ALENDRONATE SODIUM

Product NDC
68071-3771
11-digit product format
680713771
Labeler code
68071
Product ID
68071-3771_2bade79f-52fa-d5c1-e063-6294a90aa204
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
a62a50ac-1535-4461-9768-8ae703e2e9fbProduct name120210525
60c52429-fcef-eb54-2387-43bc9e4f296bProduct name120140508
9514609b-a2a9-f8ec-6ba6-3f8e5ee89877Product name120140508
bc07ef78-e82d-0c19-31f4-31f263780582Product name120140508
c00e0569-fbc4-d31d-3ec8-d316fcedaffcProduct name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
68071-3771-5ALENDRONATE SODIUM15 in 1 CARTONTABLET151
68071-3771-5ALENDRONATE SODIUM1 in 1 BLISTER PACKTABLET11

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68071-3771ALENDRONATE SODIUM TABLET [NUCARE PHARMACEUTICALS, INC.]1Current NDC, 2 package rows20250116_2baf8516-4148-9007-e063-6394a90a8094.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
904431alendronate sodium 70 MG Oral TabletPSN2baf8516-4148-9007-e063-6394a90a80941
904431alendronic acid 70 MG Oral TabletSCD2baf8516-4148-9007-e063-6394a90a80941
904431alendronic acid 70 MG (as alendronate sodium 91.4 MG) Oral TabletSY2baf8516-4148-9007-e063-6394a90a80941

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
68071-3771-56807137710515 BLISTER PACK in 1 CARTON (68071-3771-5) / 1 TABLET in 1 BLISTER PACK15 blister pack2025-01-14NoNoCurrent