FDA.reportPublic FDA data

INDOCYANINE GREEN for injection, for intravenous or interstitial use

Manufacturer
Zydus Lifesciences Limited
Effective date
2026-08-04
Label type
HUMAN PRESCRIPTION DRUG LABEL
Version
1
Source
daily-update
Hydrated at
2026-08-06 06:11:24

Label at a glance#

ProductINDOCYANINE GREEN
Active ingredientINDOCYANINE GREEN, WATER
Label structure1 sections

Label contents#

Full prescribing information#

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Indocyanine Green for Injection, USP

25 mg vial

NDC 70771-1959-1

Rx only

indocyanine green vial label
indocyanine green vial label

Sterile Water for Injection, USP

10 mL vial

NDC 70771-1960-1

Rx only

sterile water for injection vial label
sterile water for injection vial label

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 5 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
70771-195970771-1959-1
70771-196070771-1960-1, 70771-1960-8
70771-196170771-1961-3

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 3 matching rows.

Name, UNII, Kind table
NameUNIIKind
INDOCYANINE GREENIX6J1063HVACTIB
SODIUM HYDROXIDE55X04QC32IIACT
WATER059QF0KO0RACTIB

Source Document#

Source XML

Orange Book application contexts#

All distinct exact application/product contexts derived from this label’s complete NDC list are paginated below.

Orange Book application contexts page 1 of 1 · 1 matching rows.

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-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A219139-001INDOCYANINE GREENINDOCYANINE GREEN25MG/VIALINJECTABLE / INJECTIONAP2026-08-03

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A219139-001AP

Orange Book exclusivity#

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

Application-product, Exclusivity code, Expiration table
Application-productExclusivity codeExpiration
A219139-001CGT2027-01-31

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
2026-10-15 13:18:302026-09A219139-001INDOCYANINE GREEN25MG/VIALINJECTABLE / INJECTIONAP2026-08-03c2088c7a36db…
2026-09-14 22:38:342026-08A219139-001INDOCYANINE GREEN25MG/VIALINJECTABLE / INJECTIONAP2026-08-0384e616aacf4f…
2026-08-18 06:07:402026-07A219139-001INDOCYANINE GREEN25MG/VIALINJECTABLE / INJECTIONAP2026-08-03caaa826d4ba7…

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-10-15 13:18:302026-09A219139-001AP1c2088c7a36db…
2026-09-14 22:38:342026-08A219139-001AP184e616aacf4f…
2026-08-18 06:07:402026-07A219139-001AP1caaa826d4ba7…

Observed Orange Book exclusivity history#

Captured, Edition, Application-product table
CapturedEditionApplication-productExclusivity codeExpirationSource SHA-256
2026-10-15 13:18:302026-09A219139-001CGT2027-01-31c2088c7a36db…
2026-09-14 22:38:342026-08A219139-001CGT2027-01-3184e616aacf4f…
2026-08-18 06:07:402026-07A219139-001CGT2027-01-31caaa826d4ba7…

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
INDOCYANINE GREENINDOCYANINE GREENZydus Lifesciences Limited2cf76db4-f637-4f18-bdcd-91096216dacf2026-08-04Exact identifier
ndc (package): 70771-1959-1
ndc (package): 70771-1961-3
ndc (package): 70771-1960-1
ndc (package): 70771-1960-8
ndc (product): 70771-1961
ndc11 (package): 70771196008
ndc11 (package): 70771195901
ndc11 (package): 70771196103
ndc11 (package): 70771196001
spl id: 31ffadd0-f5e3-453b-8d2d-11fedc44ea24
spl set id: 2cf76db4-f637-4f18-bdcd-91096216dacf

Reported adverse events (FAERS/openFDA)#

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