Zoledronic acid

Product NDC
16714-815
11-digit product format
167140815
Labeler code
16714
Product ID
16714-815_a5fc36d0-2569-52dd-e053-2a95a90a3dbf
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
zoledronic acid
Dosage form
INJECTION
Route
INTRAVENOUS
Labeler
Northstar RxLLC
Application
ANDA205279
Marketing category
ANDA
Marketing start
2018-05-30
Marketing end
0000-00-00
Substance
ZOLEDRONIC ACID
Active strength
4 mg/5mL
Pharmacologic classes
Diphosphonates [CS],Bisphosphonate [EPC]
NDC exclude flag
No
Listing certified through
2021-12-31
Current FDA listing
Historical FDA.report record

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
16714-815-01ML - Milliliter16714-8151915a255-164b-4c18-8a40-47ec0d29279112019-02-13

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
16714-815ZOLEDRONIC ACID INJECTION [NORTHSTAR RXLLC]4Legacy NDC20240718_1349fb63-3d9d-4dc0-bdbb-5af0429f9a72.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
16714-815-01167140815011 VIAL in 1 CARTON (16714-815-01) > 5 mL in 1 VIAL1 vial2018-05-300000-00-00NoNoCurrent