Zoledronic Acid

Product NDC
51991-064
11-digit product format
519910064
Labeler code
51991
Product ID
51991-064_8794650a-0a65-47a9-b38a-5546f3271442
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Zoledronic Acid
Dosage form
INJECTION
Route
INTRAVENOUS
Labeler
Breckenridge Pharmaceutical, Inc
Application
ANDA202163
Marketing category
ANDA
Marketing start
2017-09-15
Marketing end
2021-06-30
Substance
ZOLEDRONIC ACID
Active strength
5 mg/100mL
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
51991-064-98ML - Milliliter51991-06447383431-1953-4b79-b0f6-97432736aeab12017-12-14

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
51991-064-98519910064981 CONTAINER in 1 CARTON (51991-064-98) > 100 mL in 1 CONTAINER1 container2017-09-152021-06-30NoNoCurrent