Zyogreen

Product NDC: 25021-841
Requested package NDC: 25021-841-10
11-digit product format: 250210841
Labeler code: 25021
Product ID: 25021-841_1aa18dd8-8838-4698-b358-6956f8b94929
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Indocyanine Green
Dosage form: INJECTION, SOLUTION
Route: INTERSTITIAL; INTRAVENOUS
Labeler: Sagent Pharmaceuticals
Application: NDA218579
Marketing category: NDA
Marketing start: 2026-07-16
Substance: INDOCYANINE GREEN
Active strength: 2.5 mg/mL
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 44.

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
N218579-001	ZYOGREEN	INDOCYANINE GREEN	25MG/10ML (2.5MG/ML)	SOLUTION / INTRAVENOUS, INTERSTITIAL		RLD, RS	2026-07-10

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.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	RLD / RS	Approval date	Source SHA-256
2026-10-15 13:18:30	2026-09	N218579-001	ZYOGREEN	25MG/10ML (2.5MG/ML)	SOLUTION / INTRAVENOUS, INTERSTITIAL	RLD, RS	2026-07-10	`c2088c7a36db…`
2026-09-14 22:38:34	2026-08	N218579-001	ZYOGREEN	25MG/10ML (2.5MG/ML)	SOLUTION / INTRAVENOUS, INTERSTITIAL	RLD, RS	2026-07-10	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	N218579-001	ZYOGREEN	25MG/10ML (2.5MG/ML)	SOLUTION / INTRAVENOUS, INTERSTITIAL	RLD, RS	2026-07-10	`caaa826d4ba7…`

Reported adverse events (FAERS/openFDA)#

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

Additional Listing Data#

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

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
INDOCYANINE GREEN	2.5 mg/mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
IX6J1063HV	Internal UNII lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
Identifier	FDA.report destination
b2de0c9a-0065-4f2c-9983-add39525f3a3	Available on FDA.report

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
Zyogreen	INDOCYANINE GREEN	Sagent Pharmaceuticals	b2de0c9a-0065-4f2c-9983-add39525f3a3	2026-07-16	Warnings, Adverse reactions	Exact identifier application applno (NDA): 218579 application number: NDA218579 ndc (package): 25021-841-10 ndc (product): 25021-841 ndc11 (package): 25021084110

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
25021-841-10	25021084110	5 AMPULE in 1 CARTON (25021-841-10) / 10 mL in 1 AMPULE	5 ampule	2026-07-16	No	No	Current