ZOLEDRONIC ACID

Product NDC
0409-4215
11-digit product format
004094215
Labeler code
0409
Product ID
0409-4215_012b15e6-d638-400a-96b9-44f6e9741baf
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
ZOLEDRONIC ACID
Dosage form
INJECTION, SOLUTION, CONCENTRATE
Route
INTRAVENOUS
Labeler
Hospira, Inc.
Application
ANDA090621
Marketing category
ANDA
Marketing start
2017-10-19
Marketing end
0000-00-00
Substance
ZOLEDRONIC ACID
Active strength
4 mg/5mL
Pharmacologic classes
Bisphosphonate [EPC], Diphosphonates [CS]
NDC exclude flag
No
Listing certified through
2023-12-31
Current FDA listing
Historical FDA.report record

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0409-4215-01ML - Milliliter0409-42157cc0221b-0ce9-4b01-a4d0-1e0e1914a0eb12017-09-11
0409-4215-05ML - Milliliter0409-4215d363f3cf-d0ca-4e77-b13c-a1bea2a2b92312019-04-11

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
0409-4215-01004094215011 VIAL, PLASTIC in 1 CARTON (0409-4215-01) > 5 mL in 1 VIAL, PLASTIC2017-10-190000-00-00NoNoCurrent
0409-4215-05004094215051 VIAL, PLASTIC in 1 CARTON (0409-4215-05) > 5 mL in 1 VIAL, PLASTIC2019-03-180000-00-00NoNoCurrent