Alendronate

Product NDC
69543-131
11-digit product format
695430131
Labeler code
69543
Product ID
69543-131_91a3617f-bde7-4868-9334-f6f61e8440d1
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
ALENDRONATE SODIUM
Dosage form
TABLET
Route
ORAL
Labeler
Virtus Pharmaceuticals
Application
ANDA090258
Marketing category
ANDA
Marketing start
2015-10-02
Marketing end
2024-03-30
Substance
ALENDRONATE SODIUM
Active strength
70 mg/1
Pharmacologic classes
Bisphosphonate [EPC], Diphosphonates [CS]
NDC exclude flag
No
Listing certified through
0000-00-00
Current FDA listing
Historical FDA.report record

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
69543-131-04EA - Each69543-131c5a52141-7dcf-4597-8e72-69dbaeff8f2812015-11-12
69543-131-12EA - Each69543-1316896bdd3-be95-42c3-a913-067bab510f7612015-11-12
69543-131-20EA - Each69543-131693be3ab-ab73-41c4-a2be-93683e4861d712015-11-12

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
69543-131-04695430131041 BLISTER PACK in 1 CARTON (69543-131-04) > 4 TABLET in 1 BLISTER PACK1 blister pack2015-10-022024-03-30NoNoCurrent
69543-131-12695430131123 BLISTER PACK in 1 CARTON (69543-131-12) > 4 TABLET in 1 BLISTER PACK3 blister pack2016-02-230000-00-00NoNoCurrent
69543-131-20695430131202 BLISTER PACK in 1 CARTON (69543-131-20) > 10 TABLET in 1 BLISTER PACK2 blister pack2016-02-232023-03-31NoNoCurrent