2024-06-20NoNoHistorical
76420-736-147642007361414 CAPSULE in 1 BOTTLE, PLASTIC (76420-736-14) 14 capsule2024-06-20NoNoHistorical
76420-736-207642007362020 CAPSULE in 1 BOTTLE, PLASTIC (76420-736-20) 20 capsule2024-06-20NoNoHistorical
76420-736-217642007362121 CAPSULE in 1 BOTTLE, PLASTIC (76420-736-21) 21 capsule2024-06-20NoNoHistorical
76420-736-287642007362828 CAPSULE in 1 BOTTLE, PLASTIC (76420-736-28) 28 capsule2024-06-20NoNoHistorical
76420-736-307642007363030 CAPSULE in 1 BOTTLE, PLASTIC (76420-736-30) 30 capsule2024-06-20NoNoHistorical
76420-736-407642007364040 CAPSULE in 1 BOTTLE, PLASTIC (76420-736-40) 40 capsule2024-06-20NoNoHistorical