Zoledronic Acid

Product NDC: 55150-283
11-digit product format: 551500283
Labeler code: 55150
Product ID: 55150-283_ab56911b-70e0-46c4-a985-990244bd67bc
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Zoledronic Acid
Dosage form: INJECTION, SOLUTION
Route: INTRAVENOUS
Labeler: Eugia US LLC
Application: ANDA209125
Marketing category: ANDA
Marketing start: 2017-12-08
Substance: ZOLEDRONIC ACID
Active strength: 5 mg/100mL
Pharmacologic classes: Bisphosphonate [EPC], Diphosphonates [CS]
NDC exclude flag: No
Listing certified through: 2027-12-31
Current FDA listing: Yes

Source provenance: Browse the complete Orange Book source catalog · source snapshot 1.

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
A209125-001	ZOLEDRONIC ACID	ZOLEDRONIC ACID	EQ 5MG BASE/100ML	INJECTABLE / INTRAVENOUS			2017-12-08

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 1 of 2 · 41 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
2026-02-19 14:30 UTC	2026-02	A209125-001	ZOLEDRONIC ACID	EQ 5MG BASE/100ML	INJECTABLE / INTRAVENOUS		2017-12-08	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A209125-001	ZOLEDRONIC ACID	EQ 5MG BASE/100ML	INJECTABLE / INTRAVENOUS		2017-12-08	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A209125-001	ZOLEDRONIC ACID	EQ 5MG BASE/100ML	INJECTABLE / INTRAVENOUS		2017-12-08	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A209125-001	ZOLEDRONIC ACID	EQ 5MG BASE/100ML	INJECTABLE / INTRAVENOUS		2017-12-08	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A209125-001	ZOLEDRONIC ACID	EQ 5MG BASE/100ML	INJECTABLE / INTRAVENOUS		2017-12-08	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A209125-001	ZOLEDRONIC ACID	EQ 5MG BASE/100ML	INJECTABLE / INTRAVENOUS		2017-12-08	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A209125-001	ZOLEDRONIC ACID	EQ 5MG BASE/100ML	INJECTABLE / INTRAVENOUS		2017-12-08	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A209125-001	ZOLEDRONIC ACID	EQ 5MG BASE/100ML	INJECTABLE / INTRAVENOUS		2017-12-08	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A209125-001	ZOLEDRONIC ACID	EQ 5MG BASE/100ML	INJECTABLE / INTRAVENOUS		2017-12-08	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A209125-001	ZOLEDRONIC ACID	EQ 5MG BASE/100ML	INJECTABLE / INTRAVENOUS		2017-12-08	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A209125-001	ZOLEDRONIC ACID	EQ 5MG BASE/100ML	INJECTABLE / INTRAVENOUS		2017-12-08	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A209125-001	ZOLEDRONIC ACID	EQ 5MG BASE/100ML	INJECTABLE / INTRAVENOUS		2017-12-08	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A209125-001	ZOLEDRONIC ACID	EQ 5MG BASE/100ML	INJECTABLE / INTRAVENOUS		2017-12-08	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A209125-001	ZOLEDRONIC ACID	EQ 5MG BASE/100ML	INJECTABLE / INTRAVENOUS		2017-12-08	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A209125-001	ZOLEDRONIC ACID	EQ 5MG BASE/100ML	INJECTABLE / INTRAVENOUS	AP	2017-12-08	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A209125-001	ZOLEDRONIC ACID	EQ 5MG BASE/100ML	INJECTABLE / INTRAVENOUS	AP	2017-12-08	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A209125-001	ZOLEDRONIC ACID	EQ 5MG BASE/100ML	INJECTABLE / INTRAVENOUS	AP	2017-12-08	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A209125-001	ZOLEDRONIC ACID	EQ 5MG BASE/100ML	INJECTABLE / INTRAVENOUS	AP	2017-12-08	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A209125-001	ZOLEDRONIC ACID	EQ 5MG BASE/100ML	INJECTABLE / INTRAVENOUS	AP	2017-12-08	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A209125-001	ZOLEDRONIC ACID	EQ 5MG BASE/100ML	INJECTABLE / INTRAVENOUS	AP	2017-12-08	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A209125-001	ZOLEDRONIC ACID	EQ 5MG BASE/100ML	INJECTABLE / INTRAVENOUS	AP	2017-12-08	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A209125-001	ZOLEDRONIC ACID	EQ 5MG BASE/100ML	INJECTABLE / INTRAVENOUS	AP	2017-12-08	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A209125-001	ZOLEDRONIC ACID	EQ 5MG BASE/100ML	INJECTABLE / INTRAVENOUS	AP	2017-12-08	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A209125-001	ZOLEDRONIC ACID	EQ 5MG BASE/100ML	INJECTABLE / INTRAVENOUS	AP	2017-12-08	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A209125-001	ZOLEDRONIC ACID	EQ 5MG BASE/100ML	INJECTABLE / INTRAVENOUS	AP	2017-12-08	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A209125-001	ZOLEDRONIC ACID	EQ 5MG BASE/100ML	INJECTABLE / INTRAVENOUS	AP	2017-12-08	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A209125-001	ZOLEDRONIC ACID	EQ 5MG BASE/100ML	INJECTABLE / INTRAVENOUS	AP	2017-12-08	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A209125-001	ZOLEDRONIC ACID	EQ 5MG BASE/100ML	INJECTABLE / INTRAVENOUS		2017-12-08	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A209125-001	ZOLEDRONIC ACID	EQ 5MG BASE/100ML	INJECTABLE / INTRAVENOUS		2017-12-08	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A209125-001	ZOLEDRONIC ACID	EQ 5MG BASE/100ML	INJECTABLE / INTRAVENOUS		2017-12-08	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A209125-001	ZOLEDRONIC ACID	EQ 5MG BASE/100ML	INJECTABLE / INTRAVENOUS		2017-12-08	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A209125-001	ZOLEDRONIC ACID	EQ 5MG BASE/100ML	INJECTABLE / INTRAVENOUS		2017-12-08	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A209125-001	ZOLEDRONIC ACID	EQ 5MG BASE/100ML	INJECTABLE / INTRAVENOUS		2017-12-08	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A209125-001	ZOLEDRONIC ACID	EQ 5MG BASE/100ML	INJECTABLE / INTRAVENOUS		2017-12-08	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A209125-001	ZOLEDRONIC ACID	EQ 5MG BASE/100ML	INJECTABLE / INTRAVENOUS		2017-12-08	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A209125-001	ZOLEDRONIC ACID	EQ 5MG BASE/100ML	INJECTABLE / INTRAVENOUS		2017-12-08	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A209125-001	ZOLEDRONIC ACID	EQ 5MG BASE/100ML	INJECTABLE / INTRAVENOUS		2017-12-08	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A209125-001	ZOLEDRONIC ACID	EQ 5MG BASE/100ML	INJECTABLE / INTRAVENOUS		2017-12-08	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A209125-001	ZOLEDRONIC ACID	EQ 5MG BASE/100ML	INJECTABLE / INTRAVENOUS		2017-12-08	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A209125-001	ZOLEDRONIC ACID	EQ 5MG BASE/100ML	INJECTABLE / INTRAVENOUS	AP	2017-12-08	`cb3db0bc1861…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A209125-001	AP	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A209125-001	AP	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A209125-001	AP	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A209125-001	AP	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A209125-001	AP	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A209125-001	AP	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A209125-001	AP	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A209125-001	AP	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A209125-001	AP	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A209125-001	AP	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A209125-001	AP	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A209125-001	AP	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A209125-001	AP	1	`ea99ee380514…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A209125-001	AP	1	`cb3db0bc1861…`

Additional Listing Data#

Finished product: Yes
Brand name base: Zoledronic Acid
Listing expiration: 2027-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
ZOLEDRONIC ACID	5 mg/100mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
6XC1PAD3KF	Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
705824	Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
bf5f96d4-f87c-4968-bed0-a4b5e77f4162	Available on FDA.report

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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
55150-283-99	Zoledronic Acid	1 in 1 CARTON	INJECTION, SOLUTION	1		7
55150-283-99	Zoledronic Acid	100 mL in 1 BOTTLE, GLASS	INJECTION, SOLUTION	100		7

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
55150-283	ZOLEDRONIC ACID INJECTION, SOLUTION [EUGIA US LLC]	5	Current NDC, Legacy NDC, 2 package rows	20241117_bf5f96d4-f87c-4968-bed0-a4b5e77f4162.zip

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Zoledronic Acid	ZOLEDRONIC ACID	Eugia US LLC	bf5f96d4-f87c-4968-bed0-a4b5e77f4162	2026-05-15	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 209125 application number: ANDA209125 ndc (product): 55150-283

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

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
705824	zoledronic acid 5 MG in 100 ML Injection	PSN	bf5f96d4-f87c-4968-bed0-a4b5e77f4162	7
705824	100 ML zoledronic acid 0.05 MG/ML Injection	SCD	bf5f96d4-f87c-4968-bed0-a4b5e77f4162	7
705824	zoledronic acid 5 MG per 100 ML Injection	SY	bf5f96d4-f87c-4968-bed0-a4b5e77f4162	7

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Marketing end	Sample	Exclude flag	Status
55150-283-99	55150028399	1 BOTTLE, GLASS in 1 CARTON (55150-283-99) / 100 mL in 1 BOTTLE, GLASS	2017-12-08	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Zoledronic Acid	Eugia US LLC \| EUGIA PHARMA SPECIALITIES LIMITED	2026-05-15	Human Prescription Drug Label	7