FDA.reportPublic FDA data

Cephalexin

Product NDC
62250-802
11-digit product format
622500802
Labeler code
62250
Product ID
62250-802_8e2bf6a8-a967-4cec-857f-3456c87598ce
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Cephalexin
Dosage form
CAPSULE
Route
ORAL
Labeler
Belcher Pharmaceuticals, LLC
Application
ANDA062713
Marketing category
ANDA
Marketing start
2022-12-22
Marketing end
0000-00-00
Substance
CEPHALEXIN
Active strength
500 mg/1
Pharmacologic classes
Cephalosporin Antibacterial [EPC], Cephalosporins [CS]
NDC exclude flag
No
Listing certified through
2023-12-31
Current FDA listing
Historical FDA.report record

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
62250-802-022025-07-29C16284748780-1960f7f55-bf39-8e05-e053-dbdaa90a074aCEPHALEXIN CAPSULES, USP
62250-802-082025-07-29C16284748780-1960f7f55-bf39-8e05-e053-dbdaa90a074aCEPHALEXIN CAPSULES, USP
62250-802-022022-12-28C16284748780-1960f7f55-bf39-8e05-e053-dbdaa90a074aCEPHALEXIN CAPSULES, USP
62250-802-082022-12-28C16284748780-1960f7f55-bf39-8e05-e053-dbdaa90a074aCEPHALEXIN CAPSULES, USP
62250-802-022019-10-29C16284748780-1960f7f55-bf39-8e05-e053-dbdaa90a074aCEPHALEXIN CAPSULES, USP
62250-802-082019-10-29C16284748780-1960f7f55-bf39-8e05-e053-dbdaa90a074aCEPHALEXIN CAPSULES, USP

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
62250-802-02Cephalexin100 in 1 BOTTLECAPSULE10012
62250-802-08Cephalexin500 in 1 BOTTLECAPSULE50012

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
62250-802-08EA - Each62250-80226256dfd-d928-414b-8239-0aa8034719a312012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
CEPHALEXINACTIVE INGREDIENTOBN7UDS42YCEPHALEXIN CAPSULE [BELCHER PHARMACEUTICALS, LLC]5
CEPHALEXINACTIVE MOIETYOBN7UDS42YCEPHALEXIN CAPSULE [BELCHER PHARMACEUTICALS, LLC]5
ANHYDROUS LACTOSEINACTIVE INGREDIENT3SY5LH9PMKCEPHALEXIN CAPSULE [BELCHER PHARMACEUTICALS, LLC]5
GELATININACTIVE INGREDIENT2G86QN327LCEPHALEXIN CAPSULE [BELCHER PHARMACEUTICALS, LLC]5
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30CEPHALEXIN CAPSULE [BELCHER PHARMACEUTICALS, LLC]5
TALCINACTIVE INGREDIENT7SEV7J4R1UCEPHALEXIN CAPSULE [BELCHER PHARMACEUTICALS, LLC]5
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPCEPHALEXIN CAPSULE [BELCHER PHARMACEUTICALS, LLC]5

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
62250-802CEPHALEXIN CAPSULE [BELCHER PHARMACEUTICALS, LLC]12Legacy NDC, 2 package rows20250213_8494bec5-8404-43e4-bfa1-a7270b8dfbf7.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
309112cephalexin 250 MG Oral CapsulePSN8494bec5-8404-43e4-bfa1-a7270b8dfbf712
309114cephalexin 500 MG Oral CapsulePSN8494bec5-8404-43e4-bfa1-a7270b8dfbf712
309112cephalexin 250 MG Oral CapsuleSCD8494bec5-8404-43e4-bfa1-a7270b8dfbf712
309114cephalexin 500 MG Oral CapsuleSCD8494bec5-8404-43e4-bfa1-a7270b8dfbf712
309114cefalexin (as cefalexin monohydrate) 500 MG Oral CapsuleSY8494bec5-8404-43e4-bfa1-a7270b8dfbf712
309112cephalexin (as cephalexin monohydrate) 250 MG Oral CapsuleSY8494bec5-8404-43e4-bfa1-a7270b8dfbf712

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
62250-802-0262250080202100 CAPSULE in 1 BOTTLE (62250-802-02) 100 capsule2022-12-220000-00-00NoNoCurrent
62250-802-0862250080208500 CAPSULE in 1 BOTTLE (62250-802-08) 500 capsule2022-12-220000-00-00NoNoCurrent