Cephalexin

Product NDC
52959-030
11-digit product format
529590030
Labeler code
52959
Product ID
52959-030_87894a01-9fab-4362-b6d4-f9a5f6a88d0f
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Cephalexin
Dosage form
CAPSULE
Route
ORAL
Labeler
H.J. Harkins Company, Inc.
Application
ANDA065229
Marketing category
ANDA
Marketing start
2005-12-01
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#

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
52959-030-01Cephalexin100 in 1 BOTTLECAPSULE1003
52959-030-08Cephalexin8 in 1 BOTTLECAPSULE83
52959-030-12Cephalexin12 in 1 BOTTLECAPSULE123
52959-030-20Cephalexin20 in 1 BOTTLECAPSULE203
52959-030-24Cephalexin24 in 1 BOTTLECAPSULE243
52959-030-28Cephalexin28 in 1 BOTTLECAPSULE283
52959-030-30Cephalexin30 in 1 BOTTLECAPSULE303
52959-030-40Cephalexin40 in 1 BOTTLECAPSULE403
52959-030-56Cephalexin56 in 1 BOTTLECAPSULE563

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
52959-030-01EA - Each52959-030f5127944-b352-4d18-94de-a5aef2b0c84e12012-07-24
52959-030-08EA - Each52959-030c32bc9b9-1ee4-403b-b59c-aae901b4ac0d12012-07-24
52959-030-12EA - Each52959-0309b717d56-b9c5-4fec-92ed-37b48d57db8812012-07-24
52959-030-20EA - Each52959-03059b25fa0-e701-44dc-9bc6-1b8cf49413b112012-07-24
52959-030-24EA - Each52959-030258b088b-e311-4c11-a558-72da07a609af12012-07-24
52959-030-28EA - Each52959-0306c6bd164-1dd0-4f7c-a712-300a53bf519612012-07-24
52959-030-30EA - Each52959-03091a29423-07d6-4443-b13a-0d669dbf08df12012-07-24
52959-030-40EA - Each52959-0308c22059d-1c58-4f68-837d-b902d89c6fa412012-07-24
52959-030-56EA - Each52959-03034abba2e-0bfa-42cb-bf90-aeb8c099d74012012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
CEPHALEXINACTIVE INGREDIENTOBN7UDS42YCEPHALEXIN CAPSULE [H.J. HARKINS COMPANY, INC.]3
CEPHALEXIN ANHYDROUSACTIVE MOIETY5SFF1W6677CEPHALEXIN CAPSULE [H.J. HARKINS COMPANY, INC.]3
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UCEPHALEXIN CAPSULE [H.J. HARKINS COMPANY, INC.]3
D&C YELLOW NO. 10INACTIVE INGREDIENT35SW5USQ3GCEPHALEXIN CAPSULE [H.J. HARKINS COMPANY, INC.]3
FD&C BLUE NO. 1INACTIVE INGREDIENTH3R47K3TBDCEPHALEXIN CAPSULE [H.J. HARKINS COMPANY, INC.]3
FD&C GREEN NO. 3INACTIVE INGREDIENT3P3ONR6O1SCEPHALEXIN CAPSULE [H.J. HARKINS COMPANY, INC.]3
FD&C YELLOW NO. 6INACTIVE INGREDIENTH77VEI93A8CEPHALEXIN CAPSULE [H.J. HARKINS COMPANY, INC.]3
FERRIC OXIDE BLACKINACTIVE INGREDIENTXM0M87F357CEPHALEXIN CAPSULE [H.J. HARKINS COMPANY, INC.]3
GELATININACTIVE INGREDIENT2G86QN327LCEPHALEXIN CAPSULE [H.J. HARKINS COMPANY, INC.]3
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30CEPHALEXIN CAPSULE [H.J. HARKINS COMPANY, INC.]3
POTASSIUM HYDROXIDEINACTIVE INGREDIENTWZH3C48M4TCEPHALEXIN CAPSULE [H.J. HARKINS COMPANY, INC.]3
PROPYLENE GLYCOLINACTIVE INGREDIENT6DC9Q167V3CEPHALEXIN CAPSULE [H.J. HARKINS COMPANY, INC.]3
SHELLACINACTIVE INGREDIENT46N107B71OCEPHALEXIN CAPSULE [H.J. HARKINS COMPANY, INC.]3
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPCEPHALEXIN CAPSULE [H.J. HARKINS COMPANY, INC.]3

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
52959-030CEPHALEXIN CAPSULE [H.J. HARKINS COMPANY, INC.]3Legacy NDC, 9 package rows20120120_c5f1a7f6-a5a4-48f1-9022-d6d402bfd349.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
309112cephalexin 250 MG Oral CapsulePSNc5f1a7f6-a5a4-48f1-9022-d6d402bfd3493
309112cephalexin 250 MG Oral CapsuleSCDc5f1a7f6-a5a4-48f1-9022-d6d402bfd3493
309112cephalexin (as cephalexin monohydrate) 250 MG Oral CapsuleSYc5f1a7f6-a5a4-48f1-9022-d6d402bfd3493

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionStatus
52959-030-0152959003001100 in 1 BOTTLEHistorical
52959-030-08529590030088 in 1 BOTTLEHistorical
52959-030-125295900301212 in 1 BOTTLEHistorical
52959-030-205295900302020 in 1 BOTTLEHistorical
52959-030-245295900302424 in 1 BOTTLEHistorical
52959-030-285295900302828 in 1 BOTTLEHistorical
52959-030-305295900303030 in 1 BOTTLEHistorical
52959-030-405295900304040 in 1 BOTTLEHistorical
52959-030-565295900305656 in 1 BOTTLEHistorical