FDA.reportPublic FDA data

Alendronate Sodium

Product NDC
50090-3126
11-digit product format
500903126
Labeler code
50090
Product ID
50090-3126_a9a47d5f-b49e-4c5c-b3dd-1e1172fde5f4
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
70 mg/1
Pharmacologic classes
Bisphosphonate [EPC], Diphosphonates [CS]
NDC exclude flag
No
Listing certified through
2027-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Alendronate Sodium
Listing expiration
2027-12-31

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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
50090-3126-02023-02-07C16284748780-1f386c64a-2a61-0266-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
50090-3126-12023-02-07C16284748780-1f386c64a-2a61-0266-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
50090-3126-02023-01-30C16284748780-1f386c64a-2a61-0266-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
50090-3126-12023-01-30C16284748780-1f386c64a-2a61-0266-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
50090-3126-0Alendronate Sodium4 in 1 BLISTER PACKTABLET411
50090-3126-0Alendronate Sodium1 in 1 CARTONTABLET111
50090-3126-1Alendronate Sodium12 in 1 BOTTLE, PLASTICTABLET1211

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
50090-3126-0EA - Each50090-312675c6727b-b13d-4cd2-a456-2953d02e87a612019-05-02
50090-3126-1EA - Each50090-31265eba3ad0-69e3-4a7e-8d41-f02aaea0cd2912024-03-12

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50090-3126ALENDRONATE SODIUM TABLET [A-S MEDICATION SOLUTIONS]9Current NDC, Legacy NDC, 3 package rows20231222_d52cf007-5775-4dea-9f43-b1907b6ffe81.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
904431alendronate sodium 70 MG Oral TabletPSNd52cf007-5775-4dea-9f43-b1907b6ffe8111
904431alendronic acid 70 MG Oral TabletSCDd52cf007-5775-4dea-9f43-b1907b6ffe8111
904431alendronic acid 70 MG (as alendronate sodium 91.4 MG) Oral TabletSYd52cf007-5775-4dea-9f43-b1907b6ffe8111

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
50090-3126-0500903126001 BLISTER PACK in 1 CARTON (50090-3126-0) / 4 TABLET in 1 BLISTER PACK1 blister pack2017-08-240000-00-00NoNoCurrent
50090-3126-15009031260112 TABLET in 1 BOTTLE, PLASTIC (50090-3126-1) 12 tablet2014-11-280000-00-00NoNoCurrent