FDA.reportPublic FDA data

Alendronate Sodium

Product NDC
50090-5474
11-digit product format
500905474
Labeler code
50090
Product ID
50090-5474_ba2f861a-83ad-41c5-92f7-118ccd734232
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Alendronate Sodium
Dosage form
TABLET
Route
ORAL
Labeler
A-S Medication Solutions
Application
ANDA090124
Marketing category
ANDA
Marketing start
2008-08-04
Substance
ALENDRONATE SODIUM
Active strength
35 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 SODIUM35 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii2UY4M2U3RA
Rxcui904396

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
50090-5474-02023-02-07C16284748780-1f386c64a-398d-0266-e053-dadaa90a7c1aThese 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
50090-5474-02023-01-30C16284748780-1f386c64a-398d-0266-e053-dadaa90a7c1aThese 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
50090-5474-0Alendronate Sodium1 in 1 CARTONTABLET15
50090-5474-0Alendronate Sodium4 in 1 BLISTER PACKTABLET45

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50090-5474ALENDRONATE SODIUM TABLET [A-S MEDICATION SOLUTIONS]5Current NDC, Legacy NDC, 2 package rows20241114_873442b0-1932-4fa6-ba25-b4d3505f4128.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
904396alendronate sodium 35 MG Oral TabletPSN873442b0-1932-4fa6-ba25-b4d3505f41285
904396alendronic acid 35 MG Oral TabletSCD873442b0-1932-4fa6-ba25-b4d3505f41285
904396alendronic acid 35 MG (as alendronate sodium 45.7 MG) Oral TabletSY873442b0-1932-4fa6-ba25-b4d3505f41285

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
50090-5474-0500905474001 BLISTER PACK in 1 CARTON (50090-5474-0) / 4 TABLET in 1 BLISTER PACK1 blister pack2021-03-020000-00-00NoNoCurrent