FDA.reportPublic FDA data

ALENDRONATE SODIUM

Product NDC
68071-3340
11-digit product format
680713340
Labeler code
68071
Product ID
68071-3340_1cd71696-d95a-be3e-e063-6394a90a28c8
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Alendronate sodium
Dosage form
TABLET
Route
ORAL
Labeler
NuCare Pharmaceuticals,Inc.
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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
68071-3340-42024-07-09C16284748780-1ba0f9c33-1cdc-a910-e053-dadaa90a0b85These 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
68071-3340-42023-01-30C16284748780-1ba0f9c33-1cdc-a910-e053-dadaa90a0b85These 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
68071-3340-42021-02-12C16284748780-1ba0f9c33-1cdc-a910-e053-dadaa90a0b85These 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
68071-3340-42021-01-29C16284748780-1ba0f9c33-1cdc-a910-e053-dadaa90a0b85These 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
68071-3340-4ALENDRONATE SODIUM4 in 1 BOXTABLET45

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68071-3340ALENDRONATE SODIUM TABLET [NUCARE PHARMACEUTICALS,INC.]5Current NDC, Legacy NDC, 1 package rows20240711_54d6543d-4239-58b1-e054-00144ff88e88.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
904431alendronate sodium 70 MG Oral TabletPSN54d6543d-4239-58b1-e054-00144ff88e885
904431alendronic acid 70 MG Oral TabletSCD54d6543d-4239-58b1-e054-00144ff88e885
904431alendronic acid 70 MG (as alendronate sodium 91.4 MG) Oral TabletSY54d6543d-4239-58b1-e054-00144ff88e885

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
68071-3340-4680713340044 TABLET in 1 BOX (68071-3340-4) 4 tablet2017-07-210000-00-00NoNoCurrent