IC-Green
- Product NDC
- 70100-825
- 11-digit product format
- 701000825
- Labeler code
- 70100
- Product ID
- 70100-825_bb82db71-b087-4274-bd9c-cb388d7dbaeb
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Indocyanine Green
- Dosage form
- KIT
- Labeler
- Renew Pharmaceuticals Limited
- Application
- NDA011525
- Marketing category
- NDA
- Marketing start
- 2025-04-15
- NDC exclude flag
- No
- Listing certified through
- 2027-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- IC-Green
- Listing expiration
- 2027-12-31
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 0409-4887-17 | IC-Green | 10 mL in 1 VIAL, PLASTIC | INJECTION | 10 mL | 1 mL in 1mL | 4 |
| 70100-725-01 | IC-Green | 1 in 1 VIAL | INJECTION, POWDER, LYOPHILIZED, | 1 | 25 mg | 4 |
| 70100-825-02 | IC-Green | 6 in 1 CARTON | KIT | 6 | | 4 |
| 70100-825-02 | IC-Green | 1 in 1 PACKAGE | KIT | 1 | | 4 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 70100-825 | IC-GREEN (INDOCYANINE GREEN) KIT [RENEW PHARMACEUTICALS LIMITED] | 2 | Current NDC, 4 package rows | 20250416_ccd92843-1f0a-4ece-9978-4b300d158886.zip |
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Sample | Exclude flag | Status |
|---|
| 0409-4887-17 | 00409488717 | 10 mL in 1 VIAL, PLASTIC | 10 ml | | | | Historical |
| 70100-725-01 | 70100072501 | 1 in 1 VIAL | | | | | Historical |
| 70100-825-02 | 70100082502 | 6 PACKAGE in 1 CARTON (70100-825-02) / 1 KIT in 1 PACKAGE * 1 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION in 1 VIAL (70100-725-01) * 10 mL in 1 VIAL, PLASTIC (0409-4887-17) | 6 package | 2025-04-15 | No | No | Current |