FDA.reportPublic FDA data

Zoledronic Acid

Product NDC
55150-266
11-digit product format
551500266
Labeler code
55150
Product ID
55150-266_c85e7c96-b74d-41ee-a07a-c3bc44ca4fc8
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Zoledronic Acid
Dosage form
INJECTION, SOLUTION, CONCENTRATE
Route
INTRAVENOUS
Labeler
AuroMedics Pharma LLC
Application
ANDA207751
Marketing category
ANDA
Marketing start
2016-09-26
Substance
ZOLEDRONIC ACID
Active strength
4 mg/5mL
Pharmacologic classes
Bisphosphonate [EPC], Diphosphonates [CS]
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Zoledronic Acid
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
ZOLEDRONIC ACID4 mg/5mL

Harmonized Identifiers#

Field, Values table
FieldValues
Unii6XC1PAD3KF
Rxcui351114

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
963c7720-927d-e443-b968-0d27f7055a69Product name820240606
95fe9bf2-51a5-1324-90da-8451ccf59619Product name920190228
76bb2633-9686-4c41-9e21-c755e223f2e0Product name120160408
94acf8b5-886e-4cdd-b38e-791d5af82ba0Product name120150325

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
55150-266-05Zoledronic Acid1 in 1 CARTONINJECTION, SOLUTION, CONCENTRATE16
55150-266-05Zoledronic Acid5 mL in 1 VIAL, SINGLE-DOSEINJECTION, SOLUTION, CONCENTRATE56

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
55150-266-05ML - Milliliter55150-2664415fe2b-ad55-44e6-9b28-b7e38847734112018-10-11

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
55150-266ZOLEDRONIC ACID INJECTION, SOLUTION, CONCENTRATE [AUROMEDICS PHARMA LLC]6Current NDC, Legacy NDC, 2 package rows20211207_ac7ff1eb-6e73-4cc8-9114-c5a4483ad4c3.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
351114zoledronic acid 4 MG in 5 ML InjectionPSNac7ff1eb-6e73-4cc8-9114-c5a4483ad4c36
3511145 ML zoledronic acid 0.8 MG/ML InjectionSCDac7ff1eb-6e73-4cc8-9114-c5a4483ad4c36
351114zoledronic acid 4 MG per 5 ML InjectionSYac7ff1eb-6e73-4cc8-9114-c5a4483ad4c36

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
55150-266-05551500266051 VIAL, SINGLE-DOSE in 1 CARTON (55150-266-05) / 5 mL in 1 VIAL, SINGLE-DOSE2016-09-260000-00-00NoNoCurrent