Cephalexin

Product NDC
10544-004
11-digit product format
105440004
Labeler code
10544
Product ID
10544-004_1109c5be-5749-398c-e054-00144ff8d46c
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Cephalexin
Dosage form
CAPSULE
Route
ORAL
Labeler
Blenheim Pharmacal, Inc.
Application
ANDA065253
Marketing category
ANDA
Marketing start
2010-06-11
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#

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
10544-004-14Cephalexin14 in 1 BOTTLECAPSULE144
10544-004-20Cephalexin20 in 1 BOTTLECAPSULE204
10544-004-28Cephalexin28 in 1 BOTTLECAPSULE284
10544-004-30Cephalexin30 in 1 BOTTLECAPSULE304

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
10544-004-14EA - Each10544-004762d5d08-d118-44e7-a134-cdf4b088876d12015-02-02
10544-004-20EA - Each10544-004393932aa-dce2-4b58-bc6a-8b730678f61f12015-02-02
10544-004-28EA - Each10544-0043d4dcc4b-1148-4f94-8369-c158afddb53912015-02-02
10544-004-30EA - Each10544-0044b6c7b6a-bd13-422d-8ec8-9b37ac5a937012015-10-02

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
CEPHALEXINACTIVE INGREDIENTOBN7UDS42YCEPHALEXIN CAPSULE [BLENHEIM PHARMACAL, INC.]4
CEPHALEXIN ANHYDROUSACTIVE MOIETY5SFF1W6677CEPHALEXIN CAPSULE [BLENHEIM PHARMACAL, INC.]4
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UCEPHALEXIN CAPSULE [BLENHEIM PHARMACAL, INC.]4
CROSCARMELLOSE SODIUMINACTIVE INGREDIENTM28OL1HH48CEPHALEXIN CAPSULE [BLENHEIM PHARMACAL, INC.]4
D&C YELLOW NO. 10INACTIVE INGREDIENT35SW5USQ3GCEPHALEXIN CAPSULE [BLENHEIM PHARMACAL, INC.]4
FD&C BLUE NO. 1INACTIVE INGREDIENTH3R47K3TBDCEPHALEXIN CAPSULE [BLENHEIM PHARMACAL, INC.]4
FD&C YELLOW NO. 6INACTIVE INGREDIENTH77VEI93A8CEPHALEXIN CAPSULE [BLENHEIM PHARMACAL, INC.]4
GELATININACTIVE INGREDIENT2G86QN327LCEPHALEXIN CAPSULE [BLENHEIM PHARMACAL, INC.]4
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30CEPHALEXIN CAPSULE [BLENHEIM PHARMACAL, INC.]4
SODIUM LAURYL SULFATEINACTIVE INGREDIENT368GB5141JCEPHALEXIN CAPSULE [BLENHEIM PHARMACAL, INC.]4
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPCEPHALEXIN CAPSULE [BLENHEIM PHARMACAL, INC.]4

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
10544-004CEPHALEXIN CAPSULE [BLENHEIM PHARMACAL, INC.]4Legacy NDC, 4 package rows20150321_c6d56d5e-856e-4e48-85f7-fce2beade4d1.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
309112cephalexin 250 MG Oral CapsulePSNc6d56d5e-856e-4e48-85f7-fce2beade4d14
309114cephalexin 500 MG Oral CapsulePSNc6d56d5e-856e-4e48-85f7-fce2beade4d14
309112cephalexin 250 MG Oral CapsuleSCDc6d56d5e-856e-4e48-85f7-fce2beade4d14
309114cephalexin 500 MG Oral CapsuleSCDc6d56d5e-856e-4e48-85f7-fce2beade4d14
309114cefalexin (as cefalexin monohydrate) 500 MG Oral CapsuleSYc6d56d5e-856e-4e48-85f7-fce2beade4d14
309112cephalexin (as cephalexin monohydrate) 250 MG Oral CapsuleSYc6d56d5e-856e-4e48-85f7-fce2beade4d14

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionStatus
10544-004-141054400041414 in 1 BOTTLEHistorical
10544-004-201054400042020 in 1 BOTTLEHistorical
10544-004-281054400042828 in 1 BOTTLEHistorical
10544-004-301054400043030 in 1 BOTTLEHistorical