Cephalexin

Product NDC
63629-8858
11-digit product format
636298858
Labeler code
63629
Product ID
63629-8858_1c0fd0cc-6a43-4af7-a550-3ec25d98d2e5
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
63629-8858-1Cephalexin200 mL in 1 BOTTLEFOR SUSPENSION200107

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
63629-8858-1ML - Milliliter63629-88586f48e422-0f79-4b8b-82c6-c8b6925aff1412021-12-08

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
63629-8858CEPHALEXIN FOR SUSPENSION [BRYANT RANCH PREPACK]107Current NDC, Legacy NDC, 1 package rows20240823_df6bb893-e3d7-4c8f-8cec-35b4d2fa33b3.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
309113cephalexin 250 MG in 5 mL Oral SuspensionPSNdf6bb893-e3d7-4c8f-8cec-35b4d2fa33b3107
309113cephalexin 50 MG/ML Oral SuspensionSCDdf6bb893-e3d7-4c8f-8cec-35b4d2fa33b3107
309113cefalexin 50 MG/ML Oral SuspensionSYdf6bb893-e3d7-4c8f-8cec-35b4d2fa33b3107
309113cephalexin 250 MG per 5 ML Oral SuspensionSYdf6bb893-e3d7-4c8f-8cec-35b4d2fa33b3107

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
63629-8858-163629885801200 mL in 1 BOTTLE (63629-8858-1) 200 ml2019-03-280000-00-00NoNoCurrent