FDA.reportPublic FDA data

Zyogreen

Product NDC
25021-841
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 43.

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
N218579-001ZYOGREENINDOCYANINE GREEN25MG/10ML (2.5MG/ML)SOLUTION / INTRAVENOUS, INTERSTITIALRLD, RS2026-07-10

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
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-09-14 22:38:342026-08N218579-001ZYOGREEN25MG/10ML (2.5MG/ML)SOLUTION / INTRAVENOUS, INTERSTITIALRLD, RS2026-07-1084e616aacf4f…
2026-08-18 06:07:402026-07N218579-001ZYOGREEN25MG/10ML (2.5MG/ML)SOLUTION / INTRAVENOUS, INTERSTITIALRLD, RS2026-07-10caaa826d4ba7…

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
IngredientStrength
INDOCYANINE GREEN2.5 mg/mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
IX6J1063HVInternal UNII lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
b2de0c9a-0065-4f2c-9983-add39525f3a3Available 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
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
ZyogreenINDOCYANINE GREENSagent Pharmaceuticalsb2de0c9a-0065-4f2c-9983-add39525f3a32026-07-16Warnings, Adverse reactionsExact identifier
application applno (NDA): 218579
application number: NDA218579
ndc (product): 25021-841

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
25021-841-10250210841105 AMPULE in 1 CARTON (25021-841-10) / 10 mL in 1 AMPULE5 ampule2026-07-16NoNoCurrent