FDA.reportPublic FDA data

Cephalexin

Product NDC
10544-020
11-digit product format
105440020
Labeler code
10544
Product ID
10544-020_9fc0b42f-ecb7-4070-a18c-e57d5a53778a
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Cephalexin
Dosage form
CAPSULE
Route
ORAL
Labeler
Blenheim Pharmacal, Inc.
Application
ANDA062702
Marketing category
ANDA
Marketing start
2010-09-28
Marketing end
0000-00-00
Substance
CEPHALEXIN
Active strength
500 mg/1
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
10544-020-102019-10-29C16284748780-1960f7f55-d22c-8e05-e053-dbdaa90a074aCEPHALEXIN CAPSULES USP, 250 mg and 500 mg / CEPHALEXIN FOR ORAL SUSPENSION USP, 125 mg/5 mL and 250 mg/5 mL / CEPHALEXIN TABLETS USP, 250 mg and 500 mg 3145 3147 4175 4177 2238 2240 Rx only
10544-020-142019-10-29C16284748780-1960f7f55-d22c-8e05-e053-dbdaa90a074aCEPHALEXIN CAPSULES USP, 250 mg and 500 mg / CEPHALEXIN FOR ORAL SUSPENSION USP, 125 mg/5 mL and 250 mg/5 mL / CEPHALEXIN TABLETS USP, 250 mg and 500 mg 3145 3147 4175 4177 2238 2240 Rx only
10544-020-202019-10-29C16284748780-1960f7f55-d22c-8e05-e053-dbdaa90a074aCEPHALEXIN CAPSULES USP, 250 mg and 500 mg / CEPHALEXIN FOR ORAL SUSPENSION USP, 125 mg/5 mL and 250 mg/5 mL / CEPHALEXIN TABLETS USP, 250 mg and 500 mg 3145 3147 4175 4177 2238 2240 Rx only
10544-020-282019-10-29C16284748780-1960f7f55-d22c-8e05-e053-dbdaa90a074aCEPHALEXIN CAPSULES USP, 250 mg and 500 mg / CEPHALEXIN FOR ORAL SUSPENSION USP, 125 mg/5 mL and 250 mg/5 mL / CEPHALEXIN TABLETS USP, 250 mg and 500 mg 3145 3147 4175 4177 2238 2240 Rx only
10544-020-302019-10-29C16284748780-1960f7f55-d22c-8e05-e053-dbdaa90a074aCEPHALEXIN CAPSULES USP, 250 mg and 500 mg / CEPHALEXIN FOR ORAL SUSPENSION USP, 125 mg/5 mL and 250 mg/5 mL / CEPHALEXIN TABLETS USP, 250 mg and 500 mg 3145 3147 4175 4177 2238 2240 Rx only
10544-020-402019-10-29C16284748780-1960f7f55-d22c-8e05-e053-dbdaa90a074aCEPHALEXIN CAPSULES USP, 250 mg and 500 mg / CEPHALEXIN FOR ORAL SUSPENSION USP, 125 mg/5 mL and 250 mg/5 mL / CEPHALEXIN TABLETS USP, 250 mg and 500 mg 3145 3147 4175 4177 2238 2240 Rx only

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
10544-020-10Cephalexin10 in 1 BOTTLECAPSULE101
10544-020-14Cephalexin14 in 1 BOTTLECAPSULE141
10544-020-20Cephalexin20 in 1 BOTTLECAPSULE201
10544-020-28Cephalexin28 in 1 BOTTLECAPSULE281
10544-020-30Cephalexin30 in 1 BOTTLECAPSULE301
10544-020-40Cephalexin40 in 1 BOTTLECAPSULE401

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
10544-020-10EA - Each10544-020a6d9ba0a-c953-4e62-8288-886770403b1512015-02-02

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
CEPHALEXINACTIVE INGREDIENTOBN7UDS42YCEPHALEXIN CAPSULE [BLENHEIM PHARMACAL, INC.]1
CEPHALEXINACTIVE MOIETYOBN7UDS42YCEPHALEXIN CAPSULE [BLENHEIM PHARMACAL, INC.]1
ALUMINUM OXIDEINACTIVE INGREDIENTLMI26O6933CEPHALEXIN CAPSULE [BLENHEIM PHARMACAL, INC.]1
CARBOXYMETHYLCELLULOSE SODIUMINACTIVE INGREDIENTK679OBS311CEPHALEXIN CAPSULE [BLENHEIM PHARMACAL, INC.]1
D&C YELLOW NO. 10INACTIVE INGREDIENT35SW5USQ3GCEPHALEXIN CAPSULE [BLENHEIM PHARMACAL, INC.]1
FD&C BLUE NO. 1INACTIVE INGREDIENTH3R47K3TBDCEPHALEXIN CAPSULE [BLENHEIM PHARMACAL, INC.]1
FD&C BLUE NO. 2INACTIVE INGREDIENTL06K8R7DQKCEPHALEXIN CAPSULE [BLENHEIM PHARMACAL, INC.]1
FD&C RED NO. 40INACTIVE INGREDIENTWZB9127XOACEPHALEXIN CAPSULE [BLENHEIM PHARMACAL, INC.]1
FERROSOFERRIC OXIDEINACTIVE INGREDIENTXM0M87F357CEPHALEXIN CAPSULE [BLENHEIM PHARMACAL, INC.]1
GELATININACTIVE INGREDIENT2G86QN327LCEPHALEXIN CAPSULE [BLENHEIM PHARMACAL, INC.]1
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30CEPHALEXIN CAPSULE [BLENHEIM PHARMACAL, INC.]1
PROPYLENE GLYCOLINACTIVE INGREDIENT6DC9Q167V3CEPHALEXIN CAPSULE [BLENHEIM PHARMACAL, INC.]1
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4CEPHALEXIN CAPSULE [BLENHEIM PHARMACAL, INC.]1
SODIUM LAURYL SULFATEINACTIVE INGREDIENT368GB5141JCEPHALEXIN CAPSULE [BLENHEIM PHARMACAL, INC.]1
SODIUM STARCH GLYCOLATE TYPE A POTATOINACTIVE INGREDIENT5856J3G2A2CEPHALEXIN CAPSULE [BLENHEIM PHARMACAL, INC.]1
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPCEPHALEXIN CAPSULE [BLENHEIM PHARMACAL, INC.]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
10544-020CEPHALEXIN CAPSULE [BLENHEIM PHARMACAL, INC.]1Legacy NDC, 6 package rows20101007_12b6bac5-00a3-437b-a172-d4e09c273c8c.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
309114cephalexin 500 MG Oral CapsulePSN12b6bac5-00a3-437b-a172-d4e09c273c8c1
309114cephalexin 500 MG Oral CapsuleSCD12b6bac5-00a3-437b-a172-d4e09c273c8c1
309114cefalexin (as cefalexin monohydrate) 500 MG Oral CapsuleSY12b6bac5-00a3-437b-a172-d4e09c273c8c1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionStatus
10544-020-101054400201010 in 1 BOTTLEHistorical
10544-020-141054400201414 in 1 BOTTLEHistorical
10544-020-201054400202020 in 1 BOTTLEHistorical
10544-020-281054400202828 in 1 BOTTLEHistorical
10544-020-301054400203030 in 1 BOTTLEHistorical
10544-020-401054400204040 in 1 BOTTLEHistorical