Cephalexin

Product NDC
63629-8857
11-digit product format
636298857
Labeler code
63629
Product ID
63629-8857_1bad368b-39aa-4981-858b-c26da25e6036
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Cephalexin
Dosage form
FOR SUSPENSION
Route
ORAL
Labeler
Bryant Ranch Prepack
Application
ANDA210221
Marketing category
ANDA
Marketing start
2019-03-28
Substance
CEPHALEXIN
Active strength
250 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
CEPHALEXIN250 mg/5mL

Harmonized Identifiers#

Field, Values table
FieldValues
UniiOBN7UDS42Y
Rxcui309113

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
63629-8857-1Cephalexin100 mL in 1 BOTTLEFOR SUSPENSION100106

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
63629-8857-1ML - Milliliter63629-88577b3a3159-029d-48cb-b8eb-a8d67c15e47d12021-12-08

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
63629-8857CEPHALEXIN FOR SUSPENSION [BRYANT RANCH PREPACK]105Current NDC, Legacy NDC, 1 package rows20240727_8d7f247a-3b42-4823-96fb-5f5c1bd94d49.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
309113cephalexin 250 MG in 5 mL Oral SuspensionPSN8d7f247a-3b42-4823-96fb-5f5c1bd94d49106
309113cephalexin 50 MG/ML Oral SuspensionSCD8d7f247a-3b42-4823-96fb-5f5c1bd94d49106
309113cefalexin 50 MG/ML Oral SuspensionSY8d7f247a-3b42-4823-96fb-5f5c1bd94d49106
309113cephalexin 250 MG per 5 ML Oral SuspensionSY8d7f247a-3b42-4823-96fb-5f5c1bd94d49106

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
63629-8857-163629885701100 mL in 1 BOTTLE (63629-8857-1) 100 ml2019-03-280000-00-00NoNoCurrent