FDA.reportPublic FDA data

Alendronate Sodium

Product NDC
0115-1679
11-digit product format
001151679
Labeler code
0115
Product ID
0115-1679_0bb7b70c-72e0-4bb8-9d3a-0fc8e4762dd1
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Alendronate Sodium
Dosage form
TABLET
Route
ORAL
Labeler
Amneal Pharmaceuticals of New York LLC
Application
ANDA075710
Marketing category
ANDA
Marketing start
2008-02-06
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, 904405, 904419, 904425, 904431

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
0115-1679-262020-12-29C16284748780-1ab0e2407-2660-f274-e053-dbdaa90a6471These 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
0115-1679-342020-12-29C16284748780-1ab0e2407-2660-f274-e053-dbdaa90a6471These 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
0115-1679-262020-09-27C16284748780-1ab0e2407-2660-f274-e053-dbdaa90a6471These 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
0115-1679-342020-09-27C16284748780-1ab0e2407-2660-f274-e053-dbdaa90a6471These 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
0115-1679-262020-09-25C16284748780-1ab0e2407-2660-f274-e053-dbdaa90a6471These 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
0115-1679-342020-09-25C16284748780-1ab0e2407-2660-f274-e053-dbdaa90a6471These 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
0115-1679-262020-07-22C16284748780-1ab0e2407-2660-f274-e053-dbdaa90a6471These 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
0115-1679-342020-07-22C16284748780-1ab0e2407-2660-f274-e053-dbdaa90a6471These 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
0115-1679-26Alendronate Sodium12 in 1 CARTONTABLET1240
0115-1679-30Alendronate Sodium1 in 1 BLISTER PACKTABLET140
0115-1679-34Alendronate Sodium4 in 1 CARTONTABLET440

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0115-1679-26EA - Each0115-16792405624c-7aec-4142-ae34-2152d94d37e512017-06-15
0115-1679-30EA - Each0115-16797a8a05f4-d6e0-4fb5-b8c5-3b503a933e3e12017-06-15
0115-1679-34EA - Each0115-16791ecbd50d-f5d0-4ec6-b9cf-d315c54b1b3c12017-03-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0115-1679ALENDRONATE SODIUM TABLET [AMNEAL PHARMACEUTICALS OF NEW YORK LLC]40Current NDC, Legacy NDC, 3 package rows20231231_c23fb7fe-c6b9-4f77-bde7-992222b589d3.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
904419alendronate sodium 10 MG Oral TabletPSNc23fb7fe-c6b9-4f77-bde7-992222b589d340
904396alendronate sodium 35 MG Oral TabletPSNc23fb7fe-c6b9-4f77-bde7-992222b589d340
904405alendronate sodium 40 MG Oral TabletPSNc23fb7fe-c6b9-4f77-bde7-992222b589d340
904425alendronate sodium 5 MG Oral TabletPSNc23fb7fe-c6b9-4f77-bde7-992222b589d340
904431alendronate sodium 70 MG Oral TabletPSNc23fb7fe-c6b9-4f77-bde7-992222b589d340
904419alendronic acid 10 MG Oral TabletSCDc23fb7fe-c6b9-4f77-bde7-992222b589d340
904396alendronic acid 35 MG Oral TabletSCDc23fb7fe-c6b9-4f77-bde7-992222b589d340
904405alendronic acid 40 MG Oral TabletSCDc23fb7fe-c6b9-4f77-bde7-992222b589d340
904425alendronic acid 5 MG Oral TabletSCDc23fb7fe-c6b9-4f77-bde7-992222b589d340
904431alendronic acid 70 MG Oral TabletSCDc23fb7fe-c6b9-4f77-bde7-992222b589d340
904419alendronic acid 10 MG (as alendronate sodium 13.1 MG) Oral TabletSYc23fb7fe-c6b9-4f77-bde7-992222b589d340
904396alendronic acid 35 MG (as alendronate sodium 45.7 MG) Oral TabletSYc23fb7fe-c6b9-4f77-bde7-992222b589d340
904405alendronic acid 40 MG (as alendronate sodium 52.21 MG) Oral TabletSYc23fb7fe-c6b9-4f77-bde7-992222b589d340
904425alendronic acid 5 MG (as alendronate sodium 6.53 MG) Oral TabletSYc23fb7fe-c6b9-4f77-bde7-992222b589d340
904431alendronic acid 70 MG (as alendronate sodium 91.4 MG) Oral TabletSYc23fb7fe-c6b9-4f77-bde7-992222b589d340

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0115-1679-260011516792612 BLISTER PACK in 1 CARTON (0115-1679-26) / 1 TABLET in 1 BLISTER PACK (0115-1679-30) 12 blister pack2008-02-060000-00-00NoNoCurrent
0115-1679-30001151679301 in 1 BLISTER PACKHistorical
0115-1679-34001151679344 BLISTER PACK in 1 CARTON (0115-1679-34) / 1 TABLET in 1 BLISTER PACK (0115-1679-30) 4 blister pack2008-02-060000-00-00NoNoCurrent