FDA.reportPublic FDA data

Cephalexin

Product NDC
10544-946
11-digit product format
105440946
Labeler code
10544
Product ID
10544-946_1ff373df-bc3c-70d8-e054-00144ff88e88
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
cephalexin
Dosage form
CAPSULE
Route
ORAL
Labeler
Blenheim Pharmacal, Inc.
Application
ANDA062713
Marketing category
ANDA
Marketing start
2015-09-15
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
10544-946-082020-01-31C16284748780-19d75b9d0-d0e1-f424-e053-dadaa90a57ceCEPHALEXIN CAPSULES, USP
10544-946-212020-01-31C16284748780-19d75b9d0-d0e1-f424-e053-dadaa90a57ceCEPHALEXIN CAPSULES, USP
10544-946-282020-01-31C16284748780-19d75b9d0-d0e1-f424-e053-dadaa90a57ceCEPHALEXIN CAPSULES, USP
10544-946-302020-01-31C16284748780-19d75b9d0-d0e1-f424-e053-dadaa90a57ceCEPHALEXIN CAPSULES, USP
10544-946-402020-01-31C16284748780-19d75b9d0-d0e1-f424-e053-dadaa90a57ceCEPHALEXIN CAPSULES, USP

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
10544-946-08Cephalexin8 in 1 BOTTLECAPSULE82
10544-946-21Cephalexin21 in 1 BOTTLECAPSULE212
10544-946-28Cephalexin28 in 1 BOTTLECAPSULE282
10544-946-30Cephalexin30 in 1 BOTTLECAPSULE302
10544-946-40Cephalexin40 in 1 BOTTLECAPSULE402

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
10544-946-08EA - Each10544-9468f753fd7-3ba3-47c0-9a9a-56ff8bc5882712016-01-13
10544-946-21EA - Each10544-946cf930b8e-ed01-4bf6-8c35-9f4466e79a0412016-01-13
10544-946-28EA - Each10544-946a67251b5-5c3c-4b41-a4de-349b804caf6512016-01-13
10544-946-30EA - Each10544-946c355c0a4-b1cd-437b-b96a-cf4f7a2c8e5e12016-01-13
10544-946-40EA - Each10544-9466c771a69-a8fb-490d-9adc-0320028b715212016-01-13

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
CEPHALEXINACTIVE INGREDIENTOBN7UDS42YCEPHALEXIN CAPSULE [BLENHEIM PHARMACAL, INC.]2
CEPHALEXIN ANHYDROUSACTIVE MOIETY5SFF1W6677CEPHALEXIN CAPSULE [BLENHEIM PHARMACAL, INC.]2
ANHYDROUS LACTOSEINACTIVE INGREDIENT3SY5LH9PMKCEPHALEXIN CAPSULE [BLENHEIM PHARMACAL, INC.]2
FERROSOFERRIC OXIDEINACTIVE INGREDIENTXM0M87F357CEPHALEXIN CAPSULE [BLENHEIM PHARMACAL, INC.]2
GELATININACTIVE INGREDIENT2G86QN327LCEPHALEXIN CAPSULE [BLENHEIM PHARMACAL, INC.]2
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30CEPHALEXIN CAPSULE [BLENHEIM PHARMACAL, INC.]2
TALCINACTIVE INGREDIENT7SEV7J4R1UCEPHALEXIN CAPSULE [BLENHEIM PHARMACAL, INC.]2
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPCEPHALEXIN CAPSULE [BLENHEIM PHARMACAL, INC.]2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
10544-946CEPHALEXIN CAPSULE [BLENHEIM PHARMACAL, INC.]2Legacy NDC, 5 package rows20150917_1fcb287b-618f-67cc-e054-00144ff88e88.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
309112cephalexin 250 MG Oral CapsulePSN1fcb287b-618f-67cc-e054-00144ff88e882
309114cephalexin 500 MG Oral CapsulePSN1fcb287b-618f-67cc-e054-00144ff88e882
309112cephalexin 250 MG Oral CapsuleSCD1fcb287b-618f-67cc-e054-00144ff88e882
309114cephalexin 500 MG Oral CapsuleSCD1fcb287b-618f-67cc-e054-00144ff88e882
309114cefalexin (as cefalexin monohydrate) 500 MG Oral CapsuleSY1fcb287b-618f-67cc-e054-00144ff88e882
309112cephalexin (as cephalexin monohydrate) 250 MG Oral CapsuleSY1fcb287b-618f-67cc-e054-00144ff88e882

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionStatus
10544-946-08105440946088 in 1 BOTTLEHistorical
10544-946-211054409462121 in 1 BOTTLEHistorical
10544-946-281054409462828 in 1 BOTTLEHistorical
10544-946-301054409463030 in 1 BOTTLEHistorical
10544-946-401054409464040 in 1 BOTTLEHistorical