Reclast

Product NDC
0078-0435
11-digit product format
000780435
Labeler code
0078
Product ID
0078-0435_ae5a6cfc-93e8-4095-be3d-b4db71b57545
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
zoledronic acid
Dosage form
INJECTION, SOLUTION
Route
INTRAVENOUS
Labeler
Novartis Pharmaceuticals Corporation
Application
NDA021817
Marketing category
NDA
Marketing start
2007-04-01
Marketing end
0000-00-00
Substance
ZOLEDRONIC ACID
Active strength
5 mg/100mL
Pharmacologic classes
Bisphosphonate [EPC], Diphosphonates [CS]
NDC exclude flag
No
Listing certified through
2023-12-31
Current FDA listing
Historical FDA.report record

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
963c7720-927d-e443-b968-0d27f7055a69Product name820240606
a62a50ac-1535-4461-9768-8ae703e2e9fbProduct name120210525
95fe9bf2-51a5-1324-90da-8451ccf59619Product name920190228
76bb2633-9686-4c41-9e21-c755e223f2e0Product name120160408
94acf8b5-886e-4cdd-b38e-791d5af82ba0Product name120150325
9514609b-a2a9-f8ec-6ba6-3f8e5ee89877Product name120140508
bc07ef78-e82d-0c19-31f4-31f263780582Product name120140508

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0078-0435-61ML - Milliliter0078-0435ee33744d-55df-408e-8c2c-c87ca709587012012-07-24

DailyMed Socrata Ingredients#

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0078-0435RECLAST (ZOLEDRONIC ACID) INJECTION, SOLUTION [NOVARTIS PHARMACEUTICALS CORPORATION]22Legacy NDC20220709_3c79ff9c-a6f4-405d-b19c-7e473a61dedc.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0078-0435-6100078043561100 mL in 1 BOTTLE (0078-0435-61) 100 ml2007-04-010000-00-00NoNoCurrent