FDA.reportPublic FDA data

Cephalexin

Product NDC
70518-3362
11-digit product format
705183362
Labeler code
70518
Product ID
70518-3362_4e64c840-b86a-2f20-e063-6294a90a3d13
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Cephalexin
Dosage form
CAPSULE
Route
ORAL
Labeler
REMEDYREPACK INC.
Application
ANDA062702
Marketing category
ANDA
Marketing start
2022-02-08
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
70518-3362-0Cephalexin30 in 1 BLISTER PACKCAPSULE307
70518-3362-1Cephalexin100 in 1 BOXCAPSULE1007
70518-3362-2Cephalexin1 in 1 POUCHCAPSULE17
70518-3362-3Cephalexin40 in 1 BOTTLE, PLASTICCAPSULE407
70518-3362-4Cephalexin28 in 1 BOTTLE, PLASTICCAPSULE287
70518-3362-5Cephalexin30 in 1 BLISTER PACKCAPSULE307

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
70518-3362-0EA - Each70518-3362a33c1f81-7679-4008-aa87-78016e9a4fd712026-02-05

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
70518-3362CEPHALEXIN CAPSULE [REMEDYREPACK INC.]4Current NDC, Legacy NDC, 6 package rows20240117_b73593ce-0b1f-4371-bae1-140742de3b42.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
309114cephalexin 500 MG Oral CapsulePSNb73593ce-0b1f-4371-bae1-140742de3b427
309114cephalexin 500 MG Oral CapsuleSCDb73593ce-0b1f-4371-bae1-140742de3b427
309114cefalexin (as cefalexin monohydrate) 500 MG Oral CapsuleSYb73593ce-0b1f-4371-bae1-140742de3b427

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
70518-3362-07051833620030 CAPSULE in 1 BLISTER PACK (70518-3362-0) 30 capsule2022-02-080000-00-00NoNoCurrent
70518-3362-170518336201100 in 1 BOXHistorical
70518-3362-2705183362021 in 1 POUCHHistorical
70518-3362-37051833620340 CAPSULE in 1 BOTTLE, PLASTIC (70518-3362-3) 40 capsule2024-01-13NoNoCurrent
70518-3362-47051833620428 CAPSULE in 1 BOTTLE, PLASTIC (70518-3362-4) 28 capsule2025-12-01NoNoCurrent
70518-3362-57051833620530 CAPSULE in 1 BLISTER PACK (70518-3362-5) 30 capsule2026-04-01NoNoCurrent