FDA.reportPublic FDA data

Cephalexin

Product NDC
63187-046
11-digit product format
631870046
Labeler code
63187
Product ID
63187-046_8202b9f1-6f03-4f64-a300-062d1679d0e8
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Cephalexin
Dosage form
CAPSULE
Route
ORAL
Labeler
Proficient Rx LP
Application
ANDA065229
Marketing category
ANDA
Marketing start
2006-01-11
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
63187-046-06Cephalexin6 in 1 BOTTLECAPSULE610
63187-046-14Cephalexin14 in 1 BOTTLECAPSULE1410
63187-046-15Cephalexin15 in 1 BOTTLECAPSULE1510
63187-046-20Cephalexin20 in 1 BOTTLECAPSULE2010
63187-046-21Cephalexin21 in 1 BOTTLECAPSULE2110
63187-046-28Cephalexin28 in 1 BOTTLECAPSULE2810
63187-046-30Cephalexin30 in 1 BOTTLECAPSULE3010
63187-046-40Cephalexin40 in 1 BOTTLECAPSULE4010

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
63187-046-06EA - Each63187-0461a0695fb-57da-4c7c-b591-4f0dbab7676d12018-08-13
63187-046-14EA - Each63187-0469653b805-3a70-47a5-af10-f50f3056c9e112018-12-13
63187-046-15EA - Each63187-04636532d0b-11a9-4246-81a7-d6584556ea9312019-04-11
63187-046-20EA - Each63187-04656551b30-ef54-4c09-9632-18f7f05145fb12021-08-05
63187-046-28EA - Each63187-046157d8ee2-2952-420d-8498-b64311b4a7ae12018-05-09
63187-046-30EA - Each63187-046a423f9aa-3bff-4a2f-8b6b-b23ee463ec1612015-07-20
63187-046-40EA - Each63187-04654db13b5-ad5c-47ed-9cf4-48acc97f380f12015-05-05

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
CEPHALEXINACTIVE INGREDIENTOBN7UDS42YCEPHALEXIN CAPSULE [PROFICIENT RX LP]2
CEPHALEXIN ANHYDROUSACTIVE MOIETY5SFF1W6677CEPHALEXIN CAPSULE [PROFICIENT RX LP]2
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UCEPHALEXIN CAPSULE [PROFICIENT RX LP]2
D&C YELLOW NO. 10INACTIVE INGREDIENT35SW5USQ3GCEPHALEXIN CAPSULE [PROFICIENT RX LP]2
FD&C BLUE NO. 1INACTIVE INGREDIENTH3R47K3TBDCEPHALEXIN CAPSULE [PROFICIENT RX LP]2
FD&C GREEN NO. 3INACTIVE INGREDIENT3P3ONR6O1SCEPHALEXIN CAPSULE [PROFICIENT RX LP]2
FD&C YELLOW NO. 6INACTIVE INGREDIENTH77VEI93A8CEPHALEXIN CAPSULE [PROFICIENT RX LP]2
FERROSOFERRIC OXIDEINACTIVE INGREDIENTXM0M87F357CEPHALEXIN CAPSULE [PROFICIENT RX LP]2
GELATININACTIVE INGREDIENT2G86QN327LCEPHALEXIN CAPSULE [PROFICIENT RX LP]2
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30CEPHALEXIN CAPSULE [PROFICIENT RX LP]2
POTASSIUM HYDROXIDEINACTIVE INGREDIENTWZH3C48M4TCEPHALEXIN CAPSULE [PROFICIENT RX LP]2
PROPYLENE GLYCOLINACTIVE INGREDIENT6DC9Q167V3CEPHALEXIN CAPSULE [PROFICIENT RX LP]2
SHELLACINACTIVE INGREDIENT46N107B71OCEPHALEXIN CAPSULE [PROFICIENT RX LP]2
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPCEPHALEXIN CAPSULE [PROFICIENT RX LP]2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
63187-046CEPHALEXIN CAPSULE [PROFICIENT RX LP]10Current NDC, Legacy NDC, 8 package rows20220517_dec3a1ef-1e85-4236-804b-e7a343d3a58f.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
309114cephalexin 500 MG Oral CapsulePSNdec3a1ef-1e85-4236-804b-e7a343d3a58f10
309114cephalexin 500 MG Oral CapsuleSCDdec3a1ef-1e85-4236-804b-e7a343d3a58f10
309114cefalexin (as cefalexin monohydrate) 500 MG Oral CapsuleSYdec3a1ef-1e85-4236-804b-e7a343d3a58f10

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
63187-046-06631870046066 CAPSULE in 1 BOTTLE (63187-046-06) 6 capsule2018-04-020000-00-00NoNoCurrent
63187-046-146318700461414 CAPSULE in 1 BOTTLE (63187-046-14) 14 capsule2018-10-010000-00-00NoNoCurrent
63187-046-156318700461515 CAPSULE in 1 BOTTLE (63187-046-15) 15 capsule2019-03-010000-00-00NoNoCurrent
63187-046-206318700462020 CAPSULE in 1 BOTTLE (63187-046-20) 20 capsule2014-04-010000-00-00NoNoCurrent
63187-046-216318700462121 CAPSULE in 1 BOTTLE (63187-046-21) 21 capsule2014-04-010000-00-00NoNoCurrent
63187-046-286318700462828 CAPSULE in 1 BOTTLE (63187-046-28) 28 capsule2018-01-010000-00-00NoNoCurrent
63187-046-306318700463030 CAPSULE in 1 BOTTLE (63187-046-30) 30 capsule2014-04-010000-00-00NoNoCurrent
63187-046-406318700464040 CAPSULE in 1 BOTTLE (63187-046-40) 40 capsule2014-04-010000-00-00NoNoCurrent