FDA.reportPublic FDA data

alendronate sodium

Product NDC
53217-321
11-digit product format
532170321
Labeler code
53217
Product ID
53217-321_65fcb8c2-b214-43c8-a98c-f594c4921af4
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
alendronate sodium
Dosage form
TABLET
Route
ORAL
Labeler
Aidarex Pharmaceuticals LLC
Application
ANDA076984
Marketing category
ANDA
Marketing start
2017-05-01
Marketing end
0000-00-00
Substance
ALENDRONATE SODIUM
Active strength
35 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#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
53217-321-012020-01-31C16284748780-19d75b9d0-b8f0-f424-e053-dadaa90a57ceThese 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
53217-321-01alendronate sodium4 in 1 BLISTER PACKTABLET41

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
53217-321-01EA - Each53217-321f8e71020-3dcd-4b7e-a43e-c301d77ca8cb12017-12-14

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
53217-321ALENDRONATE SODIUM TABLET [AIDAREX PHARMACEUTICALS LLC]1Legacy NDC, 1 package rows20170921_c4e0cbfb-d448-4332-99c4-07ca434c1a5e.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
904396alendronate sodium 35 MG Oral TabletPSNc4e0cbfb-d448-4332-99c4-07ca434c1a5e1
904396alendronic acid 35 MG Oral TabletSCDc4e0cbfb-d448-4332-99c4-07ca434c1a5e1
904396alendronic acid 35 MG (as alendronate sodium 45.7 MG) Oral TabletSYc4e0cbfb-d448-4332-99c4-07ca434c1a5e1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionStatus
53217-321-01532170321014 in 1 BLISTER PACKHistorical