Bludigo
- Product NDC
- 25021-840
- 11-digit product format
- 250210840
- Labeler code
- 25021
- Product ID
- 25021-840_7617daa7-3c14-4541-8117-690125e356c5
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Indigotindisulfonate Sodium
- Dosage form
- INJECTION
- Route
- INTRAVENOUS
- Labeler
- Sagent Pharmaceuticals
- Application
- NDA216264
- Marketing category
- NDA
- Marketing start
- 2026-04-15
- Substance
- INDIGOTINDISULFONATE SODIUM
- Active strength
- 8 mg/mL
- Pharmacologic classes
- Diagnostic Dye [EPC], Dyes [MoA]
- NDC exclude flag
- No
- Listing certified through
- 2027-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Bludigo
- Listing expiration
- 2027-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| INDIGOTINDISULFONATE SODIUM | 8 mg/mL |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | D3741U8K7L |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 25021-840-05 | Bludigo | 5 mL in 1 AMPULE | INJECTION | 5 | | 1 |
| 25021-840-05 | Bludigo | 5 in 1 CARTON | INJECTION | 5 | | 1 |
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Sample | Exclude flag | Status |
|---|
| 25021-840-05 | 25021084005 | 5 AMPULE in 1 CARTON (25021-840-05) / 5 mL in 1 AMPULE | 5 ampule | 2026-04-15 | No | No | Historical |