zoledronic acid

Product NDC
25021-830
11-digit product format
250210830
Labeler code
25021
Product ID
25021-830_dd7663fa-8a03-4717-a3fb-c4c03e6300e8
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
zoledronic acid
Dosage form
INJECTION, SOLUTION
Route
INTRAVENOUS
Labeler
Sagent Pharmaceuticals
Application
ANDA202828
Marketing category
ANDA
Marketing start
2013-03-02
Substance
ZOLEDRONIC ACID
Active strength
.05 mg/mL
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 ACID.05 mg/mL

Harmonized Identifiers#

Field, Values table
FieldValues
Unii6XC1PAD3KF
Rxcui705824

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
963c7720-927d-e443-b968-0d27f7055a69Product name820240606
a62a50ac-1535-4461-9768-8ae703e2e9fbProduct name120210525
95fe9bf2-51a5-1324-90da-8451ccf59619Product name920190228
76bb2633-9686-4c41-9e21-c755e223f2e0Product name120160408
d5e51f11-ad28-caa4-4b49-4143974782adProduct name120150831
94acf8b5-886e-4cdd-b38e-791d5af82ba0Product name120150325
9514609b-a2a9-f8ec-6ba6-3f8e5ee89877Product name120140508
bc07ef78-e82d-0c19-31f4-31f263780582Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
25021-830-82zoledronic acid100 mL in 1 BAGINJECTION, SOLUTION10021
25021-830-82zoledronic acid1 in 1 CARTONINJECTION, SOLUTION121
25021-830-87zoledronic acid5 in 1 CARTONINJECTION, SOLUTION521
25021-830-87zoledronic acid100 mL in 1 BAGINJECTION, SOLUTION10021

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
25021-830-82ML - Milliliter25021-830e1e9a2b4-5294-4137-ab7f-3260867311a012013-11-04
25021-830-87ML - Milliliter25021-8306b127684-6756-4468-9bc2-2743a99dbbc712025-06-13

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
zoledronic acidACTIVE INGREDIENT6XC1PAD3KFZOLEDRONIC ACID INJECTION, SOLUTION [SAGENT PHARMACEUTICALS]14
zoledronic acid anhydrousACTIVE MOIETY70HZ18PH24ZOLEDRONIC ACID INJECTION, SOLUTION [SAGENT PHARMACEUTICALS]14
mannitolINACTIVE INGREDIENT3OWL53L36AZOLEDRONIC ACID INJECTION, SOLUTION [SAGENT PHARMACEUTICALS]14
sodium citrateINACTIVE INGREDIENT1Q73Q2JULRZOLEDRONIC ACID INJECTION, SOLUTION [SAGENT PHARMACEUTICALS]14
waterINACTIVE INGREDIENT059QF0KO0RZOLEDRONIC ACID INJECTION, SOLUTION [SAGENT PHARMACEUTICALS]14

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
25021-830ZOLEDRONIC ACID INJECTION, SOLUTION [SAGENT PHARMACEUTICALS]21Current NDC, Legacy NDC, 4 package rows20250325_164500d7-51cf-438a-8bee-7a7dce76ad7a.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
705824zoledronic acid 5 MG in 100 ML InjectionPSN164500d7-51cf-438a-8bee-7a7dce76ad7a21
705824100 ML zoledronic acid 0.05 MG/ML InjectionSCD164500d7-51cf-438a-8bee-7a7dce76ad7a21
705824zoledronic acid 5 MG per 100 ML InjectionSY164500d7-51cf-438a-8bee-7a7dce76ad7a21

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
25021-830-82250210830821 BAG in 1 CARTON (25021-830-82) / 100 mL in 1 BAG1 bag2013-03-020000-00-00NoNoCurrent
25021-830-87250210830875 BAG in 1 CARTON (25021-830-87) / 100 mL in 1 BAG5 bag2025-04-15NoNoHistorical