FDA.reportPublic FDA data

Cephalexin

Product NDC
67296-0320
11-digit product format
672960320
Labeler code
67296
Product ID
67296-0320_76d06a53-0446-440a-9786-8ced37e43f04
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Cephalexin
Dosage form
CAPSULE
Route
ORAL
Labeler
RedPharm Drug Inc.
Application
ANDA065229
Marketing category
ANDA
Marketing start
2005-12-01
Marketing end
0000-00-00
Substance
CEPHALEXIN
Active strength
500 mg/1
Pharmacologic classes
Cephalosporin Antibacterial [EPC],Cephalosporins [CS]
NDC exclude flag
E
Listing certified through
2017-12-31
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
67296-0320-22026-01-29C16284748780-149896155-ae67-586f-e063-e6dba90add90These highlights do not include all the information needed to use CEPHALEXIN CAPSULES USP safely and effectively. See full prescribing information for CEPHALEXIN CAPSULES USP CEPHALEXIN capsules USP, for oral use Initial U.S. Approval: 1971
67296-0320-82026-01-29C16284748780-149896155-ae67-586f-e063-e6dba90add90These highlights do not include all the information needed to use CEPHALEXIN CAPSULES USP safely and effectively. See full prescribing information for CEPHALEXIN CAPSULES USP CEPHALEXIN capsules USP, for oral use Initial U.S. Approval: 1971
67296-0320-72019-10-29C16284748780-1960f7f55-c1ee-8e05-e053-dbdaa90a074aCephalexin Capsule

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
67296-0320-7Cephalexin15 in 1 BOTTLECAPSULE152
67296-0320-2Cephalexin30 in 1 BOTTLECAPSULE301
67296-0320-8Cephalexin21 in 1 BOTTLECAPSULE211

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
CEPHALEXINACTIVE INGREDIENTOBN7UDS42YCEPHALEXIN CAPSULE [REDPHARM DRUG INC.]2
CEPHALEXIN ANHYDROUSACTIVE MOIETY5SFF1W6677CEPHALEXIN CAPSULE [REDPHARM DRUG INC.]2
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UCEPHALEXIN CAPSULE [REDPHARM DRUG INC.]2
D&C YELLOW NO. 10INACTIVE INGREDIENT35SW5USQ3GCEPHALEXIN CAPSULE [REDPHARM DRUG INC.]2
FD&C BLUE NO. 1INACTIVE INGREDIENTH3R47K3TBDCEPHALEXIN CAPSULE [REDPHARM DRUG INC.]2
FD&C GREEN NO. 3INACTIVE INGREDIENT3P3ONR6O1SCEPHALEXIN CAPSULE [REDPHARM DRUG INC.]2
FD&C YELLOW NO. 6INACTIVE INGREDIENTH77VEI93A8CEPHALEXIN CAPSULE [REDPHARM DRUG INC.]2
FERRIC OXIDE BLACKINACTIVE INGREDIENTXM0M87F357CEPHALEXIN CAPSULE [REDPHARM DRUG INC.]2
GELATININACTIVE INGREDIENT2G86QN327LCEPHALEXIN CAPSULE [REDPHARM DRUG INC.]2
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30CEPHALEXIN CAPSULE [REDPHARM DRUG INC.]2
POTASSIUM HYDROXIDEINACTIVE INGREDIENTWZH3C48M4TCEPHALEXIN CAPSULE [REDPHARM DRUG INC.]2
PROPYLENE GLYCOLINACTIVE INGREDIENT6DC9Q167V3CEPHALEXIN CAPSULE [REDPHARM DRUG INC.]2
SHELLACINACTIVE INGREDIENT46N107B71OCEPHALEXIN CAPSULE [REDPHARM DRUG INC.]2
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPCEPHALEXIN CAPSULE [REDPHARM DRUG INC.]2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
67296-0320CEPHALEXIN CAPSULE [REDPHARM DRUG INC.]2Legacy NDC, 1 package rows20110708_278c84f7-530c-45d5-bdcb-78a3cc1a3700.zip
67296-0320CEPHALEXIN CAPSULE [REDPHARM DRUG]1Legacy NDC, 2 package rows20240913_21ddeb9e-60ed-1c66-e063-6394a90a3eb5.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
309114cephalexin 500 MG Oral CapsulePSN278c84f7-530c-45d5-bdcb-78a3cc1a37002
309114cephalexin 500 MG Oral CapsuleSCD278c84f7-530c-45d5-bdcb-78a3cc1a37002
309114cefalexin (as cefalexin monohydrate) 500 MG Oral CapsuleSY278c84f7-530c-45d5-bdcb-78a3cc1a37002
309114cephalexin 500 MG Oral CapsulePSN21ddeb9e-60ed-1c66-e063-6394a90a3eb51
309114cephalexin 500 MG Oral CapsuleSCD21ddeb9e-60ed-1c66-e063-6394a90a3eb51
309114cefalexin (as cefalexin monohydrate) 500 MG Oral CapsuleSY21ddeb9e-60ed-1c66-e063-6394a90a3eb51

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionStatus
67296-0320-26729603200230 in 1 BOTTLEHistorical
67296-0320-76729603200715 in 1 BOTTLEHistorical
67296-0320-86729603200821 in 1 BOTTLEHistorical