IBANDRONATE SODIUM

Product NDC
51224-008
11-digit product format
512240008
Labeler code
51224
Product ID
51224-008_4d64c479-f90c-40a5-bfaf-c92f884b5133
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Ibandronate Sodium
Dosage form
INJECTION, SOLUTION
Route
INTRAVENOUS
Labeler
TAGI Pharma, Inc.
Application
ANDA204329
Marketing category
ANDA
Marketing start
2022-06-30
Marketing end
0000-00-00
Substance
IBANDRONATE SODIUM
Active strength
3 mg/3mL
Pharmacologic classes
Bisphosphonate [EPC], Diphosphonates [CS]
NDC exclude flag
No
Listing certified through
2023-12-31
Current FDA listing
Historical FDA.report record

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
51224-008-012025-12-30C16284748780-12cef2736-80a5-d83d-e063-dadaa90ab31f57970375-1b7f-43ec-b1f1-43b03168ac4a
51224-008-012025-01-30C16284748780-12cef2736-80a5-d83d-e063-dadaa90ab31f57970375-1b7f-43ec-b1f1-43b03168ac4a

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
51224-008IBANDRONATE SODIUM INJECTION, SOLUTION [TAGI PHARMA, INC.]11Legacy NDC20250101_57970375-1b7f-43ec-b1f1-43b03168ac4a.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
51224-008-01512240008011 SYRINGE, GLASS in 1 CARTON (51224-008-01) > 3 mL in 1 SYRINGE, GLASS2022-06-300000-00-00NoNoCurrent