FDA.reportPublic FDA data

Cephalexin

Product NDC
70518-3857
11-digit product format
705183857
Labeler code
70518
Product ID
70518-3857_3f8c5246-ad33-1c5f-e063-6394a90afbdf
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Cephalexin
Dosage form
CAPSULE
Route
ORAL
Labeler
REMEDYREPACK INC.
Application
ANDA065229
Marketing category
ANDA
Marketing start
2023-09-07
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
70518-3857-0Cephalexin42 in 1 BOTTLE, PLASTICCAPSULE426
70518-3857-1Cephalexin30 in 1 BLISTER PACKCAPSULE306
70518-3857-2Cephalexin10 in 1 BOTTLE, PLASTICCAPSULE106
70518-3857-3Cephalexin40 in 1 BOTTLE, PLASTICCAPSULE406

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
70518-3857-3EA - Each70518-3857d29f7fcf-c907-47ba-b453-09315c0b55a612026-02-05

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
70518-3857CEPHALEXIN CAPSULE [REMEDYREPACK INC.]4Current NDC, 4 package rows20241018_8499aa5a-49b1-4555-bd27-6177d92b261d.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
309114cephalexin 500 MG Oral CapsulePSN8499aa5a-49b1-4555-bd27-6177d92b261d6
309114cephalexin 500 MG Oral CapsuleSCD8499aa5a-49b1-4555-bd27-6177d92b261d6
309114cefalexin (as cefalexin monohydrate) 500 MG Oral CapsuleSY8499aa5a-49b1-4555-bd27-6177d92b261d6
309114cephalexin 500 MG Oral CapsulePSN945552cb-90e4-41fb-afe2-8ee8785e94da1
309114cephalexin 500 MG Oral CapsuleSCD945552cb-90e4-41fb-afe2-8ee8785e94da1
309114cefalexin (as cefalexin monohydrate) 500 MG Oral CapsuleSY945552cb-90e4-41fb-afe2-8ee8785e94da1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
70518-3857-07051838570042 in 1 BOTTLE, PLASTICHistorical
70518-3857-17051838570130 in 1 BLISTER PACKHistorical
70518-3857-27051838570210 in 1 BOTTLE, PLASTICHistorical
70518-3857-37051838570340 CAPSULE in 1 BOTTLE, PLASTIC (70518-3857-3) 40 capsule2023-12-22NoNoHistorical