IC-Green

Product NDC: 70100-810
11-digit product format: 701000810
Labeler code: 70100
Product ID: 70100-810_bb82db71-b087-4274-bd9c-cb388d7dbaeb
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Indocyanine Green
Dosage form: KIT
Labeler: Renew Pharmaceuticals Limited
Application: NDA011525
Marketing category: NDA
Marketing start: 2026-04-15
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 1.

Orange Book products#

Current product rows page 1 of 1 · 4 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS
N011525-001	IC-GREEN	INDOCYANINE GREEN	25MG/VIAL	INJECTABLE / INJECTION	AP	RLD, Approved before 1982
N011525-002	IC-GREEN	INDOCYANINE GREEN	50MG/VIAL Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INJECTION		Approved before 1982
N011525-003	IC-GREEN	INDOCYANINE GREEN	10MG/VIAL Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INJECTION		RS, Approved before 1982
N011525-004	IC-GREEN	INDOCYANINE GREEN	40MG/VIAL Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INJECTION		Approved before 1982

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
N011525-001	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 5 · 164 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Product TE source text	RLD / RS	Source SHA-256
2026-02-19 14:30 UTC	2026-02	N011525-001	IC-GREEN	25MG/VIAL	INJECTABLE / INJECTION	AP	RLD, Approved before 1982	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N011525-002	IC-GREEN	50MG/VIAL Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INJECTION		Approved before 1982	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N011525-003	IC-GREEN	10MG/VIAL Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INJECTION		Approved before 1982	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N011525-004	IC-GREEN	40MG/VIAL Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INJECTION		Approved before 1982	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N011525-001	IC-GREEN	25MG/VIAL	INJECTABLE / INJECTION	AP	RLD, Approved before 1982	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N011525-002	IC-GREEN	50MG/VIAL Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INJECTION		Approved before 1982	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N011525-003	IC-GREEN	10MG/VIAL Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INJECTION		Approved before 1982	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N011525-004	IC-GREEN	40MG/VIAL Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INJECTION		Approved before 1982	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N011525-001	IC-GREEN	25MG/VIAL	INJECTABLE / INJECTION	AP	RLD, Approved before 1982	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N011525-002	IC-GREEN	50MG/VIAL Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INJECTION		Approved before 1982	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N011525-003	IC-GREEN	10MG/VIAL Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INJECTION		Approved before 1982	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N011525-004	IC-GREEN	40MG/VIAL Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INJECTION		Approved before 1982	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N011525-001	IC-GREEN	25MG/VIAL	INJECTABLE / INJECTION		RLD, Approved before 1982	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N011525-002	IC-GREEN	50MG/VIAL Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INJECTION		Approved before 1982	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N011525-003	IC-GREEN	10MG/VIAL Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INJECTION		Approved before 1982	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N011525-004	IC-GREEN	40MG/VIAL Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INJECTION		Approved before 1982	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N011525-001	IC-GREEN	25MG/VIAL	INJECTABLE / INJECTION		RLD, Approved before 1982	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N011525-002	IC-GREEN	50MG/VIAL Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INJECTION		Approved before 1982	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N011525-003	IC-GREEN	10MG/VIAL Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INJECTION		Approved before 1982	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N011525-004	IC-GREEN	40MG/VIAL Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INJECTION		Approved before 1982	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N011525-001	IC-GREEN	25MG/VIAL	INJECTABLE / INJECTION		RLD, Approved before 1982	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N011525-002	IC-GREEN	50MG/VIAL Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INJECTION		Approved before 1982	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N011525-003	IC-GREEN	10MG/VIAL Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INJECTION		Approved before 1982	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N011525-004	IC-GREEN	40MG/VIAL Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INJECTION		Approved before 1982	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N011525-001	IC-GREEN	25MG/VIAL	INJECTABLE / INJECTION		RLD, Approved before 1982	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N011525-002	IC-GREEN	50MG/VIAL Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INJECTION		Approved before 1982	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N011525-003	IC-GREEN	10MG/VIAL Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INJECTION		Approved before 1982	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N011525-004	IC-GREEN	40MG/VIAL Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INJECTION		Approved before 1982	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N011525-001	IC-GREEN	25MG/VIAL	INJECTABLE / INJECTION		RLD, Approved before 1982	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N011525-002	IC-GREEN	50MG/VIAL Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INJECTION		Approved before 1982	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N011525-003	IC-GREEN	10MG/VIAL Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INJECTION		Approved before 1982	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N011525-004	IC-GREEN	40MG/VIAL Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INJECTION		Approved before 1982	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N011525-001	IC-GREEN	25MG/VIAL	INJECTABLE / INJECTION		RLD, Approved before 1982	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N011525-002	IC-GREEN	50MG/VIAL Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INJECTION		Approved before 1982	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N011525-003	IC-GREEN	10MG/VIAL Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INJECTION		Approved before 1982	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N011525-004	IC-GREEN	40MG/VIAL Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INJECTION		Approved before 1982	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N011525-001	IC-GREEN	25MG/VIAL	INJECTABLE / INJECTION		RLD, Approved before 1982	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N011525-002	IC-GREEN	50MG/VIAL Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INJECTION		Approved before 1982	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N011525-003	IC-GREEN	10MG/VIAL Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INJECTION		Approved before 1982	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N011525-004	IC-GREEN	40MG/VIAL Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INJECTION		Approved before 1982	`d06236e962d9…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-02-19 14:30 UTC	2026-02	N011525-001	AP	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N011525-001	AP	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N011525-001	AP	1	`6a471c1ec25d…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N011525-001	AP	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N011525-001	AP	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N011525-001	AP	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N011525-001	AP	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N011525-001	AP	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N011525-001	AP	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N011525-001	AP	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N011525-001	AP	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N011525-001	AP	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N011525-001	AP	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N011525-001	AP	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N011525-001	AP	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N011525-001	AP	1	`ea99ee380514…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N011525-001	AP	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N011525-001	AP	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	N011525-001	AP	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	N011525-001	AP	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N011525-001	AP	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	N011525-001	AP	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	N011525-001	AP	1	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	N011525-001	AP	1	`cb3db0bc1861…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	N011525-001	AP	1	`a50c72e98297…`

Additional Listing Data#

Finished product: Yes
Brand name base: IC-Green
Listing expiration: 2027-12-31

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
Identifier	FDA.report destination
ccd92843-1f0a-4ece-9978-4b300d158886	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	IC-Green	10 mL in 1 VIAL, PLASTIC	INJECTION	10 mL	1 mL in 1mL	4
70100-710-01	IC-Green	1 in 1 VIAL	INJECTION, POWDER, LYOPHILIZED,	1	10 mg	4
70100-810-02	IC-Green	1 in 1 PACKAGE	KIT	1		4
70100-810-02	IC-Green	6 in 1 CARTON	KIT	6		4

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 · 1 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
IC-Green	INDOCYANINE GREEN	Renew Pharmaceuticals Limited	ccd92843-1f0a-4ece-9978-4b300d158886	2026-01-30	Warnings, Adverse reactions	Exact identifier application applno (NDA): 011525 application number: NDA011525 ndc (product): 70100-810

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
IX6J1063HV	INDOCYANINE GREEN	3599-32-4	Indocyanine Green

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Sample	Exclude flag	Status
0409-4887-17	00409488717	10 mL in 1 VIAL, PLASTIC	10 ml				Historical
70100-710-01	70100071001	1 in 1 VIAL					Historical
70100-810-02	70100081002	6 PACKAGE in 1 CARTON (70100-810-02) / 1 KIT in 1 PACKAGE * 1 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION in 1 VIAL (70100-710-01) * 10 mL in 1 VIAL, PLASTIC (0409-4887-17)	6 package	2026-04-15	No	No	Current