ALENDRONATE SODIUM

Product NDC
50090-4692
11-digit product format
500904692
Labeler code
50090
Product ID
50090-4692_789fd89e-ccc6-4b79-9611-c35fa3061ba7
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Alendronate sodium
Dosage form
TABLET
Route
ORAL
Labeler
A-S Medication Solutions
Application
ANDA076768
Marketing category
ANDA
Marketing start
2008-08-04
Substance
ALENDRONATE SODIUM
Active strength
70 mg/1
Pharmacologic classes
Bisphosphonate [EPC], Diphosphonates [CS]
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
ALENDRONATE SODIUM
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
ALENDRONATE SODIUM70 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii2UY4M2U3RA
Rxcui904431

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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
50090-4692-0ALENDRONATE SODIUM4 in 1 BLISTER PACKTABLET412
50090-4692-0ALENDRONATE SODIUM1 in 1 CARTONTABLET112
50090-4692-1ALENDRONATE SODIUM3 in 1 CARTONTABLET312
50090-4692-1ALENDRONATE SODIUM4 in 1 BLISTER PACKTABLET412

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50090-4692ALENDRONATE SODIUM TABLET [A-S MEDICATION SOLUTIONS]10Current NDC, Legacy NDC, 4 package rows20231026_fe1dd324-eb02-4a73-97f5-9b77a7df10a7.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
904431alendronate sodium 70 MG Oral TabletPSNfe1dd324-eb02-4a73-97f5-9b77a7df10a712
904431alendronic acid 70 MG Oral TabletSCDfe1dd324-eb02-4a73-97f5-9b77a7df10a712
904431alendronic acid 70 MG (as alendronate sodium 91.4 MG) Oral TabletSYfe1dd324-eb02-4a73-97f5-9b77a7df10a712

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
50090-4692-0500904692001 BLISTER PACK in 1 CARTON (50090-4692-0) / 4 TABLET in 1 BLISTER PACK1 blister pack2019-11-070000-00-00NoNoCurrent
50090-4692-1500904692013 BLISTER PACK in 1 CARTON (50090-4692-1) / 4 TABLET in 1 BLISTER PACK3 blister pack2019-11-070000-00-00NoNoCurrent