Cephalexin

Product NDC
50090-0070
11-digit product format
500900070
Labeler code
50090
Product ID
50090-0070_07affd1a-d231-4c13-97fe-81dd11b3ee8d
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Cephalexin
Dosage form
CAPSULE
Route
ORAL
Labeler
A-S Medication Solutions
Application
ANDA065253
Marketing category
ANDA
Marketing start
2005-11-16
Marketing end
0000-00-00
Substance
CEPHALEXIN
Active strength
250 mg/1
Pharmacologic classes
Cephalosporin Antibacterial [EPC],Cephalosporins [CS]
NDC exclude flag
No
Listing certified through
2021-12-31
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
50090-0070-22024-10-24C16284748780-1f386c649-a04c-0266-e053-dadaa90a7c1aThese 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
50090-0070-32024-10-24C16284748780-1f386c649-a04c-0266-e053-dadaa90a7c1aThese 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
50090-0070-42024-10-24C16284748780-1f386c649-a04c-0266-e053-dadaa90a7c1aThese 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
50090-0070-52024-10-24C16284748780-1f386c649-a04c-0266-e053-dadaa90a7c1aThese 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
50090-0070-82024-10-24C16284748780-1f386c649-a04c-0266-e053-dadaa90a7c1aThese 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
50090-0070-22023-01-30C16284748780-1f386c649-a04c-0266-e053-dadaa90a7c1aThese 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
50090-0070-32023-01-30C16284748780-1f386c649-a04c-0266-e053-dadaa90a7c1aThese 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
50090-0070-42023-01-30C16284748780-1f386c649-a04c-0266-e053-dadaa90a7c1aThese 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
50090-0070-52023-01-30C16284748780-1f386c649-a04c-0266-e053-dadaa90a7c1aThese 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
50090-0070-82023-01-30C16284748780-1f386c649-a04c-0266-e053-dadaa90a7c1aThese 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
50090-0070-2Cephalexin20 in 1 BOTTLECAPSULE2014
50090-0070-3Cephalexin28 in 1 BOTTLECAPSULE2814
50090-0070-4Cephalexin40 in 1 BOTTLECAPSULE4014
50090-0070-5Cephalexin30 in 1 BOTTLECAPSULE3014
50090-0070-8Cephalexin4 in 1 BOTTLECAPSULE414

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
50090-0070-2EA - Each50090-0070bf8230ca-ec47-4894-9e47-73c69e854da312018-08-13

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
CEPHALEXINACTIVE INGREDIENTOBN7UDS42YCEPHALEXIN CAPSULE [A-S MEDICATION SOLUTIONS LLC]1
CEPHALEXIN ANHYDROUSACTIVE MOIETY5SFF1W6677CEPHALEXIN CAPSULE [A-S MEDICATION SOLUTIONS LLC]1
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UCEPHALEXIN CAPSULE [A-S MEDICATION SOLUTIONS LLC]1
CROSCARMELLOSE SODIUMINACTIVE INGREDIENTM28OL1HH48CEPHALEXIN CAPSULE [A-S MEDICATION SOLUTIONS LLC]1
D&C YELLOW NO. 10INACTIVE INGREDIENT35SW5USQ3GCEPHALEXIN CAPSULE [A-S MEDICATION SOLUTIONS LLC]1
FD&C BLUE NO. 1INACTIVE INGREDIENTH3R47K3TBDCEPHALEXIN CAPSULE [A-S MEDICATION SOLUTIONS LLC]1
FD&C YELLOW NO. 6INACTIVE INGREDIENTH77VEI93A8CEPHALEXIN CAPSULE [A-S MEDICATION SOLUTIONS LLC]1
GELATININACTIVE INGREDIENT2G86QN327LCEPHALEXIN CAPSULE [A-S MEDICATION SOLUTIONS LLC]1
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30CEPHALEXIN CAPSULE [A-S MEDICATION SOLUTIONS LLC]1
SODIUM LAURYL SULFATEINACTIVE INGREDIENT368GB5141JCEPHALEXIN CAPSULE [A-S MEDICATION SOLUTIONS LLC]1
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPCEPHALEXIN CAPSULE [A-S MEDICATION SOLUTIONS LLC]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50090-0070CEPHALEXIN CAPSULE [A-S MEDICATION SOLUTIONS]14Legacy NDC, 5 package rows20241027_99ef59d5-bc44-4727-86fe-dc81357207c3.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
309112cephalexin 250 MG Oral CapsulePSN99ef59d5-bc44-4727-86fe-dc81357207c314
309114cephalexin 500 MG Oral CapsulePSN99ef59d5-bc44-4727-86fe-dc81357207c314
309112cephalexin 250 MG Oral CapsuleSCD99ef59d5-bc44-4727-86fe-dc81357207c314
309114cephalexin 500 MG Oral CapsuleSCD99ef59d5-bc44-4727-86fe-dc81357207c314
309114cefalexin (as cefalexin monohydrate) 500 MG Oral CapsuleSY99ef59d5-bc44-4727-86fe-dc81357207c314
309112cephalexin (as cephalexin monohydrate) 250 MG Oral CapsuleSY99ef59d5-bc44-4727-86fe-dc81357207c314

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
50090-0070-25009000700220 CAPSULE in 1 BOTTLE (50090-0070-2) 20 capsule2014-11-280000-00-00NoNoCurrent
50090-0070-35009000700328 CAPSULE in 1 BOTTLE (50090-0070-3) 28 capsule2014-11-280000-00-00NoNoCurrent
50090-0070-45009000700440 CAPSULE in 1 BOTTLE (50090-0070-4) 40 capsule2014-11-280000-00-00NoNoCurrent
50090-0070-55009000700530 in 1 BOTTLEHistorical
50090-0070-8500900070084 CAPSULE in 1 BOTTLE (50090-0070-8) 4 capsule2015-10-060000-00-00NoNoCurrent