FDA.reportPublic FDA data

Cephalexin

Product NDC
42043-143
11-digit product format
420430143
Labeler code
42043
Product ID
42043-143_63242ddf-3c2f-4f74-b95e-dd29cafa8f84
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Cephalexin
Dosage form
POWDER, FOR SUSPENSION
Route
ORAL
Labeler
OrchidPharma Inc
Application
ANDA065326
Marketing category
ANDA
Marketing start
2007-04-12
Marketing end
2021-01-31
Substance
CEPHALEXIN
Active strength
250 mg/5mL
Pharmacologic classes
Cephalosporin Antibacterial [EPC],Cephalosporins [CS]
NDC exclude flag
No
Listing certified through
0000-00-00
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

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
42043-143-38ML - Milliliter42043-1437caf83b8-8238-43f7-81fa-e720e909014312012-07-24
42043-143-58ML - Milliliter42043-1436d888021-61ba-4bbf-9f3f-81474c29e94c12012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
CEPHALEXINACTIVE INGREDIENTOBN7UDS42YCEPHALEXIN POWDER, FOR SUSPENSION [STAT RX USA LLC]2
CEPHALEXIN ANHYDROUSACTIVE MOIETY5SFF1W6677CEPHALEXIN POWDER, FOR SUSPENSION [STAT RX USA LLC]2
FD&C YELLOW NO. 6INACTIVE INGREDIENTH77VEI93A8CEPHALEXIN POWDER, FOR SUSPENSION [STAT RX USA LLC]2
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4CEPHALEXIN POWDER, FOR SUSPENSION [STAT RX USA LLC]2
SODIUM LAURYL SULFATEINACTIVE INGREDIENT368GB5141JCEPHALEXIN POWDER, FOR SUSPENSION [STAT RX USA LLC]2
SUCROSEINACTIVE INGREDIENTC151H8M554CEPHALEXIN POWDER, FOR SUSPENSION [STAT RX USA LLC]2
XANTHAN GUMINACTIVE INGREDIENTTTV12P4NEECEPHALEXIN POWDER, FOR SUSPENSION [STAT RX USA LLC]2

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
309113cephalexin 250 MG in 5 mL Oral SuspensionPSN5c60a424-8ec5-003e-e053-2a91aa0ab3f03
309113cephalexin 50 MG/ML Oral SuspensionSCD5c60a424-8ec5-003e-e053-2a91aa0ab3f03
309113cefalexin 50 MG/ML Oral SuspensionSY5c60a424-8ec5-003e-e053-2a91aa0ab3f03
309113cephalexin 250 MG per 5 ML Oral SuspensionSY5c60a424-8ec5-003e-e053-2a91aa0ab3f03
309110cephalexin 125 MG in 5 mL Oral SuspensionPSNb5da860d-9cfc-4020-bc81-11f2a01e660b2
309113cephalexin 250 MG in 5 mL Oral SuspensionPSNb5da860d-9cfc-4020-bc81-11f2a01e660b2
309110cephalexin 25 MG/ML Oral SuspensionSCDb5da860d-9cfc-4020-bc81-11f2a01e660b2
309113cephalexin 50 MG/ML Oral SuspensionSCDb5da860d-9cfc-4020-bc81-11f2a01e660b2
309110cefalexin 25 MG/ML Oral SuspensionSYb5da860d-9cfc-4020-bc81-11f2a01e660b2
309113cefalexin 50 MG/ML Oral SuspensionSYb5da860d-9cfc-4020-bc81-11f2a01e660b2
309110cephalexin 125 MG per 5 ML Oral SuspensionSYb5da860d-9cfc-4020-bc81-11f2a01e660b2
309113cephalexin 250 MG per 5 ML Oral SuspensionSYb5da860d-9cfc-4020-bc81-11f2a01e660b2