Bludigo Injection
NDC Package 81284-315-05

View Billable Units, 11-Digit Conversion Format, and RxNorm mappings
Table of Contents
    1. Package Information
    2. NDC HCPCS Crosswalk
    3. Frequently Asked Questions

Package Information

Bludigo (indigotindisulfonate sodium) injection is bLUDIGO is indicated for use as a visualization aid in the cystoscopic assessment of the integrity of the ureters in adults following urological and gynecological open, robotic, or endoscopic surgical procedures. This formulation utilizes a injection delivery system. Marketed by Provepharm Inc., this product is identified by NDC 81284-315 and is authorized under FDA application NDA216264.

Identification & Billing

NDC Package Code
81284-315-05
Package Description
5 AMPULE in 1 CARTON / 5 mL in 1 AMPULE (81284-315-00)
Product Code
81284-315
11-Digit Billing Format
81284031505
Billing Unit
ML - Billing unit of "milliliter" is used when a product is measured by its liquid volume.

Clinical Specifications

Proprietary Name
Bludigo
Non-Proprietary Name
Indigotindisulfonate Sodium
Substance Name
Indigotindisulfonate Sodium
Dosage Form
Injection - A sterile preparation intended for parenteral use; five distinct classes of injections exist as defined by the USP.
Administration Route
Intravenous - Administration within or into a vein or veins.
Active Ingredient(s)
INDIGOTINDISULFONATE SODIUM 8 mg/mL
Pharmacologic Class
Usage Information
BLUDIGO is indicated for use as a visualization aid in the cystoscopic assessment of the integrity of the ureters in adults following urological and gynecological open, robotic, or endoscopic surgical procedures.

Regulatory & Marketing

Labeler Name
Provepharm Inc.
Product Type
Human Prescription Drug
FDA Application #
NDA216264
Marketing Category
NDA - A product marketed under an approved New Drug Application.
Start Marketing Date
09-06-2022
Listing Expiration
12-31-2026
Exclude Flag
N
Sample Package
No

Hierarchy Structure

Code Lineage

The NDC Directory contains ONLY information on final marketed drugs submitted to FDA electronically by labelers. A labeler might be a manufacturer, re-packager or re-labeler. The product information included in the NDC directory does not indicate that FDA has verified the information provided by the product labeler. Assigned NDC numbers are not in any way an indication of FDA approval of the product.

* Please review the full disclaimer at the bottom of this page.

Billing & HCPCS Mapping

To facilitate insurance claims and reimbursement, this drug package is mapped to specific HCPCS administrative codes. This crosswalk aligns clinical data with the billing standards used in ASP (Average Sales Price), AWP, and OPPS payment systems. Use the cards below to identify the correct billable units for provider claims.

J9220
Source: OPPS
Indigotindisulfonate sod 1mg
HCPCS Dosage 1 MG
Units / Pkg 200

Note for Medical Coders: These mappings are synthesized from various CMS datasets including OPPS, PrEP, and DAC (Data Analysis and Coding) contractors. Always confirm unit conversions against the current quarter's pricing files before final submission.

* Please review the full disclaimer at the bottom of this page.

Frequently Asked Questions

What is the distribution configuration for this product package?

The code 81284-315-05 identifies a specific commercial package of 5 ampule in 1 carton / 5 ml in 1 ampule (81284-315-00) of Bludigo, a human prescription drug labeled by Provepharm Inc.. This injection is formulated for intravenous use and contains indigotindisulfonate sodium as the active substance.

Is this product currently listed with the FDA?

Yes, this product is active and verified within the NDC Directory. It was introduced to the market by Provepharm Inc. on September 06, 2022. The current certification is valid through December 31, 2026.

How is this Provepharm Inc. product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 81284031505. Quantities are measured in per "ml or milliliter", products billed per milliliter are usually products measured by liquid volume.. The table below illustrates the segment conversion from the 10-digit labeler code to the 11-digit provider format.

11-Digit Code Conversion

Billing payers usually require a 5-4-2 segment configuration. Below is the conversion from the 10-digit package format to the 11-digit billing format:

10-Digit Format (5-3-2)
81284-315-05
11-Digit CMS (5-4-2)
81284-0315-05

Note: The zero is added to the Product segment to maintain the 5-4-2 structure.