Alendronate Sodium

Product NDC
21695-902
11-digit product format
216950902
Labeler code
21695
Product ID
21695-902_eb668bf3-aab0-4529-bf8f-e740a5d5f3b8
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
alendronate sodium
Dosage form
TABLET
Route
ORAL
Labeler
Rebel Distributors Corp
Application
ANDA076768
Marketing category
ANDA
Marketing start
2008-08-04
Marketing end
0000-00-00
Substance
ALENDRONATE SODIUM
Active strength
70 mg/1
Pharmacologic classes
Bisphosphonate [EPC],Diphosphonates [CS]
NDC exclude flag
E
Listing certified through
2017-12-31
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
21695-902-042019-09-24C16284748780-1934fe258-4d49-48b1-e053-8cdaa90a720aALENDRONATE SODIUM TABLETS, USP

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
21695-902-04Alendronate Sodium4 in 1 BLISTER PACKTABLET41

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
21695-902ALENDRONATE SODIUM TABLET [REBEL DISTRIBUTORS CORP]1Legacy NDC, 1 package rows20110201_eb668bf3-aab0-4529-bf8f-e740a5d5f3b8.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
904396alendronate sodium 35 MG Oral TabletPSNeb668bf3-aab0-4529-bf8f-e740a5d5f3b81
904431alendronate sodium 70 MG Oral TabletPSNeb668bf3-aab0-4529-bf8f-e740a5d5f3b81
904396alendronic acid 35 MG Oral TabletSCDeb668bf3-aab0-4529-bf8f-e740a5d5f3b81
904431alendronic acid 70 MG Oral TabletSCDeb668bf3-aab0-4529-bf8f-e740a5d5f3b81
904396alendronic acid 35 MG (as alendronate sodium 45.7 MG) Oral TabletSYeb668bf3-aab0-4529-bf8f-e740a5d5f3b81
904431alendronic acid 70 MG (as alendronate sodium 91.4 MG) Oral TabletSYeb668bf3-aab0-4529-bf8f-e740a5d5f3b81

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionStatus
21695-902-04216950902044 in 1 BLISTER PACKHistorical