Zoledronic Acid

Product NDC
68001-366
11-digit product format
680010366
Labeler code
68001
Product ID
68001-366_95987211-1d84-429b-839f-2fc7c816061e
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Zoledronic Acid
Dosage form
INJECTION, SOLUTION, CONCENTRATE
Route
INTRAVENOUS
Labeler
BluePoint Laboratories
Application
ANDA091170
Marketing category
ANDA
Marketing start
2018-10-05
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
68001-366-22ML - Milliliter68001-366a6267a9f-8734-407b-aed3-728e774b5bf712018-10-11
68001-366-25ML - Milliliter68001-36617a15222-3402-4650-b027-9f04290fd7a812018-10-11

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
68001-366-25680010366251 VIAL in 1 CARTON (68001-366-25) > 5 mL in 1 VIAL (68001-366-22) 1 vial2018-10-052022-05-31NoNoCurrent
68001-366-87680010366871 VIAL in 1 CARTON (68001-366-87) > 5 mL in 1 VIAL1 vial2020-02-100000-00-00NoNoCurrent