Zoledronic acid

Product NDC
23155-170
11-digit product format
231550170
Labeler code
23155
Product ID
23155-170_f4991976-8a87-4a00-839f-3f62c561c230
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Zoledronic acid
Dosage form
INJECTION, SOLUTION, CONCENTRATE
Route
INTRAVENOUS
Labeler
Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc.
Application
ANDA201783
Marketing category
ANDA
Marketing start
2023-08-31
Substance
ZOLEDRONIC ACID
Active strength
4 mg/5mL
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 ACID4 mg/5mL

Harmonized Identifiers#

Field, Values table
FieldValues
Unii6XC1PAD3KF
Rxcui351114

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
963c7720-927d-e443-b968-0d27f7055a69Product name820240606
3c386306-c48a-413e-bb69-70cb268496f3Product name120210727
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
23155-170-31Zoledronic acid5 mL in 1 VIAL, GLASSINJECTION, SOLUTION, CONCENTRATE522
23155-170-31Zoledronic acid1 in 1 CARTONINJECTION, SOLUTION, CONCENTRATE122

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
23155-170-31ML - Milliliter23155-170eea8fa89-272a-41b6-b164-91567078e19912013-06-04

DailyMed Socrata Ingredients#

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
23155-170ZOLEDRONIC ACID INJECTION, SOLUTION, CONCENTRATE [HERITAGE PHARMACEUTICALS INC. D/B/A AVET PHARMACEUTICALS INC.]22Current NDC, Legacy NDC, 2 package rows20230922_00a5bd5a-e5ee-4bad-b510-a4d4485485c8.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
351114zoledronic acid 4 MG in 5 ML InjectionPSN00a5bd5a-e5ee-4bad-b510-a4d4485485c822
3511145 ML zoledronic acid 0.8 MG/ML InjectionSCD00a5bd5a-e5ee-4bad-b510-a4d4485485c822
351114zoledronic acid 4 MG per 5 ML InjectionSY00a5bd5a-e5ee-4bad-b510-a4d4485485c822

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
23155-170-31231550170311 VIAL, GLASS in 1 CARTON (23155-170-31) / 5 mL in 1 VIAL, GLASS2023-08-310000-00-00NoNoCurrent