Zoledronic Acid

Product NDC
55150-283
11-digit product format
551500283
Labeler code
55150
Product ID
55150-283_ab56911b-70e0-46c4-a985-990244bd67bc
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Zoledronic Acid
Dosage form
INJECTION, SOLUTION
Route
INTRAVENOUS
Labeler
Eugia US LLC
Application
ANDA209125
Marketing category
ANDA
Marketing start
2017-12-08
Substance
ZOLEDRONIC ACID
Active strength
5 mg/100mL
Pharmacologic classes
Bisphosphonate [EPC], Diphosphonates [CS]
NDC exclude flag
No
Listing certified through
2027-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Zoledronic Acid
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
ZOLEDRONIC ACID5 mg/100mL

Harmonized Identifiers#

Field, Values table
FieldValues
Unii6XC1PAD3KF
Rxcui705824

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
55150-283-99Zoledronic Acid1 in 1 CARTONINJECTION, SOLUTION17
55150-283-99Zoledronic Acid100 mL in 1 BOTTLE, GLASSINJECTION, SOLUTION1007

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
55150-283ZOLEDRONIC ACID INJECTION, SOLUTION [EUGIA US LLC]5Current NDC, Legacy NDC, 2 package rows20241117_bf5f96d4-f87c-4968-bed0-a4b5e77f4162.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
705824zoledronic acid 5 MG in 100 ML InjectionPSNbf5f96d4-f87c-4968-bed0-a4b5e77f41627
705824100 ML zoledronic acid 0.05 MG/ML InjectionSCDbf5f96d4-f87c-4968-bed0-a4b5e77f41627
705824zoledronic acid 5 MG per 100 ML InjectionSYbf5f96d4-f87c-4968-bed0-a4b5e77f41627

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
55150-283-99551500283991 BOTTLE, GLASS in 1 CARTON (55150-283-99) / 100 mL in 1 BOTTLE, GLASS2017-12-080000-00-00NoNoCurrent