cephalexin

Product NDC
68788-8686
11-digit product format
687888686
Labeler code
68788
Product ID
68788-8686_3a87a0b6-8329-4c01-9c1d-bcc8ccb74c91
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Cephalexin
Dosage form
FOR SUSPENSION
Route
ORAL
Labeler
Preferred Pharmaceuticals Inc.
Application
ANDA065234
Marketing category
ANDA
Marketing start
2024-06-03
Substance
CEPHALEXIN
Active strength
250 mg/5mL
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/5mL

Harmonized Identifiers#

Field, Values table
FieldValues
UniiOBN7UDS42Y
Rxcui309113

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
68788-8686-2cephalexin200 mL in 1 BOTTLEFOR SUSPENSION2003

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
68788-8686-2ML - Milliliter68788-868698e3989f-5204-4b13-bdeb-01ddbc407a8112024-08-12

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68788-8686CEPHALEXIN FOR SUSPENSION [PREFERRED PHARMACEUTICALS INC.]2Current NDC, 1 package rows20250224_553485f8-890d-4929-a6bb-905221cf411d.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
309113cephalexin 250 MG in 5 mL Oral SuspensionPSN553485f8-890d-4929-a6bb-905221cf411d3
309113cephalexin 50 MG/ML Oral SuspensionSCD553485f8-890d-4929-a6bb-905221cf411d3
309113cefalexin 50 MG/ML Oral SuspensionSY553485f8-890d-4929-a6bb-905221cf411d3
309113cephalexin 250 MG per 5 ML Oral SuspensionSY553485f8-890d-4929-a6bb-905221cf411d3

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
68788-8686-268788868602200 mL in 1 BOTTLE (68788-8686-2) 200 ml2024-06-03NoNoHistorical