Alendronate

Product NDC
50090-3593
11-digit product format
500903593
Labeler code
50090
Product ID
50090-3593_be64fe04-2b96-4ad4-a888-6298df3ad68d
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
ALENDRONATE SODIUM
Dosage form
TABLET
Route
ORAL
Labeler
A-S Medication Solutions
Application
ANDA090258
Marketing category
ANDA
Marketing start
2016-05-12
Marketing end
0000-00-00
Substance
ALENDRONATE SODIUM
Active strength
35 mg/1
Pharmacologic classes
Bisphosphonate [EPC],Diphosphonates [CS]
NDC exclude flag
No
Listing certified through
2021-12-31
Current FDA listing
Historical FDA.report record

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
b55122e7-1795-3be6-8216-d42256d80e7dProduct name220250224
c3d77bcb-5cf1-4ea6-9307-38d8932a8b0aProduct name120240513
60c52429-fcef-eb54-2387-43bc9e4f296bProduct name120140508
c00e0569-fbc4-d31d-3ec8-d316fcedaffcProduct name120140508

FDA-Initiated Inactive NDC Indexing#

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
50090-3593-0Alendronate4 in 1 BLISTER PACKTABLET43
50090-3593-0Alendronate1 in 1 CARTONTABLET13

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50090-3593ALENDRONATE (ALENDRONATE SODIUM) TABLET [A-S MEDICATION SOLUTIONS]3Legacy NDC, 2 package rows20200122_9955ffad-e774-4e2c-a42b-77118ba7bd21.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
904396alendronate sodium 35 MG Oral TabletPSN9955ffad-e774-4e2c-a42b-77118ba7bd213
904396alendronic acid 35 MG Oral TabletSCD9955ffad-e774-4e2c-a42b-77118ba7bd213
904396alendronic acid 35 MG (as alendronate sodium 45.7 MG) Oral TabletSY9955ffad-e774-4e2c-a42b-77118ba7bd213

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
50090-3593-0500903593001 BLISTER PACK in 1 CARTON (50090-3593-0) > 4 TABLET in 1 BLISTER PACK1 blister pack2018-10-010000-00-00NoNoCurrent