Isosulfan Blue
- Product NDC
- 71288-805
- 11-digit product format
- 712880805
- Labeler code
- 71288
- Product ID
- 71288-805_1c9d3281-9ee0-4e8c-9d36-7736ada64138
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Isosulfan Blue
- Dosage form
- INJECTION, SOLUTION
- Route
- SUBCUTANEOUS
- Labeler
- Meitheal Pharmaceuticals Inc.
- Application
- ANDA213130
- Marketing category
- ANDA
- Marketing start
- 2021-11-03
- 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 |
|---|
| 71288-805-05 | Isosulfan Blue | 5 mL in 1 VIAL, SINGLE-DOSE | INJECTION, SOLUTION | 5 | | 4 |
| 71288-805-06 | 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 |
|---|
| 71288-805 | ISOSULFAN BLUE INJECTION, SOLUTION [MEITHEAL PHARMACEUTICALS INC.] | 4 | Current NDC, Legacy NDC, 2 package rows | 20211106_d36ae5af-6351-497a-9151-82bcb2c62fa0.zip |
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 71288-805-05 | 71288080505 | 5 mL in 1 VIAL, SINGLE-DOSE | 5 ml | | | | | Historical |
| 71288-805-06 | 71288080506 | 6 VIAL, SINGLE-DOSE in 1 CARTON (71288-805-06) / 5 mL in 1 VIAL, SINGLE-DOSE (71288-805-05) | | 2021-11-03 | 0000-00-00 | No | No | Current |