FDA.reportPublic FDA data

Cephalexin

Product NDC
70518-3066
11-digit product format
705183066
Labeler code
70518
Product ID
70518-3066_4e910379-ec8c-3abc-e063-6394a90a9ab9
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Cephalexin
Dosage form
CAPSULE
Route
ORAL
Labeler
REMEDYREPACK INC.
Application
ANDA065253
Marketing category
ANDA
Marketing start
2021-04-07
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
70518-3066-0Cephalexin30 in 1 BLISTER PACKCAPSULE3010
70518-3066-1Cephalexin40 in 1 BOTTLE, PLASTICCAPSULE4010
70518-3066-2Cephalexin30 in 1 BOTTLE, PLASTICCAPSULE3010
70518-3066-3Cephalexin21 in 1 BOTTLE, PLASTICCAPSULE2110
70518-3066-4Cephalexin14 in 1 BOTTLE, PLASTICCAPSULE1410
70518-3066-5Cephalexin20 in 1 BOTTLE, PLASTICCAPSULE2010
70518-3066-6Cephalexin28 in 1 BOTTLE, PLASTICCAPSULE2810

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
309114cephalexin 500 MG Oral CapsulePSN2506895d-f3e0-4be9-95cb-7a6fd44de46d10
309114cephalexin 500 MG Oral CapsuleSCD2506895d-f3e0-4be9-95cb-7a6fd44de46d10
309114cefalexin (as cefalexin monohydrate) 500 MG Oral CapsuleSY2506895d-f3e0-4be9-95cb-7a6fd44de46d10

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
70518-3066-07051830660030 CAPSULE in 1 BLISTER PACK (70518-3066-0) 30 capsule2021-04-070000-00-00NoNoCurrent
70518-3066-17051830660140 CAPSULE in 1 BOTTLE, PLASTIC (70518-3066-1) 40 capsule2021-06-160000-00-00NoNoCurrent
70518-3066-27051830660230 CAPSULE in 1 BOTTLE, PLASTIC (70518-3066-2) 30 capsule2021-09-030000-00-00NoNoCurrent
70518-3066-37051830660321 CAPSULE in 1 BOTTLE, PLASTIC (70518-3066-3) 21 capsule2022-05-120000-00-00NoNoCurrent
70518-3066-47051830660414 CAPSULE in 1 BOTTLE, PLASTIC (70518-3066-4) 14 capsule2022-05-260000-00-00NoNoCurrent
70518-3066-57051830660520 CAPSULE in 1 BOTTLE, PLASTIC (70518-3066-5) 20 capsule2022-05-260000-00-00NoNoCurrent
70518-3066-67051830660628 CAPSULE in 1 BOTTLE, PLASTIC (70518-3066-6) 28 capsule2025-10-27NoNoHistorical