Zoledronic acid

Product NDC
72266-152
11-digit product format
722660152
Labeler code
72266
Product ID
72266-152_181b55f6-9f8c-671b-e063-6394a90a22b3
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Zoledronic acid
Dosage form
INJECTION
Route
INTRAVENOUS
Labeler
FOSUN PHARMA USA INC
Application
ANDA209578
Marketing category
ANDA
Marketing start
2023-06-12
Substance
ZOLEDRONIC ACID
Active strength
5 mg/100mL
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 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
72266-152-01Zoledronic acid100 mL in 1 BAGINJECTION1003
72266-152-01Zoledronic acid1 in 1 CARTONINJECTION13

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
72266-152ZOLEDRONIC ACID INJECTION [FOSUN PHARMA USA INC]3Current NDC, 2 package rows20240511_fd0324d8-b9bd-fd4c-e053-6394a90a5465.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
705824zoledronic acid 5 MG in 100 ML InjectionPSNfd0324d8-b9bd-fd4c-e053-6394a90a54653
705824100 ML zoledronic acid 0.05 MG/ML InjectionSCDfd0324d8-b9bd-fd4c-e053-6394a90a54653
705824zoledronic acid 5 MG per 100 ML InjectionSYfd0324d8-b9bd-fd4c-e053-6394a90a54653

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
72266-152-01722660152011 BAG in 1 CARTON (72266-152-01) / 100 mL in 1 BAG1 bag2023-06-12NoNoCurrent