Indocyanine green
- Product NDC
- 70710-2018
- Requested package NDC
- 70710-2018-3
- 11-digit product format
- 707102018
- Labeler code
- 70710
- Product ID
- 70710-2018_fc51c2e6-0cce-4a2d-9fbb-2568352c7a5e
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Indocyanine green
- Dosage form
- KIT
- Labeler
- Zydus Pharmaceuticals USA Inc.
- Application
- ANDA219139
- Marketing category
- ANDA
- Marketing start
- 2026-08-04
- NDC exclude flag
- No
- Listing certified through
- 2027-12-31
- Current FDA listing
- Yes
Orange Book products#
| 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#
| Application-product | TE code |
|---|---|
| A219139-001 | AP |
Orange Book exclusivity#
| 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 | 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 | 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 | 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#
| Identifier | FDA.report destination |
|---|---|
| edf5b8f3-8542-42f7-bc08-f71843c1be4c | 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.
| Brand | Generic | Manufacturer | SPL set ID | Effective date | Available safety fields | Join |
|---|---|---|---|---|---|---|
| INDOCYANINE GREEN | INDOCYANINE GREEN | Zydus Lifesciences Limited | 2cf76db4-f637-4f18-bdcd-91096216dacf | 2026-08-04 | 219139 ANDA219139 | |
| Indocyanine green | INDOCYANINE GREEN | Zydus Pharmaceuticals USA Inc. | edf5b8f3-8542-42f7-bc08-f71843c1be4c | 2026-08-04 | Warnings, Adverse reactions | 219139 ANDA219139 70710-2018-3 70710-2018 70710201803 |
Packages#
| Package NDC | 11-digit format | Description | Units | Marketing start | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|
| 70710-2018-3 | 70710201803 | 6 KIT in 1 CARTON (70710-2018-3) / 1 KIT in 1 KIT * 1 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION in 1 VIAL (70710-2031-1) * 6 VIAL in 1 CARTON (70710-2032-8) / 10 mL in 1 VIAL (70710-2032-1) | 6 kit | 2026-08-04 | No | No | Current |