FDA.reportPublic FDA data

Alendronate Sodium

Product NDC
50090-1802
11-digit product format
500901802
Labeler code
50090
Product ID
50090-1802_741552af-641a-4bf2-a9fb-765ad7f7b9e8
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Alendronate Sodium
Dosage form
TABLET
Route
ORAL
Labeler
A-S Medication Solutions
Application
ANDA090022
Marketing category
ANDA
Marketing start
2014-12-15
Marketing end
0000-00-00
Substance
ALENDRONATE SODIUM
Active strength
70 mg/1
Pharmacologic classes
Bisphosphonate [EPC],Diphosphonates [CS]
NDC exclude flag
No
Listing certified through
2019-12-31
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#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
50090-1802-02020-01-31C16284748780-19d75b9d0-bb21-f424-e053-dadaa90a57ceThese highlights do not include all the information needed to use ALENDRONATE SODIUM TABLETS safely and effectively. See full prescribing information for ALENDRONATE SODIUM TABLETS. ALENDRONATE SODIUM tablets, for oral use Initial U.S. Approval: 1995
50090-1802-12020-01-31C16284748780-19d75b9d0-bb21-f424-e053-dadaa90a57ceThese highlights do not include all the information needed to use ALENDRONATE SODIUM TABLETS safely and effectively. See full prescribing information for ALENDRONATE SODIUM TABLETS. ALENDRONATE SODIUM tablets, for oral use Initial U.S. Approval: 1995

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
50090-1802-0Alendronate Sodium1 in 1 CARTONTABLET15
50090-1802-0Alendronate Sodium4 in 1 BLISTER PACKTABLET45
50090-1802-1Alendronate Sodium1 in 1 CARTONTABLET15
50090-1802-1Alendronate Sodium12 in 1 BLISTER PACKTABLET125

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50090-1802ALENDRONATE SODIUM TABLET [A-S MEDICATION SOLUTIONS]5Legacy NDC, 4 package rows20190225_6b12b9c6-9619-48be-977a-f78cc8c288ab.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
904396alendronate sodium 35 MG Oral TabletPSN6b12b9c6-9619-48be-977a-f78cc8c288ab5
904431alendronate sodium 70 MG Oral TabletPSN6b12b9c6-9619-48be-977a-f78cc8c288ab5
904396alendronic acid 35 MG Oral TabletSCD6b12b9c6-9619-48be-977a-f78cc8c288ab5
904431alendronic acid 70 MG Oral TabletSCD6b12b9c6-9619-48be-977a-f78cc8c288ab5
904396alendronic acid 35 MG (as alendronate sodium 45.7 MG) Oral TabletSY6b12b9c6-9619-48be-977a-f78cc8c288ab5
904431alendronic acid 70 MG (as alendronate sodium 91.4 MG) Oral TabletSY6b12b9c6-9619-48be-977a-f78cc8c288ab5

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionStatus
50090-1802-0500901802001 in 1 CARTONHistorical
50090-1802-1500901802011 in 1 CARTONHistorical