Isosulfan Blue
- Product NDC
- 70069-221
- 11-digit product format
- 700690221
- Labeler code
- 70069
- Product ID
- 70069-221_ed436868-8729-4a79-b5b5-15c1b12bde81
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Isosulfan Blue
- Dosage form
- INJECTION, SOLUTION
- Route
- SUBCUTANEOUS
- Labeler
- Somerset Therapeutics, LLC
- Application
- ANDA210558
- Marketing category
- ANDA
- Marketing start
- 2019-07-23
- Substance
- ISOSULFAN BLUE
- Active strength
- 10 mg/mL
- NDC exclude flag
- No
- Listing certified through
- 2026-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Isosulfan Blue
- Listing expiration
- 2026-12-31
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 |
|---|
| 70069-221-01 | Isosulfan Blue | 5 mL in 1 VIAL | INJECTION, SOLUTION | 5 | | 4 |
| 70069-221-06 | Isosulfan Blue | 6 in 1 CARTON | INJECTION, SOLUTION | 6 | | 4 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 70069-221 | ISOSULFAN BLUE INJECTION, SOLUTION [SOMERSET THERAPEUTICS, LLC] | 4 | Current NDC, Legacy NDC, 2 package rows | 20250112_a4c7400a-ff36-4a76-aa84-7f91e303f937.zip |
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 70069-221-01 | 70069022101 | 5 mL in 1 VIAL | 5 ml | | | | | Historical |
| 70069-221-06 | 70069022106 | 6 VIAL in 1 CARTON (70069-221-06) / 5 mL in 1 VIAL (70069-221-01) | 6 vial | 2019-07-23 | 0000-00-00 | No | No | Current |