Zoledronic Acid

Product NDC: 42023-167
11-digit product format: 420230167
Labeler code: 42023
Product ID: 42023-167_7133e3cf-682e-4098-867b-66a9185e5c88
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Zoledronic Acid
Dosage form: INJECTION, SOLUTION, CONCENTRATE
Route: INTRAVENOUS
Labeler: JHP Pharmaceuticals, LLC.
Application: ANDA202571
Marketing category: ANDA
Marketing start: 2013-05-07
Marketing end: 0000-00-00
Substance: ZOLEDRONIC ACID
Active strength: 4 mg/5mL
Pharmacologic classes: Diphosphonates [CS],Bisphosphonate [EPC]
NDC exclude flag: E
Listing certified through: 2017-12-31
Current FDA listing: Historical FDA.report record

NDC auxiliary status#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

Current NDC status page 1 of 1 · 2 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
excluded product	product	42023-167		D	Discontinued by firm		2026-10-16
excluded package	package	42023-167	42023-167-01	D	Discontinued by firm		2026-10-16

Observed NDC auxiliary status history#

This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.

Historic NDC status page 1 of 1 · 26 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Dataset, Scope table
Captured / source date	Dataset	Scope	Package NDC	Code	Status	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	excluded product	product		D	Discontinued by firm	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	42023-167-01	D	Discontinued by firm	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded product	product		D	Discontinued by firm	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	42023-167-01	D	Discontinued by firm	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded product	product		D	Discontinued by firm	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	42023-167-01	D	Discontinued by firm	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded product	product		D	Discontinued by firm	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	42023-167-01	D	Discontinued by firm	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded product	product		D	Discontinued by firm	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	42023-167-01	D	Discontinued by firm	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded product	product		D	Discontinued by firm	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	42023-167-01	D	Discontinued by firm	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded product	product		D	Discontinued by firm	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	42023-167-01	D	Discontinued by firm	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded product	product		D	Discontinued by firm	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	42023-167-01	D	Discontinued by firm	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded product	product		D	Discontinued by firm	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	42023-167-01	D	Discontinued by firm	`0efc9e666f02…`	`f202fb6c5f17…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded product	product		D	Discontinued by firm	`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	42023-167-01	D	Discontinued by firm	`ad56d346431e…`	`cc804d4bbf1e…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded product	product		D	Discontinued by firm	`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	42023-167-01	D	Discontinued by firm	`367a005e9d99…`	`383a685ebd0f…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded product	product		D	Discontinued by firm	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	42023-167-01	D	Discontinued by firm	`557ba5c1ecfa…`	`9c80585c8c6e…`
2019-12-08 06:16 UTC · source 2019-12-05	excluded product	product		I	Inactivated by FDA	`110d247fa046…`	`a55b01930146…`
2019-12-08 06:16 UTC · source 2019-12-05	excluded package	package	42023-167-01	I	Inactivated by FDA	`110d247fa046…`	`a55b01930146…`

Source provenance: Browse the complete Orange Book source catalog · source snapshot 44.

Orange Book products#

Current product rows page 1 of 1 · 1 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
A202571-001	ZOLEDRONIC ACID	ZOLEDRONIC ACID	EQ 4MG BASE/5ML	INJECTABLE / INTRAVENOUS	AP		2013-05-07

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 1 matching rows.

Application-product, TE code table
Application-product	TE code
A202571-001	AP

Observed Orange Book product history#

Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.

Product history page 2 of 2 · 44 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Product TE source text	Approval date	Source SHA-256
2022-10-28 04:53 UTC	2022-10	A202571-001	ZOLEDRONIC ACID	EQ 4MG BASE/5ML	INJECTABLE / INTRAVENOUS	AP	2013-05-07	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A202571-001	ZOLEDRONIC ACID	EQ 4MG BASE/5ML	INJECTABLE / INTRAVENOUS	AP	2013-05-07	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A202571-001	ZOLEDRONIC ACID	EQ 4MG BASE/5ML	INJECTABLE / INTRAVENOUS	AP	2013-05-07	`cb3db0bc1861…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A202571-001	ZOLEDRONIC ACID	EQ 4MG BASE/5ML	INJECTABLE / INTRAVENOUS	AP	2013-05-07	`a50c72e98297…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 44 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-10-15 13:18:30	2026-09	A202571-001	AP	1	`c2088c7a36db…`
2026-09-14 22:38:34	2026-08	A202571-001	AP	1	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A202571-001	AP	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A202571-001	AP	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A202571-001	AP	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A202571-001	AP	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A202571-001	AP	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A202571-001	AP	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A202571-001	AP	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A202571-001	AP	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A202571-001	AP	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A202571-001	AP	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A202571-001	AP	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A202571-001	AP	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A202571-001	AP	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A202571-001	AP	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A202571-001	AP	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A202571-001	AP	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A202571-001	AP	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A202571-001	AP	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A202571-001	AP	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A202571-001	AP	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A202571-001	AP	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A202571-001	AP	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A202571-001	AP	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A202571-001	AP	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A202571-001	AP	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A202571-001	AP	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A202571-001	AP	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A202571-001	AP	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A202571-001	AP	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A202571-001	AP	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A202571-001	AP	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A202571-001	AP	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A202571-001	AP	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A202571-001	AP	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A202571-001	AP	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A202571-001	AP	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A202571-001	AP	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A202571-001	AP	1	`3a93d1ddd44b…`

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
42023-167-01	2020-03-18	C162847	48780-1	9855d018-e696-cd31-e053-dbdaa90ab51a	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
42023-167-01	2019-11-27	C162847	48780-1	9855d018-e696-cd31-e053-dbdaa90ab51a	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 Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
Zoledronic Acid	ACTIVE INGREDIENT	6XC1PAD3KF	ZOLEDRONIC ACID INJECTION, SOLUTION, CONCENTRATE [JHP PHARMACEUTICALS, LLC.]	2
ZOLEDRONIC ACID ANHYDROUS	ACTIVE MOIETY	70HZ18PH24	ZOLEDRONIC ACID INJECTION, SOLUTION, CONCENTRATE [JHP PHARMACEUTICALS, LLC.]	2
Mannitol	INACTIVE INGREDIENT	3OWL53L36A	ZOLEDRONIC ACID INJECTION, SOLUTION, CONCENTRATE [JHP PHARMACEUTICALS, LLC.]	2
Sodium Citrate	INACTIVE INGREDIENT	1Q73Q2JULR	ZOLEDRONIC ACID INJECTION, SOLUTION, CONCENTRATE [JHP PHARMACEUTICALS, LLC.]	2
Water	INACTIVE INGREDIENT	059QF0KO0R	ZOLEDRONIC ACID INJECTION, SOLUTION, CONCENTRATE [JHP PHARMACEUTICALS, LLC.]	2

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
6XC1PAD3KF	ZOLEDRONIC ACID	165800-06-6	ZOLEDRONIC ACID

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Zoledronic Acid	JHP Pharmaceuticals, LLC. \| Pharmaceutics International, Inc. (Pii)	2013-02-28	HUMAN PRESCRIPTION DRUG LABEL	2