BLUDIGO
- Product NDC
- 81284-315
- 11-digit product format
- 812840315
- Labeler code
- 81284
- Product ID
- 81284-315_2d60b6a4-17d2-4864-b01c-9862283da8de
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- indigotindisulfonate sodium
- Dosage form
- INJECTION
- Route
- INTRAVENOUS
- Labeler
- Provepharm Inc.
- Application
- NDA216264
- Marketing category
- NDA
- Marketing start
- 2022-09-06
- Substance
- INDIGOTINDISULFONATE SODIUM
- Active strength
- 8 mg/mL
- Pharmacologic classes
- Diagnostic Dye [EPC], Dyes [MoA]
- NDC exclude flag
- No
- Listing certified through
- 2026-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- BLUDIGO
- Listing expiration
- 2026-12-31
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 |
|---|
| 81284-315-00 | BLUDIGO | 5 mL in 1 AMPULE | INJECTION | 5 | | 6 |
| 81284-315-05 | BLUDIGO | 5 in 1 CARTON | INJECTION | 5 | | 6 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 81284-315 | BLUDIGO (INDIGOTINDISULFONATE SODIUM) INJECTION [PROVEPHARM INC.] | 5 | Current NDC, Legacy NDC, 2 package rows | 20240522_73f246c4-b127-452e-856f-134b56cb8870.zip |
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 81284-315-00 | 81284031500 | 5 mL in 1 AMPULE | 5 ml | | | | | Historical |
| 81284-315-05 | 81284031505 | 5 AMPULE in 1 CARTON (81284-315-05) / 5 mL in 1 AMPULE (81284-315-00) | 5 ampule | 2022-09-06 | 0000-00-00 | No | No | Current |