Zoledronic Acid

Product NDC: 83634-801
Requested package NDC: 83634-801-05
11-digit product format: 836340801
Labeler code: 83634
Product ID: 83634-801_1063bd7e-52b7-4df2-bd99-64929854a7d2
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: zoledronic acid
Dosage form: INJECTION, SOLUTION, CONCENTRATE
Route: INTRAVENOUS
Labeler: Avenacy Inc.
Application: ANDA201783
Marketing category: ANDA
Marketing start: 2025-01-15
Substance: ZOLEDRONIC ACID
Active strength: 4 mg/5mL
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 43.

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
A201783-001	ZOLEDRONIC ACID	ZOLEDRONIC ACID	EQ 4MG BASE/5ML	INJECTABLE / INTRAVENOUS	AP		2013-03-12

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A201783-001	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 1 of 2 · 43 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
2026-09-14 22:38:34	2026-08	A201783-001	ZOLEDRONIC ACID	EQ 4MG BASE/5ML	INJECTABLE / INTRAVENOUS	AP	2013-03-12	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A201783-001	ZOLEDRONIC ACID	EQ 4MG BASE/5ML	INJECTABLE / INTRAVENOUS	AP	2013-03-12	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A201783-001	ZOLEDRONIC ACID	EQ 4MG BASE/5ML	INJECTABLE / INTRAVENOUS	AP	2013-03-12	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A201783-001	ZOLEDRONIC ACID	EQ 4MG BASE/5ML	INJECTABLE / INTRAVENOUS	AP	2013-03-12	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A201783-001	ZOLEDRONIC ACID	EQ 4MG BASE/5ML	INJECTABLE / INTRAVENOUS	AP	2013-03-12	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A201783-001	ZOLEDRONIC ACID	EQ 4MG BASE/5ML	INJECTABLE / INTRAVENOUS	AP	2013-03-12	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A201783-001	ZOLEDRONIC ACID	EQ 4MG BASE/5ML	INJECTABLE / INTRAVENOUS	AP	2013-03-12	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A201783-001	ZOLEDRONIC ACID	EQ 4MG BASE/5ML	INJECTABLE / INTRAVENOUS	AP	2013-03-12	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A201783-001	ZOLEDRONIC ACID	EQ 4MG BASE/5ML	INJECTABLE / INTRAVENOUS	AP	2013-03-12	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A201783-001	ZOLEDRONIC ACID	EQ 4MG BASE/5ML	INJECTABLE / INTRAVENOUS	AP	2013-03-12	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A201783-001	ZOLEDRONIC ACID	EQ 4MG BASE/5ML	INJECTABLE / INTRAVENOUS	AP	2013-03-12	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A201783-001	ZOLEDRONIC ACID	EQ 4MG BASE/5ML	INJECTABLE / INTRAVENOUS	AP	2013-03-12	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A201783-001	ZOLEDRONIC ACID	EQ 4MG BASE/5ML	INJECTABLE / INTRAVENOUS	AP	2013-03-12	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A201783-001	ZOLEDRONIC ACID	EQ 4MG BASE/5ML	INJECTABLE / INTRAVENOUS	AP	2013-03-12	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A201783-001	ZOLEDRONIC ACID	EQ 4MG BASE/5ML	INJECTABLE / INTRAVENOUS	AP	2013-03-12	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A201783-001	ZOLEDRONIC ACID	EQ 4MG BASE/5ML	INJECTABLE / INTRAVENOUS	AP	2013-03-12	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A201783-001	ZOLEDRONIC ACID	EQ 4MG BASE/5ML	INJECTABLE / INTRAVENOUS		2013-03-12	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A201783-001	ZOLEDRONIC ACID	EQ 4MG BASE/5ML	INJECTABLE / INTRAVENOUS		2013-03-12	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A201783-001	ZOLEDRONIC ACID	EQ 4MG BASE/5ML	INJECTABLE / INTRAVENOUS		2013-03-12	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A201783-001	ZOLEDRONIC ACID	EQ 4MG BASE/5ML	INJECTABLE / INTRAVENOUS	AP	2013-03-12	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A201783-001	ZOLEDRONIC ACID	EQ 4MG BASE/5ML	INJECTABLE / INTRAVENOUS		2013-03-12	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A201783-001	ZOLEDRONIC ACID	EQ 4MG BASE/5ML	INJECTABLE / INTRAVENOUS		2013-03-12	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A201783-001	ZOLEDRONIC ACID	EQ 4MG BASE/5ML	INJECTABLE / INTRAVENOUS	AP	2013-03-12	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A201783-001	ZOLEDRONIC ACID	EQ 4MG BASE/5ML	INJECTABLE / INTRAVENOUS	AP	2013-03-12	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A201783-001	ZOLEDRONIC ACID	EQ 4MG BASE/5ML	INJECTABLE / INTRAVENOUS	AP	2013-03-12	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A201783-001	ZOLEDRONIC ACID	EQ 4MG BASE/5ML	INJECTABLE / INTRAVENOUS	AP	2013-03-12	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A201783-001	ZOLEDRONIC ACID	EQ 4MG BASE/5ML	INJECTABLE / INTRAVENOUS	AP	2013-03-12	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A201783-001	ZOLEDRONIC ACID	EQ 4MG BASE/5ML	INJECTABLE / INTRAVENOUS	AP	2013-03-12	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A201783-001	ZOLEDRONIC ACID	EQ 4MG BASE/5ML	INJECTABLE / INTRAVENOUS	AP	2013-03-12	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A201783-001	ZOLEDRONIC ACID	EQ 4MG BASE/5ML	INJECTABLE / INTRAVENOUS	AP	2013-03-12	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A201783-001	ZOLEDRONIC ACID	EQ 4MG BASE/5ML	INJECTABLE / INTRAVENOUS	AP	2013-03-12	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A201783-001	ZOLEDRONIC ACID	EQ 4MG BASE/5ML	INJECTABLE / INTRAVENOUS	AP	2013-03-12	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A201783-001	ZOLEDRONIC ACID	EQ 4MG BASE/5ML	INJECTABLE / INTRAVENOUS	AP	2013-03-12	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A201783-001	ZOLEDRONIC ACID	EQ 4MG BASE/5ML	INJECTABLE / INTRAVENOUS	AP	2013-03-12	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A201783-001	ZOLEDRONIC ACID	EQ 4MG BASE/5ML	INJECTABLE / INTRAVENOUS		2013-03-12	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A201783-001	ZOLEDRONIC ACID	EQ 4MG BASE/5ML	INJECTABLE / INTRAVENOUS		2013-03-12	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A201783-001	ZOLEDRONIC ACID	EQ 4MG BASE/5ML	INJECTABLE / INTRAVENOUS		2013-03-12	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A201783-001	ZOLEDRONIC ACID	EQ 4MG BASE/5ML	INJECTABLE / INTRAVENOUS		2013-03-12	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A201783-001	ZOLEDRONIC ACID	EQ 4MG BASE/5ML	INJECTABLE / INTRAVENOUS		2013-03-12	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A201783-001	ZOLEDRONIC ACID	EQ 4MG BASE/5ML	INJECTABLE / INTRAVENOUS		2013-03-12	`f41ea6bd6efb…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-09-14 22:38:34	2026-08	A201783-001	AP	1	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A201783-001	AP	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A201783-001	AP	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A201783-001	AP	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A201783-001	AP	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A201783-001	AP	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A201783-001	AP	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A201783-001	AP	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A201783-001	AP	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A201783-001	AP	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A201783-001	AP	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A201783-001	AP	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A201783-001	AP	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A201783-001	AP	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A201783-001	AP	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A201783-001	AP	1	`8072bd15b7f6…`
2019-12-13 00:20 UTC	2019-12	A201783-001	AP	1	`74a2ff9319b5…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A201783-001	AP	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A201783-001	AP	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A201783-001	AP	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A201783-001	AP	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A201783-001	AP	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A201783-001	AP	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A201783-001	AP	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A201783-001	AP	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A201783-001	AP	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A201783-001	AP	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A201783-001	AP	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A201783-001	AP	1	`9b2671bbb829…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A201783-001	AP	1	`a50c72e98297…`

Reported adverse events (FAERS/openFDA)#

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

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	4 mg/5mL

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
351114	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
4b699dd8-d232-4bdb-88ce-9b42ed93e036	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
a62a50ac-1535-4461-9768-8ae703e2e9fb	Product name	1	20210525
95fe9bf2-51a5-1324-90da-8451ccf59619	Product name	9	20190228
76bb2633-9686-4c41-9e21-c755e223f2e0	Product name	1	20160408
d5e51f11-ad28-caa4-4b49-4143974782ad	Product name	1	20150831
94acf8b5-886e-4cdd-b38e-791d5af82ba0	Product name	1	20150325
9514609b-a2a9-f8ec-6ba6-3f8e5ee89877	Product name	1	20140508
bc07ef78-e82d-0c19-31f4-31f263780582	Product name	1	20140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
83634-801-05	Zoledronic Acid	5 mL in 1 VIAL, SINGLE-DOSE	INJECTION, SOLUTION, CONCENTRATE	5		1
83634-801-05	Zoledronic Acid	1 in 1 CARTON	INJECTION, SOLUTION, CONCENTRATE	1		1

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
83634-801-05	ML - Milliliter	83634-801	d2d3ff67-571e-49e0-a98a-70ab509a36c6	1	2025-03-04

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
83634-801	ZOLEDRONIC ACID INJECTION, SOLUTION, CONCENTRATE [AVENACY INC.]	1	Current NDC, 2 package rows	20250115_4b699dd8-d232-4bdb-88ce-9b42ed93e036.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 · 4 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Zoledronic acid	ZOLEDRONIC ACID	BluePoint Laboratories	f433c13c-dd8c-4dca-834e-a4ecf09d1eab	2025-09-03	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 201783 application number: ANDA201783
Zoledronic Acid	ZOLEDRONIC ACID	Avenacy Inc.	4b699dd8-d232-4bdb-88ce-9b42ed93e036	2025-01-15	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 201783 application number: ANDA201783 ndc (package): 83634-801-05 ndc (product): 83634-801 ndc11 (package): 83634080105
Zoledronic acid	ZOLEDRONIC ACID	Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc.	00a5bd5a-e5ee-4bad-b510-a4d4485485c8	2023-09-18	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 201783 application number: ANDA201783
Zoledronic acid	ZOLEDRONIC ACID	NORTHSTAR RX LLC	3885488c-6b83-421b-afee-61abceb95634	2023-09-06	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 201783 application number: ANDA201783

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
351114	zoledronic acid 4 MG in 5 ML Injection	PSN	4b699dd8-d232-4bdb-88ce-9b42ed93e036	1
351114	5 ML zoledronic acid 0.8 MG/ML Injection	SCD	4b699dd8-d232-4bdb-88ce-9b42ed93e036	1
351114	zoledronic acid 4 MG per 5 ML Injection	SY	4b699dd8-d232-4bdb-88ce-9b42ed93e036	1

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Sample	Exclude flag	Status
83634-801-05	83634080105	1 VIAL, SINGLE-DOSE in 1 CARTON (83634-801-05) / 5 mL in 1 VIAL, SINGLE-DOSE	2025-01-15	No	No	Current