Home NDC 70771-1961 INDOCYANINE GREEN
Product NDC 70771-1961
11-digit product format 707711961
Labeler code 70771
Product ID 70771-1961_31ffadd0-f5e3-453b-8d2d-11fedc44ea24
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name INDOCYANINE GREEN
Dosage form KIT
Labeler Zydus Lifesciences Limited
Application ANDA219139
Marketing category ANDA
Marketing start 2026-08-04
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-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date A219139-001 INDOCYANINE GREEN INDOCYANINE GREEN 25MG/VIAL INJECTABLE / INJECTION AP 2026-08-03
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code A219139-001 AP
Orange Book exclusivity# Current exclusivity rows page 1 of 1 · 1 matching rows.
Application-product, Exclusivity code, Expiration table Application-product Exclusivity code Expiration A219139-001 CGT 2027-01-31
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 Captured Edition Application-product Trade name Strength Dosage form / route Product TE source text RLD / RS Approval date Source SHA-256 2026-09-14 22:38:34 2026-08 A219139-001 INDOCYANINE GREEN 25MG/VIAL INJECTABLE / INJECTION AP 2026-08-03 84e616aacf4f…2026-08-18 06:07:40 2026-07 A219139-001 INDOCYANINE GREEN 25MG/VIAL INJECTABLE / INJECTION AP 2026-08-03 caaa826d4ba7…
Observed Orange Book normalized TE history# Captured, Edition, Application-product table Captured Edition Application-product TE code Order Source SHA-256 2026-09-14 22:38:34 2026-08 A219139-001 AP 1 84e616aacf4f…2026-08-18 06:07:40 2026-07 A219139-001 AP 1 caaa826d4ba7…
Observed Orange Book exclusivity history# Captured, Edition, Application-product table Captured Edition Application-product Exclusivity code Expiration Source SHA-256 2026-09-14 22:38:34 2026-08 A219139-001 CGT 2027-01-31 84e616aacf4f…2026-08-18 06:07:40 2026-07 A219139-001 CGT 2027-01-31 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 INDOCYANINE GREEN
Listing expiration 2027-12-31 Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
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.
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Sample Exclude flag Status 70771-1961-3 70771196103 6 PACKAGE in 1 CARTON (70771-1961-3) / 1 KIT in 1 PACKAGE * 1 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION in 1 VIAL (70771-1959-1) * 6 VIAL in 1 CARTON (70771-1960-8) / 10 mL in 1 VIAL (70771-1960-1) 6 package 2026-08-04 No No Current