Zoledronic Acid

Product NDC: 17478-327
11-digit product format: 174780327
Labeler code: 17478
Product ID: 17478-327_a8e4a09f-afe8-41ff-b53c-14182070d102
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Zoledronic Acid
Dosage form: INJECTION, SOLUTION, CONCENTRATE
Route: INTRAVENOUS
Labeler: Akorn
Application: ANDA202548
Marketing category: ANDA
Marketing start: 2014-05-22
Marketing end: 0000-00-00
Substance: ZOLEDRONIC ACID
Active strength: 4 mg/5mL
Pharmacologic classes: Bisphosphonate [EPC], Diphosphonates [CS]
NDC exclude flag: No
Listing certified through: 2023-12-31
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 · 3 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Source date
excluded product	product	17478-327		I	Inactivated by FDA	2026-08-11
excluded package	package	17478-327	17478-327-05	I	Inactivated by FDA	2026-08-11
excluded package	package	17478-327	17478-327-45	I	Inactivated by FDA	2026-08-11

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 · 45 matching rows.

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

Captured / source date, Dataset, Scope table
Captured / source date	Dataset	Scope	Package NDC	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	excluded product	product		`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	17478-327-05	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	17478-327-45	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded product	product		`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	17478-327-05	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	17478-327-45	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded product	product		`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	17478-327-05	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	17478-327-45	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded product	product		`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	17478-327-05	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	17478-327-45	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded product	product		`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	17478-327-05	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	17478-327-45	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded product	product		`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	17478-327-05	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	17478-327-45	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded product	product		`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	17478-327-05	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	17478-327-45	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded product	product		`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	17478-327-05	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	17478-327-45	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded product	product		`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	17478-327-05	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	17478-327-45	`0efc9e666f02…`	`f202fb6c5f17…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded product	product		`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	17478-327-05	`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	17478-327-45	`ad56d346431e…`	`cc804d4bbf1e…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded product	product		`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	17478-327-05	`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	17478-327-45	`367a005e9d99…`	`383a685ebd0f…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded product	product		`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	17478-327-05	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	17478-327-45	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-05-28 21:12 UTC · source 2024-05-28	excluded product	product		`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-28 21:12 UTC · source 2024-05-28	excluded package	package	17478-327-05	`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-28 21:12 UTC · source 2024-05-28	excluded package	package	17478-327-45	`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-15 03:39 UTC · source 2024-05-14	excluded product	product		`834df4deac94…`	`adcc014656a3…`
2024-05-15 03:39 UTC · source 2024-05-14	excluded package	package	17478-327-05	`834df4deac94…`	`adcc014656a3…`
2024-05-15 03:39 UTC · source 2024-05-14	excluded package	package	17478-327-45	`834df4deac94…`	`adcc014656a3…`
2024-03-11 06:39 UTC · source 2024-03-08	excluded product	product		`1332a3947898…`	`d4bfe170f9cd…`
2024-03-11 06:39 UTC · source 2024-03-08	excluded package	package	17478-327-05	`1332a3947898…`	`d4bfe170f9cd…`
2024-03-11 06:39 UTC · source 2024-03-08	excluded package	package	17478-327-45	`1332a3947898…`	`d4bfe170f9cd…`

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
A202548-001	ZOLEDRONIC ACID	ZOLEDRONIC ACID	EQ 4MG BASE/5ML	INJECTABLE / INTRAVENOUS	AP		2014-05-22

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A202548-001	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 · 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	A202548-001	ZOLEDRONIC ACID	EQ 4MG BASE/5ML	INJECTABLE / INTRAVENOUS	AP	2014-05-22	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A202548-001	ZOLEDRONIC ACID	EQ 4MG BASE/5ML	INJECTABLE / INTRAVENOUS	AP	2014-05-22	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A202548-001	ZOLEDRONIC ACID	EQ 4MG BASE/5ML	INJECTABLE / INTRAVENOUS	AP	2014-05-22	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A202548-001	ZOLEDRONIC ACID	EQ 4MG BASE/5ML	INJECTABLE / INTRAVENOUS	AP	2014-05-22	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A202548-001	ZOLEDRONIC ACID	EQ 4MG BASE/5ML	INJECTABLE / INTRAVENOUS	AP	2014-05-22	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A202548-001	ZOLEDRONIC ACID	EQ 4MG BASE/5ML	INJECTABLE / INTRAVENOUS	AP	2014-05-22	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A202548-001	ZOLEDRONIC ACID	EQ 4MG BASE/5ML	INJECTABLE / INTRAVENOUS	AP	2014-05-22	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A202548-001	ZOLEDRONIC ACID	EQ 4MG BASE/5ML	INJECTABLE / INTRAVENOUS	AP	2014-05-22	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A202548-001	ZOLEDRONIC ACID	EQ 4MG BASE/5ML	INJECTABLE / INTRAVENOUS	AP	2014-05-22	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A202548-001	ZOLEDRONIC ACID	EQ 4MG BASE/5ML	INJECTABLE / INTRAVENOUS	AP	2014-05-22	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A202548-001	ZOLEDRONIC ACID	EQ 4MG BASE/5ML	INJECTABLE / INTRAVENOUS	AP	2014-05-22	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A202548-001	ZOLEDRONIC ACID	EQ 4MG BASE/5ML	INJECTABLE / INTRAVENOUS	AP	2014-05-22	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A202548-001	ZOLEDRONIC ACID	EQ 4MG BASE/5ML	INJECTABLE / INTRAVENOUS	AP	2014-05-22	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A202548-001	ZOLEDRONIC ACID	EQ 4MG BASE/5ML	INJECTABLE / INTRAVENOUS	AP	2014-05-22	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A202548-001	ZOLEDRONIC ACID	EQ 4MG BASE/5ML	INJECTABLE / INTRAVENOUS	AP	2014-05-22	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A202548-001	ZOLEDRONIC ACID	EQ 4MG BASE/5ML	INJECTABLE / INTRAVENOUS	AP	2014-05-22	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A202548-001	ZOLEDRONIC ACID	EQ 4MG BASE/5ML	INJECTABLE / INTRAVENOUS	AP	2014-05-22	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A202548-001	ZOLEDRONIC ACID	EQ 4MG BASE/5ML	INJECTABLE / INTRAVENOUS	AP	2014-05-22	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A202548-001	ZOLEDRONIC ACID	EQ 4MG BASE/5ML	INJECTABLE / INTRAVENOUS	AP	2014-05-22	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A202548-001	ZOLEDRONIC ACID	EQ 4MG BASE/5ML	INJECTABLE / INTRAVENOUS	AP	2014-05-22	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A202548-001	ZOLEDRONIC ACID	EQ 4MG BASE/5ML	INJECTABLE / INTRAVENOUS	AP	2014-05-22	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A202548-001	ZOLEDRONIC ACID	EQ 4MG BASE/5ML	INJECTABLE / INTRAVENOUS	AP	2014-05-22	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A202548-001	ZOLEDRONIC ACID	EQ 4MG BASE/5ML	INJECTABLE / INTRAVENOUS	AP	2014-05-22	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A202548-001	ZOLEDRONIC ACID	EQ 4MG BASE/5ML	INJECTABLE / INTRAVENOUS	AP	2014-05-22	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A202548-001	ZOLEDRONIC ACID	EQ 4MG BASE/5ML	INJECTABLE / INTRAVENOUS	AP	2014-05-22	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A202548-001	ZOLEDRONIC ACID	EQ 4MG BASE/5ML	INJECTABLE / INTRAVENOUS	AP	2014-05-22	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A202548-001	ZOLEDRONIC ACID	EQ 4MG BASE/5ML	INJECTABLE / INTRAVENOUS	AP	2014-05-22	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A202548-001	ZOLEDRONIC ACID	EQ 4MG BASE/5ML	INJECTABLE / INTRAVENOUS	AP	2014-05-22	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A202548-001	ZOLEDRONIC ACID	EQ 4MG BASE/5ML	INJECTABLE / INTRAVENOUS	AP	2014-05-22	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A202548-001	ZOLEDRONIC ACID	EQ 4MG BASE/5ML	INJECTABLE / INTRAVENOUS	AP	2014-05-22	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A202548-001	ZOLEDRONIC ACID	EQ 4MG BASE/5ML	INJECTABLE / INTRAVENOUS	AP	2014-05-22	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A202548-001	ZOLEDRONIC ACID	EQ 4MG BASE/5ML	INJECTABLE / INTRAVENOUS	AP	2014-05-22	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A202548-001	ZOLEDRONIC ACID	EQ 4MG BASE/5ML	INJECTABLE / INTRAVENOUS	AP	2014-05-22	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A202548-001	ZOLEDRONIC ACID	EQ 4MG BASE/5ML	INJECTABLE / INTRAVENOUS	AP	2014-05-22	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A202548-001	ZOLEDRONIC ACID	EQ 4MG BASE/5ML	INJECTABLE / INTRAVENOUS	AP	2014-05-22	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A202548-001	ZOLEDRONIC ACID	EQ 4MG BASE/5ML	INJECTABLE / INTRAVENOUS	AP	2014-05-22	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A202548-001	ZOLEDRONIC ACID	EQ 4MG BASE/5ML	INJECTABLE / INTRAVENOUS	AP	2014-05-22	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A202548-001	ZOLEDRONIC ACID	EQ 4MG BASE/5ML	INJECTABLE / INTRAVENOUS	AP	2014-05-22	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A202548-001	ZOLEDRONIC ACID	EQ 4MG BASE/5ML	INJECTABLE / INTRAVENOUS	AP	2014-05-22	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A202548-001	ZOLEDRONIC ACID	EQ 4MG BASE/5ML	INJECTABLE / INTRAVENOUS	AP	2014-05-22	`cb3db0bc1861…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 41 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A202548-001	AP	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A202548-001	AP	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A202548-001	AP	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A202548-001	AP	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A202548-001	AP	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A202548-001	AP	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A202548-001	AP	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A202548-001	AP	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A202548-001	AP	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A202548-001	AP	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A202548-001	AP	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A202548-001	AP	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A202548-001	AP	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A202548-001	AP	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A202548-001	AP	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A202548-001	AP	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A202548-001	AP	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A202548-001	AP	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A202548-001	AP	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A202548-001	AP	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A202548-001	AP	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A202548-001	AP	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A202548-001	AP	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A202548-001	AP	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A202548-001	AP	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A202548-001	AP	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A202548-001	AP	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A202548-001	AP	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A202548-001	AP	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A202548-001	AP	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A202548-001	AP	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A202548-001	AP	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A202548-001	AP	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A202548-001	AP	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A202548-001	AP	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A202548-001	AP	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A202548-001	AP	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A202548-001	AP	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A202548-001	AP	1	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A202548-001	AP	1	`cb3db0bc1861…`

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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
17478-327-05	2024-01-30	C162847	48780-1	1030e365-5ad4-111a-e063-dadaa90a10e2	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, for intravenous use Initial U.S. Approval: 2001
17478-327-45	2024-01-30	C162847	48780-1	1030e365-5ad4-111a-e063-dadaa90a10e2	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, for intravenous use Initial U.S. Approval: 2001

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
17478-327-05	Zoledronic Acid	1 in 1 CARTON	INJECTION, SOLUTION, CONCENTRATE	1	8
17478-327-05	Zoledronic Acid	5 mL in 1 VIAL, SINGLE-DOSE	INJECTION, SOLUTION, CONCENTRATE	5	8
17478-327-45	Zoledronic Acid	5 mL in 1 VIAL, SINGLE-DOSE	INJECTION, SOLUTION, CONCENTRATE	5	8
17478-327-45	Zoledronic Acid	4 in 1 CARTON	INJECTION, SOLUTION, CONCENTRATE	4	8

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
17478-327-05	ML - Milliliter	17478-327	1cf89d67-b9c8-4a56-a442-182f2e3564b9	1	2015-11-12
17478-327-45	ML - Milliliter	17478-327	98f8ea25-6371-4ee2-abec-a63576c11d0a	1	2015-11-12

DailyMed Socrata Ingredients#

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

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
17478-327	ZOLEDRONIC ACID INJECTION, SOLUTION, CONCENTRATE [AKORN]	8	Legacy NDC, 4 package rows	20220922_2191fccc-9f90-486c-8f30-dc828b62fe15.zip

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	2191fccc-9f90-486c-8f30-dc828b62fe15	8
351114	5 ML zoledronic acid 0.8 MG/ML Injection	SCD	2191fccc-9f90-486c-8f30-dc828b62fe15	8
351114	zoledronic acid 4 MG per 5 ML Injection	SY	2191fccc-9f90-486c-8f30-dc828b62fe15	8

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Marketing end	Sample	Exclude flag	Status
17478-327-05	17478032705	1 VIAL, SINGLE-USE in 1 CARTON (17478-327-05) > 5 mL in 1 VIAL, SINGLE-USE	2014-05-22	0000-00-00	No	No	Current
17478-327-45	17478032745	4 VIAL, SINGLE-USE in 1 CARTON (17478-327-45) > 5 mL in 1 VIAL, SINGLE-USE	2014-05-22	0000-00-00	No	No	Current