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NDC 81284-0315-05 BLUDIGO 8 mg/mL Details
BLUDIGO 8 mg/mL
BLUDIGO is a INTRAVENOUS INJECTION in the HUMAN PRESCRIPTION DRUG category. It is labeled and distributed by Provepharm Inc.. The primary component is INDIGOTINDISULFONATE SODIUM.
Product Information
| NDC | 81284-0315 |
|---|---|
| Product ID | 81284-315_689e77d3-6ca0-4b8a-9240-a4fdf5eaa9f0 |
| Associated GPIs | |
| GCN Sequence Number | 083598 |
| GCN Sequence Number Description | indigotindisulfonate sodium AMPUL 8 MG/ML INTRAVEN |
| HIC3 | R1U |
| HIC3 Description | RENAL FUNCTION DIAGNOSTICS AGENTS |
| GCN | 52592 |
| HICL Sequence Number | 003691 |
| HICL Sequence Number Description | INDIGOTINDISULFONATE SODIUM |
| Brand/Generic | Brand |
| Proprietary Name | BLUDIGO |
| Proprietary Name Suffix | n/a |
| Non-Proprietary Name | indigotindisulfonate sodium |
| Product Type | HUMAN PRESCRIPTION DRUG |
| Dosage Form | INJECTION |
| Route | INTRAVENOUS |
| Active Ingredient Strength | 8 |
| Active Ingredient Units | mg/mL |
| Substance Name | INDIGOTINDISULFONATE SODIUM |
| Labeler Name | Provepharm Inc. |
| Pharmaceutical Class | Diagnostic Dye [EPC], Dyes [MoA] |
| DEA Schedule | n/a |
| Marketing Category | NDA |
| Application Number | NDA216264 |
| Listing Certified Through | 2024-12-31 |
Package
NDC 81284-0315-05 (81284031505)
| NDC Package Code | 81284-315-05 |
|---|---|
| Billing NDC | 81284031505 |
| Package | 5 AMPULE in 1 CARTON (81284-315-05) / 5 mL in 1 AMPULE (81284-315-00) |
| Marketing Start Date | 2022-09-06 |
| NDC Exclude Flag | N |
| Pricing Information | N/A |