Indocyanine Green

Product NDC: 70100-424
Requested package NDC: 70100-424-02
11-digit product format: 701000424
Labeler code: 70100
Product ID: 70100-424_3abdfd10-c4e6-472e-b4eb-d4953f029132
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Indocyanine Green and Water
Dosage form: KIT
Labeler: Renew Pharmaceuticals Limited
Application: ANDA040811
Marketing category: ANDA
Marketing start: 2008-01-01
NDC exclude flag: No
Listing certified through: 2026-12-31
Current FDA listing: Yes

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 · 1 matching rows.

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

Captured / source date, Dataset, Scope table
Captured / source date	Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Archive	Snapshot	Source SHA-256
2019-12-08 06:16 UTC · source 2019-12-05	excluded package	package	70100-424	70100-424-02	E	Excluded after deficient or non-compliant submission was not corrected		excluded / ndc_excluded.zip	`110d247fa046…`	`a55b01930146…`

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…`

Additional Listing Data#

Finished product: Yes
Brand name base: Indocyanine Green
Listing expiration: 2026-12-31

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
Identifier	FDA.report destination
a6f24787-c243-445a-9c55-7c7479b292d9	Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
e86469f1-0431-b4e2-fe09-0dbe527624d7	Product name	2	20250804
e4138432-bbdb-43bd-8e68-9964f0048734	Product name	1	20190228

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
0409-4887-17	Indocyanine Green	10 mL in 1 VIAL, PLASTIC	INJECTION	10 mL	1 mL in 1mL	9
70100-424-02	Indocyanine Green	6 in 1 CARTON	KIT	6		9
70100-424-02	Indocyanine Green	1 in 1 PACKAGE	KIT	1		9

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
70100-424-02	EA - Each	70100-424	9e374052-644e-48ed-ae67-e812ef5374fe	1	2019-09-05

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
INDOCYANINE GREEN	ACTIVE INGREDIENT	IX6J1063HV	INDOCYANINE GREEN (INDOCYANINE GREEN AND WATER) KIT [DIAGNOSTIC GREEN GMBH]	1
WATER	ACTIVE INGREDIENT	059QF0KO0R	INDOCYANINE GREEN (INDOCYANINE GREEN AND WATER) KIT [DIAGNOSTIC GREEN GMBH]	1
INDOCYANINE GREEN ACID FORM	ACTIVE MOIETY	C4V974V932	INDOCYANINE GREEN (INDOCYANINE GREEN AND WATER) KIT [DIAGNOSTIC GREEN GMBH]	1
WATER	ACTIVE MOIETY	059QF0KO0R	INDOCYANINE GREEN (INDOCYANINE GREEN AND WATER) KIT [DIAGNOSTIC GREEN GMBH]	1
SODIUM IODIDE	INACTIVE INGREDIENT	F5WR8N145C	INDOCYANINE GREEN (INDOCYANINE GREEN AND WATER) KIT [DIAGNOSTIC GREEN GMBH]	1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
70100-424	INDOCYANINE GREEN (INDOCYANINE GREEN AND WATER) KIT [RENEW PHARMACEUTICALS LIMITED]	9	Current NDC, Legacy NDC, 3 package rows	20250423_a6f24787-c243-445a-9c55-7c7479b292d9.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 ndc (package): 70100-424-02 ndc (product): 70100-424 ndc11 (package): 70100042402
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
70100-424-02	70100042402	6 PACKAGE in 1 CARTON (70100-424-02) / 1 KIT in 1 PACKAGE * 1 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION in 1 VIAL * 10 mL in 1 VIAL, PLASTIC (0409-4887-17)	6 package	2008-01-01	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Indocyanine Green	Renew Pharmaceuticals Limited \| Umforana Labor für Umweltanalytik und Auftragsforschung GmbH & Co. KG	2025-04-13	HUMAN PRESCRIPTION DRUG LABEL	9