Indocyanine Green

Product NDC
73624-424
11-digit product format
736240424
Labeler code
73624
Product ID
73624-424_e6cdd6c3-3611-4ced-9cd6-6642718999de
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Indocyanine Green and Water
Dosage form
KIT
Labeler
Olympus America, Inc.
Application
ANDA040811
Marketing category
ANDA
Marketing start
2021-04-01
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Source provenance: Browse the complete Orange Book source catalog · source snapshot 42.

Orange Book products#

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

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A040811-001INDOCYANINE GREENINDOCYANINE GREEN25MG/VIALINJECTABLE / INJECTIONAPRS2007-11-21

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A040811-001AP

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 · 42 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-08-18 06:07:402026-07A040811-001INDOCYANINE GREEN25MG/VIALINJECTABLE / INJECTIONAPRS2007-11-21caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A040811-001INDOCYANINE GREEN25MG/VIALINJECTABLE / INJECTIONAPRS2007-11-21011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A040811-001INDOCYANINE GREEN25MG/VIALINJECTABLE / INJECTIONAPRS2007-11-2131067a03dcf5…
2025-08-23 18:47 UTC2025-08A040811-001INDOCYANINE GREEN25MG/VIALINJECTABLE / INJECTIONAPRS2007-11-216a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A040811-001INDOCYANINE GREEN25MG/VIALINJECTABLE / INJECTIONRS2007-11-21fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A040811-001INDOCYANINE GREEN25MG/VIALINJECTABLE / INJECTIONRS2007-11-21b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A040811-001INDOCYANINE GREEN25MG/VIALINJECTABLE / INJECTIONRS2007-11-2103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A040811-001INDOCYANINE GREEN25MG/VIALINJECTABLE / INJECTIONRS2007-11-212680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A040811-001INDOCYANINE GREEN25MG/VIALINJECTABLE / INJECTIONRS2007-11-215bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A040811-001INDOCYANINE GREEN25MG/VIALINJECTABLE / INJECTIONRS2007-11-21d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A040811-001INDOCYANINE GREEN25MG/VIALINJECTABLE / INJECTIONRS2007-11-21d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A040811-001INDOCYANINE GREEN25MG/VIALINJECTABLE / INJECTIONRS2007-11-2179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A040811-001INDOCYANINE GREEN25MG/VIALINJECTABLE / INJECTIONRS2007-11-21301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A040811-001INDOCYANINE GREEN25MG/VIALINJECTABLE / INJECTIONRS2007-11-211e350fbaab3a…
2024-05-31 18:47 UTC2024-05A040811-001INDOCYANINE GREEN25MG/VIALINJECTABLE / INJECTIONRS2007-11-218072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A040811-001INDOCYANINE GREEN25MG/VIALINJECTABLE / INJECTIONAP2007-11-215c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A040811-001INDOCYANINE GREEN25MG/VIALINJECTABLE / INJECTIONAP2007-11-215d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A040811-001INDOCYANINE GREEN25MG/VIALINJECTABLE / INJECTIONAP2007-11-214b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A040811-001INDOCYANINE GREEN25MG/VIALINJECTABLE / INJECTIONAP2007-11-2174a2ff9319b5…
2022-03-09 01:35 UTC2022-03A040811-001INDOCYANINE GREEN25MG/VIALINJECTABLE / INJECTIONAP2007-11-21bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A040811-001INDOCYANINE GREEN25MG/VIALINJECTABLE / INJECTIONAP2007-11-21782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A040811-001INDOCYANINE GREEN25MG/VIALINJECTABLE / INJECTIONAP2007-11-2187673890dc5c…
2021-03-12 10:30 UTC2021-03A040811-001INDOCYANINE GREEN25MG/VIALINJECTABLE / INJECTIONAP2007-11-215aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A040811-001INDOCYANINE GREEN25MG/VIALINJECTABLE / INJECTIONAP2007-11-218869cabd3fbd…
2020-11-12 02:37 UTC2020-11A040811-001INDOCYANINE GREEN25MG/VIALINJECTABLE / INJECTIONAP2007-11-21c0c555d07b60…
2019-12-14 00:12 UTC2019-12A040811-001INDOCYANINE GREEN25MG/VIALINJECTABLE / INJECTIONAP2007-11-213f01610625f2…
2019-09-15 20:21 UTC2019-09A040811-001INDOCYANINE GREEN25MG/VIALINJECTABLE / INJECTIONAP2007-11-21b00525d2431f…
2019-07-19 19:46 UTC2019-07A040811-001INDOCYANINE GREEN25MG/VIALINJECTABLE / INJECTIONAP2007-11-21ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A040811-001INDOCYANINE GREEN25MG/VIALINJECTABLE / INJECTIONRS2007-11-216a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A040811-001INDOCYANINE GREEN25MG/VIALINJECTABLE / INJECTIONRS2007-11-211c564ffb4f44…
2023-12-20 04:57 UTC2023-12A040811-001INDOCYANINE GREEN25MG/VIALINJECTABLE / INJECTIONRS2007-11-21ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A040811-001INDOCYANINE GREEN25MG/VIALINJECTABLE / INJECTIONRS2007-11-21a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A040811-001INDOCYANINE GREEN25MG/VIALINJECTABLE / INJECTIONRS2007-11-219b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A040811-001INDOCYANINE GREEN25MG/VIALINJECTABLE / INJECTIONAP2007-11-21a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A040811-001INDOCYANINE GREEN25MG/VIALINJECTABLE / INJECTIONAP2007-11-213f0d92c62455…
2023-05-13 08:27 UTC2023-05A040811-001INDOCYANINE GREEN25MG/VIALINJECTABLE / INJECTIONAP2007-11-21053a50430f4f…
2023-01-26 05:58 UTC2023-01A040811-001INDOCYANINE GREEN25MG/VIALINJECTABLE / INJECTIONAP2007-11-213bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A040811-001INDOCYANINE GREEN25MG/VIALINJECTABLE / INJECTIONAP2007-11-213a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A040811-001INDOCYANINE GREEN25MG/VIALINJECTABLE / INJECTIONAP2007-11-21f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09A040811-001INDOCYANINE GREEN25MG/VIALINJECTABLE / INJECTIONAP2007-11-21e64feba35796…

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-08-18 06:07:402026-07A040811-001AP1caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A040811-001AP1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A040811-001AP131067a03dcf5…
2025-08-23 18:47 UTC2025-08A040811-001AP16a471c1ec25d…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A040811-001AP15c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A040811-001AP15d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A040811-001AP14b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A040811-001AP174a2ff9319b5…
2022-03-09 01:35 UTC2022-03A040811-001AP1bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A040811-001AP1782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A040811-001AP187673890dc5c…
2021-03-12 10:30 UTC2021-03A040811-001AP15aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A040811-001AP18869cabd3fbd…
2020-11-12 02:37 UTC2020-11A040811-001AP1c0c555d07b60…
2019-12-14 00:12 UTC2019-12A040811-001AP13f01610625f2…
2019-09-15 20:21 UTC2019-09A040811-001AP1b00525d2431f…
2019-07-19 19:46 UTC2019-07A040811-001AP1ea99ee380514…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A040811-001AP1a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A040811-001AP13f0d92c62455…
2023-05-13 08:27 UTC2023-05A040811-001AP1053a50430f4f…
2023-01-26 05:58 UTC2023-01A040811-001AP13bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A040811-001AP13a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A040811-001AP1f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09A040811-001AP1e64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07A040811-001AP1cb3db0bc1861…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A040811-001AP1a50c72e98297…

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
IdentifierFDA.report destination
91c206e8-fab9-4bf3-afcf-304eddf0d54eAvailable on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
e86469f1-0431-b4e2-fe09-0dbe527624d7Product name220250804
e4138432-bbdb-43bd-8e68-9964f0048734Product name120190228

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0409-4887-17Indocyanine Green10 mL in 1 VIAL, PLASTICINJECTION10 mL1 mL in 1mL2
73624-424-02Indocyanine Green6 in 1 CARTONKIT62
73624-424-02Indocyanine Green1 in 1 PACKAGEKIT12

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
73624-424INDOCYANINE GREEN (INDOCYANINE GREEN AND WATER) KIT [OLYMPUS AMERICA, INC.]2Current NDC, Legacy NDC, 3 package rows20230620_91c206e8-fab9-4bf3-afcf-304eddf0d54e.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
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Indocyanine GreenINDOCYANINE GREEN AND WATERRenew Pharmaceuticals Limiteda6f24787-c243-445a-9c55-7c7479b292d92025-04-13Warnings, Adverse reactionsExact identifier
application applno (ANDA): 040811
application number: ANDA040811
Indocyanine GreenINDOCYANINE GREEN AND WATEROlympus America, Inc.91c206e8-fab9-4bf3-afcf-304eddf0d54e2020-06-01Warnings, Adverse reactionsExact identifier
application applno (ANDA): 040811
application number: ANDA040811
ndc (product): 73624-424

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0409-4887-170040948871710 mL in 1 VIAL, PLASTIC10 mlHistorical
73624-424-02736240424026 PACKAGE in 1 CARTON (73624-424-02) / 1 KIT in 1 PACKAGE * 1 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION in 1 VIAL * 10 mL in 1 VIAL, PLASTIC (0409-4887-17) 6 package2021-04-010000-00-00NoNoCurrent