Cephalexin

Product NDC
55289-057
11-digit product format
552890057
Labeler code
55289
Product ID
55289-057_4d51b7fa-92f9-1fdd-e063-6394a90af262
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
250 mg/1
Pharmacologic classes
Cephalosporin Antibacterial [EPC], Cephalosporins [CS]
NDC exclude flag
No
Listing certified through
2027-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Cephalexin
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
CEPHALEXIN250 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiOBN7UDS42Y
Rxcui309112

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
55289-057-06Cephalexin6 in 1 BOTTLE, PLASTICCAPSULE627
55289-057-15Cephalexin15 in 1 BOTTLE, PLASTICCAPSULE1527
55289-057-20Cephalexin20 in 1 BOTTLE, PLASTICCAPSULE2027
55289-057-28Cephalexin28 in 1 BOTTLE, PLASTICCAPSULE2827
55289-057-30Cephalexin30 in 1 BOTTLE, PLASTICCAPSULE3027
55289-057-40Cephalexin40 in 1 BOTTLE, PLASTICCAPSULE4027

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
55289-057-06EA - Each55289-0573c8d5a70-3ce6-4927-bc80-827a64e9691c12012-07-24
55289-057-10EA - Each55289-057c82cd5da-8b59-45aa-9c20-4a7f5c06edbb12012-07-24
55289-057-15EA - Each55289-057f8300571-2248-4519-96c8-834718b4107212012-07-24
55289-057-20EA - Each55289-05762d4d437-8c1c-47a4-b6ab-7c45c578d48812012-07-24
55289-057-24EA - Each55289-05756ed8e3f-18f5-47cf-9326-57238432767012012-07-24
55289-057-28EA - Each55289-057da3f3f1c-05a9-4542-86b0-7be82fbd1cd012012-07-24
55289-057-30EA - Each55289-057d655e474-ddd0-4e6f-876a-c0d1731008cd12012-07-24
55289-057-40EA - Each55289-057682f0a61-4b9a-45ba-8c5e-148aaa04cf9a12012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
CEPHALEXINACTIVE INGREDIENTOBN7UDS42YCEPHALEXIN CAPSULE [PD-RX PHARMACEUTICALS, INC.]9
CEPHALEXINACTIVE MOIETYOBN7UDS42YCEPHALEXIN CAPSULE [PD-RX PHARMACEUTICALS, INC.]9
ALUMINUM OXIDEINACTIVE INGREDIENTLMI26O6933CEPHALEXIN CAPSULE [PD-RX PHARMACEUTICALS, INC.]9
CARBOXYMETHYLCELLULOSE SODIUMINACTIVE INGREDIENTK679OBS311CEPHALEXIN CAPSULE [PD-RX PHARMACEUTICALS, INC.]9
D&C YELLOW NO. 10INACTIVE INGREDIENT35SW5USQ3GCEPHALEXIN CAPSULE [PD-RX PHARMACEUTICALS, INC.]9
FD&C BLUE NO. 1INACTIVE INGREDIENTH3R47K3TBDCEPHALEXIN CAPSULE [PD-RX PHARMACEUTICALS, INC.]9
FD&C BLUE NO. 2INACTIVE INGREDIENTL06K8R7DQKCEPHALEXIN CAPSULE [PD-RX PHARMACEUTICALS, INC.]9
FD&C RED NO. 40INACTIVE INGREDIENTWZB9127XOACEPHALEXIN CAPSULE [PD-RX PHARMACEUTICALS, INC.]9
FERRIC OXIDE YELLOWINACTIVE INGREDIENTEX438O2MRTCEPHALEXIN CAPSULE [PD-RX PHARMACEUTICALS, INC.]9
FERROSOFERRIC OXIDEINACTIVE INGREDIENTXM0M87F357CEPHALEXIN CAPSULE [PD-RX PHARMACEUTICALS, INC.]9
GELATININACTIVE INGREDIENT2G86QN327LCEPHALEXIN CAPSULE [PD-RX PHARMACEUTICALS, INC.]9
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30CEPHALEXIN CAPSULE [PD-RX PHARMACEUTICALS, INC.]9
PROPYLENE GLYCOLINACTIVE INGREDIENT6DC9Q167V3CEPHALEXIN CAPSULE [PD-RX PHARMACEUTICALS, INC.]9
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4CEPHALEXIN CAPSULE [PD-RX PHARMACEUTICALS, INC.]9
SODIUM LAURYL SULFATEINACTIVE INGREDIENT368GB5141JCEPHALEXIN CAPSULE [PD-RX PHARMACEUTICALS, INC.]9
SODIUM STARCH GLYCOLATE TYPE A POTATOINACTIVE INGREDIENT5856J3G2A2CEPHALEXIN CAPSULE [PD-RX PHARMACEUTICALS, INC.]9
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPCEPHALEXIN CAPSULE [PD-RX PHARMACEUTICALS, INC.]9

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
55289-057CEPHALEXIN CAPSULE [PD-RX PHARMACEUTICALS, INC.]25Current NDC, Legacy NDC, 6 package rows20241011_3fed2817-fc0d-43cd-9f02-948fbc76672c.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
309112cephalexin 250 MG Oral CapsulePSN3fed2817-fc0d-43cd-9f02-948fbc76672c27
309112cephalexin 250 MG Oral CapsuleSCD3fed2817-fc0d-43cd-9f02-948fbc76672c27
309112cephalexin (as cephalexin monohydrate) 250 MG Oral CapsuleSY3fed2817-fc0d-43cd-9f02-948fbc76672c27

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
55289-057-06552890057066 CAPSULE in 1 BOTTLE, PLASTIC (55289-057-06) 6 capsule2011-06-060000-00-00NoNoCurrent
55289-057-105528900571010 CAPSULE in 1 BOTTLE, PLASTIC (55289-057-10) 10 capsule2011-06-060000-00-00NoNoCurrent
55289-057-155528900571515 CAPSULE in 1 BOTTLE, PLASTIC (55289-057-15) 15 capsule2011-06-060000-00-00NoNoCurrent
55289-057-205528900572020 CAPSULE in 1 BOTTLE, PLASTIC (55289-057-20) 20 capsule2011-06-060000-00-00NoNoCurrent
55289-057-245528900572424 CAPSULE in 1 BOTTLE, PLASTIC (55289-057-24) 24 capsule2011-06-060000-00-00NoNoCurrent
55289-057-285528900572828 CAPSULE in 1 BOTTLE, PLASTIC (55289-057-28) 28 capsule2011-06-060000-00-00NoNoCurrent
55289-057-305528900573030 CAPSULE in 1 BOTTLE, PLASTIC (55289-057-30) 30 capsule2011-06-060000-00-00NoNoCurrent
55289-057-405528900574040 CAPSULE in 1 BOTTLE, PLASTIC (55289-057-40) 40 capsule2011-06-060000-00-00NoNoCurrent