SPY Elite Kit

Product NDC: 66259-306
11-digit product format: 662590306
Labeler code: 66259
Product ID: 66259-306_6f8cce61-6751-4924-a7f0-c90d532a9002
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: indocyanine green
Dosage form: KIT
Route: INTRAVASCULAR; INTRAVENOUS
Labeler: Novadaq Technologies Inc
Application: NDA211580
Marketing category: NDA
Marketing start: 2018-11-21
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

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	66259-306		I	Inactivated by FDA	2026-08-11
excluded package	package	66259-306	66259-306-13	I	Inactivated by FDA	2026-08-11
excluded package	package	66259-306	66259-306-23	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 · 27 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	66259-306-13	I	Inactivated by FDA	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	66259-306-23	I	Inactivated by FDA	`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	66259-306-13	I	Inactivated by FDA	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	66259-306-23	I	Inactivated by FDA	`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	66259-306-13	I	Inactivated by FDA	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	66259-306-23	I	Inactivated by FDA	`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	66259-306-13	I	Inactivated by FDA	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	66259-306-23	I	Inactivated by FDA	`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	66259-306-13	I	Inactivated by FDA	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	66259-306-23	I	Inactivated by FDA	`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	66259-306-13	I	Inactivated by FDA	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	66259-306-23	I	Inactivated by FDA	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded product	product		U	Excluded because listing certification expired	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	66259-306-23	U	Excluded because listing certification expired	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	66259-306-13	U	Excluded because listing certification expired	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded product	product		U	Excluded because listing certification expired	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	66259-306-23	U	Excluded because listing certification expired	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	66259-306-13	U	Excluded because listing certification expired	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded product	product		U	Excluded because listing certification expired	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	66259-306-23	U	Excluded because listing certification expired	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	66259-306-13	U	Excluded because listing certification expired	`0efc9e666f02…`	`f202fb6c5f17…`

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
N211580-001	SPY AGENT GREEN KIT	INDOCYANINE GREEN	25MG/VIAL	POWDER / INTRAVENOUS, INTERSTITIAL		RLD, RS	2018-11-21

Orange Book patents#

Current patent rows page 1 of 1 · 6 matching rows.

Application-product, Patent, Expiration table
Application-product	Patent	Expiration	Use code	Coverage / status	Submission date
N211580-001	8185176	2028-06-04	U-2462		2018-12-20
N211580-001	8647605	2029-02-11	U-2464		2018-12-20
N211580-001	8647605	2029-02-11	U-2468		2018-12-20
N211580-001	8406860	2029-04-09	U-2463		2018-12-20
N211580-001	10631746	2035-08-04	U-2815	Drug product	2020-05-27
N211580-001	11712320	2039-07-14		Drug product	2023-08-31

Orange Book exclusivity#

Current exclusivity rows page 1 of 1 · 1 matching rows.

Application-product, Exclusivity code, Expiration table
Application-product	Exclusivity code	Expiration
N211580-001	I-911	2026-06-05

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	RLD / RS	Approval date	Source SHA-256
2026-02-19 14:30 UTC	2026-02	N211580-001	SPY AGENT GREEN KIT	25MG/VIAL	POWDER / INTRAVENOUS, INTERSTITIAL	RLD, RS	2018-11-21	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N211580-001	SPY AGENT GREEN KIT	25MG/VIAL	POWDER / INTRAVENOUS, INTERSTITIAL	RLD, RS	2018-11-21	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N211580-001	SPY AGENT GREEN KIT	25MG/VIAL	POWDER / INTRAVENOUS, INTERSTITIAL	RLD, RS	2018-11-21	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N211580-001	SPY AGENT GREEN KIT	25MG/VIAL	POWDER / INTRAVENOUS, INTERSTITIAL	RLD, RS	2018-11-21	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N211580-001	SPY AGENT GREEN KIT	25MG/VIAL	POWDER / INTRAVENOUS, INTERSTITIAL	RLD, RS	2018-11-21	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N211580-001	SPY AGENT GREEN KIT	25MG/VIAL	POWDER / INTRAVENOUS, INTERSTITIAL	RLD, RS	2018-11-21	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N211580-001	SPY AGENT GREEN KIT	25MG/VIAL	POWDER / INTRAVENOUS, INTERSTITIAL	RLD, RS	2018-11-21	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N211580-001	SPY AGENT GREEN KIT	25MG/VIAL	POWDER / INTRAVENOUS, INTERSTITIAL	RLD, RS	2018-11-21	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N211580-001	SPY AGENT GREEN KIT	25MG/VIAL	POWDER / INTRAVENOUS, INTERSTITIAL	RLD, RS	2018-11-21	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N211580-001	SPY AGENT GREEN KIT	25MG/VIAL	POWDER / INTRAVENOUS, INTERSTITIAL	RLD, RS	2018-11-21	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N211580-001	SPY AGENT GREEN KIT	25MG/VIAL	POWDER / INTRAVENOUS, INTERSTITIAL	RLD, RS	2018-11-21	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N211580-001	SPY AGENT GREEN KIT	25MG/VIAL	POWDER / INTRAVENOUS, INTERSTITIAL	RLD, RS	2018-11-21	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N211580-001	SPY AGENT GREEN KIT	25MG/VIAL	POWDER / INTRAVENOUS, INTERSTITIAL	RLD, RS	2018-11-21	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N211580-001	SPY AGENT GREEN KIT	25MG/VIAL	POWDER / INTRAVENOUS, INTERSTITIAL	RLD, RS	2018-11-21	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N211580-001	SPY AGENT GREEN KIT	25MG/VIAL	POWDER / INTRAVENOUS, INTERSTITIAL	RLD, RS	2018-11-21	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N211580-001	SPY AGENT GREEN KIT	25MG/VIAL	POWDER / INTRAVENOUS, INTERSTITIAL	RLD, RS	2018-11-21	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N211580-001	SPY AGENT GREEN KIT	25MG/VIAL	POWDER / INTRAVENOUS, INTERSTITIAL	RLD, RS	2018-11-21	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N211580-001	SPY AGENT GREEN KIT	25MG/VIAL	POWDER / INTRAVENOUS, INTERSTITIAL	RLD, RS	2018-11-21	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N211580-001	SPY AGENT GREEN KIT	25MG/VIAL	POWDER / INTRAVENOUS, INTERSTITIAL	RLD, RS	2018-11-21	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N211580-001	SPY AGENT GREEN KIT	25MG/VIAL	POWDER / INTRAVENOUS, INTERSTITIAL	RLD, RS	2018-11-21	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N211580-001	SPY AGENT GREEN KIT	25MG/VIAL	POWDER / INTRAVENOUS, INTERSTITIAL	RLD, RS	2018-11-21	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N211580-001	SPY AGENT GREEN KIT	25MG/VIAL	POWDER / INTRAVENOUS, INTERSTITIAL	RLD, RS	2018-11-21	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N211580-001	SPY AGENT GREEN KIT	25MG/VIAL	POWDER / INTRAVENOUS, INTERSTITIAL	RLD, RS	2018-11-21	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N211580-001	SPY AGENT GREEN KIT	25MG/VIAL	POWDER / INTRAVENOUS, INTERSTITIAL	RLD, RS	2018-11-21	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N211580-001	SPY AGENT GREEN KIT	25MG/VIAL	POWDER / INTRAVENOUS, INTERSTITIAL	RLD, RS	2018-11-21	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N211580-001	SPY AGENT GREEN KIT	25MG/VIAL	POWDER / INTRAVENOUS, INTERSTITIAL	RLD, RS	2018-11-21	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N211580-001	SPY AGENT GREEN KIT	25MG/VIAL	POWDER / INTRAVENOUS, INTERSTITIAL	RLD, RS	2018-11-21	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N211580-001	SPY AGENT GREEN KIT	25MG/VIAL	POWDER / INTRAVENOUS, INTERSTITIAL	RLD, RS	2018-11-21	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	N211580-001	SPY AGENT GREEN KIT	25MG/VIAL	POWDER / INTRAVENOUS, INTERSTITIAL	RLD, RS	2018-11-21	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	N211580-001	SPY AGENT GREEN KIT	25MG/VIAL	POWDER / INTRAVENOUS, INTERSTITIAL	RLD, RS	2018-11-21	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N211580-001	SPY AGENT GREEN KIT	25MG/VIAL	POWDER / INTRAVENOUS, INTERSTITIAL	RLD, RS	2018-11-21	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N211580-001	SPY AGENT GREEN KIT	25MG/VIAL	POWDER / INTRAVENOUS, INTERSTITIAL	RLD, RS	2018-11-21	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N211580-001	SPY AGENT GREEN KIT	25MG/VIAL	POWDER / INTRAVENOUS, INTERSTITIAL	RLD, RS	2018-11-21	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N211580-001	SPY AGENT GREEN KIT	25MG/VIAL	POWDER / INTRAVENOUS, INTERSTITIAL	RLD, RS	2018-11-21	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	N211580-001	SPY AGENT GREEN KIT	25MG/VIAL	POWDER / INTRAVENOUS, INTERSTITIAL	RLD, RS	2018-11-21	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	N211580-001	SPY AGENT GREEN KIT	25MG/VIAL	POWDER / INTRAVENOUS, INTERSTITIAL	RLD, RS	2018-11-21	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N211580-001	SPY AGENT GREEN KIT	25MG/VIAL	POWDER / INTRAVENOUS, INTERSTITIAL	RLD, RS	2018-11-21	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	N211580-001	SPY AGENT GREEN KIT	25MG/VIAL	POWDER / INTRAVENOUS, INTERSTITIAL	RLD, RS	2018-11-21	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	N211580-001	SPY AGENT GREEN KIT	25MG/VIAL	POWDER / INTRAVENOUS, INTERSTITIAL	RLD, RS	2018-11-21	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	N211580-001	SPY AGENT GREEN KIT	25MG/VIAL	POWDER / INTRAVENOUS, INTERSTITIAL	RLD, RS	2018-11-21	`cb3db0bc1861…`

Observed Orange Book patent history#

Patent history page 1 of 9 · 323 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Patent	Expiration	Use code	Coverage / status	Submission date	Source SHA-256
2026-02-19 14:30 UTC	2026-02	N211580-001	8185176	2028-06-04	U-2462		2018-12-20	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N211580-001	8647605	2029-02-11	U-2468		2018-12-20	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N211580-001	8647605	2029-02-11	U-2464		2018-12-20	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N211580-001	8406860	2029-04-09	U-2463		2018-12-20	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N211580-001	10631746	2035-08-04	U-2815	Drug product	2020-05-27	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N211580-001	11712320	2039-07-14		Drug product	2023-08-31	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N211580-001	9421280	2025-11-24	U-2466		2018-12-20	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N211580-001	9421280	2025-11-24	U-2467		2018-12-20	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N211580-001	8185176	2028-06-04	U-2462		2018-12-20	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N211580-001	8647605	2029-02-11	U-2468		2018-12-20	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N211580-001	8647605	2029-02-11	U-2464		2018-12-20	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N211580-001	8406860	2029-04-09	U-2463		2018-12-20	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N211580-001	10631746	2035-08-04	U-2815	Drug product	2020-05-27	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N211580-001	11712320	2039-07-14		Drug product	2023-08-31	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N211580-001	9421280	2025-11-24	U-2466		2018-12-20	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N211580-001	9421280	2025-11-24	U-2467		2018-12-20	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N211580-001	8185176	2028-06-04	U-2462		2018-12-20	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N211580-001	8647605	2029-02-11	U-2468		2018-12-20	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N211580-001	8647605	2029-02-11	U-2464		2018-12-20	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N211580-001	8406860	2029-04-09	U-2463		2018-12-20	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N211580-001	10631746	2035-08-04	U-2815	Drug product	2020-05-27	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N211580-001	11712320	2039-07-14		Drug product	2023-08-31	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N211580-001	9421280	2025-11-24	U-2466		2018-12-20	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N211580-001	9421280	2025-11-24	U-2467		2018-12-20	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N211580-001	8185176	2028-06-04	U-2462		2018-12-20	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N211580-001	8647605	2029-02-11	U-2468		2018-12-20	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N211580-001	8647605	2029-02-11	U-2464		2018-12-20	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N211580-001	8406860	2029-04-09	U-2463		2018-12-20	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N211580-001	10631746	2035-08-04	U-2815	Drug product	2020-05-27	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N211580-001	11712320	2039-07-14		Drug product	2023-08-31	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N211580-001	9421280	2025-11-24	U-2466		2018-12-20	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N211580-001	9421280	2025-11-24	U-2467		2018-12-20	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N211580-001	8185176	2028-06-04	U-2462		2018-12-20	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N211580-001	8647605	2029-02-11	U-2468		2018-12-20	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N211580-001	8647605	2029-02-11	U-2464		2018-12-20	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N211580-001	8406860	2029-04-09	U-2463		2018-12-20	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N211580-001	10631746	2035-08-04	U-2815	Drug product	2020-05-27	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N211580-001	11712320	2039-07-14		Drug product	2023-08-31	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N211580-001	9421280	2025-11-24	U-2466		2018-12-20	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N211580-001	9421280	2025-11-24	U-2467		2018-12-20	`03ed91905a0d…`

Observed Orange Book exclusivity history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	Exclusivity code	Expiration	Source SHA-256
2026-02-19 14:30 UTC	2026-02	N211580-001	I-911	2026-06-05	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N211580-001	I-911	2026-06-05	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N211580-001	I-911	2026-06-05	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N211580-001	I-911	2026-06-05	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N211580-001	I-911	2026-06-05	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N211580-001	I-911	2026-06-05	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N211580-001	I-911	2026-06-05	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N211580-001	I-911	2026-06-05	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N211580-001	I-911	2026-06-05	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N211580-001	I-911	2026-06-05	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N211580-001	I-911	2026-06-05	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N211580-001	I-911	2026-06-05	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N211580-001	I-911	2026-06-05	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N211580-001	I-911	2026-06-05	`8072bd15b7f6…`
2019-12-13 00:20 UTC	2019-12	N211580-001	NP	2021-11-21	`74a2ff9319b5…`
2021-12-28 21:50 UTC	2021-12	N211580-001	NP	2021-11-21	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N211580-001	NP	2021-11-21	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N211580-001	NP	2021-11-21	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N211580-001	NP	2021-11-21	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N211580-001	NP	2021-11-21	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N211580-001	NP	2021-11-21	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N211580-001	NP	2021-11-21	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N211580-001	NP	2021-11-21	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N211580-001	I-911	2026-06-05	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	N211580-001	I-911	2026-06-05	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	N211580-001	I-911	2026-06-05	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N211580-001	I-911	2026-06-05	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N211580-001	I-911	2026-06-05	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N211580-001	I-911	2026-06-05	`a67488948f0b…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	N211580-001	I-911	2026-06-05	`a50c72e98297…`

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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
66259-306-13	2025-01-30	C162847	48780-1	2cef2736-a32d-d83d-e063-dadaa90ab31f	These highlights do not include all the information needed to use SPY AGENT GREEN safely and effectively. See full prescribing information for SPY AGENT GREEN. SPY AGENT ® GREEN (indocyanine green for injection), for intravenous, interstitial, or intradermal use Initial U.S. Approval: 1959
66259-306-23	2025-01-30	C162847	48780-1	2cef2736-a32d-d83d-e063-dadaa90ab31f	These highlights do not include all the information needed to use SPY AGENT GREEN safely and effectively. See full prescribing information for SPY AGENT GREEN. SPY AGENT ® GREEN (indocyanine green for injection), for intravenous, interstitial, or intradermal use Initial U.S. Approval: 1959

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
66259-146-01	SPY Elite Kit	1 in 1 VIAL	INJECTION, POWDER, LYOPHILIZED,	1	25 mg	16
66259-146-02	SPY Elite Kit	1 in 1 VIAL	INJECTION, POWDER, LYOPHILIZED,		25 mg	16
66259-306-13	SPY Elite Kit	1 in 1 KIT	KIT	1		16
66259-306-23	SPY Elite Kit	1 in 1 KIT	KIT	1		16
66259-306-23	SPY Elite Kit	6 in 1 CASE	KIT	6		16

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
66259-306	SPY ELITE KIT (INDOCYANINE GREEN) KIT SPY-PHI KIT (INDOCYANINE GREEN) KIT SPY-MIS KIT (INDOCYANINE GREEN) KIT SPY LYMPHATICS KIT (INDOCYANINE GREEN) KIT PINPOINT LYMPHATICS KIT (INDOCYANINE GREEN) KIT [NOVADAQ TECHNOLOGIES INC]	16	Legacy NDC, 5 package rows	20230616_95d11200-1cca-4044-b652-82dac72103b9.zip

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	Marketing end	Sample	Exclude flag	Status
66259-146-01	66259014601	1 in 1 VIAL						Historical
66259-146-02	66259014602	1 in 1 VIAL						Historical
66259-306-13	66259030613	1 KIT in 1 KIT (66259-306-13) * 10 mL in 1 VIAL, PLASTIC * 1 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION in 1 VIAL (66259-146-01)	1 kit	2018-11-21	0000-00-00	No	No	Current
66259-306-23	66259030623	6 KIT in 1 CASE (66259-306-23) > 1 KIT in 1 KIT * 10 mL in 1 VIAL, PLASTIC * 1 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION in 1 VIAL (66259-146-01)	6 kit	2018-11-21	0000-00-00	No	No	Current