FDA.reportPublic FDA data

zoledronic acid

Product NDC
25021-826
11-digit product format
250210826
Labeler code
25021
Product ID
25021-826_cd9bea2a-6045-452d-9ac5-e70d08e9e26f
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
zoledronic acid
Dosage form
INJECTION, SOLUTION
Route
INTRAVENOUS
Labeler
Sagent Pharmaceuticals
Application
NDA203231
Marketing category
NDA
Marketing start
2013-03-02
Substance
ZOLEDRONIC ACID
Active strength
.04 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.04 mg/mL

Harmonized Identifiers#

Field, Values table
FieldValues
Unii6XC1PAD3KF
Rxcui1114085

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
25021-826-82zoledronic acid1 in 1 CARTONINJECTION, SOLUTION121
25021-826-82zoledronic acid100 mL in 1 BAGINJECTION, SOLUTION10021
25021-826-87zoledronic acid100 mL in 1 BAGINJECTION, SOLUTION10021
25021-826-87zoledronic acid5 in 1 CARTONINJECTION, SOLUTION521
25021-826-67zoledronic acid100 mL in 1 BAGINJECTION, SOLUTION10011
25021-826-67zoledronic acid1 in 1 CARTONINJECTION, SOLUTION111

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
25021-826-66ML - Milliliter25021-826c3b61292-1a29-42b2-b9e8-51392e29cbec12015-12-02
25021-826-67ML - Milliliter25021-8266aed9593-17c3-4275-a905-06d2a806a0bb12015-12-02
25021-826-82ML - Milliliter25021-826c6494fa9-20fa-4709-8e4d-775aaaf7192f12013-09-04
25021-826-87ML - Milliliter25021-82699e78708-a56a-4f87-a754-086ba18e3aff12025-06-13

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
zoledronic acidACTIVE INGREDIENT6XC1PAD3KFZOLEDRONIC ACID INJECTION, SOLUTION [SAGENT PHARMACEUTICALS]12
zoledronic acid anhydrousACTIVE MOIETY70HZ18PH24ZOLEDRONIC ACID INJECTION, SOLUTION [SAGENT PHARMACEUTICALS]12
mannitolINACTIVE INGREDIENT3OWL53L36AZOLEDRONIC ACID INJECTION, SOLUTION [SAGENT PHARMACEUTICALS]12
sodium chlorideINACTIVE INGREDIENT451W47IQ8XZOLEDRONIC ACID INJECTION, SOLUTION [SAGENT PHARMACEUTICALS]12
sodium citrateINACTIVE INGREDIENT1Q73Q2JULRZOLEDRONIC ACID INJECTION, SOLUTION [SAGENT PHARMACEUTICALS]12
waterINACTIVE INGREDIENT059QF0KO0RZOLEDRONIC ACID INJECTION, SOLUTION [SAGENT PHARMACEUTICALS]12
zoledronic acidACTIVE INGREDIENT6XC1PAD3KFZOLEDRONIC ACID INJECTION, SOLUTION [SAGENT PHARMACEUTICALS]2
zoledronic acid anhydrousACTIVE MOIETY70HZ18PH24ZOLEDRONIC ACID INJECTION, SOLUTION [SAGENT PHARMACEUTICALS]2
mannitolINACTIVE INGREDIENT3OWL53L36AZOLEDRONIC ACID INJECTION, SOLUTION [SAGENT PHARMACEUTICALS]2
sodium chlorideINACTIVE INGREDIENT451W47IQ8XZOLEDRONIC ACID INJECTION, SOLUTION [SAGENT PHARMACEUTICALS]2
sodium citrateINACTIVE INGREDIENT1Q73Q2JULRZOLEDRONIC ACID INJECTION, SOLUTION [SAGENT PHARMACEUTICALS]2
waterINACTIVE INGREDIENT059QF0KO0RZOLEDRONIC ACID INJECTION, SOLUTION [SAGENT PHARMACEUTICALS]2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
25021-826ZOLEDRONIC ACID INJECTION, SOLUTION [SAGENT PHARMACEUTICALS]21Current NDC, Legacy NDC, 4 package rows20250325_567578e6-cd2d-4339-b0f6-7a15444c0639.zip
25021-826ZOLEDRONIC ACID INJECTION, SOLUTION [SAGENT PHARMACEUTICALS]11Current NDC, Legacy NDC, 2 package rows20220309_deb89be7-f40e-4fd4-a2cb-96634b45da84.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1114085zoledronic acid 4 MG in 100 ML InjectionPSN567578e6-cd2d-4339-b0f6-7a15444c063921
1114085100 ML zoledronic acid 0.04 MG/ML InjectionSCD567578e6-cd2d-4339-b0f6-7a15444c063921
1114085zoledronic acid 4 MG per 100 ML InjectionSY567578e6-cd2d-4339-b0f6-7a15444c063921
1114085zoledronic acid 4 MG in 100 ML InjectionPSNdeb89be7-f40e-4fd4-a2cb-96634b45da8411
1114085100 ML zoledronic acid 0.04 MG/ML InjectionSCDdeb89be7-f40e-4fd4-a2cb-96634b45da8411
1114085zoledronic acid 4 MG per 100 ML InjectionSYdeb89be7-f40e-4fd4-a2cb-96634b45da8411

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
25021-826-67250210826671 BAG in 1 CARTON (25021-826-67) / 100 mL in 1 BAG1 bag2015-09-010000-00-00NoNoCurrent
25021-826-82250210826821 BAG in 1 CARTON (25021-826-82) / 100 mL in 1 BAG1 bag2013-03-020000-00-00NoNoCurrent
25021-826-87250210826875 BAG in 1 CARTON (25021-826-87) / 100 mL in 1 BAG5 bag2025-04-15NoNoCurrent