ICG

Product NDC: 70599-424
11-digit product format: 705990424
Labeler code: 70599
Product ID: 70599-424_84872330-522f-4e7a-83d4-8906bc1a02da
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Indocyanine Green and Water
Dosage form: KIT
Labeler: KARL STORZ Endoscopy-America, Inc.
Application: ANDA040811
Marketing category: ANDA
Marketing start: 2016-06-01
Marketing end: 0000-00-00
Active strength: 0
NDC exclude flag: No
Listing certified through: 2021-12-31
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	70599-424		I	Inactivated by FDA		2026-09-14
excluded package	package	70599-424	70599-424-02	D	Discontinued by firm		2026-09-14

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 · 30 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		I	Inactivated by FDA	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	70599-424-02	D	Discontinued by firm	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded product	product		I	Inactivated by FDA	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	70599-424-02	D	Discontinued by firm	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded product	product		I	Inactivated by FDA	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	70599-424-02	D	Discontinued by firm	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded product	product		I	Inactivated by FDA	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	70599-424-02	D	Discontinued by firm	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded product	product		I	Inactivated by FDA	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	70599-424-02	D	Discontinued by firm	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded product	product		I	Inactivated by FDA	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	70599-424-02	D	Discontinued by firm	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded product	product		I	Inactivated by FDA	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	70599-424-02	D	Discontinued by firm	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded product	product		I	Inactivated by FDA	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	70599-424-02	D	Discontinued by firm	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded product	product		I	Inactivated by FDA	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	70599-424-02	D	Discontinued by firm	`0efc9e666f02…`	`f202fb6c5f17…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded product	product		I	Inactivated by FDA	`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	70599-424-02	D	Discontinued by firm	`ad56d346431e…`	`cc804d4bbf1e…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded product	product		I	Inactivated by FDA	`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	70599-424-02	D	Discontinued by firm	`367a005e9d99…`	`383a685ebd0f…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded product	product		I	Inactivated by FDA	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	70599-424-02	D	Discontinued by firm	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-05-28 21:12 UTC · source 2024-05-28	excluded product	product		I	Inactivated by FDA	`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-15 03:39 UTC · source 2024-05-14	excluded product	product		I	Inactivated by FDA	`834df4deac94…`	`adcc014656a3…`
2024-03-11 06:39 UTC · source 2024-03-08	excluded product	product		I	Inactivated by FDA	`1332a3947898…`	`d4bfe170f9cd…`
2022-08-30 03:57 UTC · source 2022-08-29	excluded product	product		I	Inactivated by FDA	`fb8cb913e6d1…`	`eb8c232b6be0…`
2022-04-09 23:13 UTC · source 2022-04-08	excluded product	product		I	Inactivated by FDA	`86f5da6cb304…`	`a595104c45d7…`
2022-04-04 05:40 UTC · source 2022-04-01	excluded product	product		I	Inactivated by FDA	`bd6a592717d7…`	`303034d00443…`

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
A040811-001	INDOCYANINE GREEN	INDOCYANINE GREEN	25MG/VIAL	INJECTABLE / INJECTION	AP	RS	2007-11-21

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A040811-001	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	RLD / RS	Approval date	Source SHA-256
2026-09-14 22:38:34	2026-08	A040811-001	INDOCYANINE GREEN	25MG/VIAL	INJECTABLE / INJECTION	AP	RS	2007-11-21	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A040811-001	INDOCYANINE GREEN	25MG/VIAL	INJECTABLE / INJECTION	AP	RS	2007-11-21	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A040811-001	INDOCYANINE GREEN	25MG/VIAL	INJECTABLE / INJECTION	AP	RS	2007-11-21	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A040811-001	INDOCYANINE GREEN	25MG/VIAL	INJECTABLE / INJECTION	AP	RS	2007-11-21	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A040811-001	INDOCYANINE GREEN	25MG/VIAL	INJECTABLE / INJECTION	AP	RS	2007-11-21	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A040811-001	INDOCYANINE GREEN	25MG/VIAL	INJECTABLE / INJECTION		RS	2007-11-21	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A040811-001	INDOCYANINE GREEN	25MG/VIAL	INJECTABLE / INJECTION		RS	2007-11-21	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A040811-001	INDOCYANINE GREEN	25MG/VIAL	INJECTABLE / INJECTION		RS	2007-11-21	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A040811-001	INDOCYANINE GREEN	25MG/VIAL	INJECTABLE / INJECTION		RS	2007-11-21	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A040811-001	INDOCYANINE GREEN	25MG/VIAL	INJECTABLE / INJECTION		RS	2007-11-21	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A040811-001	INDOCYANINE GREEN	25MG/VIAL	INJECTABLE / INJECTION		RS	2007-11-21	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A040811-001	INDOCYANINE GREEN	25MG/VIAL	INJECTABLE / INJECTION		RS	2007-11-21	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A040811-001	INDOCYANINE GREEN	25MG/VIAL	INJECTABLE / INJECTION		RS	2007-11-21	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A040811-001	INDOCYANINE GREEN	25MG/VIAL	INJECTABLE / INJECTION		RS	2007-11-21	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A040811-001	INDOCYANINE GREEN	25MG/VIAL	INJECTABLE / INJECTION		RS	2007-11-21	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A040811-001	INDOCYANINE GREEN	25MG/VIAL	INJECTABLE / INJECTION		RS	2007-11-21	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A040811-001	INDOCYANINE GREEN	25MG/VIAL	INJECTABLE / INJECTION	AP		2007-11-21	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A040811-001	INDOCYANINE GREEN	25MG/VIAL	INJECTABLE / INJECTION	AP		2007-11-21	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A040811-001	INDOCYANINE GREEN	25MG/VIAL	INJECTABLE / INJECTION	AP		2007-11-21	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A040811-001	INDOCYANINE GREEN	25MG/VIAL	INJECTABLE / INJECTION	AP		2007-11-21	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A040811-001	INDOCYANINE GREEN	25MG/VIAL	INJECTABLE / INJECTION	AP		2007-11-21	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A040811-001	INDOCYANINE GREEN	25MG/VIAL	INJECTABLE / INJECTION	AP		2007-11-21	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A040811-001	INDOCYANINE GREEN	25MG/VIAL	INJECTABLE / INJECTION	AP		2007-11-21	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A040811-001	INDOCYANINE GREEN	25MG/VIAL	INJECTABLE / INJECTION	AP		2007-11-21	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A040811-001	INDOCYANINE GREEN	25MG/VIAL	INJECTABLE / INJECTION	AP		2007-11-21	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A040811-001	INDOCYANINE GREEN	25MG/VIAL	INJECTABLE / INJECTION	AP		2007-11-21	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A040811-001	INDOCYANINE GREEN	25MG/VIAL	INJECTABLE / INJECTION	AP		2007-11-21	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A040811-001	INDOCYANINE GREEN	25MG/VIAL	INJECTABLE / INJECTION	AP		2007-11-21	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A040811-001	INDOCYANINE GREEN	25MG/VIAL	INJECTABLE / INJECTION	AP		2007-11-21	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A040811-001	INDOCYANINE GREEN	25MG/VIAL	INJECTABLE / INJECTION		RS	2007-11-21	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A040811-001	INDOCYANINE GREEN	25MG/VIAL	INJECTABLE / INJECTION		RS	2007-11-21	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A040811-001	INDOCYANINE GREEN	25MG/VIAL	INJECTABLE / INJECTION		RS	2007-11-21	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A040811-001	INDOCYANINE GREEN	25MG/VIAL	INJECTABLE / INJECTION		RS	2007-11-21	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A040811-001	INDOCYANINE GREEN	25MG/VIAL	INJECTABLE / INJECTION		RS	2007-11-21	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A040811-001	INDOCYANINE GREEN	25MG/VIAL	INJECTABLE / INJECTION	AP		2007-11-21	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A040811-001	INDOCYANINE GREEN	25MG/VIAL	INJECTABLE / INJECTION	AP		2007-11-21	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A040811-001	INDOCYANINE GREEN	25MG/VIAL	INJECTABLE / INJECTION	AP		2007-11-21	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A040811-001	INDOCYANINE GREEN	25MG/VIAL	INJECTABLE / INJECTION	AP		2007-11-21	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A040811-001	INDOCYANINE GREEN	25MG/VIAL	INJECTABLE / INJECTION	AP		2007-11-21	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A040811-001	INDOCYANINE GREEN	25MG/VIAL	INJECTABLE / INJECTION	AP		2007-11-21	`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	A040811-001	AP	1	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A040811-001	AP	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A040811-001	AP	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A040811-001	AP	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A040811-001	AP	1	`6a471c1ec25d…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A040811-001	AP	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A040811-001	AP	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A040811-001	AP	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A040811-001	AP	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A040811-001	AP	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A040811-001	AP	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A040811-001	AP	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A040811-001	AP	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A040811-001	AP	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A040811-001	AP	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A040811-001	AP	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A040811-001	AP	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A040811-001	AP	1	`ea99ee380514…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A040811-001	AP	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A040811-001	AP	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A040811-001	AP	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A040811-001	AP	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A040811-001	AP	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A040811-001	AP	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A040811-001	AP	1	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A040811-001	AP	1	`cb3db0bc1861…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A040811-001	AP	1	`a50c72e98297…`

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
e86469f1-0431-b4e2-fe09-0dbe527624d7	Product name	2	20250804
3c386306-c48a-413e-bb69-70cb268496f3	Product name	1	20210727
e4138432-bbdb-43bd-8e68-9964f0048734	Product name	1	20190228

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
70599-424-02	2022-01-28	C162847	48780-1	d6a99b39-b38d-a426-e053-dadaa90af4c2	These highlights do not include all the information needed to use ICG for Injection Set safely and effectively. See full prescribing information for Indocyanine Green for Injection, USP. Initial U.S. Approval: 1959

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
0409-4887-17	ICG	10 mL in 1 VIAL, PLASTIC	INJECTION	10 mL	1 mL in 1mL	3
70599-424-02	ICG	1 in 1 PACKAGE	KIT	1		3
70599-424-02	ICG	6 in 1 CARTON	KIT	6		3

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
70599-424	ICG (INDOCYANINE GREEN AND WATER) KIT [KARL STORZ ENDOSCOPY-AMERICA, INC.]	3	Legacy NDC, 3 package rows	20201118_06c018a4-293e-42b5-b77a-bb121501cb16.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 · 2 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Indocyanine Green	INDOCYANINE GREEN AND WATER	Renew Pharmaceuticals Limited	a6f24787-c243-445a-9c55-7c7479b292d9	2025-04-13	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 040811 application number: ANDA040811
Indocyanine Green	INDOCYANINE GREEN AND WATER	Olympus America, Inc.	91c206e8-fab9-4bf3-afcf-304eddf0d54e	2020-06-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 040811 application number: ANDA040811

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Status
0409-4887-17	00409488717	10 mL in 1 VIAL, PLASTIC	10 ml	Historical
70599-424-02	70599042402	1 in 1 PACKAGE		Historical

ICG