Zoledronic Acid

Product NDC: 60505-6110
11-digit product format: 605056110
Labeler code: 60505
Product ID: 60505-6110_9950935d-8c2c-4023-ae74-102d41444d12
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Zoledronic Acid
Dosage form: INJECTION, SOLUTION, CONCENTRATE
Route: INTRAVENOUS
Labeler: Apotex Corp
Application: ANDA202930
Marketing category: ANDA
Marketing start: 2017-03-24
Marketing end: 0000-00-00
Substance: ZOLEDRONIC ACID
Active strength: 4 mg/5mL
Pharmacologic classes: Diphosphonates [CS],Bisphosphonate [EPC]
NDC exclude flag: No
Listing certified through: 2021-12-31
Current FDA listing: Historical FDA.report record

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
963c7720-927d-e443-b968-0d27f7055a69	Product name	8	20240606
95fe9bf2-51a5-1324-90da-8451ccf59619	Product name	9	20190228
76bb2633-9686-4c41-9e21-c755e223f2e0	Product name	1	20160408
94acf8b5-886e-4cdd-b38e-791d5af82ba0	Product name	1	20150325

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
60505-6110-0	2023-01-30	C162847	48780-1	f386c649-baa2-0266-e053-dadaa90a7c1a	These highlights do not include all the information needed to use ZOLEDRONIC ACID INJECTION safely and effectively. See full prescribing information for ZOLEDRONIC ACID INJECTION. ZOLEDRONIC ACID injection, concentrate for intravenous infusion Initial U.S. Approval: 2001

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
60505-6110-0	Zoledronic Acid	5 mL in 1 VIAL	INJECTION, SOLUTION, CONCENTRATE	5		11
60505-6110-0	Zoledronic Acid	1 in 1 CARTON	INJECTION, SOLUTION, CONCENTRATE	1		11

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
60505-6110-0	ML - Milliliter	60505-6110	76ef30c0-f8b6-41c6-91a5-8de35cd019a2	1	2013-11-04

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version	Uploaded
ZOLEDRONIC ACID	ACTIVE INGREDIENT	6XC1PAD3KF	ZOLEDRONIC ACID INJECTION, SOLUTION, CONCENTRATE [APOTEX CORP]	8
ZOLEDRONIC ACID ANHYDROUS	ACTIVE MOIETY	70HZ18PH24	ZOLEDRONIC ACID INJECTION, SOLUTION, CONCENTRATE [APOTEX CORP]	8
MANNITOL	INACTIVE INGREDIENT	3OWL53L36A	ZOLEDRONIC ACID INJECTION, SOLUTION, CONCENTRATE [APOTEX CORP]	8
SODIUM CITRATE	INACTIVE INGREDIENT	1Q73Q2JULR	ZOLEDRONIC ACID INJECTION, SOLUTION, CONCENTRATE [APOTEX CORP]	8
WATER	INACTIVE INGREDIENT	059QF0KO0R	ZOLEDRONIC ACID INJECTION, SOLUTION, CONCENTRATE [APOTEX CORP]	8

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
60505-6110	ZOLEDRONIC ACID INJECTION, SOLUTION, CONCENTRATE [APOTEX CORP]	11	Legacy NDC, 2 package rows	20170324_aa160b73-9a99-48ac-a9b7-32e2b4b1c79e.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
351114	zoledronic acid 4 MG in 5 ML Injection	PSN	aa160b73-9a99-48ac-a9b7-32e2b4b1c79e	11
351114	5 ML zoledronic acid 0.8 MG/ML Injection	SCD	aa160b73-9a99-48ac-a9b7-32e2b4b1c79e	11
351114	zoledronic acid 4 MG per 5 ML Injection	SY	aa160b73-9a99-48ac-a9b7-32e2b4b1c79e	11

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
60505-6110-0	60505611000	1 VIAL in 1 CARTON (60505-6110-0) > 5 mL in 1 VIAL	1 vial	2017-03-24	0000-00-00	No	No	Current