Cephalexin

Product NDC
10544-025
11-digit product format
105440025
Labeler code
10544
Product ID
10544-025_bb6ce0ee-0d20-43d0-b3b7-78518fec1cf3
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Cephalexin
Dosage form
CAPSULE
Route
ORAL
Labeler
Blenheim Pharmacal, Inc.
Application
ANDA065152
Marketing category
ANDA
Marketing start
2010-11-05
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
10544-025-10Cephalexin10 in 1 BOTTLECAPSULE101
10544-025-14Cephalexin14 in 1 BOTTLECAPSULE141
10544-025-20Cephalexin20 in 1 BOTTLECAPSULE201
10544-025-28Cephalexin28 in 1 BOTTLECAPSULE281
10544-025-30Cephalexin30 in 1 BOTTLECAPSULE301
10544-025-40Cephalexin40 in 1 BOTTLECAPSULE401

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
10544-025-10EA - Each10544-0250d2161ae-a6c8-4e49-a2ad-cb2024ad4d5f12015-10-02
10544-025-14EA - Each10544-025af8dcbd2-44c8-4e68-80c0-e7250a57ece112015-10-02
10544-025-28EA - Each10544-025b1adb3e8-be80-4dd0-9e73-4e3aedd6057712015-10-02
10544-025-30EA - Each10544-025fcb211cb-7042-46ff-a1cc-0c1a2cf3724b12015-10-02
10544-025-40EA - Each10544-025e0cef7cb-0edf-49b3-8ace-eb19883a84f412015-10-02

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
AlcoholINACTIVE INGREDIENT3K9958V90MCEPHALEXIN CAPSULE [BLENHEIM PHARMACAL, INC.]1
AmmoniaINACTIVE INGREDIENT5138Q19F1XCEPHALEXIN CAPSULE [BLENHEIM PHARMACAL, INC.]1
Butyl AlcoholINACTIVE INGREDIENT8PJ61P6TS3CEPHALEXIN CAPSULE [BLENHEIM PHARMACAL, INC.]1
Colloidal Silicon DioxideINACTIVE INGREDIENTETJ7Z6XBU4CEPHALEXIN CAPSULE [BLENHEIM PHARMACAL, INC.]1
FD&C Blue No. 1INACTIVE INGREDIENTH3R47K3TBDCEPHALEXIN CAPSULE [BLENHEIM PHARMACAL, INC.]1
FD&C Yellow No. 5INACTIVE INGREDIENTI753WB2F1MCEPHALEXIN CAPSULE [BLENHEIM PHARMACAL, INC.]1
Ferrosoferric OxideINACTIVE INGREDIENTXM0M87F357CEPHALEXIN CAPSULE [BLENHEIM PHARMACAL, INC.]1
GelatinINACTIVE INGREDIENT2G86QN327LCEPHALEXIN CAPSULE [BLENHEIM PHARMACAL, INC.]1
Isopropyl AlcoholINACTIVE INGREDIENTND2M416302CEPHALEXIN CAPSULE [BLENHEIM PHARMACAL, INC.]1
LactoseINACTIVE INGREDIENTJ2B2A4N98GCEPHALEXIN CAPSULE [BLENHEIM PHARMACAL, INC.]1
Magnesium StearateINACTIVE INGREDIENT70097M6I30CEPHALEXIN CAPSULE [BLENHEIM PHARMACAL, INC.]1
Potassium HydroxideINACTIVE INGREDIENTWZH3C48M4TCEPHALEXIN CAPSULE [BLENHEIM PHARMACAL, INC.]1
Propylene GlycolINACTIVE INGREDIENT6DC9Q167V3CEPHALEXIN CAPSULE [BLENHEIM PHARMACAL, INC.]1
ShellacINACTIVE INGREDIENT46N107B71OCEPHALEXIN CAPSULE [BLENHEIM PHARMACAL, INC.]1
Sodium Starch Glycolate Type A PotatoINACTIVE INGREDIENT5856J3G2A2CEPHALEXIN CAPSULE [BLENHEIM PHARMACAL, INC.]1
TalcINACTIVE INGREDIENT7SEV7J4R1UCEPHALEXIN CAPSULE [BLENHEIM PHARMACAL, INC.]1
Titanium DioxideINACTIVE INGREDIENT15FIX9V2JPCEPHALEXIN CAPSULE [BLENHEIM PHARMACAL, INC.]1
WaterINACTIVE INGREDIENT059QF0KO0RCEPHALEXIN CAPSULE [BLENHEIM PHARMACAL, INC.]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
10544-025CEPHALEXIN CAPSULE [BLENHEIM PHARMACAL, INC.]1Legacy NDC, 6 package rows20130525_5399cebf-caf8-40f8-a1fa-a2e547a2b817.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
309114cephalexin 500 MG Oral CapsulePSN5399cebf-caf8-40f8-a1fa-a2e547a2b8171
309114cephalexin 500 MG Oral CapsuleSCD5399cebf-caf8-40f8-a1fa-a2e547a2b8171
309114cefalexin (as cefalexin monohydrate) 500 MG Oral CapsuleSY5399cebf-caf8-40f8-a1fa-a2e547a2b8171

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionStatus
10544-025-101054400251010 in 1 BOTTLEHistorical
10544-025-141054400251414 in 1 BOTTLEHistorical
10544-025-201054400252020 in 1 BOTTLEHistorical
10544-025-281054400252828 in 1 BOTTLEHistorical
10544-025-301054400253030 in 1 BOTTLEHistorical
10544-025-401054400254040 in 1 BOTTLEHistorical