Isosulfan Blue
- Product NDC
- 72078-069
- 11-digit product format
- 720780069
- Labeler code
- 72078
- Product ID
- 72078-069_17faad04-f361-4b65-8f37-964efd5c74e0
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Isosulfan Blue
- Dosage form
- INJECTION, SOLUTION
- Route
- SUBCUTANEOUS
- Labeler
- Mylan Institutional LLC
- Application
- ANDA090874
- Marketing category
- ANDA
- Marketing start
- 2026-02-01
- Substance
- ISOSULFAN BLUE
- Active strength
- 10 mg/mL
- NDC exclude flag
- No
- Listing certified through
- 2027-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Isosulfan Blue
- Listing expiration
- 2027-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| ISOSULFAN BLUE | 10 mg/mL |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | 39N9K8S2A4 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 72078-069-01 | Isosulfan Blue | 1 in 1 CARTON | INJECTION, SOLUTION | 1 | | 2 |
| 72078-069-01 | Isosulfan Blue | 1 mL in 1 SYRINGE | INJECTION, SOLUTION | 1 | | 2 |
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Sample | Exclude flag | Status |
|---|
| 72078-069-01 | 72078006901 | 1 SYRINGE in 1 CARTON (72078-069-01) / 1 mL in 1 SYRINGE | 1 syringe | 2026-02-01 | No | No | Current |