FDA.reportPublic FDA data

Cephalexin

Product NDC
50090-5948
11-digit product format
500905948
Labeler code
50090
Product ID
50090-5948_1e7cbdfc-183a-407e-b3f2-6985ababb93e
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Cephalexin
Dosage form
CAPSULE
Route
ORAL
Labeler
A-S Medication Solutions
Application
ANDA090836
Marketing category
ANDA
Marketing start
2015-10-19
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
50090-5948-0Cephalexin20 in 1 BOTTLECAPSULE204
50090-5948-1Cephalexin28 in 1 BOTTLECAPSULE284
50090-5948-2Cephalexin40 in 1 BOTTLECAPSULE404
50090-5948-3Cephalexin14 in 1 BOTTLECAPSULE144
50090-5948-5Cephalexin10 in 1 BOTTLECAPSULE104
50090-5948-7Cephalexin100 in 1 BOTTLECAPSULE1004
50090-5948-8Cephalexin4 in 1 BOTTLECAPSULE44

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
50090-5948-0EA - Each50090-594810e5f767-7e8c-4ee9-808c-f2655ebed6f312024-02-14
50090-5948-1EA - Each50090-5948d738e9cb-a70c-4f71-b571-bec3377bc05612024-02-14
50090-5948-2EA - Each50090-59488983c57b-4c07-4605-9c98-c3040940f42b12024-02-14
50090-5948-3EA - Each50090-594811420113-aa69-4cbd-9704-24a08f750e3c12024-02-14
50090-5948-5EA - Each50090-594839e7e96b-af57-4f37-87a8-56bdf6689dff12024-02-14
50090-5948-7EA - Each50090-5948040c6dcf-f2ff-4807-83f9-bf1895c1143b12024-02-14
50090-5948-8EA - Each50090-594875602bce-69f7-4985-a3f7-4245d3d5d5da12024-02-14

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50090-5948CEPHALEXIN CAPSULE [A-S MEDICATION SOLUTIONS]4Current NDC, 7 package rows20240518_712a6789-7aab-4114-ae92-d1c7686c6b96.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
309114cephalexin 500 MG Oral CapsulePSN712a6789-7aab-4114-ae92-d1c7686c6b964
309114cephalexin 500 MG Oral CapsuleSCD712a6789-7aab-4114-ae92-d1c7686c6b964
309114cefalexin (as cefalexin monohydrate) 500 MG Oral CapsuleSY712a6789-7aab-4114-ae92-d1c7686c6b964

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
50090-5948-05009059480020 CAPSULE in 1 BOTTLE (50090-5948-0) 20 capsule2024-01-08NoNoCurrent
50090-5948-15009059480128 CAPSULE in 1 BOTTLE (50090-5948-1) 28 capsule2024-01-08NoNoCurrent
50090-5948-25009059480240 CAPSULE in 1 BOTTLE (50090-5948-2) 40 capsule2024-01-08NoNoCurrent
50090-5948-35009059480314 CAPSULE in 1 BOTTLE (50090-5948-3) 14 capsule2024-01-08NoNoCurrent
50090-5948-55009059480510 CAPSULE in 1 BOTTLE (50090-5948-5) 10 capsule2024-01-08NoNoCurrent
50090-5948-750090594807100 CAPSULE in 1 BOTTLE (50090-5948-7) 100 capsule2024-01-08NoNoCurrent
50090-5948-8500905948084 CAPSULE in 1 BOTTLE (50090-5948-8) 4 capsule2022-03-31NoNoCurrent