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
- Listing certified through
- 2027-12-31
- Current FDA listing
- Yes
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 | 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 | 0 | Current |