FDA.reportPublic FDA data

Cephalexin

Product NDC
63629-7743
11-digit product format
636297743
Labeler code
63629
Product ID
63629-7743_62107f37-8740-47e8-98b3-90108908591a
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Cephalexin
Dosage form
CAPSULE
Route
ORAL
Labeler
Bryant Ranch Prepack
Application
ANDA090836
Marketing category
ANDA
Marketing start
2011-01-19
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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
63629-7743-12020-10-14C16284748780-19d75b9d0-3814-f424-e053-dadaa90a57ceThese highlights do not include all the information needed to use CEPHALEXIN CAPSULES safely and effectively. See full prescribing information for CEPHALEXIN CAPSULES. CEPHALEXIN capsules, for oral use Initial U.S. Approval: 1971
63629-7743-12020-01-31C16284748780-19d75b9d0-3814-f424-e053-dadaa90a57ceThese highlights do not include all the information needed to use CEPHALEXIN CAPSULES safely and effectively. See full prescribing information for CEPHALEXIN CAPSULES. CEPHALEXIN capsules, for oral use Initial U.S. Approval: 1971

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
63629-7743-1Cephalexin14 in 1 BOTTLECAPSULE147

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
63629-7743-1EA - Each63629-774340b215bc-51a6-4c6e-9c7b-a74a734dd22012022-06-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
63629-7743CEPHALEXIN CAPSULE [BRYANT RANCH PREPACK]7Current NDC, Legacy NDC, 1 package rows20240119_759c3856-8d3a-4036-926c-8508b573c736.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
309114cephalexin 500 MG Oral CapsulePSN759c3856-8d3a-4036-926c-8508b573c7367
309114cephalexin 500 MG Oral CapsuleSCD759c3856-8d3a-4036-926c-8508b573c7367
309114cefalexin (as cefalexin monohydrate) 500 MG Oral CapsuleSY759c3856-8d3a-4036-926c-8508b573c7367

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
63629-7743-16362977430114 CAPSULE in 1 BOTTLE (63629-7743-1) 14 capsule2022-09-020000-00-00NoNoCurrent