FDA.reportPublic FDA data

ALENDRONATE SODIUM

Product NDC
76282-681
11-digit product format
762820681
Labeler code
76282
Product ID
76282-681_2012c7a8-8aa7-4c18-a8c3-fe74d74ac873
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Alendronate sodium
Dosage form
TABLET
Route
ORAL
Labeler
EXELAN PHARMACEUTICALS INC.
Application
ANDA076768
Marketing category
ANDA
Marketing start
2021-02-02
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, 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
76282-681-462023-08-29C16284748780-1e4f33bdf-9b5d-d8a0-e053-dadaa90a6e4eThese 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
76282-681-462022-07-29C16284748780-1e4f33bdf-9b5d-d8a0-e053-dadaa90a6e4eThese 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
76282-681-45ALENDRONATE SODIUM4 in 1 BLISTER PACKTABLET42
76282-681-46ALENDRONATE SODIUM3 in 1 CARTONTABLET32

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
76282-681ALENDRONATE SODIUM TABLET [EXELAN PHARMACEUTICALS INC.]2Current NDC, Legacy NDC, 2 package rows20230830_91a0f73a-d8cd-4197-b431-40707a2150b9.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
904396alendronate sodium 35 MG Oral TabletPSN91a0f73a-d8cd-4197-b431-40707a2150b92
904431alendronate sodium 70 MG Oral TabletPSN91a0f73a-d8cd-4197-b431-40707a2150b92
904396alendronic acid 35 MG Oral TabletSCD91a0f73a-d8cd-4197-b431-40707a2150b92
904431alendronic acid 70 MG Oral TabletSCD91a0f73a-d8cd-4197-b431-40707a2150b92
904396alendronic acid 35 MG (as alendronate sodium 45.7 MG) Oral TabletSY91a0f73a-d8cd-4197-b431-40707a2150b92
904431alendronic acid 70 MG (as alendronate sodium 91.4 MG) Oral TabletSY91a0f73a-d8cd-4197-b431-40707a2150b92

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
76282-681-45762820681454 in 1 BLISTER PACKHistorical
76282-681-46762820681463 BLISTER PACK in 1 CARTON (76282-681-46) / 4 TABLET in 1 BLISTER PACK (76282-681-45) 3 blister pack2021-02-020000-00-00NoNoCurrent