FDA.reportPublic FDA data

Cephalexin

Product NDC
69543-102
11-digit product format
695430102
Labeler code
69543
Product ID
69543-102_b35b6662-11c3-435e-9cae-12ed3dcd15b4
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
cephalexin
Dosage form
CAPSULE
Route
ORAL
Labeler
Virtus Pharmaceuticals
Application
ANDA062713
Marketing category
ANDA
Marketing start
2015-06-02
Marketing end
2020-11-30
Substance
CEPHALEXIN
Active strength
500 mg/1
Pharmacologic classes
Cephalosporin Antibacterial [EPC],Cephalosporins [CS]
NDC exclude flag
No
Listing certified through
0000-00-00
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

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
69543-102-10EA - Each69543-102910a53ce-a743-4e5c-b45d-5d386c5ca5d912015-08-04
69543-102-50EA - Each69543-1027b404295-acb7-4928-a0d4-ba6fbf3a613112015-08-04

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
CEPHALEXINACTIVE INGREDIENTOBN7UDS42YCEPHALEXIN CAPSULE [BLENHEIM PHARMACAL, INC.]2
cephalexinACTIVE INGREDIENTOBN7UDS42YCEPHALEXIN CAPSULE [DIRECTRX]2
CEPHALEXIN ANHYDROUSACTIVE MOIETY5SFF1W6677CEPHALEXIN CAPSULE [BLENHEIM PHARMACAL, INC.]2
CEPHALEXIN ANHYDROUSACTIVE MOIETY5SFF1W6677CEPHALEXIN CAPSULE [DIRECTRX]2
ANHYDROUS LACTOSEINACTIVE INGREDIENT3SY5LH9PMKCEPHALEXIN CAPSULE [BLENHEIM PHARMACAL, INC.]2
anhydrous lactoseINACTIVE INGREDIENT3SY5LH9PMKCEPHALEXIN CAPSULE [DIRECTRX]2
FERROSOFERRIC OXIDEINACTIVE INGREDIENTXM0M87F357CEPHALEXIN CAPSULE [BLENHEIM PHARMACAL, INC.]2
ferrosoferric oxideINACTIVE INGREDIENTXM0M87F357CEPHALEXIN CAPSULE [DIRECTRX]2
GELATININACTIVE INGREDIENT2G86QN327LCEPHALEXIN CAPSULE [BLENHEIM PHARMACAL, INC.]2
gelatinINACTIVE INGREDIENT2G86QN327LCEPHALEXIN CAPSULE [DIRECTRX]2
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30CEPHALEXIN CAPSULE [BLENHEIM PHARMACAL, INC.]2
magnesium stearateINACTIVE INGREDIENT70097M6I30CEPHALEXIN CAPSULE [DIRECTRX]2
TALCINACTIVE INGREDIENT7SEV7J4R1UCEPHALEXIN CAPSULE [BLENHEIM PHARMACAL, INC.]2
talcINACTIVE INGREDIENT7SEV7J4R1UCEPHALEXIN CAPSULE [DIRECTRX]2
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPCEPHALEXIN CAPSULE [BLENHEIM PHARMACAL, INC.]2
titanium dioxideINACTIVE INGREDIENT15FIX9V2JPCEPHALEXIN CAPSULE [DIRECTRX]2

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
309114cephalexin 500 MG Oral CapsulePSN4f1bf27a-e9d7-347b-e054-00144ff88e884
309114cephalexin 500 MG Oral CapsulePSN2d12e6a9-f7dd-25ed-e054-00144ff8d46c4
309114cephalexin 500 MG Oral CapsuleSCD2d12e6a9-f7dd-25ed-e054-00144ff8d46c4
309114cephalexin 500 MG Oral CapsuleSCD4f1bf27a-e9d7-347b-e054-00144ff88e884
309114cefalexin (as cefalexin monohydrate) 500 MG Oral CapsuleSY4f1bf27a-e9d7-347b-e054-00144ff88e884
309114cefalexin (as cefalexin monohydrate) 500 MG Oral CapsuleSY2d12e6a9-f7dd-25ed-e054-00144ff8d46c4
309112cephalexin 250 MG Oral CapsulePSN1fcb287b-618f-67cc-e054-00144ff88e882
309114cephalexin 500 MG Oral CapsulePSNdecf91ad-f1fd-48f7-9d29-9a590548d5e62
309114cephalexin 500 MG Oral CapsulePSN1fcb287b-618f-67cc-e054-00144ff88e882
309114cephalexin 500 MG Oral CapsulePSN2081f146-534f-4bc6-ab56-448bf9a9a81a2
309112cephalexin 250 MG Oral CapsuleSCD1fcb287b-618f-67cc-e054-00144ff88e882
309114cephalexin 500 MG Oral CapsuleSCD1fcb287b-618f-67cc-e054-00144ff88e882
309114cephalexin 500 MG Oral CapsuleSCDdecf91ad-f1fd-48f7-9d29-9a590548d5e62
309114cephalexin 500 MG Oral CapsuleSCD2081f146-534f-4bc6-ab56-448bf9a9a81a2
309114cefalexin (as cefalexin monohydrate) 500 MG Oral CapsuleSY2081f146-534f-4bc6-ab56-448bf9a9a81a2
309114cefalexin (as cefalexin monohydrate) 500 MG Oral CapsuleSY1fcb287b-618f-67cc-e054-00144ff88e882
309114cefalexin (as cefalexin monohydrate) 500 MG Oral CapsuleSYdecf91ad-f1fd-48f7-9d29-9a590548d5e62
309112cephalexin (as cephalexin monohydrate) 250 MG Oral CapsuleSY1fcb287b-618f-67cc-e054-00144ff88e882