Alendronate Sodium

Product NDC
33261-554
11-digit product format
332610554
Labeler code
33261
Product ID
33261-554_533f028c-bba8-491b-9860-bd45f27d352b
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Alendronate Sodium
Dosage form
TABLET
Route
ORAL
Labeler
Aidarex Pharmaceuticals LLC
Application
ANDA075710
Marketing category
ANDA
Marketing start
2008-02-06
Marketing end
0000-00-00
Substance
ALENDRONATE SODIUM
Active strength
70 mg/1
Pharmacologic classes
Bisphosphonate [EPC],Diphosphonates [CS]
NDC exclude flag
No
Listing certified through
2019-12-31
Current FDA listing
Historical FDA.report record

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#

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
33261-554-01Alendronate Sodium4 in 1 BOXTABLET41
33261-554-01Alendronate Sodium1 in 1 BLISTER PACKTABLET11

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
33261-554ALENDRONATE SODIUM TABLET [AIDAREX PHARMACEUTICALS LLC]1Legacy NDC, 2 package rows20140331_00b5de12-6ee7-400f-92da-dcdc17249328.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
904431alendronate sodium 70 MG Oral TabletPSN00b5de12-6ee7-400f-92da-dcdc172493281
904431alendronic acid 70 MG Oral TabletSCD00b5de12-6ee7-400f-92da-dcdc172493281
904431alendronic acid 70 MG (as alendronate sodium 91.4 MG) Oral TabletSY00b5de12-6ee7-400f-92da-dcdc172493281

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionStatus
33261-554-01332610554014 in 1 BOXHistorical