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BLUDIGO indigotindisulfonate sodium 8 mg/mL Injection — NDC 81284-0315-05 package photo

BLUDIGO indigotindisulfonate sodium 8 mg/mL Injection

by Provepharm Inc. · 5 AMPULE in 1 CARTON (81284-315-05) / 5 mL in 1 AMPULE (81284-315-00)
NDC 81284-0315-05
🏷️ FDA NDC (as labeled) 81284-315-05 billing pads the product segment with a zero
Rx only Brand On market Non-controlled
🗂️ Data synced Jul 24, 2026 · sources: openFDA · FDA label (DailyMed) · FDA Orange & Purple Book · First Databank · CMS NADAC, ASP, Medicare & Medicaid · RxNorm
📋 All sources & update times →

This page is curated, coded, and maintained by

Compiled from public FDA, CMS, DailyMed, NADAC, and related drug data sources. Editorial policy

🆔 Identity & classification

FDA NDC (as labeled) 81284-315-05
Product NDC 81284-315
11-digit billing NDC 81284031505
NCPDP billing unit ML — per mL (volume)
UNII D3741U8K7L
UPC 0381284315050
Application # NDA216264
SPL Set ID 73f246c4-b127-452e-856f-134b56cb8870
Established class (EPC) Diagnostic Dye
Mechanism of action Dyes
DEA schedule Non-controlled
Marketing category NDA
Marketing status On market
FDA listing status Listed (active directory)
Marketing start 2022-09-06
Route INTRAVENOUS
Dosage form INJECTION
Substance INDIGOTINDISULFONATE SODIUM
GCN Seq No 083598
GCN 52592
HICL code 003691
Ingredient (HICL) Indigotindisulfonate Sodium
HIC1 code R
Therapeutic class — broad (HIC1) Kidney/Urinary Tract
HIC2 code R1
Therapeutic class — intermediate (HIC2) Affect Primarily Kidneys/Urinary Tract
HIC3 code R1U
Therapeutic class — specific (HIC3) Renal Function Diagnostics Agents
AHFS code 36:40.00.00
AHFS class Kidney Function
FDB label name BLUDIGO 40 MG/5 ML AMPULE
FDB brand name Bludigo
Legend status F — Federal legend — prescription drug or device
Why two NDCs? The FDA registers this code as 81284-315-05 — a 5-3-2 layout, and that's what's printed on the package and shown on DailyMed. For insurance claims, every NDC is standardized to a uniform 11-digit 5-4-2 format by adding a zero to the product segment → 81284-0315-05. Same drug, same package — only the format differs.
Where does this data come from?
Identifiers from the FDA openFDA NDC Directory and Structured Product Labeling; RxCUI from RxNorm (NLM); GPI from Medi-Span; GCN / HIC / AHFS / legend from First Databank.

🏭 Manufacturer & labeler

LabelerProvepharm Inc.
Application holderPROVEPHARM SAS
FDA applicationNDA216264 (NDA)
Labeler code81284
First marketedSep 2022
Product typeHuman Prescription Drug
Portfolio13 products on file
The labeler markets the product; the application holder owns the FDA approval. They’re often the same company but can differ (e.g. a repackager or an authorized generic). A mailing address / phone appears here when the manufacturer includes it in the product’s FDA label (not all do).
Where does this data come from?
Labeler, application holder and registered establishment from the FDA openFDA NDC Directory and Drugs@FDA; address/contact from the product’s FDA label.

🩺 Clinical

Label name BLUDIGO 40 MG/5 ML AMPULE Ingredient Indigotindisulfonate Sodium

Supplement & herbal interactions

🌿 Drug–supplement interaction checker →
Where does this data come from?
Plain-language summary from MedlinePlus (U.S. National Library of Medicine); supplement & herbal interactions and nutrient depletion data from the Natural Medicines database; our full guide is HelloPharmacist editorial content.

🧪 Inactive Ingredients / Excipients

Inactive ingredients, also called excipients, are components of the drug product other than the active ingredient. They may include fillers, dyes, coatings, preservatives, flavors, or other formulation ingredients.

💡 Tap an ingredient (hover on desktop) to see what it is and why it’s used.

  • UNII 2968PHW8QP
    A weak organic acid derived from citrus fruits or made through fermentation. It works as a buffer to control pH, a preservative to extend shelf life, and a flavoring agent in medications.
  • UNII 1Q73Q2JULR
    Sodium citrate is a salt derived from citric acid. It works as a buffer to maintain the medicine's pH level and may also help improve taste or act as a preservative in the formulation.

2 inactive ingredients listed in the exact product block matched to this NDC.

Where does this data come from?
Data sourced from official FDA Structured Product Labeling (SPL) via DailyMed — ingredient classCode="IACT" elements from the exact product block matched by this NDC. Label-section narrative from DailyMed / the openFDA label index is shown separately when available.

Inactive ingredient FAQ

Are inactive ingredients the same for every manufacturer?
No. Inactive ingredients can differ by manufacturer, dosage form, strength, and package / product version.
Why might an inactive ingredient be missing?
Some SPLs do not provide a complete structured inactive-ingredient list, and older or unusual labels may only include the information in narrative text.
Can inactive ingredients matter?
Yes. They can matter for allergies, intolerances, dyes, gluten / lactose concerns, preservatives, and formulation differences — but confirm with a pharmacist or the manufacturer when it’s clinically important.

💲 Pricing

A drug doesn't have one price. Each row is a different public payment system, and none is what you'd pay at the counter — that depends on your insurance. The ⓘ on each row explains what it measures.

Price systemPer eachPer package
Retail pharmacies payNADAC · weekly Not in the retail survey — common for institutional, discontinued, or low-volume packs.
Medicaid paysCMS SDUD · 12 mo No recent Medicaid claims on file for this NDC — rare and low-volume NDCs are suppressed in the public data.
Medicare drug plans payPart D · quarterly No Part D plan price is available for this NDC in our data.
ℹ️
No price is published for this exact package yet. CMS surveys NADAC per package size, so a different pack of the same drug often has one.
Where does this data come from?
NADAC (National Average Drug Acquisition Cost) is the CMS weekly pharmacy-acquisition-cost survey — what pharmacies pay. ASP (Average Sales Price) is the CMS Medicare Part B drug-payment file, published quarterly. Medicaid pays is computed by us from CMS State Drug Utilization Data (total reimbursed ÷ units, trailing 12 months) — gross of rebates and inclusive of dispensing fees, so it reflects what Medicaid paid, not an acquisition cost. Medicare drug plans pay is the median negotiated point-of-sale unit cost across plans listing this NDC in the CMS quarterly Prescription Drug Plan pricing files, before rebates. The VA pays is the federal contract price (FSS, and the statutory Big 4 ceiling where listed) from the VA National Acquisition Center pharmaceutical price file. All are free public government data; each measures a different payer, so the figures are not directly comparable.

🔁 Therapeutic equivalents

ProductLabelerPackNADAC/unitTEStatusPrice vs. this
Bludigo 8 mg/mL 25021-0840-05 Sagent 5 ampules — — FDA listed —
Bludigo 8 mg/mLthis 81284-0315-05 Provepharm 5 ampules — — FDA listed —
About this product: this is the brand-name version. We did not find an FDA-approved generic match for this exact strength, form and route.
Where does this data come from?
Equivalents are other NDCs of the same ingredient, form and route from the openFDA NDC Directory, ranked least-expensive-first by NADAC. Therapeutic-equivalence (AB) ratings come from the FDA Orange Book; biologics use the FDA Purple Book for biosimilar & interchangeable status.

⏳ Availability & generic status

🏛️
2022
First FDA approval
Jul 2022
📍
2026
Currently FDA-listed
4 years listed
🛡️
2037
Latest patent/protection listed
not a guaranteed launch date
🔒No FDA-approved generic found

We did not find an FDA-approved generic match for this exact strength, form and route. Patent/protection dates below may affect future generic timing.

🛡️ Latest patent/protection date listed: FDA patent/protection data lists protections through Dec 2037. This may affect when a full generic version becomes widely available, but it is not a guaranteed launch date.
📅 FDA approved Jul 8, 2022 RLD RS ⏳ ~11.3 yr to latest listed protection

Why the date isn’t exact: Generic timing can change because patents may be challenged, settled, licensed, added, removed, or worked around with a narrower label — and FDA approval does not always mean a pharmacy can get the generic today.

Patents & exclusivity — FDA Orange Book
US 11845867 — drug substance
US 10927258 — drug substance
US 11499050 — drug substance
Exclusivity NCE
2022 2024 2026 2028 2030 2032 2034 2036 2038
Today
LOE
Substance patent Formulation patent Method-of-use patent Exclusivity Pediatric +6mo
🏛️FDA exclusivity
FDA-granted marketing protection. It’s separate from patents and may be shorter than patent protection.
🧪Product / substance patents
Patents covering the active ingredient, product, formulation, or related drug features.
🎯Method-of-use patents
Patents covering specific approved uses. These can sometimes be carved out with a “skinny label,” but not always.
🛈 What do these terms mean?
Patent
Legal protection listed in the Orange Book that may delay generic approval or launch. Issued by the U.S. Patent & Trademark Office.
Substance patent
Covers the active drug molecule itself — the hardest to design around. A generic generally can’t launch until it expires.
Formulation (product) patent
Covers a specific formulation or dosage form. A generic can sometimes work around it with a different formulation.
Method-of-use patent
A patent covering one specific approved use of the drug — not necessarily the whole molecule. A generic can sometimes launch with a “skinny label” that carves out the protected use and keeps the others.
Skinny label
A generic label that omits a still-patented use when the FDA allows it — letting a generic reach the market for the unprotected uses.
Exclusivity
FDA-granted marketing protection, separate from patents — e.g. 5-yr new chemical entity, 7-yr orphan drug, or a +6-month pediatric extension.
Paragraph IV
A generic applicant’s formal challenge to a listed patent. It can potentially lead to earlier generic entry, but often involves litigation or a settlement.
RLD / RS
Reference Listed Drug — the brand product the FDA uses as the reference for generic applications. Reference Standard — the product the FDA expects generics to compare against in bioequivalence testing.
TE / AB rating
FDA therapeutic-equivalence rating. An AB rating generally means the FDA considers a generic therapeutically equivalent to — and substitutable for — the brand.
LOE (loss of exclusivity)
The latest patent or exclusivity currently listed — the loss-of-exclusivity / latest-listed-protection date shown on this page. Paragraph-IV challenges and settlements can move the real date earlier; FDA approval and a manufacturer’s decision to market can move it later.

Built from the FDA Orange Book. The bars above are scaled to each protection’s expiry; the red LOE marker is the last one to lapse.

Listed patents (3)
PatentTypeUse codeExpires
US 11845867 ↗ Drug substance — Nov 25, 2036
US 10927258 ↗ Drug substance — Dec 23, 2037
US 11499050 ↗ Drug substance — Dec 23, 2037
FDA exclusivity
CodeWhat it grantsExpires
NCENew Chemical Entity (5-year)Jul 8, 2027
Common questions
Is there a generic version of BLUDIGO 40 MG/5 ML AMPULE?
No FDA-approved generic equivalent is currently listed in the FDA Orange Book for BLUDIGO 40 MG/5 ML AMPULE. Based on the patents and exclusivity currently listed, the Orange Book estimate is that full-label generic entry may be delayed until Dec 2037 — an estimate, not a guaranteed launch date.
The FDA approved a generic — why can’t I get it at my pharmacy yet?
FDA approval and pharmacy availability are two different things. The FDA can approve a generic years before it actually reaches pharmacies, because the brand company may still hold patents or have a settlement that delays the launch. A manufacturer also has to choose to make and sell it, and have supply ready. So a drug can be “FDA-approved generic exists” and still be brand-only at the counter today.
Why do different websites show different generic release dates?
Generic availability is not based on one single date. Some sources use the first exclusivity expiration, some use the last product patent, and others use the latest method-of-use patent. Patent challenges, settlements, licenses, and label carve-outs can also change the real-world launch date. This page shows the underlying Orange Book dates so you can see why estimates may differ.
What does “FDA listed” mean?
It means the product appears in the FDA’s official NDC directory. That’s a good sign a product exists and is intended for the U.S. market, but on its own it does not confirm a pharmacy can fill it today. Where we have recent retail pricing data (NADAC) for a product, we label it “Availability likely” instead.
What does a patent or protection date mean here?
It’s the latest date currently listed in the FDA Orange Book for a patent or exclusivity on the brand product. It can affect when a full generic version becomes widely available — but it is not a guaranteed generic launch date. Generics sometimes arrive earlier (through a settlement or patent challenge) or later (a manufacturer still has to make and sell one).
What does “current Orange Book estimate” mean?
It means we are using the latest patent and exclusivity dates currently listed in the FDA Orange Book. It is not a guaranteed launch date.
Can a generic come out before the last patent expires?
Sometimes. A generic company may challenge a patent, settle with the brand manufacturer, receive a license, or obtain approval with a narrower label that avoids a patented use. In other cases, the last listed protection may delay full-label generic competition.
Can a generic come out after the listed dates?
Yes. Even after patents or exclusivity expire, a generic still needs FDA approval and a manufacturer must choose to market it. Supply, litigation, business decisions, or regulatory issues can delay actual availability.
What is the difference between patents and exclusivity?
Patents are legal protections usually issued by the U.S. Patent and Trademark Office. FDA exclusivity is marketing protection granted by the FDA. They are separate, and either one can affect generic timing.
Why are there multiple patent dates?
One drug can have several patents covering different things: the active ingredient, a formulation, a manufacturing process, or a specific approved use. That is why a page may show several expiration dates instead of one simple generic date.
Built from FDA Orange Book patent and exclusivity data. Dates are refreshed from public FDA data when available; the marker is max(latest patent expiry, latest exclusivity expiry). Paragraph-IV settlements and first-filer 180-day exclusivity can shift the real date; a method-of-use patent may allow an earlier skinny-label generic for non-protected indications. Generic launch timing is an estimate, not a guarantee.
Where does this data come from?
Patents and exclusivity from the FDA Orange Book (small-molecule drugs), refreshed from public FDA data. Generic launch timing is an estimate, not a guarantee.

🔬 Reported adverse events (FAERS)

Read carefully: FAERS reports are voluntary and unverified. Counts are not incidence, do not establish causation, are subject to reporting bias, and cannot be used to compare one drug to another. Shown for signal context only. Reports for Bludigo (this brand).

Top reported reactions

Anaphylactic Reaction1
Cheilitis1
Dermatitis1
Extravasation1
Radiation Skin Injury1
Reaction To Excipient1
Stomatitis1

Age at onset

Elderly1

Reporter sex

4 reports
Male · 50%
Female · 50%

Serious outcomes

Hospitalization1
Reports over time (by year) — tap or hover for the count & year
2023 2024 2025 2026 1 0
Most recent year is provisional (FAERS lags ~3 months).
Where does this data come from?
Adverse-event reports from the FDA Adverse Event Reporting System (FAERS) via openFDA. FAERS reports are voluntary and unverified — counts are not incidence and don’t establish causation.

📦 Packaging — all sizes for this product

Package NDCDescription Marketing startStatus
81284-0315-05 You're viewing this 5 AMPULE in 1 CARTON (81284-315-05) / 5 mL in 1 AMPULE (81284-315-00) 2022-09-06 Active

🧭 About this NDC listing & data coverage

Finished prescription product
What data is (and isn’t) available for this NDC — tap to expand
NDC identity (package / product / labeler codes) ✓ Available
Labeler ✓ Available
Product & package description ✓ Available
Marketing category & status ✓ Available
Active ingredient / dosage form / route ✓ Available
FDA label (SPL via DailyMed) ✓ Available
Package photos ✓ Available
Inactive ingredients (structured) ✓ Available
NADAC pharmacy acquisition price (CMS) — Not published for this NDC CMS publishes NADAC only for NDCs reported in its retail-pharmacy survey.
Orange Book / therapeutic-equivalence data ✓ Available
HCPCS J-code billing crosswalk — Not published for this NDC Most self-administered / retail products have no J-code — that is normal.
Medicaid utilization (CMS SDUD) — Not published for this NDC CMS reports utilization only for NDCs with Medicaid claims above its privacy threshold.
“Not published” reflects what the public FDA / CMS / NLM sources provide for this exact package code — it is a property of the data feeds, not a judgment about the product.

Questions about this listing

Why is there no price listed?
The pricing shown on our NDC pages comes from CMS NADAC, a voluntary survey of retail community pharmacy invoices. CMS does not publish a NADAC for every NDC — packages outside the retail survey (institutional and hospital products, bulk packages, discontinued items, and many OTC items) may never receive one. A missing price reflects the survey's scope, not this product's actual cost, and does not mean the product is free or unavailable.
Is the NDC printed on the package the same as the 11-digit billing NDC?
Yes, they identify this exact package in different formats. The FDA registers it as 81284-315-05, which is what is printed on the packaging and shown on DailyMed. Insurance claims use a fixed 11-digit 5-4-2 format, so the short segment is padded with a leading zero: 81284-0315-05, written without dashes as 81284031505. The Identity section at the top of this page lists every form of this code.
What do the three segments of this NDC mean?
In 81284-0315-05, the first segment (81284) is the labeler code FDA assigned to Provepharm Inc.; the middle segment (0315) identifies this specific product — its ingredient, strength, and dosage form; and the last segment (05) identifies this exact package size and type. Together they name one specific package of one specific product.
Is this package still being marketed?
Yes, per the latest FDA NDC Directory data on this page: this package is listed as actively marketed, with no marketing end date reported by Provepharm Inc.. Listing status can change — the directory data on this page refreshes weekly.
Who lists this product with the FDA?
Provepharm Inc. is the labeler of record for this NDC — the company under whose FDA-assigned code the package is listed. The labeler may be the manufacturer itself or a distributor marketing the product under its own code.
Do I need a prescription for this product?
This NDC is listed with FDA as a prescription product, so it is dispensed under a prescriber's order. Your pharmacist can tell you whether any over-the-counter forms of the same medication exist.
This page identifies an FDA-listed package (the NDC) and reports public regulatory and pricing data about the listing. It is reference information, not a medical recommendation — talk to your pharmacist or prescriber about your own medication.
Where does this data come from?
Listing facts (marketing category, packager status, marketing dates) from the FDA openFDA NDC Directory; label availability from DailyMed; pricing coverage from CMS NADAC; equivalence scope from the FDA Orange Book.

📄 Full prescribing information FDA SPL

The complete FDA label for this product — the official prescribing information, verbatim, section by section. Jump with a chip, search within the label, or expand everything.
🎯 Indications and Usage ⏱️ Dosage and Administration 💊 Dosage Forms and Strengths ⛔ Contraindications ⚠️ Warnings and Cautions 🤒 Adverse Reactions 👥 Use in Specific Populations 🤰 Pregnancy 🧒 Pediatric Use 🧓 Geriatric Use 🧬 Clinical Pharmacology 🧬 Mechanism of Action 📦 How Supplied / Storage and Handling 📋 Description 💬 Information for Patients
🎯 Indications and Usage 72 words ▾

1 INDICATIONS AND USAGE 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 )

⏱️ Dosage and Administration 150 words ▾

2 DOSAGE AND ADMINISTRATION Recommended dose is 5 mL given intravenously over 1 minute. ( 2.1 ) Monitor blood pressure and heart rhythm during and after injection. ( 2.2 )

2.1Recommended Dosage The recommended dose of BLUDIGO is 5 mL given as an intravenous injection over 1 minute. The blue color is detectable at the ureteral orifices within 4 minutes to 9 minutes after the intravenous injection.

2.2Important Administration Instructions Monitor blood pressure and cardiac rhythm during and following the injection [see Warnings and Precautions ( 5.1 )]. Use immediately after opening ampule. Withdraw the contents of the ampule through a 5 micron or smaller filter straw/filter needle to ensure that the withdrawn solution contains no particulates.

The withdrawn solution should be inspected visually for particulate matter and discoloration prior to administration. Do not administer with infusion assemblies used with other diluents or drugs. Discard any unused portion.

💊 Dosage Forms and Strengths 41 words ▾

3 DOSAGE FORMS AND STRENGTHS Injection: 40 mg/5 mL (8 mg/mL) indigotindisulfonate sodium as a dark blue or bluish-purple solution in a single-dose amber glass ampule. Injection: 40 mg/5 mL (8 mg/mL) indigotindisulfonate sodium in a single-dose ampule ( 3 )

⛔ Contraindications 36 words ▾

4 CONTRAINDICATIONS BLUDIGO is contraindicated in patients with known hypersensitivity to indigotindisulfonate or any of its components [see Warnings and Precautions ( 5.2 )]. Known hypersensitivity to indigotindisulfonate or any of its components. ( 4 )

⚠️ Warnings and Cautions ~1 min read ▾

5 WARNINGS AND PRECAUTIONS Cardiovascular Reactions: Severe or life-threatening cardiovascular reactions including cardiac arrest, arrhythmia, asystole, atrioventricular block second degree, hypotension, elevation in blood pressure, bradycardia, and tachycardia have been reported. Closely monitor blood pressure and cardiac rhythm during and following the BLUDIGO injection. Interrupt administration if reactions are observed.

( 5.1 ) Hypersensitivity Reactions: Serious anaphylactic reactions with hypotension, dyspnea, bronchospasm, urticaria, or erythema have been reported. Monitor patients for anaphylactic reactions and have emergency equipment and trained personnel readily available. ( 5.2 ) Interference with Oximetry Measurements: Anesthesiologists should be aware of the potential for artifactual reduction in SpO 2 when anesthetized patients are administered BLUDIGO.

( 5.3 )

5.1Cardiovascular Reactions Severe or life-threatening cardiovascular reactions including cardiac arrest, arrhythmia, asystole, second degree atrioventricular block, hypotension, elevation in blood pressure, bradycardia, and tachycardia have been reported generally within 60 minutes following administration of indigotindisulfonate sodium injection products and required urgent intervention [see Adverse Reactions ( 6.2 )]. Indigotindisulfonate may cause vasoconstriction by interference with vasodilation mediated by nitric oxide dependent mechanisms and by direct vasoconstriction.

Indigotindisulfonate may also cause hypotension. Patients with hypertension, heart rate and conduction disorders, or medications causing bradycardia may be at increased risk for elevated blood pressure, hypotension, and bradycardia. Closely monitor blood pressure and cardiac rhythm during and following the injection of BLUDIGO.

Interrupt administration if reactions are observed.

5.2Hypersensitivity Reactions Serious anaphylactic reactions with hypotension, dyspnea, bronchospasm, urticaria, or erythema have been reported with the use of indigotindisulfonate sodium injection products [see Adverse Reactions ( 6.2 )] . BLUDIGO is contraindicated in patients with known hypersensitivity to indigotindisulfonate [see Contraindications ( 4 )] . Monitor patients for anaphylactic reactions and have emergency equipment and trained personnel readily available.

5.3Interference with Oximetry Measurements Indigotindisulfonate has been reported to interfere with light absorption and transiently interfere with pulse oximetric methods. Anesthesiologists should be aware of the potential for artifactual reduction in SpO 2 when anesthetized patients are administered BLUDIGO.

🤒 Adverse Reactions ~2 min read ▾

6 ADVERSE REACTIONS Clinically significant adverse reactions are described elsewhere in the labeling: Cardiovascular Reactions [see Warnings and Precautions ( 5.1 )] Hypersensitivity Reactions [see Warnings and Precautions ( 5.2 )] Adverse reactions (≥ 1%) are constipation, nausea, vomiting, abdominal pain, pyrexia, ALT increase, and dysuria. ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact PROVEPHARM Inc at 1–833-727-6556 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

6.1Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice. The safety of BLUDIGO was evaluated in a randomized, intra-patient controlled, blind to dose of BLUDIGO, clinical trial. A total of 118 adult patients undergoing endoscopic urological or gynecological procedures were treated intravenously; 58 (49%) of these patients received one dose of BLUDIGO 2.5 mL and 60 (51%) of patients received one dose of BLUDIGO 5 mL.

The 2.5 mL dose is not approved [see Dosage and Administration ( 2.1 )] . The mean age of patients was 51 years and 35 (30%) patients were 65 years of age or older. The majority of patients were White 105 (89%) and female 87 (74%).

The adverse reactions (≥1%) reported in the clinical trial are provided in Table 1. Table 1. Adverse Reactions Reported at ≥1% of Patients Receiving BLUDIGO 5 mL Intravenously BLUDIGO 5 mL (N=60) n (%) Constipation 3 (5.0) Nausea 2 (3.3) Vomiting 2 (3.3) Abdominal Pain 2 (3.3) Pyrexia 2 (3.3) ALT increase 2 (3.3) Dysuria 1 (1.7)

6.2Postmarketing Experience The following adverse reactions have been identified following the use of indigotindisulfonate sodium injection products. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure. Cardiovascular disorders: cardiac arrest, arrhythmia, asystole, atrioventricular block second degree, hypotension, elevation in blood pressure, bradycardia, tachycardia General disorders and administration site conditions: injection site discoloration Immune system disorders: anaphylactic reactions with hypotension, dyspnea, bronchospasm, urticaria, erythema

👥 Use in Specific Populations ~2 min read ▾

8 USE IN SPECIFIC POPULATIONS Renal Impairment: BLUDIGO is not recommended for use in patients with eGFR<30 mL/min. ( 8.6 )

8.1Pregnancy Risk Summary Available data from case reports, case series, observational studies and clinical experience with indigotindisulfonate sodium injection use in pregnant women over several decades have not identified a drug associated risk of adverse maternal and fetal adverse effects. Indigotindisulfonate sodium injection use during the first trimester of pregnancy is rare; thus, the data are insufficient to evaluate for a drug associated risk of major birth defects and miscarriage. The majority of the published data were from intra-amniotic injections.

Animal reproduction studies using the intravenous route of administration have not been conducted. Oral administration of indigotindisulfonate sodium to pregnant rats and rabbits produced no evidence of fetal harm. However, oral availability is low (3%) so that the risk of intravenous administration of indigotindisulfonate sodium during pregnancy cannot be evaluated from the data available .

The estimated background risk of major birth defects and miscarriage for the indicated population is unknown. All pregnancies have a background risk of birth defects, loss, or other adverse outcomes. In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2 to 4% and 15 to 20%, respectively.

8.2Lactation Risk Summary It is not known if indigotindisulfonate is present in animal or human milk. The transfer of indigotindisulfonate into breastmilk is likely to be low and adverse effects on the breastfed infant are not expected [see Clinical Pharmacology ( 12.3 )] . There are no data on the effect of indigotindisulfonate on the breastfed infant or milk production.

The developmental and health benefits of breastfeeding should be considered along with the mother’s clinical need for BLUDIGO and any potential adverse effects on the breastfed infant from BLUDIGO or from the underlying maternal condition.

8.4Pediatric Use The safety and effectiveness of BLUDIGO have not been established in pediatric patients.

8.5Geriatric Use Of the total number of subjects in the clinical study of BLUDIGO, 23 (20%) were 65 to 74 years of age, and 12 (10%) were 75 and older. No overall differences in safety or effectiveness were observed between these subjects and younger subjects, and other reported clinical experience has not identified differences in responses between the elderly and younger patients, but greater sensitivity of some older individuals cannot be ruled out.

8.6Renal Impairment Indigotindisulfonate is known to be excreted by the kidney through tubular secretion. No dedicated pharmacokinetic study using BLUDIGO in patients with varying degree of renal impairment has been conducted. Based on subgroup analyses in the randomized clinical trial, dose adjustment is not needed in patients with mild to moderate renal impairment (estimated glomerular filtration rate (eGFR) 30 to 89 mL/min derived from the Modification of Diet in Renal Disease formula).

BLUDIGO has not been studied in patients with eGFR < 30 mL/min and is not recommended for use in these patients.

🤰 Pregnancy 194 words ▾

8.1Pregnancy Risk Summary Available data from case reports, case series, observational studies and clinical experience with indigotindisulfonate sodium injection use in pregnant women over several decades have not identified a drug associated risk of adverse maternal and fetal adverse effects. Indigotindisulfonate sodium injection use during the first trimester of pregnancy is rare; thus, the data are insufficient to evaluate for a drug associated risk of major birth defects and miscarriage. The majority of the published data were from intra-amniotic injections.

Animal reproduction studies using the intravenous route of administration have not been conducted. Oral administration of indigotindisulfonate sodium to pregnant rats and rabbits produced no evidence of fetal harm. However, oral availability is low (3%) so that the risk of intravenous administration of indigotindisulfonate sodium during pregnancy cannot be evaluated from the data available .

The estimated background risk of major birth defects and miscarriage for the indicated population is unknown. All pregnancies have a background risk of birth defects, loss, or other adverse outcomes. In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2 to 4% and 15 to 20%, respectively.

🧒 Pediatric Use 16 words ▾

8.4Pediatric Use The safety and effectiveness of BLUDIGO have not been established in pediatric patients.

🧓 Geriatric Use 74 words ▾

8.5Geriatric Use Of the total number of subjects in the clinical study of BLUDIGO, 23 (20%) were 65 to 74 years of age, and 12 (10%) were 75 and older. No overall differences in safety or effectiveness were observed between these subjects and younger subjects, and other reported clinical experience has not identified differences in responses between the elderly and younger patients, but greater sensitivity of some older individuals cannot be ruled out.

🧬 Clinical Pharmacology 173 words ▾

12 CLINICAL PHARMACOLOGY

12.1Mechanism of Action Indigotindisulfonate is a dye excreted by the kidney through tubular secretion and enhances visualization of the ureteral orifices by its deep blue color.

12.2Pharmacodynamics The blue color is detectable at the ureteral orifices within 4 minutes to 9 minutes after the intravenous injection.

12.3Pharmacokinetics The pharmacokinetic properties of BLUDIGO are presented in Table 2. Table 2. Pharmacokinetics of Indigotindisulfonate in Healthy Adults Following Intravenous Administration of BLUDIGO 5 mL (40 mg) BLUDIGO 5 mL (40 mg) General Information C max (CV%), μg/mL 6.33 (58.4) AUC 0-INF (CV%), μg·h/mL 1.15 (36.4) Distribution Mean (CV%) Volume of Distribution, L 10.7 (36.1) Protein Binding, in vitro About 90% Elimination Mean (CV%) Elimination Half-life, minutes 12 (34.1) Mean (CV%) Clearance, L/hour Urinary 7.08 (66.3) Total 40.2 (45.1) Metabolism Primary Metabolic Pathways Oxidative metabolism Excretion Urine (CV%) a 16.0% (44.0) Feces <2% a Unchanged drug C max = maximum plasma concentration; AUC 0-INF =area under the plasma concentration-time curve from time of administration extrapolated to infinity; CV=coefficient of variation

🧬 Mechanism of Action 27 words ▾

12.1Mechanism of Action Indigotindisulfonate is a dye excreted by the kidney through tubular secretion and enhances visualization of the ureteral orifices by its deep blue color.

📦 How Supplied / Storage and Handling 82 words ▾

16 HOW SUPPLIED/STORAGE AND HANDLING How Supplied BLUDIGO (indigotindisulfonate sodium injection, USP) 40 mg/5 mL (8 mg/mL) is a dark blue or bluish-purple solution supplied in a carton of 5 single-dose amber glass ampules (NDC 81284-315-05). Storage and Handling Store at 20°C to 25°C (68°F to 77°F); excursions permitted to 15°C to 30°C (59° to 86°F) [See USP Controlled Room Temperature]. Store in original carton to protect from light.

Do not refrigerate or freeze. Use immediately after opening ampule. Discard unused portion.

📋 Description 105 words ▾

11 DESCRIPTION BLUDIGO (indigotindisulfonate sodium injection, USP) is a sterile deep blue or bluish-purple diagnostic dye for intravenous use. Each mL contains 8 mg indigotindisulfonate sodium (equivalent to 7.2 mg indigotindisulfonate) and may also contain citric acid and sodium citrate to adjust pH value between 3 and 6.5 and has an osmolality ≤ 0.05 osmol/kg. Indigotindisulfonate sodium is also known as indigo carmine.

The chemical name of indigotindisulfonate sodium is Disodium 3,3’-dioxo-[Δ 2,2’ -biindoline]-5,5’-disulfonate. Its molecular formula is C 16 H 8 N 2 Na 2 O 8 S 2 and its molecular weight is 466.35 g/mol. Its structural formula is: indigotindisulfonate sodium image description

💬 Information for Patients 121 words ▾

17 PATIENT COUNSELING INFORMATION Cardiovascular Reactions Advise the patient of the possibility of developing elevated blood pressure, hypotension, bradycardia, tachycardia, or atrioventricular block during or after the administration of BLUDIGO [see Warnings and Precautions ( 5.1 )]. Injection Site and Urine Discoloration Inform the patient that BLUDIGO may cause a blue discoloration of injection site and urine and that the discoloration should resolve within 48 hours. Advise the patient to inform the healthcare provider if the discoloration of the injection site is associated with other symptoms [see Adverse Reactions ( 6.2 )].

Manufactured for: PROVEPHARM SAS 13013 Marseille, FRANCE Manufactured by: CENEXI 52 rue Marcel et Jacques Gaucher 94120 Fontenay sous Bois, FRANCE Distributed by: PROVEPHARM INC. Collegeville, PA 19426, USA

Source: FDA Structured Product Labeling, mirrored from DailyMed / openFDA. Prefer the government’s original formatting? View this label on DailyMed ↗
← 81284-0213-01 · Provepharm 81284-0411-05 · Provepharm →
For educational and professional reference only — not medical advice. Pricing reflects published NADAC and CMS ASP (free public data) and may differ from your acquisition cost; always verify before billing or dispensing.