IBANDRONATE SODIUM

Product NDC
47781-103
11-digit product format
477810103
Labeler code
47781
Product ID
47781-103_86be42bb-38fd-8b9d-e5ee-43d0703d9fd0
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
IBANDRONATE SODIUM
Dosage form
TABLET
Route
ORAL
Labeler
Alvogen Inc.
Application
ANDA078998
Marketing category
ANDA
Marketing start
2014-05-01
Marketing end
0000-00-00
Substance
IBANDRONATE SODIUM
Active strength
150 mg/1
Pharmacologic classes
Bisphosphonate [EPC], Diphosphonates [CS]
NDC exclude flag
No
Listing certified through
2023-12-31
Current FDA listing
Historical FDA.report record

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
47781-103IBANDRONATE SODIUM TABLET [ALVOGEN INC.]14Legacy NDC20241011_acbc54fc-4248-416f-849c-2cd3bed0a843.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
47781-103-21477810103211 BLISTER PACK in 1 CARTON (47781-103-21) > 3 TABLET in 1 BLISTER PACK1 blister pack2019-12-180000-00-00NoNoCurrent
47781-103-33477810103333 BLISTER PACK in 1 BOX (47781-103-33) > 1 TABLET in 1 BLISTER PACK (47781-103-07) 3 blister pack2014-05-010000-00-00NoNoCurrent