Zoledronic Acid

Product NDC
51991-065
11-digit product format
519910065
Labeler code
51991
Product ID
51991-065_94480c71-ac79-4e8d-a6a8-fcc85fea48bd
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Zoledronic Acid
Dosage form
INJECTION, SOLUTION, CONCENTRATE
Route
INTRAVENOUS
Labeler
Breckenridge Pharmaceutical, Inc
Application
ANDA091170
Marketing category
ANDA
Marketing start
2017-09-15
Marketing end
2022-05-31
Substance
ZOLEDRONIC ACID
Active strength
4 mg/5mL
Pharmacologic classes
Diphosphonates [CS],Bisphosphonate [EPC]
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
51991-065-98ML - Milliliter51991-065538e5226-f667-483f-9ddb-87f31e20393812017-12-14

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
51991-065-98519910065981 VIAL in 1 CARTON (51991-065-98) > 5 mL in 1 VIAL1 vial2017-09-152022-05-31NoNoCurrent