Indications and uses
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 - Sagent Pharmaceuticals
- Manufacturer
- Sagent Pharmaceuticals
- Effective date
- 2026-07-20
- Label type
- HUMAN PRESCRIPTION DRUG LABEL
- Version
- 2
- Source
- daily-update
- Hydrated at
- 2026-07-25 05:10:51
Label at a glance#
ProductBludigo
Active ingredientIndigotindisulfonate Sodium
Label structure15 sections
Dosage and administration
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. 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 ...
Storage and handling
How Supplied BLUDIGO (Indigotindisulfonate Sodium Injection, USP) is a dark blue solution in amber glass ampules supplied as follows: NDC BLUDIGO ® (Indigotindisulfonate Sodium Injection, USP) Package Factor (8 mg per mL) 25021-840-05 40 mg per 5 mL Single-Dose Ampules 5 ampules per Carton 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 Control...
Contacts and useful links#
Label contents#
Full prescribing information#
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.
2 DOSAGE AND ADMINISTRATION
2.1 Recommended 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.
2.2 Important 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- Withdraw the contents of the ampule through a 5 micron or smaller filter straw/filter needle to ensure that the withdrawn solution contains no particulates. The withdrawn solution should be inspected visually for particulate matter and discoloration prior to administration.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.
3 DOSAGE FORMS AND STRENGTHS
Injection: 40 mg per 5 mL (8 mg per mL) indigotindisulfonate sodium as a dark blue solution in a single-dose amber glass ampule.
4 CONTRAINDICATIONS
BLUDIGO is contraindicated in patients with known hypersensitivity to indigotindisulfonate or any of its components [see Warnings and Precautions (5.2)].
5 WARNINGS AND PRECAUTIONS
5.1 Cardiovascular 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.
5.2 Hypersensitivity 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.
5.3 Interference 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 SpO2 when anesthetized patients are administered BLUDIGO.
6 ADVERSE REACTIONS
Clinically significant adverse reactions are described elsewhere in the labeling:
6.1 Clinical 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.
| 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) |
6.2 Postmarketing 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
8 USE IN SPECIFIC POPULATIONS
8.1 Pregnancy
SPL UNCLASSIFIED SECTION
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.
8.2 Lactation
SPL UNCLASSIFIED SECTION
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.
8.4 Pediatric Use
The safety and effectiveness of BLUDIGO have not been established in pediatric patients.
8.5 Geriatric 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.
8.6 Renal 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.
11 DESCRIPTION
BLUDIGO (indigotindisulfonate sodium injection, USP) is a sterile deep blue 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-[Δ2,2'-biindoline]-5,5'-disulfonate. Its molecular formula is C16H8N2Na2O8S2 and its molecular weight is 466.35 g/mol. Its structural formula is:
Indigotindisulfonate sodium
12 CLINICAL PHARMACOLOGY
12.1 Mechanism 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.
12.2 Pharmacodynamics
The blue color is detectable at the ureteral orifices within 4 minutes to 9 minutes after the intravenous injection.
12.3 Pharmacokinetics
The pharmacokinetic properties of BLUDIGO are presented in Table 2.
| ||
| ||
| BLUDIGO | ||
| 5 mL (40 mg) | ||
| General Information | ||
| Cmax (CV%), μg/mL | 6.33 (58.4) | |
| AUC0-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% | |
13 NONCLINICAL TOXICOLOGY
13.1 Carcinogenesis, Mutagenesis, Impairment of Fertility
SPL UNCLASSIFIED SECTION
Carcinogenicity
Carcinogenicity studies in animals have not been conducted with indigotindisulfonate sodium using the intravenous route of administration.
Long-term studies in mice with oral and subcutaneous administration of indigotindisulfonate sodium revealed no carcinogenic effects.
SPL UNCLASSIFIED SECTION
Mutagenesis
Although indigotindisulfonate sodium has been evaluated in a number of Ames assay studies, an Ames assay study that follows all currently recommended guidelines has not been performed. Indigotindisulfonate was not genotoxic in all those Ames assays. The mutagenicity of indigotindisulfonate was inconclusive in the in vitro mouse L5187Y Lymphoma TK +/- assay. Orally administered indigotindisulfonate was not mutagenic in the in vivo mouse micronucleus test. An in vivo micronucleus test with indigotindisulfonate sodium using the intravenous route of administration has not been conducted.
SPL UNCLASSIFIED SECTION
Fertility
Fertility studies with indigotindisulfonate sodium using the intravenous route of administration have not been conducted.
14 CLINICAL STUDIES
The safety and efficacy of BLUDIGO were evaluated in a randomized intra-patient controlled, blind to dose of BLUDIGO, multi-center study (NCT04228445) in 118 adult patients undergoing endoscopic urological or gynecological surgical procedures including cystoscopic (58%), robotic (28%), and transvaginal (14%) approaches.
The majority of patients were white (89%), female (74%), and younger than 65 years of age (70%). Mean age was 51 years, and age ranged from 20 to 88 years.
Patients were randomized in a 1:1 ratio to receive 2.5 mL or 5 mL of BLUDIGO intravenously prior to the end of the surgical procedure. Each patient underwent cystoscopy and received 5 mL of sodium chloride injection 0.9% followed by the randomized BLUDIGO dose for visualization of urinary flow from the ureteral orifices. The 2.5 mL dose is not approved [see Dosage and Administration (2.1)].
The ureteral orifices and urine flow were observed and video recorded from 0 to 10 minutes post injection, with separate recordings made following sodium chloride injection and BLUDIGO. The conspicuity of the urine flow from the ureteral orifices was assessed in a randomized, blinded fashion by two independent central reviewers using a 5-point scale (1 = no urine flow observed; 2 = weak urine flow, little color contrast; 3 = Color contrast or significant urine flow; 4 = strong urine flow with good color contrast; and 5 = strong urine flow with striking contrast in color) once after sodium chloride injection and twice after BLUDIGO resulting in paired data. The surgeons also reviewed and scored conspicuity of the urine flow from the ureteral orifices.
The responder for a ureter is defined as the difference in conspicuity score between BLUDIGO and sodium chloride injection being at least one point difference and the conspicuity score following BLUDIGO alone being greater than or equal to three. The reviewer agreement with the responder endpoint is acceptable. The proportion of responders along with its 95% confidence interval by ureter and reviewer or surgeon is summarized in Table 3.
| ||
| ||
| BLUDIGO 5 mL | ||
| Left Ureter (n=49) | Right Ureter (n=49) | |
| Reviewer 1 % Responder* 95% CL** | 63% (48%, 77%) | 76% (61%, 87%) |
| Reviewer 2 % responder 95% CL | 78% (63%, 88%) | 82% (68%, 91%) |
| Surgeon % responder 95% CL | 71% (57%, 83%) | 82% (68%, 91%) |
16 HOW SUPPLIED/STORAGE AND HANDLING
SPL UNCLASSIFIED SECTION
How Supplied
BLUDIGO (Indigotindisulfonate Sodium Injection, USP) is a dark blue solution in amber glass ampules supplied as follows:
| NDC | BLUDIGO® (Indigotindisulfonate Sodium Injection, USP) | Package Factor |
| (8 mg per mL) | ||
| 25021-840-05 | 40 mg per 5 mL Single-Dose Ampules | 5 ampules per Carton |
STORAGE AND HANDLING SECTION
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.
Sterile, Nonpyrogenic, Preservative-free.
Not made with natural rubber latex.
17 PATIENT COUNSELING INFORMATION
SPL UNCLASSIFIED SECTION
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 )].
SPL UNCLASSIFIED SECTION
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)].
sagent®
Mfd. for SAGENT Pharmaceuticals
Schaumburg, IL 60173 (USA)
Made in France
©2025 Sagent Pharmaceuticals
November 2025
PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
PACKAGE LABEL – PRINCIPAL DISPLAY PANEL – Ampule Label
NDC 25021-840-05
Rx only
Bludigo®
Indigotindisulfonate Sodium Injection, USP
40 mg per 5 mL
(8 mg per mL)
Intravenous Use Only
5 mL Single-Dose Ampule
Discard unused portion
PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
PACKAGE LABEL – PRINCIPAL DISPLAY PANEL – Carton Label
NDC 25021-840-05
5 x 5 mL Single-Dose Ampules
Bludigo®
Indigotindisulfonate Sodium Injection, USP
40 mg per 5 mL
(8 mg per mL)
Rx only
Intravenous Use Only
Discard unused portion
Patented: US 10,927,258
US 11,499,050; US 11,845,867
Product Linked Resources#
| Resource | Code type | Value | Equivalent identifiers | Source image |
|---|---|---|---|---|
| Barcode | DataBar Omni | (01)00325021840054 | GTIN-14: 00325021840054 GTIN-12: 325021840054 UPC-A: 325021840054 EAN-13: 0325021840054 GTIN storage (14 digits): 00325021840054 | blu00-0002-02.jpg |
| Data code | Code 128 | 072651 | blu00-0002-02.jpg | |
| Data code | Code 128 | 28072650 | blu00-0002-03.jpg |
DailyMed Product Concepts#
| Product concept | Relation | Version | Effective |
|---|---|---|---|
| 351abe41-466c-4dd8-840a-0fdb68318bd5 | Product name | 1 | 20230316 |
DailyMed Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 25021-840-05 | ML - Milliliter | 25021-840 | af363557-4241-42da-9063-5c4d68284b56 | 1 | 2026-05-22 |
Products#
Every source-derived product name is available through these pages.
- Bludigo
- Indigotindisulfonate Sodium
- INDIGOTINDISULFONIC ACID
- Citric Acid Monohydrate
- Sodium Citrate, Unspecified Form
NDC Codes#
| Product NDC | Package NDC |
|---|---|
| 25021-840 | 25021-840-05 |
Ingredients#
Every source-derived ingredient row is available through these pages.
| Name | UNII | Kind |
|---|---|---|
| Indigotindisulfonate Sodium | D3741U8K7L | ACTIB |
| Citric Acid Monohydrate | 2968PHW8QP | IACT |
| Sodium Citrate, Unspecified Form | 1Q73Q2JULR | IACT |
Source Document#
Older Hydrated Versions#
| Version | Effective date | Source | Hydrated |
|---|---|---|---|
| 1 | 2026-04-16 | full-release | 2026-05-31 22:15:49 |
Orange Book application contexts#
All distinct exact application/product contexts derived from this label’s complete NDC list are paginated below.
Orange Book products#
| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|---|---|---|---|---|---|---|
| N216264-001 | BLUDIGO | INDIGOTINDISULFONATE SODIUM | 40MG/5ML (8MG/ML) | SOLUTION / INTRAVENOUS | RLD, RS | 2022-07-08 |
Orange Book patents#
| Application-product | Patent | Expiration | Use code | Coverage / status | Submission date |
|---|---|---|---|---|---|
| N216264-001 | 11845867 | 2036-11-25 | Drug substance | 2024-01-11 | |
| N216264-001 | 10927258 | 2037-12-23 | Drug substance | 2022-08-01 | |
| N216264-001 | 11499050 | 2037-12-23 | Drug substance | 2022-11-30 |
Orange Book exclusivity#
| Application-product | Exclusivity code | Expiration |
|---|---|---|
| N216264-001 | NCE | 2027-07-08 |
Observed Orange Book product history#
Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.
| Captured | Edition | Application-product | Trade name | Strength | Dosage form / route | Product TE source text | RLD / RS | Approval date | Source SHA-256 |
|---|---|---|---|---|---|---|---|---|---|
| 2026-09-14 22:38:34 | 2026-08 | N216264-001 | BLUDIGO | 40MG/5ML (8MG/ML) | SOLUTION / INTRAVENOUS | RLD, RS | 2022-07-08 | 84e616aacf4f… | |
| 2026-08-18 06:07:40 | 2026-07 | N216264-001 | BLUDIGO | 40MG/5ML (8MG/ML) | SOLUTION / INTRAVENOUS | RLD, RS | 2022-07-08 | caaa826d4ba7… | |
| 2026-02-19 14:30 UTC | 2026-02 | N216264-001 | BLUDIGO | 40MG/5ML (8MG/ML) | SOLUTION / INTRAVENOUS | RLD, RS | 2022-07-08 | 011fe1cb6892… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N216264-001 | BLUDIGO | 40MG/5ML (8MG/ML) | SOLUTION / INTRAVENOUS | RLD, RS | 2022-07-08 | 31067a03dcf5… | |
| 2025-08-23 18:47 UTC | 2025-08 | N216264-001 | BLUDIGO | 40MG/5ML (8MG/ML) | SOLUTION / INTRAVENOUS | RLD, RS | 2022-07-08 | 6a471c1ec25d… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N216264-001 | BLUDIGO | 40MG/5ML (8MG/ML) | SOLUTION / INTRAVENOUS | RLD, RS | 2022-07-08 | fd3edfee7708… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N216264-001 | BLUDIGO | 40MG/5ML (8MG/ML) | SOLUTION / INTRAVENOUS | RLD, RS | 2022-07-08 | b8a1b40f171c… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N216264-001 | BLUDIGO | 40MG/5ML (8MG/ML) | SOLUTION / INTRAVENOUS | RLD, RS | 2022-07-08 | 03ed91905a0d… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N216264-001 | BLUDIGO | 40MG/5ML (8MG/ML) | SOLUTION / INTRAVENOUS | RLD, RS | 2022-07-08 | 2680178bc6a6… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | N216264-001 | BLUDIGO | 40MG/5ML (8MG/ML) | SOLUTION / INTRAVENOUS | RLD, RS | 2022-07-08 | 5bbf6a4d5a75… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | N216264-001 | BLUDIGO | 40MG/5ML (8MG/ML) | SOLUTION / INTRAVENOUS | RLD, RS | 2022-07-08 | d8e5a09893c0… | |
| 2024-10-29 15:01 UTC | 2024-10 | N216264-001 | BLUDIGO | 40MG/5ML (8MG/ML) | SOLUTION / INTRAVENOUS | RLD, RS | 2022-07-08 | d06236e962d9… | |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | N216264-001 | BLUDIGO | 40MG/5ML (8MG/ML) | SOLUTION / INTRAVENOUS | RLD, RS | 2022-07-08 | 79d66fd596c7… | |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | N216264-001 | BLUDIGO | 40MG/5ML (8MG/ML) | SOLUTION / INTRAVENOUS | RLD, RS | 2022-07-08 | 301d65b070ca… | |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | N216264-001 | BLUDIGO | 40MG/5ML (8MG/ML) | SOLUTION / INTRAVENOUS | RLD, RS | 2022-07-08 | 1e350fbaab3a… | |
| 2024-05-31 18:47 UTC | 2024-05 | N216264-001 | BLUDIGO | 40MG/5ML (8MG/ML) | SOLUTION / INTRAVENOUS | RLD, RS | 2022-07-08 | 8072bd15b7f6… | |
| 2024-03-16 18:09 UTC · 4 captures of this ZIP | 2024-03 | N216264-001 | BLUDIGO | 40MG/5ML (8MG/ML) | SOLUTION / INTRAVENOUS | RLD, RS | 2022-07-08 | 6a51e52b5d6a… | |
| 2024-02-18 07:12 UTC | 2024-02 | N216264-001 | BLUDIGO | 40MG/5ML (8MG/ML) | SOLUTION / INTRAVENOUS | RLD, RS | 2022-07-08 | 1c564ffb4f44… | |
| 2023-12-20 04:57 UTC | 2023-12 | N216264-001 | BLUDIGO | 40MG/5ML (8MG/ML) | SOLUTION / INTRAVENOUS | RLD, RS | 2022-07-08 | ea1830bbd6c7… | |
| 2023-11-28 05:40 UTC · 2 captures of this ZIP | 2023-11 | N216264-001 | BLUDIGO | 40MG/5ML (8MG/ML) | SOLUTION / INTRAVENOUS | RLD, RS | 2022-07-08 | a72a2bbeb626… | |
| 2023-10-25 00:34 UTC · 2 captures of this ZIP | 2023-10 | N216264-001 | BLUDIGO | 40MG/5ML (8MG/ML) | SOLUTION / INTRAVENOUS | RLD, RS | 2022-07-08 | 9b2671bbb829… | |
| 2023-07-15 15:27 UTC · 2 captures of this ZIP | 2023-07 | N216264-001 | BLUDIGO | 40MG/5ML (8MG/ML) | SOLUTION / INTRAVENOUS | RLD, RS | 2022-07-08 | a67488948f0b… | |
| 2023-06-13 01:57 UTC · 3 captures of this ZIP | 2023-06 | N216264-001 | BLUDIGO | 40MG/5ML (8MG/ML) | SOLUTION / INTRAVENOUS | RLD, RS | 2022-07-08 | 3f0d92c62455… | |
| 2023-05-13 08:27 UTC | 2023-05 | N216264-001 | BLUDIGO | 40MG/5ML (8MG/ML) | SOLUTION / INTRAVENOUS | RLD, RS | 2022-07-08 | 053a50430f4f… | |
| 2023-01-26 05:58 UTC | 2023-01 | N216264-001 | BLUDIGO | 40MG/5ML (8MG/ML) | SOLUTION / INTRAVENOUS | RLD, RS | 2022-07-08 | 3bdfa0b2c4d7… | |
| 2022-11-12 20:34 UTC · 5 captures of this ZIP | 2022-11 | N216264-001 | BLUDIGO | 40MG/5ML (8MG/ML) | SOLUTION / INTRAVENOUS | RLD, RS | 2022-07-08 | 3a93d1ddd44b… | |
| 2022-10-28 04:53 UTC | 2022-10 | N216264-001 | BLUDIGO | 40MG/5ML (8MG/ML) | SOLUTION / INTRAVENOUS | RLD, RS | 2022-07-08 | f41ea6bd6efb… | |
| 2022-09-29 23:25 UTC | 2022-09 | N216264-001 | BLUDIGO | 40MG/5ML (8MG/ML) | SOLUTION / INTRAVENOUS | RLD, RS | 2022-07-08 | e64feba35796… | |
| 2026-07-26 02:55 UTC · 3 captures of this ZIP | 2026-06 | N216264-001 | BLUDIGO | 40MG/5ML (8MG/ML) | SOLUTION / INTRAVENOUS | RLD, RS | 2022-07-08 | a50c72e98297… |
Observed Orange Book patent history#
| Captured | Edition | Application-product | Patent | Expiration | Use code | Coverage / status | Submission date | Source SHA-256 |
|---|---|---|---|---|---|---|---|---|
| 2026-09-14 22:38:34 | 2026-08 | N216264-001 | 11845867 | 2036-11-25 | Drug substance | 2024-01-11 | 84e616aacf4f… | |
| 2026-09-14 22:38:34 | 2026-08 | N216264-001 | 10927258 | 2037-12-23 | Drug substance | 2022-08-01 | 84e616aacf4f… | |
| 2026-09-14 22:38:34 | 2026-08 | N216264-001 | 11499050 | 2037-12-23 | Drug substance | 2022-11-30 | 84e616aacf4f… | |
| 2026-08-18 06:07:40 | 2026-07 | N216264-001 | 11845867 | 2036-11-25 | Drug substance | 2024-01-11 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | N216264-001 | 10927258 | 2037-12-23 | Drug substance | 2022-08-01 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | N216264-001 | 11499050 | 2037-12-23 | Drug substance | 2022-11-30 | caaa826d4ba7… | |
| 2026-02-19 14:30 UTC | 2026-02 | N216264-001 | 11845867 | 2036-11-25 | Drug substance | 2024-01-11 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | N216264-001 | 10927258 | 2037-12-23 | Drug substance | 2022-08-01 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | N216264-001 | 11499050 | 2037-12-23 | Drug substance | 2022-11-30 | 011fe1cb6892… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N216264-001 | 11845867 | 2036-11-25 | Drug substance | 2024-01-11 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N216264-001 | 10927258 | 2037-12-23 | Drug substance | 2022-08-01 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N216264-001 | 11499050 | 2037-12-23 | Drug substance | 2022-11-30 | 31067a03dcf5… | |
| 2025-08-23 18:47 UTC | 2025-08 | N216264-001 | 11845867 | 2036-11-25 | Drug substance | 2024-01-11 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | N216264-001 | 10927258 | 2037-12-23 | Drug substance | 2022-08-01 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | N216264-001 | 11499050 | 2037-12-23 | Drug substance | 2022-11-30 | 6a471c1ec25d… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N216264-001 | 11845867 | 2036-11-25 | Drug substance | 2024-01-11 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N216264-001 | 10927258 | 2037-12-23 | Drug substance | 2022-08-01 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N216264-001 | 11499050 | 2037-12-23 | Drug substance | 2022-11-30 | fd3edfee7708… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N216264-001 | 11845867 | 2036-11-25 | Drug substance | 2024-01-11 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N216264-001 | 10927258 | 2037-12-23 | Drug substance | 2022-08-01 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N216264-001 | 11499050 | 2037-12-23 | Drug substance | 2022-11-30 | b8a1b40f171c… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N216264-001 | 11845867 | 2036-11-25 | Drug substance | 2024-01-11 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N216264-001 | 10927258 | 2037-12-23 | Drug substance | 2022-08-01 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N216264-001 | 11499050 | 2037-12-23 | Drug substance | 2022-11-30 | 03ed91905a0d… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N216264-001 | 11845867 | 2036-11-25 | Drug substance | 2024-01-11 | 2680178bc6a6… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N216264-001 | 10927258 | 2037-12-23 | Drug substance | 2022-08-01 | 2680178bc6a6… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N216264-001 | 11499050 | 2037-12-23 | Drug substance | 2022-11-30 | 2680178bc6a6… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | N216264-001 | 11845867 | 2036-11-25 | Drug substance | 2024-01-11 | 5bbf6a4d5a75… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | N216264-001 | 10927258 | 2037-12-23 | Drug substance | 2022-08-01 | 5bbf6a4d5a75… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | N216264-001 | 11499050 | 2037-12-23 | Drug substance | 2022-11-30 | 5bbf6a4d5a75… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | N216264-001 | 11845867 | 2036-11-25 | Drug substance | 2024-01-11 | d8e5a09893c0… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | N216264-001 | 10927258 | 2037-12-23 | Drug substance | 2022-08-01 | d8e5a09893c0… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | N216264-001 | 11499050 | 2037-12-23 | Drug substance | 2022-11-30 | d8e5a09893c0… | |
| 2024-10-29 15:01 UTC | 2024-10 | N216264-001 | 11845867 | 2036-11-25 | Drug substance | 2024-01-11 | d06236e962d9… | |
| 2024-10-29 15:01 UTC | 2024-10 | N216264-001 | 10927258 | 2037-12-23 | Drug substance | 2022-08-01 | d06236e962d9… | |
| 2024-10-29 15:01 UTC | 2024-10 | N216264-001 | 11499050 | 2037-12-23 | Drug substance | 2022-11-30 | d06236e962d9… | |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | N216264-001 | 11845867 | 2036-11-25 | Drug substance | 2024-01-11 | 79d66fd596c7… | |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | N216264-001 | 10927258 | 2037-12-23 | Drug substance | 2022-08-01 | 79d66fd596c7… | |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | N216264-001 | 11499050 | 2037-12-23 | Drug substance | 2022-11-30 | 79d66fd596c7… | |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | N216264-001 | 11845867 | 2036-11-25 | Drug substance | 2024-01-11 | 301d65b070ca… |
Observed Orange Book exclusivity history#
| Captured | Edition | Application-product | Exclusivity code | Expiration | Source SHA-256 |
|---|---|---|---|---|---|
| 2026-09-14 22:38:34 | 2026-08 | N216264-001 | NCE | 2027-07-08 | 84e616aacf4f… |
| 2026-08-18 06:07:40 | 2026-07 | N216264-001 | NCE | 2027-07-08 | caaa826d4ba7… |
| 2026-02-19 14:30 UTC | 2026-02 | N216264-001 | NCE | 2027-07-08 | 011fe1cb6892… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N216264-001 | NCE | 2027-07-08 | 31067a03dcf5… |
| 2025-08-23 18:47 UTC | 2025-08 | N216264-001 | NCE | 2027-07-08 | 6a471c1ec25d… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N216264-001 | NCE | 2027-07-08 | fd3edfee7708… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N216264-001 | NCE | 2027-07-08 | b8a1b40f171c… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N216264-001 | NCE | 2027-07-08 | 03ed91905a0d… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N216264-001 | NCE | 2027-07-08 | 2680178bc6a6… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | N216264-001 | NCE | 2027-07-08 | 5bbf6a4d5a75… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | N216264-001 | NCE | 2027-07-08 | d8e5a09893c0… |
| 2024-10-29 15:01 UTC | 2024-10 | N216264-001 | NCE | 2027-07-08 | d06236e962d9… |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | N216264-001 | NCE | 2027-07-08 | 79d66fd596c7… |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | N216264-001 | NCE | 2027-07-08 | 301d65b070ca… |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | N216264-001 | NCE | 2027-07-08 | 1e350fbaab3a… |
| 2024-05-31 18:47 UTC | 2024-05 | N216264-001 | NCE | 2027-07-08 | 8072bd15b7f6… |
| 2024-03-16 18:09 UTC · 4 captures of this ZIP | 2024-03 | N216264-001 | NCE | 2027-07-08 | 6a51e52b5d6a… |
| 2024-02-18 07:12 UTC | 2024-02 | N216264-001 | NCE | 2027-07-08 | 1c564ffb4f44… |
| 2023-12-20 04:57 UTC | 2023-12 | N216264-001 | NCE | 2027-07-08 | ea1830bbd6c7… |
| 2023-11-28 05:40 UTC · 2 captures of this ZIP | 2023-11 | N216264-001 | NCE | 2027-07-08 | a72a2bbeb626… |
| 2023-10-25 00:34 UTC · 2 captures of this ZIP | 2023-10 | N216264-001 | NCE | 2027-07-08 | 9b2671bbb829… |
| 2023-07-15 15:27 UTC · 2 captures of this ZIP | 2023-07 | N216264-001 | NCE | 2027-07-08 | a67488948f0b… |
| 2023-06-13 01:57 UTC · 3 captures of this ZIP | 2023-06 | N216264-001 | NCE | 2027-07-08 | 3f0d92c62455… |
| 2023-05-13 08:27 UTC | 2023-05 | N216264-001 | NCE | 2027-07-08 | 053a50430f4f… |
| 2023-01-26 05:58 UTC | 2023-01 | N216264-001 | NCE | 2027-07-08 | 3bdfa0b2c4d7… |
| 2022-11-12 20:34 UTC · 5 captures of this ZIP | 2022-11 | N216264-001 | NCE | 2027-07-08 | 3a93d1ddd44b… |
| 2022-10-28 04:53 UTC | 2022-10 | N216264-001 | NCE | 2027-07-08 | f41ea6bd6efb… |
| 2022-09-29 23:25 UTC | 2022-09 | N216264-001 | NCE | 2027-07-08 | e64feba35796… |
| 2026-07-26 02:55 UTC · 3 captures of this ZIP | 2026-06 | N216264-001 | NCE | 2027-07-08 | a50c72e98297… |
openFDA label cross-check#
OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.
| Brand | Generic | Manufacturer | SPL set ID | Effective date | Available safety fields | Join |
|---|---|---|---|---|---|---|
| Bludigo | INDIGOTINDISULFONATE SODIUM | Sagent Pharmaceuticals | 2b91c39d-5f15-4dcf-9d3d-b378470e6bd7 | 2026-07-20 | Warnings, Adverse reactions | 25021-840-05 25021-840 25021084005 8a259a98-f8d9-4800-a324-d8e5f7e3a600 2b91c39d-5f15-4dcf-9d3d-b378470e6bd7 |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.