FDA.reportPublic FDA data

Cephalexin

Product NDC
62135-480
11-digit product format
621350480
Labeler code
62135
Product ID
62135-480_459b5240-6bbf-1d2d-e063-6294a90aac45
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Cephalexin
Dosage form
POWDER, FOR SUSPENSION
Route
ORAL
Labeler
Chartwell RX, LLC
Application
ANDA065336
Marketing category
ANDA
Marketing start
2018-02-28
Substance
CEPHALEXIN
Active strength
125 mg/5mL
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
CEPHALEXIN125 mg/5mL

Harmonized Identifiers#

Field, Values table
FieldValues
UniiOBN7UDS42Y
Rxcui309110, 309113

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
62135-480-42Cephalexin100 mL in 1 BOTTLEPOWDER, FOR SUSPENSION1004
62135-480-49Cephalexin200 mL in 1 BOTTLEPOWDER, FOR SUSPENSION2004

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
62135-480-42ML - Milliliter62135-480e3f510c9-0cdb-44b8-b3aa-d3b11067c1c212022-10-06
62135-480-49ML - Milliliter62135-48094ae2041-e95a-40fc-b937-6a13895d8f4b12022-10-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
62135-480CEPHALEXIN POWDER, FOR SUSPENSION [CHARTWELL RX, LLC]3Current NDC, Legacy NDC, 2 package rows20241016_8a09bccd-1864-4dc3-9c31-6187d8e0fc99.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
309110cephalexin 125 MG in 5 mL Oral SuspensionPSN8a09bccd-1864-4dc3-9c31-6187d8e0fc994
309113cephalexin 250 MG in 5 mL Oral SuspensionPSN8a09bccd-1864-4dc3-9c31-6187d8e0fc994
309110cephalexin 25 MG/ML Oral SuspensionSCD8a09bccd-1864-4dc3-9c31-6187d8e0fc994
309113cephalexin 50 MG/ML Oral SuspensionSCD8a09bccd-1864-4dc3-9c31-6187d8e0fc994
309110cefalexin 25 MG/ML Oral SuspensionSY8a09bccd-1864-4dc3-9c31-6187d8e0fc994
309113cefalexin 50 MG/ML Oral SuspensionSY8a09bccd-1864-4dc3-9c31-6187d8e0fc994
309110cephalexin 125 MG per 5 ML Oral SuspensionSY8a09bccd-1864-4dc3-9c31-6187d8e0fc994
309113cephalexin 250 MG per 5 ML Oral SuspensionSY8a09bccd-1864-4dc3-9c31-6187d8e0fc994

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
62135-480-4262135048042100 mL in 1 BOTTLE (62135-480-42) 100 ml2022-02-010000-00-00NoNoCurrent
62135-480-4962135048049200 mL in 1 BOTTLE (62135-480-49) 200 ml2022-02-010000-00-00NoNoCurrent