FDA.reportPublic FDA data

Cephalexin

Product NDC
67877-254
11-digit product format
678770254
Labeler code
67877
Product ID
67877-254_3e6d72ab-f4ea-4ca6-984d-e6de1b3e7fdf
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Cephalexin
Dosage form
CAPSULE
Route
ORAL
Labeler
Ascend Laboratories, LLC
Application
ANDA090836
Marketing category
ANDA
Marketing start
2012-06-04
Substance
CEPHALEXIN
Active strength
333 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
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
CEPHALEXIN333 mg/1

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
67877-254-01Cephalexin100 in 1 BOTTLECAPSULE10028
67877-254-05Cephalexin500 in 1 BOTTLECAPSULE50028
67877-254-10Cephalexin1000 in 1 BOTTLECAPSULE100028
67877-254-20Cephalexin20 in 1 BOTTLECAPSULE2028
67877-254-38Cephalexin1 in 1 BLISTER PACKCAPSULE128
67877-254-38Cephalexin100 in 1 CARTONCAPSULE10028

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
CEPHALEXINACTIVE INGREDIENTOBN7UDS42YCEPHALEXIN CAPSULE [ASCEND LABORATORIES, LLC]20
CEPHALEXIN ANHYDROUSACTIVE MOIETY5SFF1W6677CEPHALEXIN CAPSULE [ASCEND LABORATORIES, LLC]20
AMMONIAINACTIVE INGREDIENT5138Q19F1XCEPHALEXIN CAPSULE [ASCEND LABORATORIES, LLC]20
ANHYDROUS LACTOSEINACTIVE INGREDIENT3SY5LH9PMKCEPHALEXIN CAPSULE [ASCEND LABORATORIES, LLC]20
D&C YELLOW NO. 10INACTIVE INGREDIENT35SW5USQ3GCEPHALEXIN CAPSULE [ASCEND LABORATORIES, LLC]20
FD&C BLUE NO. 1INACTIVE INGREDIENTH3R47K3TBDCEPHALEXIN CAPSULE [ASCEND LABORATORIES, LLC]20
FD&C RED NO. 40INACTIVE INGREDIENTWZB9127XOACEPHALEXIN CAPSULE [ASCEND LABORATORIES, LLC]20
FD&C YELLOW NO. 6INACTIVE INGREDIENTH77VEI93A8CEPHALEXIN CAPSULE [ASCEND LABORATORIES, LLC]20
FERROSOFERRIC OXIDEINACTIVE INGREDIENTXM0M87F357CEPHALEXIN CAPSULE [ASCEND LABORATORIES, LLC]20
GELATININACTIVE INGREDIENT2G86QN327LCEPHALEXIN CAPSULE [ASCEND LABORATORIES, LLC]20
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30CEPHALEXIN CAPSULE [ASCEND LABORATORIES, LLC]20
POTASSIUM HYDROXIDEINACTIVE INGREDIENTWZH3C48M4TCEPHALEXIN CAPSULE [ASCEND LABORATORIES, LLC]20
PROPYLENE GLYCOLINACTIVE INGREDIENT6DC9Q167V3CEPHALEXIN CAPSULE [ASCEND LABORATORIES, LLC]20
SHELLACINACTIVE INGREDIENT46N107B71OCEPHALEXIN CAPSULE [ASCEND LABORATORIES, LLC]20
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4CEPHALEXIN CAPSULE [ASCEND LABORATORIES, LLC]20
SODIUM LAURYL SULFATEINACTIVE INGREDIENT368GB5141JCEPHALEXIN CAPSULE [ASCEND LABORATORIES, LLC]20
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPCEPHALEXIN CAPSULE [ASCEND LABORATORIES, LLC]20

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
67877-254CEPHALEXIN CAPSULE [ASCEND LABORATORIES, LLC]28Current NDC, Legacy NDC, 6 package rows20220702_4fec8daf-6e09-4153-926f-64709dbdd26c.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
309112cephalexin 250 MG Oral CapsulePSN4fec8daf-6e09-4153-926f-64709dbdd26c28
645617cephalexin 333 MG Oral CapsulePSN4fec8daf-6e09-4153-926f-64709dbdd26c28
309114cephalexin 500 MG Oral CapsulePSN4fec8daf-6e09-4153-926f-64709dbdd26c28
637173cephalexin 750 MG Oral CapsulePSN4fec8daf-6e09-4153-926f-64709dbdd26c28
309112cephalexin 250 MG Oral CapsuleSCD4fec8daf-6e09-4153-926f-64709dbdd26c28
645617cephalexin 333 MG Oral CapsuleSCD4fec8daf-6e09-4153-926f-64709dbdd26c28
309114cephalexin 500 MG Oral CapsuleSCD4fec8daf-6e09-4153-926f-64709dbdd26c28
637173cephalexin 750 MG Oral CapsuleSCD4fec8daf-6e09-4153-926f-64709dbdd26c28
309114cefalexin (as cefalexin monohydrate) 500 MG Oral CapsuleSY4fec8daf-6e09-4153-926f-64709dbdd26c28
309112cephalexin (as cephalexin monohydrate) 250 MG Oral CapsuleSY4fec8daf-6e09-4153-926f-64709dbdd26c28
309112cephalexin 250 MG Oral CapsulePSN8073f183-e11f-41af-8bd1-1505bc7e044b1
645617cephalexin 333 MG Oral CapsulePSN8073f183-e11f-41af-8bd1-1505bc7e044b1
309114cephalexin 500 MG Oral CapsulePSN8073f183-e11f-41af-8bd1-1505bc7e044b1
637173cephalexin 750 MG Oral CapsulePSN8073f183-e11f-41af-8bd1-1505bc7e044b1
309112cephalexin 250 MG Oral CapsuleSCD8073f183-e11f-41af-8bd1-1505bc7e044b1
645617cephalexin 333 MG Oral CapsuleSCD8073f183-e11f-41af-8bd1-1505bc7e044b1
309114cephalexin 500 MG Oral CapsuleSCD8073f183-e11f-41af-8bd1-1505bc7e044b1
637173cephalexin 750 MG Oral CapsuleSCD8073f183-e11f-41af-8bd1-1505bc7e044b1
309114cefalexin (as cefalexin monohydrate) 500 MG Oral CapsuleSY8073f183-e11f-41af-8bd1-1505bc7e044b1
309112cephalexin (as cephalexin monohydrate) 250 MG Oral CapsuleSY8073f183-e11f-41af-8bd1-1505bc7e044b1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
67877-254-0167877025401100 CAPSULE in 1 BOTTLE (67877-254-01) 100 capsule2012-06-040000-00-00NoNoCurrent
67877-254-0567877025405500 CAPSULE in 1 BOTTLE (67877-254-05) 500 capsule2012-06-040000-00-00NoNoCurrent
67877-254-10678770254101000 CAPSULE in 1 BOTTLE (67877-254-10) 1000 capsule2012-06-040000-00-00NoNoCurrent
67877-254-206787702542020 CAPSULE in 1 BOTTLE (67877-254-20) 20 capsule2012-06-040000-00-00NoNoCurrent
67877-254-3867877025438100 BLISTER PACK in 1 CARTON (67877-254-38) / 1 CAPSULE in 1 BLISTER PACK100 blister pack2012-06-040000-00-00NoNoCurrent