ibandronate sodium

Product NDC
67457-524
11-digit product format
674570524
Labeler code
67457
Product ID
67457-524_270c89b1-757a-41ef-8067-d9034a4bdc9e
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
ibandronate sodium
Dosage form
INJECTION, SOLUTION
Route
INTRAVENOUS
Labeler
Mylan Institutional LLC
Application
ANDA202671
Marketing category
ANDA
Marketing start
2014-09-02
Marketing end
2026-05-31
Substance
IBANDRONATE SODIUM
Active strength
3 mg/3mL
Pharmacologic classes
Bisphosphonate [EPC], Diphosphonates [CS]
NDC exclude flag
No
Current FDA listing
Yes

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
6bd95106-a412-1dad-b9cc-4cb74bfb27ceProduct name220230315
48747306-602a-42cc-957b-5b0c69158eeeProduct name120180604
fca0fe5b-9e2b-f6fc-e68d-b5f751d08578Product name320180103
a7e2afc7-9184-42ab-b6c6-6edca00dd2d2Product name420160310
d5e51f11-ad28-caa4-4b49-4143974782adProduct name120150831
290f523a-f9db-9774-b5a9-e1f908ac1782Product name120150828
0ca1d589-929b-4b33-bc5b-1d84abdafa6aProduct name120150324
fc363c46-397b-4476-ac0f-70e43e8e4592Product name120150324
c6b65c52-69c7-df49-550a-a50c137f6218Product name120140508
db5ebcdb-b6ae-21cd-4dc5-76cd84b5578bProduct name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
67457-524-33ibandronate sodium3 mL in 1 SYRINGE, GLASSINJECTION, SOLUTION36
67457-524-33ibandronate sodium1 in 1 CARTONINJECTION, SOLUTION16

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
67457-524-33ML - Milliliter67457-524d55031dd-acff-4de9-a4e8-3712b1d0c57712014-10-03

DailyMed Socrata Ingredients#

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
67457-524IBANDRONATE SODIUM INJECTION, SOLUTION [MYLAN INSTITUTIONAL LLC]6Current NDC, Legacy NDC, 2 package rows20250104_a70566e1-cbe5-472a-85ae-08a14117552a.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
67457-524-33674570524331 SYRINGE, GLASS in 1 CARTON (67457-524-33) / 3 mL in 1 SYRINGE, GLASS2014-09-022026-05-31NoNoCurrent