FDA.reportPublic FDA data

Cephalexin

Product NDC
70518-3378
11-digit product format
705183378
Labeler code
70518
Product ID
70518-3378_51b7860d-d48b-0f90-e063-6394a90a5f0d
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Cephalexin
Dosage form
CAPSULE
Route
ORAL
Labeler
REMEDYREPACK INC.
Application
ANDA090836
Marketing category
ANDA
Marketing start
2022-03-08
Substance
CEPHALEXIN
Active strength
500 mg/1
Pharmacologic classes
Cephalosporin Antibacterial [EPC], Cephalosporins [CS]
NDC exclude flag
No
Listing certified through
2027-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Cephalexin
Listing expiration
2027-12-31

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
70518-3378-0Cephalexin40 in 1 BOTTLE, PLASTICCAPSULE4010
70518-3378-1Cephalexin100 in 1 BOXCAPSULE10010
70518-3378-2Cephalexin1 in 1 POUCHCAPSULE110
70518-3378-3Cephalexin30 in 1 BLISTER PACKCAPSULE3010
70518-3378-4Cephalexin10 in 1 BOTTLE, PLASTICCAPSULE1010

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
70518-3378CEPHALEXIN CAPSULE [REMEDYREPACK INC.]5Current NDC, Legacy NDC, 5 package rows20241225_c600a2c0-42ab-4be8-b9b1-59ba39494b3f.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
309114cephalexin 500 MG Oral CapsulePSNc600a2c0-42ab-4be8-b9b1-59ba39494b3f10
309114cephalexin 500 MG Oral CapsuleSCDc600a2c0-42ab-4be8-b9b1-59ba39494b3f10
309114cefalexin (as cefalexin monohydrate) 500 MG Oral CapsuleSYc600a2c0-42ab-4be8-b9b1-59ba39494b3f10

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
70518-3378-07051833780040 CAPSULE in 1 BOTTLE, PLASTIC (70518-3378-0) 40 capsule2022-03-080000-00-00NoNoCurrent
70518-3378-170518337801100 in 1 BOXHistorical
70518-3378-2705183378021 in 1 POUCHHistorical
70518-3378-37051833780330 in 1 BLISTER PACKHistorical
70518-3378-47051833780410 CAPSULE in 1 BOTTLE, PLASTIC (70518-3378-4) 10 capsule2026-05-13NoNoHistorical