Isosulfan Blue
- Product NDC
- 67457-220
- 11-digit product format
- 674570220
- Labeler code
- 67457
- Product ID
- 67457-220_9c3ccc87-6252-4bd1-afda-4158ce4d66aa
- 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
- 2013-03-14
- 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 |
|---|
| 67457-220-05 | Isosulfan Blue | 6 in 1 CARTON | INJECTION, SOLUTION | 6 | | 9 |
| 67457-220-05 | Isosulfan Blue | 5 mL in 1 VIAL, GLASS | INJECTION, SOLUTION | 5 | | 9 |
DailyMed Socrata Ingredients#
Ingredient, Type, UNII table| Ingredient | Type | UNII | DailyMed label | SPL version | Uploaded |
|---|
| ISOSULFAN BLUE | ACTIVE INGREDIENT | 39N9K8S2A4 | ISOSULFAN BLUE INJECTION, SOLUTION [MYLAN INSTITUTIONAL LLC] | 5 | |
| ISOSULFAN BLUE INNER SALT | ACTIVE MOIETY | NS6Q291771 | ISOSULFAN BLUE INJECTION, SOLUTION [MYLAN INSTITUTIONAL LLC] | 5 | |
| POTASSIUM PHOSPHATE, MONOBASIC | INACTIVE INGREDIENT | 4J9FJ0HL51 | ISOSULFAN BLUE INJECTION, SOLUTION [MYLAN INSTITUTIONAL LLC] | 5 | |
| SODIUM PHOSPHATE, MONOBASIC, MONOHYDRATE | INACTIVE INGREDIENT | 593YOG76RN | ISOSULFAN BLUE INJECTION, SOLUTION [MYLAN INSTITUTIONAL LLC] | 5 | |
| WATER | INACTIVE INGREDIENT | 059QF0KO0R | ISOSULFAN BLUE INJECTION, SOLUTION [MYLAN INSTITUTIONAL LLC] | 5 | |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 67457-220 | ISOSULFAN BLUE INJECTION, SOLUTION [MYLAN INSTITUTIONAL LLC] | 8 | Current NDC, Legacy NDC, 2 package rows | 20210203_1878964e-5220-48c8-a872-dcadbc451aff.zip |
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 67457-220-05 | 67457022005 | 6 VIAL, GLASS in 1 CARTON (67457-220-05) / 5 mL in 1 VIAL, GLASS | 2013-03-14 | 0000-00-00 | No | No | Current |