Prescription drug · NDA
Bludigo (Indigotindisulfonate sodium) NDC 81284-315
Indigotindisulfonate sodium 8 mg/mL · Injection · Intravenous · Provepharm Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 81284-315-05 | 8128403150581284031505 | 5 AMPULE in 1 CARTON (81284-315-05) / 5 mL in 1 AMPULE (81284-315-00)Marketed from Sep 6, 2022 |
How the 11-digit form is made: The product segment has 3 digits, so one leading zero is added to it (5-3-2 → 5-4-2). Formatting the NDC does not by itself make it billable — the product, package and quantity must match what was dispensed or administered, and payer rules apply. Conversion rules
Product information
- Brand name (proprietary)
- Bludigo
- Generic name (nonproprietary)
- indigotindisulfonate sodium
- Active ingredients
- Indigotindisulfonate sodium — 8 mg/mL
- Dosage form
- Injection
- Route
- Intravenous
- Labeler
- Provepharm Inc.NDC labeler code 81284
- Product type
- Prescription drug
- Marketing category
- NDA — New Drug ApplicationApplication NDA 216264
- Marketing start
- Listing expires
- Other FDA classes
- Dyes (Mechanism)
- Identifiers
- Product ID 81284-315_2d60b6a4-17d2-4864-b01c-9862283da8deSPL ID 2d60b6a4-17d2-4864-b01c-9862283da8deSPL set ID 73f246c4-b127-452e-856f-134b56cb8870UNII D3741U8K7LUPC 0381284315050
- Pharmacologic class
- Diagnostic Dye
Billing references
What Med-Code can say about coding this product, and where each statement comes from. Nothing here is inferred from the name alone.
- HCPCS codeNo match
No drug-specific HCPCS code in Med-Code's directory for this product. The directory is curated and not complete — check the current CMS HCPCS file before billing.
- Administration
Drug administration (CPT 96360–96549)
When a clinician administers the drug, the administration is reported separately. Codes in this range cover hydration, therapeutic injections and infusions, and chemotherapy or other complex drug administration. The right code depends on route, duration and drug type, and self-administered drugs are not billed this way.
- NDC on a medical claim
N481284031505followed by a unit qualifier and the quantityPackage 81284-0315-05. Unit qualifiers: F2 (international unit), GR (gram), ME (milligram), ML (milliliter), UN (unit (each)). The qualifier and quantity depend on what was given. About the N4 qualifier
Product label
Current FDA label (SPL), effective .
Indications (excerpt from the label)
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. BLUDIGO is a diagnostic dye 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. ( 1 )
Excerpt only. Read the full label for complete information.
About NDC 81284-315
- What is NDC 81284-315?
- 81284-315 is the product NDC for Bludigo (indigotindisulfonate sodium), Indigotindisulfonate sodium 8 mg/mL injection, listed with the FDA by Provepharm Inc.. It has 1 package NDC, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Bludigo (Indigotindisulfonate sodium).
- What is the active ingredient?
- Indigotindisulfonate sodium.
- Who is the labeler?
- Provepharm Inc., NDC labeler code 81284. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for Bludigo?
- 1 other product NDC are listed under this name. See all Bludigo NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other Bludigo products
Other finished products listed under the same name: strengths, forms and labelers.
| Product | Strength | Form · route | Labeler | Product NDC | Package NDCs (11-digit) |
|---|---|---|---|---|---|
| Bludigoindigotindisulfonate sodium | Indigotindisulfonate sodium 8 mg/mL | InjectionIntravenous | Sagent Pharmaceuticals | 25021-840 | 25021-0840-05 |
Other NDCs under NDA 216264
Products listed under the same FDA application: other strengths and forms, and repackagers who relabel the same product.
| Product | Strength | Form · route | Labeler | Product NDC |
|---|---|---|---|---|
| Bludigoindigotindisulfonate sodium | Indigotindisulfonate sodium 8 mg/mL | InjectionIntravenous | Sagent Pharmaceuticals | 25021-840 |