FDA.reportPublic FDA data

Cephalexin

Product NDC
55289-058
11-digit product format
552890058
Labeler code
55289
Product ID
55289-058_4304de4b-4197-e324-e063-6394a90ad3d4
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Cephalexin
Dosage form
CAPSULE
Route
ORAL
Labeler
PD-Rx Pharmaceuticals, Inc.
Application
ANDA062702
Marketing category
ANDA
Marketing start
1990-09-30
Substance
CEPHALEXIN
Active strength
500 mg/1
Pharmacologic classes
Cephalosporin Antibacterial [EPC], Cephalosporins [CS]
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Cephalexin
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
CEPHALEXIN500 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiOBN7UDS42Y
Rxcui309114

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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
55289-058-10Cephalexin10 in 1 BOTTLE, PLASTICCAPSULE1025
55289-058-14Cephalexin14 in 1 BOTTLE, PLASTICCAPSULE1425
55289-058-20Cephalexin20 in 1 BOTTLE, PLASTICCAPSULE2025
55289-058-28Cephalexin28 in 1 BOTTLE, PLASTICCAPSULE2825
55289-058-30Cephalexin30 in 1 BOTTLE, PLASTICCAPSULE3025
55289-058-40Cephalexin40 in 1 BOTTLE, PLASTICCAPSULE4025

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
55289-058-04EA - Each55289-058b86f91d2-ecd4-4bbc-80d3-ea47129bd30f12012-07-24
55289-058-08EA - Each55289-0583ca02006-349c-42d5-8fb8-e36d3cd2c8ca12012-07-24
55289-058-10EA - Each55289-058b087d70b-6a40-4f33-8795-97d27d1dd03b12012-07-24
55289-058-14EA - Each55289-0582b36b440-d059-409d-a87b-b266c50d3a7a12012-07-24
55289-058-20EA - Each55289-05835d2e2fa-2b17-4d6f-8037-728b75a0acd812012-07-24
55289-058-21EA - Each55289-058554a729c-7c3b-48c1-9e1e-6865938dd5d712012-07-24
55289-058-24EA - Each55289-058def5bb03-52fb-4e47-83d0-ee22189f5e2712012-07-24
55289-058-28EA - Each55289-05856b5b7e5-03c2-4e11-9c76-9658adec919212012-07-24
55289-058-30EA - Each55289-0586aaa7394-5e23-4304-bde0-e9613d51961712012-07-24
55289-058-40EA - Each55289-058054b394d-0441-4fee-a758-9cfd3be85e7412012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
CEPHALEXINACTIVE INGREDIENTOBN7UDS42YCEPHALEXIN CAPSULE [PD-RX PHARMACEUTICALS, INC.]10
CEPHALEXIN ANHYDROUSACTIVE MOIETY5SFF1W6677CEPHALEXIN CAPSULE [PD-RX PHARMACEUTICALS, INC.]10
ALUMINUM OXIDEINACTIVE INGREDIENTLMI26O6933CEPHALEXIN CAPSULE [PD-RX PHARMACEUTICALS, INC.]10
CARBOXYMETHYLCELLULOSE SODIUMINACTIVE INGREDIENTK679OBS311CEPHALEXIN CAPSULE [PD-RX PHARMACEUTICALS, INC.]10
D&C YELLOW NO. 10INACTIVE INGREDIENT35SW5USQ3GCEPHALEXIN CAPSULE [PD-RX PHARMACEUTICALS, INC.]10
FD&C BLUE NO. 1INACTIVE INGREDIENTH3R47K3TBDCEPHALEXIN CAPSULE [PD-RX PHARMACEUTICALS, INC.]10
FD&C BLUE NO. 2INACTIVE INGREDIENTL06K8R7DQKCEPHALEXIN CAPSULE [PD-RX PHARMACEUTICALS, INC.]10
FD&C RED NO. 40INACTIVE INGREDIENTWZB9127XOACEPHALEXIN CAPSULE [PD-RX PHARMACEUTICALS, INC.]10
FERROSOFERRIC OXIDEINACTIVE INGREDIENTXM0M87F357CEPHALEXIN CAPSULE [PD-RX PHARMACEUTICALS, INC.]10
GELATININACTIVE INGREDIENT2G86QN327LCEPHALEXIN CAPSULE [PD-RX PHARMACEUTICALS, INC.]10
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30CEPHALEXIN CAPSULE [PD-RX PHARMACEUTICALS, INC.]10
PROPYLENE GLYCOLINACTIVE INGREDIENT6DC9Q167V3CEPHALEXIN CAPSULE [PD-RX PHARMACEUTICALS, INC.]10
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4CEPHALEXIN CAPSULE [PD-RX PHARMACEUTICALS, INC.]10
SODIUM LAURYL SULFATEINACTIVE INGREDIENT368GB5141JCEPHALEXIN CAPSULE [PD-RX PHARMACEUTICALS, INC.]10
SODIUM STARCH GLYCOLATE TYPE A POTATOINACTIVE INGREDIENT5856J3G2A2CEPHALEXIN CAPSULE [PD-RX PHARMACEUTICALS, INC.]10
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPCEPHALEXIN CAPSULE [PD-RX PHARMACEUTICALS, INC.]10

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
55289-058CEPHALEXIN CAPSULE [PD-RX PHARMACEUTICALS, INC.]23Current NDC, Legacy NDC, 6 package rows20241011_6ce11859-aa21-4b3f-bd59-3cd26deca82b.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
309114cephalexin 500 MG Oral CapsulePSN6ce11859-aa21-4b3f-bd59-3cd26deca82b25
309114cephalexin 500 MG Oral CapsuleSCD6ce11859-aa21-4b3f-bd59-3cd26deca82b25
309114cefalexin (as cefalexin monohydrate) 500 MG Oral CapsuleSY6ce11859-aa21-4b3f-bd59-3cd26deca82b25

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
55289-058-04552890058044 CAPSULE in 1 BOTTLE, PLASTIC (55289-058-04) 4 capsule2011-06-060000-00-00NoNoCurrent
55289-058-08552890058088 CAPSULE in 1 BOTTLE, PLASTIC (55289-058-08) 8 capsule2011-06-060000-00-00NoNoCurrent
55289-058-105528900581010 CAPSULE in 1 BOTTLE, PLASTIC (55289-058-10) 10 capsule2011-06-060000-00-00NoNoCurrent
55289-058-145528900581414 CAPSULE in 1 BOTTLE, PLASTIC (55289-058-14) 14 capsule2011-06-060000-00-00NoNoCurrent
55289-058-205528900582020 CAPSULE in 1 BOTTLE, PLASTIC (55289-058-20) 20 capsule2011-06-060000-00-00NoNoCurrent
55289-058-215528900582121 CAPSULE in 1 BOTTLE, PLASTIC (55289-058-21) 21 capsule2011-06-060000-00-00NoNoCurrent
55289-058-245528900582424 CAPSULE in 1 BOTTLE, PLASTIC (55289-058-24) 24 capsule2011-06-060000-00-00NoNoCurrent
55289-058-285528900582828 CAPSULE in 1 BOTTLE, PLASTIC (55289-058-28) 28 capsule2011-06-060000-00-00NoNoCurrent
55289-058-305528900583030 CAPSULE in 1 BOTTLE, PLASTIC (55289-058-30) 30 capsule2011-06-060000-00-00NoNoCurrent
55289-058-405528900584040 CAPSULE in 1 BOTTLE, PLASTIC (55289-058-40) 40 capsule2011-06-060000-00-00NoNoCurrent