Zoledronic acid

Product NDC
68001-611
11-digit product format
680010611
Labeler code
68001
Product ID
68001-611_4f5b57fa-c20a-bcf5-e063-6294a90abe32
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Zoledronic acid
Dosage form
INJECTION
Route
INTRAVENOUS
Labeler
BluePoint Laboratories
Application
ANDA209578
Marketing category
ANDA
Marketing start
2024-03-08
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
d5e51f11-ad28-caa4-4b49-4143974782adProduct name120150831
94acf8b5-886e-4cdd-b38e-791d5af82ba0Product name120150325

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
68001-611-33Zoledronic acid100 mL in 1 BAGINJECTION1003
68001-611-33Zoledronic acid1 in 1 CARTONINJECTION13

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
68001-611-33ML - Milliliter68001-611881053ba-0818-43cc-9d89-9ba2831e86aa12024-05-16

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68001-611ZOLEDRONIC ACID INJECTION [BLUEPOINT LABORATORIES]2Current NDC, 2 package rows20240809_5de65a7f-a219-4b22-9155-61fedc84433b.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
705824zoledronic acid 5 MG in 100 ML InjectionPSN5de65a7f-a219-4b22-9155-61fedc84433b3
705824100 ML zoledronic acid 0.05 MG/ML InjectionSCD5de65a7f-a219-4b22-9155-61fedc84433b3
705824zoledronic acid 5 MG per 100 ML InjectionSY5de65a7f-a219-4b22-9155-61fedc84433b3

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
68001-611-33680010611331 BAG in 1 CARTON (68001-611-33) / 100 mL in 1 BAG1 bag2024-07-06NoNoHistorical