Indocyanine Green

Product NDC: 17238-424
Requested package NDC: 17238-424-02
11-digit product format: 172380424
Labeler code: 17238
Product ID: 17238-424_efbb879e-9788-9b9b-e053-2a95a90a36ee
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Indocyanine Green and Water
Dosage form: KIT
Labeler: HUB Pharmaceuticals LLC
Application: ANDA040811
Marketing category: ANDA
Marketing start: 2008-01-01
Marketing end: 0000-00-00
Active strength: 0
NDC exclude flag: No
Listing certified through: 2023-12-31
Current FDA listing: Historical FDA.report record

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…`

Reported adverse events (FAERS/openFDA)#

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

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
17238-424-06	EA - Each	17238-424	05a31a71-d3d6-4855-bbe8-5afc5505b071	1	2024-02-14

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	Marketing start	Marketing end	Sample	Exclude flag	Status
17238-424-02	17238042402	1 KIT in 1 CARTON (17238-424-02)	1 kit	2015-10-01	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Indocyanine Green for Injection USP	HUB Pharmaceuticals LLC \| Hospira, Inc. \| Fresenius Kabi USA, LLC	2024-01-01	HUMAN PRESCRIPTION DRUG LABEL	8