Zoledronic Acid

Product NDC
43598-331
11-digit product format
435980331
Labeler code
43598
Product ID
43598-331_d89899a3-8ada-0438-07b9-2164c640995a
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Zoledronic Acid
Dosage form
INJECTION, SOLUTION
Route
INTRAVENOUS
Labeler
Dr.Reddy's Laboratories Inc
Application
ANDA091363
Marketing category
ANDA
Marketing start
2013-08-19
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
43598-331-11Zoledronic Acid100 mL in 1 BOTTLE, GLASSINJECTION, SOLUTION1004

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
43598-331-11ML - Milliliter43598-331dab63e98-82e9-4970-b5c7-7a062b43a87212013-09-04

DailyMed Socrata Ingredients#

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
43598-331ZOLEDRONIC ACID (ZOLEDRONIC ACID ) INJECTION, SOLUTION [DR.REDDY'S LABORATORIES INC]4Current NDC, Legacy NDC, 1 package rows20181128_c8e02635-4473-8ba2-248f-ced58dbeabce.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
705824zoledronic acid 5 MG in 100 ML InjectionPSNc8e02635-4473-8ba2-248f-ced58dbeabce4
705824100 ML zoledronic acid 0.05 MG/ML InjectionSCDc8e02635-4473-8ba2-248f-ced58dbeabce4
705824zoledronic acid 5 MG per 100 ML InjectionSYc8e02635-4473-8ba2-248f-ced58dbeabce4

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
43598-331-1143598033111100 mL in 1 BOTTLE, GLASS (43598-331-11) 100 ml2013-08-190000-00-00NoNoCurrent