FDA.reportPublic FDA data

Cephalexin

Product NDC
10544-868
11-digit product format
105440868
Labeler code
10544
Product ID
10544-868_34878bc2-1a24-4a65-b613-50a73930da66
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Cephalexin
Dosage form
CAPSULE
Route
ORAL
Labeler
Blenheim Pharmacal, Inc.
Application
ANDA062713
Marketing category
ANDA
Marketing start
2014-08-18
Marketing end
0000-00-00
Substance
CEPHALEXIN
Active strength
250 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
10544-868-302020-01-31C16284748780-19d75b9d0-01db-f424-e053-dadaa90a57ceCEPHALEXIN CAPSULES, USP
10544-868-402020-01-31C16284748780-19d75b9d0-01db-f424-e053-dadaa90a57ceCEPHALEXIN CAPSULES, USP

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
10544-868-30Cephalexin30 in 1 BOTTLECAPSULE301
10544-868-40Cephalexin40 in 1 BOTTLECAPSULE401

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
10544-868-30EA - Each10544-8688d69978c-9216-4c79-92c7-f4ca04d15db812015-04-03
10544-868-40EA - Each10544-8688aad06b8-8c99-495f-b199-0648a9eb014412015-04-03

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
CEPHALEXINACTIVE INGREDIENTOBN7UDS42YCEPHALEXIN CAPSULE [BLENHEIM PHARMACAL, INC.]1
CEPHALEXIN ANHYDROUSACTIVE MOIETY5SFF1W6677CEPHALEXIN CAPSULE [BLENHEIM PHARMACAL, INC.]1
ANHYDROUS LACTOSEINACTIVE INGREDIENT3SY5LH9PMKCEPHALEXIN CAPSULE [BLENHEIM PHARMACAL, INC.]1
GELATININACTIVE INGREDIENT2G86QN327LCEPHALEXIN CAPSULE [BLENHEIM PHARMACAL, INC.]1
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30CEPHALEXIN CAPSULE [BLENHEIM PHARMACAL, INC.]1
TALCINACTIVE INGREDIENT7SEV7J4R1UCEPHALEXIN 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
10544-868CEPHALEXIN CAPSULE [BLENHEIM PHARMACAL, INC.]1Legacy NDC, 2 package rows20150220_34878bc2-1a24-4a65-b613-50a73930da66.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
309112cephalexin 250 MG Oral CapsulePSN34878bc2-1a24-4a65-b613-50a73930da661
309112cephalexin 250 MG Oral CapsuleSCD34878bc2-1a24-4a65-b613-50a73930da661
309112cephalexin (as cephalexin monohydrate) 250 MG Oral CapsuleSY34878bc2-1a24-4a65-b613-50a73930da661

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionStatus
10544-868-301054408683030 in 1 BOTTLEHistorical
10544-868-401054408684040 in 1 BOTTLEHistorical