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gadobutrol 604.72 mg/mL Injection — NDC 70710-2065-06 package photo
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gadobutrol 604.72 mg/mL Injection — NDC 70710-2065-6 (Billing 70710-2065-06)

by Zydus Pharmaceuticals USA Inc. · 10 VIAL, SINGLE-DOSE in 1 CARTON / 10 mL in 1 VIAL, SINGLE-DOSE

This is a package of gadobutrol 604.72 mg/mL Injection from Zydus Pharmaceuticals USA Inc., marketed since Jul 2026 and currently FDA-listed. It is this product's only package size.

NDC 70710-2065-06
🏷️ FDA NDC (as labeled) 70710-2065-6 billing pads the package segment with a zero
Rx only Generic On market Non-controlled ⇄ Compare with another NDC
🗂️ FDA directory synced Oct 1, 2026 · this listing last changed Jul 27, 2026 · sources: openFDA · FDA label (DailyMed) · FDA Orange & Purple Book · First Databank · CMS NADAC, ASP, Medicare & Medicaid · RxNorm
📋 All sources & update times →

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

NDC database record

One package, one record: these facts belong to NDC 70710-2065-6 alone.

Record
FDA NDC Directory package listing · Human prescription drug
Code segments
70710 labeler · 2065 product · 6 package
Package marketed since
Jul 14, 2026
Sample package
No — commercial package
Listing certified through
Dec 31, 2027
Barcode (UPC)
0370710206512, 0370710206611, 0370710206413
FDA record last changed
Jul 27, 2026

Identity & classification

Regulatory identifiers FDA, NLM and CMS codes for this package

FDA NDC (as labeled) 70710-2065-6
Product NDC 70710-2065
11-digit billing NDC 70710206506
UNII 1BJ477IO2L
UPC 0370710206512, 0370710206611, 0370710206413
Application # ANDA219287
SPL Set ID 4ea8ae43-22ca-40c0-be72-c91a321cafd1
Established class (EPC) Gadolinium-based Contrast Agent
Mechanism of action Magnetic Resonance Contrast Activity
DEA schedule Non-controlled
Marketing category ANDA
Marketing status On market
FDA listing status Listed (active directory)
Marketing start 2026-07-14
Route INTRAVENOUS
Dosage form INJECTION
Substance GADOBUTROL
TE code (Orange Book) AP · RLD · RS
Why two NDCs? The FDA registers this code as 70710-2065-6 — a 5-4-1 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 package segment → 70710-2065-06. 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.

Clinical

📗 Our plain-language guide HelloPharmacist
  • It is a contrast dye that makes your MRI pictures clearer. It is used for scans of the brain and spine, breast, blood vessels and heart. It does not treat a condition. It helps you...
  • A healthcare professional injects it into a vein, usually followed by a saline flush. The amount is based on your weight. You do not take it at home.
  • Most people have none. When they do occur, they are usually mild, such as headache, nausea, dizziness, an odd taste or feeling warm. Let your care team know if anything bothers you...
  • Get help right away for trouble breathing, swelling of the face or throat, hives or fainting. Allergic reactions can sometimes show up days later. Also call if your skin thickens o...
📖 Read our full Gadobutrol guide →

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.

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.

Packaging — all sizes for this product

Package NDCDescription Marketing startMarketing endStatus
70710-2065-06 You're viewing this Main listing 10 VIAL, SINGLE-DOSE in 1 CARTON / 10 mL in 1 VIAL, SINGLE-DOSE 2026-07-14 — Active

Therapeutic equivalents

ProductLabelerPackNADAC/unitTEStatusPrice vs. this
Gadobutrol 604.72 mg/mL 65219-0287-30 Fresenius 10 bottles — — FDA listed —
gadobutrol 604.72 mg/mL 70436-0217-80 Slate 1 vial — AP FDA listed —
Gadavist 604.72 mg/mL 50419-0325-14 Bayer 5 bottles — AP Discontinued —
gadobutrol 604.72 mg/mL 70436-0214-54 Slate 20 vials — AP FDA listed —
gadobutrol 604.72 mg/mL 70436-0213-82 Slate 10 vials — AP FDA listed —
gadobutrol 604.72 mg/mL 70436-0218-84 Slate 3 vials — AP FDA listed —
gadobutrol 604.72 mg/mL 70436-0212-54 Slate 20 vials — AP FDA listed —
Gadobutrol 604.72 mg/mL 65219-0289-65 Fresenius 10 bottles — — FDA listed —
gadobutrol 604.72 mg/mL 70436-0216-81 Slate 5 vials — AP FDA listed —
Gadobutrol 604.72 mg/mL 65219-0281-02 Fresenius 3 vials — — FDA listed —
gadobutrol 604.72 mg/mL 42337-0007-02 Viwit 10 vials — AP FDA listed —
gadobutrol 604.72 mg/mL 70710-2066-06 Zydus 10 vials — AP FDA listed —
gadobutrol 604.72 mg/mL 42337-0005-02 Viwit 10 vials — AP FDA listed —
gadobutrol 604.72 mg/mL 70710-2064-06 Zydus 10 vials — AP FDA listed —
gadobutrol 604.72 mg/mLthis 70710-2065-06 Zydus 10 vials — AP FDA listed —
gadobutrol 604.72 mg/mL 42337-0006-02 Viwit 10 vials — AP FDA listed —
About this product: this is a generic version of the medicine. FDA equivalence ratings are shown when available, and other versions are listed above, least expensive first.
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

🏛️
2026
On the market since
Jul 2026
📍
2026
Currently FDA-listed
listed with the FDA
🔓
·
Generic on the market
this product is a generic
✅This is a generic drug

This product is an FDA-approved generic. Other versions of the same drug are listed under Therapeutic equivalents, least expensive first.

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.

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 PO5286589K
    A synthetic compound used as a preservative and antimicrobial agent in medicines. It helps prevent bacterial and fungal growth, extending the product's shelf life and maintaining stability.
  • UNII QTT17582CB
    A strong acid used to adjust and maintain the proper pH level in liquid medicines, ensuring stability and preventing breakdown of active ingredients.
  • UNII 023C2WHX2V
    Tromethamine is a chemical buffer that helps maintain the proper acidity level in liquid medicines. It neutralizes acids and stabilizes the solution so the medication remains effective and safe throughout its shelf life.
  • UNII 059QF0KO0R
    Water is a liquid solvent that dissolves and mixes ingredients together in liquid medicines, syrups, and injections. It helps distribute the active drug evenly throughout the product.

4 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.

Manufacturer & labeler

LabelerZydus Pharmaceuticals USA Inc.
Application holderVIWIT PHARMACEUTICAL CO LTD
FDA applicationANDA219287 (ANDA)
Labeler code70710
First marketedJul 2026
Product typeHuman Prescription Drug
Portfolio454 products on file

More NDCs from Zydus Pharmaceuticals USA Inc. labeler code 70710

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.

Full prescribing information FDA SPL

The complete FDA label for this product — the official prescribing information, verbatim, section by section. Very long sections are excerpted here and marked; the full text is on DailyMed (linked in the sources below). Jump with a chip, search within the label, or expand everything.
🚨 Boxed Warning 🎯 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 🆘 Overdosage 🧬 Clinical Pharmacology 🧬 Mechanism of Action 📦 How Supplied / Storage and Handling 📋 Description 💬 Information for Patients 💬 Medication Guide 🧬 Pharmacokinetics 🧬 Pharmacodynamics 🔬 Clinical Studies 🧪 Nonclinical Toxicology 📄 Carcinogenesis, Mutagenesis, Impairment of Fertility 📄 Recent Major Changes 📄 Package Label / Principal Display Panel
🚨 Boxed Warning ~2 min read ▾

WARNING: RISK ASSOCIATED WITH INTRATHECAL USE and NEPHROGENIC SYSTEMIC FIBROSIS Risk Associated with Intrathecal Use Intrathecal administration of gadolinium-based contrast agents (GBCAs) can cause serious adverse reactions including death, coma, encephalopathy, and seizures. Gadobutrol Injection is not approved for intrathecal use [see Warnings and Precautions (5.1) ]. Nephrogenic Systemic Fibrosis GBCAs increase the risk for nephrogenic systemic fibrosis (NSF) among patients with impaired elimination of the drugs.

Avoid use of Gadobutrol Injection in these patients unless the diagnostic information is essential and not available with non-contrasted MRI or other modalities. NSF may result in fatal or debilitating fibrosis affecting the skin, muscle and internal organs. The risk for NSF appears highest among patients with: o Chronic, severe kidney disease (GFR < 30 mL/min/1.73m 2 ), or o Acute kidney injury.

Screen patients for acute kidney injury and other conditions that may reduce renal function. For patients at risk for chronically reduced renal function (for example, age > 60 years, hypertension or diabetes), estimate the glomerular filtration rate (GFR) through laboratory testing. For patients at highest risk for NSF, do not exceed the recommended Gadobutrol Injection dose and allow a sufficient period of time for elimination of the drug from the body prior to any re-administration [see Warnings and Precautions (5.2) ].

WARNING: RISK ASSOCIATED WITH INTRATHECAL USE and NEPHROGENIC SYSTEMIC FIBROSIS See full prescribing information for complete boxed warning . Intrathecal administration of gadolinium-based contrast agents (GBCAs) can cause serious adverse reactions including death, coma, encephalopathy, and seizures. Gadobutrol Injection is not approved for intrathecal use.

( 5.1 ) GBCAs increase the risk for nephrogenic systemic fibrosis (NSF) among patients with impaired elimination of the drugs. Avoid use of Gadobutrol Injection in these patients unless the diagnostic information is essential and not available with non-contrasted MRI or other modalities. The risk for NSF appears highest among patients with: o Chronic, severe kidney disease (GFR < 30 mL/min/1.73m 2 ), or o Acute kidney injury .

Screen patients for acute kidney injury and other conditions that may reduce renal function. For patients at risk for chronically reduced renal function (for example, age >60 years, hypertension or diabetes), estimate the glomerular filtration rate (GFR) through laboratory testing. ( 5.2 )

🎯 Indications and Usage 199 words ▾

1 INDICATIONS AND USAGE Gadobutrol Injection is indicated for: Magnetic resonance imaging (MRI) of the central nervous system (CNS) to detect and visualize areas with disrupted blood brain barrier and/or abnormal vascularity in adult and pediatric patients including term neonates MRI of the breast to assess the presence and extent of malignant breast disease in adult patients Magnetic resonance angiography (MRA) to evaluate known or suspected supra-aortic or renal artery disease in adult and pediatric patients including term neonates Cardiac MRI (CMRI) to assess myocardial perfusion (stress, rest) and late gadolinium enhancement in adult patients with known or suspected coronary artery disease (CAD) Gadobutrol Injection is a gadolinium-based contrast agent indicated for use with magnetic resonance imaging (MRI): To detect and visualize areas with disrupted blood brain barrier and/or abnormal vascularity of the central nervous system in adult and pediatric patients, including term neonates To assess the presence and extent of malignant breast disease in adult patients To evaluate known or suspected supra-aortic or renal artery disease in adult and pediatric patients including term neonates To assess myocardial perfusion (stress, rest) and late gadolinium enhancement in adult patients with known or suspected coronary artery disease (CAD).

( 1 ).

⏱️ Dosage and Administration ~3 min read ▾

2 DOSAGE AND ADMINISTRATION Recommended dose for adults and pediatric patients, including term neonates, is 0.1 mmol/kg actual body weight (equivalent to 0.1 mL/kg) administered by intravenous bolus injection. ( 2.1 , 2.2 ) See Full Prescribing Information for administration, imaging, and handling.( 2.2 , 2.3 )

2.1Recommended Dose The recommended dose of Gadobutrol Injection for adult and pediatric patients, including term neonates, is 0.1 mmol/kg actual body weight (equivalent to 0.1 mL/kg) administered intravenously. For CMRI, the dose is divided into two separate, equal injections [see Dosage and Administration (2.2) ] . Refer to Table 1 for volumes to be administered for example body weights.

Table 1: Volume of Gadobutrol Injection for Example Body Weights Body Weight (kg) Volume to be Administered (mL) 2.5 0.25 5 0.5 10 1 15 1.5 20 2 25 2.5 30 3 35 3.5 40 4 45 4.5 50 5 60 6 70 7 80 8 90 9 100 10 110 11 120 12 130 13 140 14

2.2Administration and Imaging Instructions General Gadobutrol Injection is formulated at a higher concentration (1 mmol/mL) compared to certain other gadolinium-based contrast agents, resulting in a lower volume of administration [see Dosage and Administration (2.1) ] . Gadobutrol Injection is for intravenous use only and must not be administered intrathecally [see Warnings and Precautions (5.1) ] . Use aseptic technique when preparing and administering Gadobutrol Injection.

Visually inspect Gadobutrol Injection for particulate matter and discoloration prior to administration. Do not use the solution if it is discolored, if particulate matter is present, or if the container appears damaged. If solidification occurs due to cold exposure, bring Gadobutrol Injection to room temperature before use and inspect to ensure that the solution is clear and colorless to pale yellow.

Do not mix Gadobutrol Injection with other medications and do not administer Gadobutrol Injection in the same intravenous line simultaneously with other medications. MRI of the CNS in Adult and Pediatric Patients Including Term Neonates Administer Gadobutrol Injection as an intravenous injection, manually or by power injector, at a flow rate of approximately 2 mL/sec. Follow Gadobutrol Injection with a flush of 0.9% Sodium Chloride Injection to ensure complete administration of the contrast.

Post contrast MRI can commence immediately following contrast administration. MRI of the Breast in Adults Administer Gadobutrol Injection as an intravenous bolus by power injector, followed by a flush of 0.9% Sodium Chloride Injection to ensure complete administration of the contrast. Start image acquisition following Gadobutrol Injection administration and then repeat sequentially to determine peak intensity and wash-out.

MR Angiography in Adult and Pediatric Patients Including Term Neonates Image acquisition should coincide with peak arterial concentration, which varies among patients. For adults, administer Gadobutrol Injection as an intravenous injection by power injector, at a flow rate of approximately 1.5 mL/sec, followed by a 30 mL flush of 0.9% Sodium Chloride Injection at the same rate to ensure complete administration of the contrast. For pediatric patients including term neonates, administer Gadobutrol Injection as an intravenous injection by power injector or manually, followed by a flush of 0.9% Sodium Chloride Injection to ensure complete administration of the contrast.

Cardiac MRI in Adults Administer Gadobutrol Injection through a separate intravenous line in the contralateral arm if concomitantly providing a continuous infusion of a pharmacologic stress agent. Administer Gadobutrol Injection as two separate bolus injections: 0.05 mmol/kg actual body weight (equivalent to 0.05 mL/kg) at peak pharmacologic stress followed by 0.05 mmol/kg (equivalent to 0.05 mL/kg) at rest. Administer Gadobutrol Injection via a power injector at a flow rate of approximately 4 mL/sec and follow each injection with a 20 mL flush of 0.9% Sodium Chlorid… [Excerpted — this section continues on DailyMed.]

💊 Dosage Forms and Strengths 56 words ▾

3 DOSAGE FORMS AND STRENGTHS Injection: 1 mmol/mL of gadobutrol as a clear and colorless to pale yellow solution available in the following strengths: Strength Package Type 7.5 mmol/7.5 mL (1 mmol/mL) 10 mmol/10 mL (1 mmol/mL) 15 mmol/15 mL (1 mmol/mL) Single-Dose Vial Injection: 1 mmol/mL of gadobutrol available in single-dose vial ( 3 )

⛔ Contraindications 35 words ▾

4 CONTRAINDICATIONS Gadobutrol Injection is contraindicated in patients with history of severe hypersensitivity reactions to Gadobutrol Injection [see Warnings and Precautions (5.3) ] . History of severe hypersensitivity reaction to Gadobutrol Injection ( 4 )

⚠️ Warnings and Cautions ~3 min read ▾

5 WARNINGS AND PRECAUTIONS Hypersensitivity Reactions:Anaphylactic and other hypersensitivity reactions with cardiovascular, respiratory or cutaneous manifestations, ranging from mild to severe, including death, have occurred. Monitor patients closely during and after administration of Gadobutrol Injection. ( 5.3 ) Acute Respiratory Distress Syndrome: For patients demonstrating respiratory distress after administration, assess oxygen requirement and monitor for worsening respiratory function.

( 5.4 ) Gadolinium Retention: Gadolinium is retained for months or years in brain, bone, and other organs. ( 5.5 )

5.1Risk Associated with Intrathecal Use Intrathecal administration of GBCAs can cause serious adverse reactions including death, coma, encephalopathy, and seizures. The safety and effectiveness of Gadobutrol Injection have not been established with intrathecal use. Gadobutrol Injection is not approved for intrathecal use [see Dosage and Administration (2.2) ] .

5.2Nephrogenic Systemic Fibrosis GBCAs increase the risk for nephrogenic systemic fibrosis (NSF) among patients with impaired elimination of the drugs. Avoid use of Gadobutrol Injection among these patients unless the diagnostic information is essential and not available with non-contrast MRI or other modalities. The GBCA-associated NSF risk appears highest for patients with chronic, severe kidney disease (GFR < 30 mL/min/1.73m 2 ) as well as patients with acute kidney injury.

The risk appears lower for patients with chronic, moderate kidney disease (GFR 30 to 59 mL/min/1.73m 2 ) and little, if any, for patients with chronic, mild kidney disease (GFR 60 to 89 mL/min/1.73m 2 ). NSF may result in fatal or debilitating fibrosis affecting the skin, muscle and internal organs. Report any diagnosis of NSF following Gadobutrol Injection administration to Zydus Pharmaceuticals (USA) Inc.

(1-877-993-8779) or FDA (1-800-FDA-1088 or www.fda.gov/medwatch). Screen patients for acute kidney injury and other conditions that may reduce renal function. Features of acute kidney injury consist of rapid (over hours to days) and usually reversible decrease in kidney function, commonly in the setting of surgery, severe infection, injury or drug-induced kidney toxicity.

Serum creatinine levels and estimated GFR may not reliably assess renal function in the setting of acute kidney injury. For patients at risk for chronically reduced renal function (for example, age > 60 years, diabetes mellitus or chronic hypertension), estimate the GFR through laboratory testing. Among the factors that may increase the risk for NSF are repeated or higher than recommended doses of a GBCA and degree of renal impairment at the time of exposure.

Record the specific GBCA and the dose administered to a patient. For patients at highest risk for NSF, do not exceed the recommended Gadobutrol Injection dose and allow a sufficient period of time for elimination of the drug prior to re-administration. For patients receiving hemodialysis, consider the prompt initiation of hemodialysis following the administration of a GBCA in order to enhance the contrast agent's elimination [see Use in Specific Populations (8.6) and Clinical Pharmacology (12.3) ] .

The usefulness of hemodialysis in the prevention of NSF is unknown.

5.3Hypersensitivity Reactions Anaphylactic and other hypersensitivity reactions with cardiovascular, respiratory or cutaneous manifestations, ranging from mild to severe, have occurred following Gadobutrol Injection administration [see Adverse Reactions (6.1 , 6.2 )] . There have been reports of life-threatening and fatal outcomes from these adverse reactions. Most hypersensitivity reactions to Gadobutrol Injection have occurred within half an hour after administration.

Delayed reactions can occur up to several days after administration. Before Gadobutrol Injection administration, assess all patients for any history of a reaction to contrast media, bronchial asthma and/or allergic disorders. These patients… [Excerpted — this section continues on DailyMed.]

🤒 Adverse Reactions ~2 min read ▾

6 ADVERSE REACTIONS The following clinically significant adverse reactions are discussed elsewhere in labeling: Nephrogenic Systemic Fibrosis [see Warnings and Precautions (5.2) ] Hypersensitivity Reactions [see Contraindications (4) and Warnings and Precautions (5.3) ] Acute Respiratory Distress Syndrome [see Warnings and Precautions (5.4) ] Most common adverse reactions (incidence ≥ 0.5%) are headache, nausea, and dizziness. ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Zydus Pharmaceuticals (USA) Inc. at 1-877-993-8779 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 clinical practice. The safety of Gadobutrol Injection was evaluated in 7,713 subjects (including 184 pediatric population, ages 0 to 17 years) who received Gadobutrol Injection in clinical trials. Approximately 52% of the subjects were male and the racial and ethnic distribution was 62% White, 28% Asian, 5% Hispanic or Latino, 2.5% Black or African American, and 2.5% other ethnic groups.

The average age was 56 years (range from 1 week to 93 years). Table 2 lists adverse reactions that occurred in ≥ 0.1% subjects who received Gadobutrol Injection. Table 2: Adverse Reactions Reported in ≥0.1% Subjects who Received Gadobutrol Injection in Clinical Trials Adverse Reaction Gadobutrol Injection n=7,713 Rate (%) Headache

1.7 Nausea

1.2 Dizziness

0.5 Dysgeusia

0.4 Feeling Hot

0.4 Injection site reactions

0.4 Vomiting

0.4 Rash (includes generalized, macular, papular, pruritic)

0.3 Erythema

0.2 Paresthesia

0.2 Pruritus (includes generalized)

0.2 Dyspnea

0.1 Urticaria

0.1Adverse reactions that occurred with a frequency of < 0.1% in subjects who received Gadobutrol Injection include: hypersensitivity/anaphylactic reaction, loss of consciousness, convulsion, parosmia, tachycardia, palpitation, dry mouth, malaise and feeling cold. Adverse Reactions in Pediatric Patients The frequency, type, and severity of adverse reactions observed in pediatric patients from the clinical studies were similar to adverse reactions in adults [see Use in Specific Populations (8.4) ] .

6.2Postmarketing Experience The following additional adverse reactions have been identified during postmarketing use of Gadobutrol Injection or other GBCAs. Because these reactions are reported voluntarily from a population of uncertain size, it is not possible to reliably estimate their frequency or establish a causal relationship to drug exposure. Cardiac Disorders: Cardiac arrest Gastrointestinal Disorders: Acute pancreatitis with onset within 48 hours after GBCA administration General Disorders and Administration Site Conditions: Fatigue, asthenia, pain syndromes, and heterogeneous clusters of symptoms in the neurological, cutaneous, and musculoskeletal systems with variable onset and duration after GBCA administration [see Warnings and Precautions (5.5) ] Immune System Disorders: Hypersensitivity reactions (anaphylactic shock, circulatory collapse, respiratory arrest, bronchospasm, cyanosis, oropharyngeal swelling, laryngeal edema, blood pressure increased, chest pain, angioedema, conjunctivitis, hyperhidrosis, cough, sneezing, burning sensation, and pallor).

Renal Disorders: Nephrogenic systemic fibrosis Respiratory, Thoracic, and Mediastinal Disorders: Acute respiratory distress syndrome, pulmonary edema Skin Disorders: Gadolinium associated plaques

👥 Use in Specific Populations ~3 min read ▾

8 USE IN SPECIFIC POPULATIONS Pregnancy: Use only if imaging is essential during pregnancy and cannot be delayed. ( 8.1 )

8.1Pregnancy Risk Summary GBCAs cross the placenta and result in fetal exposure. In human placental imaging studies, contrast was visualized in the placenta and fetal tissues after maternal GBCA administration. Based on animal studies, use of GBCAs during pregnancy may result in fetal gadolinium retention.

Published epidemiological studies on the association between GBCAs and adverse fetal outcomes have reported inconsistent findings and have important methodological limitations (see Data) . In animal reproduction studies, although teratogenicity was not observed, embryolethality was observed in monkeys, rabbits and rats receiving intravenous gadobutrol during organogenesis at doses 8 times and above the recommended human dose. Retardation of embryonal development was observed in rabbits and rats receiving intravenous gadobutrol during organogenesis at doses 8 and 12 times, respectively, the recommended human dose (see Data) .

Because of the potential risks of gadolinium to the fetus, use Gadobutrol Injection only if imaging is essential during pregnancy and cannot be delayed. The background risk of major birth defects and miscarriage for the indicated population is unknown. All pregnancies have a background risk of birth defect, 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 is 15% to 20%, respectively. Data Human Data Available data regarding exposure to GBCAs during pregnancy from published epidemiological studies are not sufficient to assess the risk of adverse fetal and neonatal effects that may be associated with GBCAs. A retrospective cohort study of over 1.4 million pregnancies in Ontario, Canada, comparing pregnant women who had a GBCA MRI to pregnant women who did not have an MRI, reported a higher occurrence of stillbirths and neonatal deaths in the group receiving GBCA MRI.

Limitations of this study include a lack of comparison with non- contrast MRI and lack of information about the maternal indication for MRI. Another retrospective cohort study of over 11 million pregnancies in the Medicaid database found no increased risk of fetal or neonatal death or Neonatal Intensive Care Unit admission when comparing pregnancies exposed to GBCA MRI versus non-contrast MRI. These two retrospective observational studies assessed a limited number of potential pregnancy outcomes and did not evaluate the full spectrum of potential fetal risk.

Animal Data Gadolinium Retention GBCAs administered to pregnant non-human primates (0.1 mmol/kg on gestational days 85 and 135) result in measurable gadolinium concentration in the offspring in bone, brain, skin, liver, kidney, and spleen for at least 7 months. GBCAs administered to pregnant mice (2 mmol/kg daily on gestational days 16 through 19) result in measurable gadolinium concentrations in the pups in bone, brain, kidney, liver, blood, muscle, and spleen at one month postnatal age. Reproductive Toxicology Embryolethality was observed when gadobutrol was administered intravenously to monkeys during organogenesis at doses 8 times the recommended single human dose (based on body surface area); gadobutrol was not maternally toxic or teratogenic at this dose.

Embryolethality and retardation of embryonal development also occurred in pregnant rats receiving maternally toxic doses of gadobutrol (≥ 7.5 mmol/kg body weight; equivalent to 12 times the human dose based on body surface area) and in pregnant rabbits (≥ 2.5 mmol/kg body weight; equivalent to 8 times the recommended human dose based on body surface area). In rabbits, this finding occurred without evidence of pronounced maternal toxicity and with minimal placental transfer (0.01% of the administered dose detected in the fetuses).

Because pregnant animals received repeated dail… [Excerpted — this section continues on DailyMed.]

🤰 Pregnancy ~3 min read ▾

8.1Pregnancy Risk Summary GBCAs cross the placenta and result in fetal exposure. In human placental imaging studies, contrast was visualized in the placenta and fetal tissues after maternal GBCA administration. Based on animal studies, use of GBCAs during pregnancy may result in fetal gadolinium retention.

Published epidemiological studies on the association between GBCAs and adverse fetal outcomes have reported inconsistent findings and have important methodological limitations (see Data) . In animal reproduction studies, although teratogenicity was not observed, embryolethality was observed in monkeys, rabbits and rats receiving intravenous gadobutrol during organogenesis at doses 8 times and above the recommended human dose. Retardation of embryonal development was observed in rabbits and rats receiving intravenous gadobutrol during organogenesis at doses 8 and 12 times, respectively, the recommended human dose (see Data) .

Because of the potential risks of gadolinium to the fetus, use Gadobutrol Injection only if imaging is essential during pregnancy and cannot be delayed. The background risk of major birth defects and miscarriage for the indicated population is unknown. All pregnancies have a background risk of birth defect, 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 is 15% to 20%, respectively. Data Human Data Available data regarding exposure to GBCAs during pregnancy from published epidemiological studies are not sufficient to assess the risk of adverse fetal and neonatal effects that may be associated with GBCAs. A retrospective cohort study of over 1.4 million pregnancies in Ontario, Canada, comparing pregnant women who had a GBCA MRI to pregnant women who did not have an MRI, reported a higher occurrence of stillbirths and neonatal deaths in the group receiving GBCA MRI.

Limitations of this study include a lack of comparison with non- contrast MRI and lack of information about the maternal indication for MRI. Another retrospective cohort study of over 11 million pregnancies in the Medicaid database found no increased risk of fetal or neonatal death or Neonatal Intensive Care Unit admission when comparing pregnancies exposed to GBCA MRI versus non-contrast MRI. These two retrospective observational studies assessed a limited number of potential pregnancy outcomes and did not evaluate the full spectrum of potential fetal risk.

Animal Data Gadolinium Retention GBCAs administered to pregnant non-human primates (0.1 mmol/kg on gestational days 85 and 135) result in measurable gadolinium concentration in the offspring in bone, brain, skin, liver, kidney, and spleen for at least 7 months. GBCAs administered to pregnant mice (2 mmol/kg daily on gestational days 16 through 19) result in measurable gadolinium concentrations in the pups in bone, brain, kidney, liver, blood, muscle, and spleen at one month postnatal age. Reproductive Toxicology Embryolethality was observed when gadobutrol was administered intravenously to monkeys during organogenesis at doses 8 times the recommended single human dose (based on body surface area); gadobutrol was not maternally toxic or teratogenic at this dose.

Embryolethality and retardation of embryonal development also occurred in pregnant rats receiving maternally toxic doses of gadobutrol (≥ 7.5 mmol/kg body weight; equivalent to 12 times the human dose based on body surface area) and in pregnant rabbits (≥ 2.5 mmol/kg body weight; equivalent to 8 times the recommended human dose based on body surface area). In rabbits, this finding occurred without evidence of pronounced maternal toxicity and with minimal placental transfer (0.01% of the administered dose detected in the fetuses).

Because pregnant animals received repeated daily doses of Gadobutrol Injection, their overall exposure was significantly higher than that achieved with the standard sing… [Excerpted — this section continues on DailyMed.]

🧒 Pediatric Use 209 words ▾

8.4Pediatric Use The safety and effectiveness of Gadobutrol Injection have been established in pediatric patients, including term neonates, for use with MRI to detect and visualize areas with disrupted blood brain barrier and/or abnormal vascularity of the CNS and for use in MRA to evaluate known or suspected supra-aortic or renal artery disease. Use of Gadobutrol Injection for these indications is supported by adequate and well-controlled studies in adults and by additional imaging, pharmacokinetic, and safety data from two studies (i.e., Trials 1 and 2) in a total of 182 pediatric patients aged less than 18 years, including term neonates, with CNS and non-CNS lesions.

Trial 1 included 138 patients aged 2 to less than 18 years and Trial 2 included 44 patients aged less than 2 years [see Adverse Reactions (6.1) , Clinical Pharmacology (12.3) , and Clinical Studies (14.1 , 14.3 )] . The safety and effectiveness of Gadobutrol Injection have not been established in preterm neonates for any indication or in pediatric patients of any age for use with MRI to assess the presence and extent of malignant breast disease, or for use in CMRI to assess myocardial perfusion (stress, rest) and late gadolinium enhancement in patients with known or suspected coronary artery disease (CAD).

🧓 Geriatric Use 118 words ▾

8.5Geriatric Use In clinical studies of Gadobutrol Injection, 1,377 patients were 65 years of age and over, while 104 patients were 80 years of age and over. No overall differences in safety or effectiveness were observed between these subjects and younger subjects, and other reported clinical experience has not identified differences between the elderly and younger patients. This drug is known to be excreted by the kidney, and the risk of adverse reactions to this drug may be greater in patients with impaired renal function.

Because elderly patients are more likely to have decreased renal function, it may be useful to monitor renal function [see Warnings and Precautions (5.2) and Use in Specific Populations (8.6) ] .

🆘 Overdosage 42 words ▾

10 OVERDOSAGE In the event of an overdose with Gadobutrol Injection, the substance can be removed by hemodialysis [see Clinical Pharmacology (12.3) ] . For additional overdose management recommendations, consider contacting the Poison Help line at 1-800-222-1222 or consulting a medical toxicologist.

🧬 Clinical Pharmacology ~3 min read ▾

12 CLINICAL PHARMACOLOGY

12.1Mechanism of Action Gadobutrol is a paramagnetic molecule (macrocyclic non-ionic complex of gadolinium) that develops a magnetic moment when placed in a magnetic field. The magnetic moment alters the relaxation rates of water protons in its vicinity in the body, leading to an increase in signal intensity (brightness) of tissues.

12.2Pharmacodynamics In MRI, visualization of normal and pathological tissue depends in part on variations in the radiofrequency signal intensity that occurs with: Differences in proton density Differences of the spin-lattice or longitudinal relaxation times (T 1 ) Differences in the spin-spin or transverse relaxation time (T 2 ) When placed in a magnetic field, gadobutrol shortens the T 1 and T 2 relaxation times in targeted tissues. The extent to which a contrast agent can affect the relaxation rate of tissue water (1/T 1 or 1/T 2 ) is termed relaxivity (r 1 or r 2 ).

The relaxivity of GBCAs is presented in Table 4. Table 4: Relaxivity (r 1 ) of GBCAs in Human Plasma at

1.5 T and 37 °C Gadolinium-Chelate r 1 (L·mmol -1 ·s -1 ) Gadobenate

6.3 Gadobutrol

5.2 Gadodiamide

4.3 Gadopiclenol

12.8 Gadoterate

3.6 Gadoteridol

4.1 Gadoxetate

6.9Compared to 0.5 molar gadolinium-based contrast agents, the higher concentration of Gadobutrol Injection results in half the volume of administration and a more compact contrast bolus injection. At the site of imaging, the relative height and width of the time intensity curve for Gadobutrol Injection varies as a function of imaging location and multiple patient, injection, and device-specific factors.

12.3Pharmacokinetics After intravenous administration of 0.1 mmol/kg Gadobutrol Injection, average plasma levels of gadobutrol are 0.59 mmol/L at 2 minutes after injection and 0.3 mmol/L at 60 minutes after injection, with an AUC of 1,072 μmol∙h/L. Values for further PK parameters are given in Table 5 below. Distribution After intravenous administration, gadobutrol is distributed in the extracellular space.

Gadobutrol does not display any particular protein binding. Following GBCA administration, gadolinium is present for months or years in brain, bone, skin, and other organs [see Warnings and Precautions (5.5) ] . Elimination The average elimination half-life (t 1/2 ) of gadobutrol is 1.8 hours.

Metabolism Gadobutrol is not metabolized. Excretion Gadobutrol is excreted in an unchanged form through the kidneys by glomerular filtration. In healthy subjects, renal clearance of gadobutrol is 1.1 to 1.7 mL/(min∙kg) and thus comparable to the renal clearance of inulin.

Within 2 hours after intravenous administration more than 50% and within 12 hours more than 90% of the given dose is eliminated via the urine. Extra-renal elimination is negligible. Specific Populations Geriatric Patients A single intravenous dose of 0.1 mmol/kg Gadobutrol Injection was administered to 15 elderly and 16 non-elderly subjects.

AUC was slightly higher (43%) and clearance slightly lower (31%) in elderly subjects as compared to non-elderly subjects [see Use in Specific Populations (8.5) ] . Pediatric Patients The pharmacokinetics of gadobutrol were evaluated in a total of 173 pediatric patients aged less than 18 years (including term neonates) who received a single intravenous dose of 0.1 mmol/kg of Gadobutrol Injection. Table 5 shows the pharmacokinetic parameters of gadobutrol by age group.

The pharmacokinetic profile of gadobutrol in pediatric patients is similar to that in adults, resulting in similar values for AUC, body weight normalized plasma clearance, as well as elimination half-life. Approximately 99% (median value) of the dose was recovered in urine within 6 hours (this information was derived from the 2 to less than 18 year-old age group). Table 5: Pharmacokinetics by Age Group (Median [Range]) 0 to < 2 years N=43 2 to 6 years N=45 7 to 11 years N=39 12 to < 18 years N=46 Adults N=93 AUC (µmol∙h/L) 781 [513, 1891] 846 [412, 1331] 1025 [623, 2285] 1237 [946,… [Excerpted — this section continues on DailyMed.]

🧬 Mechanism of Action 51 words ▾

12.1Mechanism of Action Gadobutrol is a paramagnetic molecule (macrocyclic non-ionic complex of gadolinium) that develops a magnetic moment when placed in a magnetic field. The magnetic moment alters the relaxation rates of water protons in its vicinity in the body, leading to an increase in signal intensity (brightness) of tissues.

📦 How Supplied / Storage and Handling 131 words ▾

16 HOW SUPPLIED/STORAGE AND HANDLING How Supplied Gadobutrol Injection is supplied at a concentration of 1 mmol/mL of gadobutrol as a clear and colorless to pale yellow solution available in the following strengths: NDC 70710-2064-6: 7.5 mmol/7.5 mL (1 mmol/mL) single-dose vials (70710-2064-1) rubber stoppered in cartons of 10. NDC 70710-2065-6: 10 mmol/10 mL (1 mmol/mL) single-dose vials (70710-2065-1) rubber stoppered in cartons of 10. NDC 70710-2066-6: 15 mmol/15 mL (1 mmol/mL) single-dose vials (70710-2066-1) rubber stoppered in cartons of 10.

Storage and Handling Store at 25°C (77°F); excursions permitted to 15°C to 30°C (59°F to 86°F) [see USP Controlled Room Temperature]. If solidification occurs due to cold exposure, bring Gadobutrol Injection to room temperature before use and inspect to ensure that the solution is clear and colorless to pale yellow.

📋 Description 190 words ▾

11 DESCRIPTION Gadobutrol Injection is a paramagnetic macrocyclic gadolinium-based contrast agent for intravenous use. The chemical name for gadobutrol is 10–[(1SR,2RS)–2,3–dihydroxy–1–hydroxymethylpropyl]–1,4,7,10–tetraazacyclododecane–1,4,7–triacetic acid, gadolinium complex. Gadobutrol is a water-soluble, hydrophilic compound with a partition coefficient between n-butanol and buffer at pH 7.6 of 0.006,and has a molecular formula of C 18 H 31 GdN 4 O 9 and a molecular weight of 604.72.The structural formula of gadobutrol is: Gadobutrol Injection is a sterile, clear, colorless to pale yellow solution.

Each mL contains 604.72 mg (1 mmol) of gadobutrol (containing 1 mmol of gadolinium) and the following inactive ingredients: 0.513 mg of calcobutrol sodium, 1.211 mg of trometamol, hydrochloric acid (for pH adjustment), and water for injection. Gadobutrol Injection contains no preservatives. The main physicochemical properties of Gadobutrol Injection are listed in Table 3.

Table 3: Physicochemical Properties of Gadobutrol Injection Parameter Value Density (g/mL at 37°C)

1.3Osmolarity at 37°C (mOsm/L solution) 1117 Osmolality at 37°C (mOsm/kg H 2 O) 1603 Viscosity at 37°C (mPa·s) 4.96 pH 6.6 to 8 The thermodynamic stability constants for gadobutrol (log Ktherm and log Kcond at pH 7.4) are 21.8 and 15.3, respectively. Structural Formula

💬 Information for Patients ~1 min read ▾

17 PATIENT COUNSELING INFORMATION Advise the patient to read the FDA-approved patient labeling (Medication Guide). Nephrogenic Systemic Fibrosis Inform the patient that Gadobutrol Injection may increase the risk of NSF among patients with impaired elimination of the drug and that NSF may result in fatal or debilitating fibrosis affecting the skin, muscle, and internal organs. Instruct the patients to contact their physician if they develop signs or symptoms of NSF following Gadobutrol Injection administration, such as burning, itching, swelling, scaling, hardening and tightening of the skin; red or dark patches on the skin; stiffness in joints with trouble moving, bending or straightening the arms, hands, legs or feet; pain in the hip bones or ribs; or muscle weakness. [see Warnings and Precautions (5.2) ] .

Acute Respiratory Distress Syndrome Advise patients that acute respiratory distress syndrome (ARDS) has occurred with Gadobutrol Injection. Inform patients on the symptoms of the observed ARDS cases, and instruct patients to inform their healthcare provider if they experience these symptoms [see Warnings and Precautions (5.4) ] . Gadolinium Retention Advise patients that gadolinium is retained for months or years in brain, bone, skin, and other organs following Gadobutrol Injection administration even in patients with normal renal function.

The clinical consequences of retention are unknown. Retention depends on multiple factors and is greater following administration of linear GBCAs than following administration of macrocyclic GBCAs. [see Warnings and Precautions (5.5) ] . Pregnancy Advise pregnant women of the potential risk of fetal exposure to Gadobutrol Injection [see Use in Specific Populations (8.1) ] .

Manufactured by: Viwit Pharmaceutical Co., Ltd. Zaozhuang, Shandong, China Distributed by: Zydus Pharmaceuticals (USA) Inc. Pennington, NJ 08534 Revised: 05/2026

💬 Medication Guide ~3 min read ▾

This Medication Guide has been approved by the U.S. Food and Drug Administration. Revised: 05/2026 MEDICATION GUIDE Gadobutrol (GAD oh BUE trol) Injection Injection for intravenous use What is the most important information I should know about Gadobutrol Injection?

GBCAs like Gadobutrol Injection may cause serious side effects including death, coma, encephalopathy, and seizures when it is given intrathecally (injection given into the spinal canal). It is not known if Gadobutrol Injection is safe and effective with intrathecal use. Gadobutrol Injection is not approved for this use.

Gadobutrol Injection contains a metal called gadolinium. Small amounts of gadolinium can stay in your body including the brain, bones, skin and other parts of your body for a long time (several months to years). It is not known how gadolinium may affect you, but so far, studies have not found harmful effects in patients with normal kidneys.

Rarely, patients have reported pains, tiredness, and skin, muscle or bone ailments for a long time, but these symptoms have not been directly linked to gadolinium. There are different GBCAs that can be used for your MRI exam. The amount of gadolinium that stays in the body is different for different gadolinium medicines.

Gadolinium stays in the body more after gadodiamide than after gadoxetate disodium or gadobenate dimeglumine. Gadolinium stays in the body the least after gadoterate meglumine, gadobutrol, gadoteridol, and gadopiclenol. People who get many doses of gadolinium medicines, women who are pregnant and young children may be at increased risk from gadolinium staying in the body.

Some people with kidney problems who get gadolinium medicines can develop a condition with severe thickening of the skin, muscles and other organs in the body (nephrogenic systemic fibrosis). Your healthcare provider should screen you to see how well your kidneys are working before you receive Gadobutrol Injection. What is Gadobutrol Injection?

Gadobutrol Injection is a prescription medicine called a gadolinium-based contrast agent (GBCA). Gadobutrol Injection, like other GBCAs, is injected into your vein and used with a magnetic resonance imaging (MRI) scanner. An MRI exam with a GBCA, including Gadobutrol Injection, helps your doctor to see problems better than an MRI exam without a GBCA.

Your doctor has reviewed your medical records and has determined that you would benefit from using a GBCA with your MRI exam. Do not receive Gadobutrol Injection if you have had a severe allergic reaction to Gadobutrol Injection. Before receiving Gadobutrol Injection, tell your healthcare provider about all your medical conditions, including if you: have had any MRI procedures in the past where you received a GBCA.

Your healthcare provider may ask you for more information including the dates of these MRI procedures. are pregnant or plan to become pregnant. It is not known if Gadobutrol Injection can harm your unborn baby. Talk to your healthcare provider about the possible risks to an unborn baby if a GBCA such as Gadobutrol Injection is received during pregnancy. have kidney problems, diabetes, or high blood pressure. have had an allergic reaction to dyes (contrast agents) including GBCAs.

What are the possible side effects of Gadobutrol Injection? See " What is the most important information I should know about Gadobutrol Injection? " Allergic reactions. Gadobutrol Injection can cause allergic reactions that can sometimes be serious.

Your healthcare provider will monitor you closely for symptoms of an allergic reaction. A serious lung problem called acute respiratory distress syndrome (ARDS). Call your healthcare provider right away if you have shortness of breath with or without a fever, trouble breathing, or a fast rate of breathing after receiving Gadobutrol Injection.

The most common side effects of Gadobutrol Injection include: headache, nausea, and dizziness. These are not all the possible side effects of Gadobutrol Injection. Call you… [Excerpted — this section continues on DailyMed.]

🧬 Pharmacokinetics ~3 min read ▾

12.3Pharmacokinetics After intravenous administration of 0.1 mmol/kg Gadobutrol Injection, average plasma levels of gadobutrol are 0.59 mmol/L at 2 minutes after injection and 0.3 mmol/L at 60 minutes after injection, with an AUC of 1,072 μmol∙h/L. Values for further PK parameters are given in Table 5 below. Distribution After intravenous administration, gadobutrol is distributed in the extracellular space.

Gadobutrol does not display any particular protein binding. Following GBCA administration, gadolinium is present for months or years in brain, bone, skin, and other organs [see Warnings and Precautions (5.5) ] . Elimination The average elimination half-life (t 1/2 ) of gadobutrol is 1.8 hours.

Metabolism Gadobutrol is not metabolized. Excretion Gadobutrol is excreted in an unchanged form through the kidneys by glomerular filtration. In healthy subjects, renal clearance of gadobutrol is 1.1 to 1.7 mL/(min∙kg) and thus comparable to the renal clearance of inulin.

Within 2 hours after intravenous administration more than 50% and within 12 hours more than 90% of the given dose is eliminated via the urine. Extra-renal elimination is negligible. Specific Populations Geriatric Patients A single intravenous dose of 0.1 mmol/kg Gadobutrol Injection was administered to 15 elderly and 16 non-elderly subjects.

AUC was slightly higher (43%) and clearance slightly lower (31%) in elderly subjects as compared to non-elderly subjects [see Use in Specific Populations (8.5) ] . Pediatric Patients The pharmacokinetics of gadobutrol were evaluated in a total of 173 pediatric patients aged less than 18 years (including term neonates) who received a single intravenous dose of 0.1 mmol/kg of Gadobutrol Injection. Table 5 shows the pharmacokinetic parameters of gadobutrol by age group.

The pharmacokinetic profile of gadobutrol in pediatric patients is similar to that in adults, resulting in similar values for AUC, body weight normalized plasma clearance, as well as elimination half-life. Approximately 99% (median value) of the dose was recovered in urine within 6 hours (this information was derived from the 2 to less than 18 year-old age group). Table 5: Pharmacokinetics by Age Group (Median [Range]) 0 to < 2 years N=43 2 to 6 years N=45 7 to 11 years N=39 12 to < 18 years N=46 Adults N=93 AUC (µmol∙h/L) 781 [513, 1891] 846 [412, 1331] 1025 [623, 2285] 1237 [946, 2211] 1072 [667, 1992] CL (L/h/kg) 0.128 [0.053, 0.195] 0.119 [0.080, 0.215] 0.099 [0.043, 0.165] 0.081 [0.046, 0.103] 0.094 [0.051, 0.150] t1/2 (h) 2.91 [1.60, 12.4] 1.91 [1.04, 2.70] 1.66 [0.91, 2.71] 1.68 [1.31, 2.48] 1.80 [1.20, 6.55] C20 (µmol/L) 367 [280, 427] 421 [369, 673] 462 [392, 760] 511 [387, 1077] 441 [281, 829] Male and Female Patients Gender has no clinically relevant effect on the pharmacokinetics of gadobutrol.

Patients with Renal Impairment In patients with renal impairment, the serum half-life of gadobutrol is prolonged and correlated with the reduction in creatinine clearance. After intravenous injection of Gadobutrol Injection 0.1 mmol/kg, the elimination half-life was 5.8 ± 2.4 hours in patients with mild to moderate renal impairment (80 > CL CR > 30 mL/min) and 17.6 ± 6.2 hours in patients with severe renal impairment not on dialysis (CL CR < 30 mL/min). The average AUC of gadobutrol in patients with normal renal function was 1.1 ± 0.1 mmol∙h/L, compared to 4.0 ± 1.8 mmol∙h/L in patients with mild to moderate renal impairment and 11.5 ± 4.3 mmol∙h/L in patients with severe renal impairment.

Complete recovery in the urine was seen in patients with mild or moderate renal impairment within 72 hours. In patients with severely impaired renal function about 80% of the administered dose was recovered in the urine within 5 days. For patients receiving hemodialysis, 68% of gadobutrol is removed from the body after the first dialysis, 94% after the second dialysis, and 98% after the third dialysis session. [see Warnings and Precautions (5.2) and Use in Specific Populations (… [Excerpted — this section continues on DailyMed.]

🧬 Pharmacodynamics 205 words ▾

12.2Pharmacodynamics In MRI, visualization of normal and pathological tissue depends in part on variations in the radiofrequency signal intensity that occurs with: Differences in proton density Differences of the spin-lattice or longitudinal relaxation times (T 1 ) Differences in the spin-spin or transverse relaxation time (T 2 ) When placed in a magnetic field, gadobutrol shortens the T 1 and T 2 relaxation times in targeted tissues. The extent to which a contrast agent can affect the relaxation rate of tissue water (1/T 1 or 1/T 2 ) is termed relaxivity (r 1 or r 2 ).

The relaxivity of GBCAs is presented in Table 4. Table 4: Relaxivity (r 1 ) of GBCAs in Human Plasma at

1.5 T and 37 °C Gadolinium-Chelate r 1 (L·mmol -1 ·s -1 ) Gadobenate

6.3 Gadobutrol

5.2 Gadodiamide

4.3 Gadopiclenol

12.8 Gadoterate

3.6 Gadoteridol

4.1 Gadoxetate

6.9Compared to 0.5 molar gadolinium-based contrast agents, the higher concentration of Gadobutrol Injection results in half the volume of administration and a more compact contrast bolus injection. At the site of imaging, the relative height and width of the time intensity curve for Gadobutrol Injection varies as a function of imaging location and multiple patient, injection, and device-specific factors.

🔬 Clinical Studies ~3 min read ▾

14 CLINICAL STUDIES

14.1MRI of the CNS The effectiveness of Gadobutrol Injection for the visualization of lesions was evaluated in two clinical trials (i.e., Studies 1 and 2) in patients who were referred for MRI of the CNS with contrast. In both studies, patients underwent a baseline, pre-contrast MRI prior to administration of Gadobutrol Injection at a dose of 0.1 mmol/kg, followed by a post-contrast MRI. In Study 1, patients also underwent an MRI before and after the administration of gadoteridol.

The studies were designed to demonstrate superiority of Gadobutrol Injection MRI to non-contrast MRI for lesion visualization. For both studies, pre-contrast and pre-plus-post contrast images (paired images) were independently evaluated by three readers for contrast enhancement and border delineation using a scale of 1 to 4, and for internal morphology using a scale of 1 to 3 (Table 6). Lesion counting was also performed to demonstrate non-inferiority of paired Gadobutrol Injection image sets to pre-contrast MRI.

Readers were blinded to clinical information. Table 6: Primary Endpoint Visualization Scoring System Score Visualization Characteristics Contrast Enhancement Border Delineation Internal Morphology 1 None None Poorly visible 2 Weak Moderate Moderately visible 3 Clear Clear but incomplete Sufficiently visible 4 Clear and bright Clear and complete N/A A total of 657 patients were evaluated. The average age was 49 years (range 18 to 85 years) and 42% were male.

The racial and ethnic representations were 39% White, 4% Black or African American, 16% Hispanic or Latino, 38% Asian, and 3% of other ethnic groups. Table 7 shows a comparison of visualization results between paired images and pre-contrast images. Gadobutrol Injection provided a statistically significant improvement for each of the three lesion visualization parameters when averaged across three independent readers for each study.

Table 7: Visualization Endpoint Results of Central Nervous System Adult MRI Studies with 0.1 mmol/kg Gadobutrol Injection 1 Difference of means = (paired mean) (pre-contrast mean) 2 p<0.001 3 Met noninferiority margin of -0.35 4 Did not meet noninferiority margin of -0.35 Endpoint Study 1 N=336 Study 2 N=321 Pre-contrast Paired Difference 1 Pre-contrast Paired Difference Contrast Enhancement 0.97 2.26 1.29 2 0.93 2.86 1.94 2 Border Delineation 1.98 2.58 0.60 2 1.92 2.94 1.02 2 Internal Morphology 1.32 1.93 0.60 2 1.57 2.35 0.78 2 Average # Lesions Detected 8.08 8.25 0.17 4 2.65 2.97 0.32 3 Performances of Gadobutrol Injection and gadoteridol for visualization parameters were similar.

Regarding the number of lesions detected, Study 2 met the prespecified noninferiority margin of -0.35 for paired read versus pre-contrast read while in Study 1, Gadobutrol Injection and gadoteridol did not. For the visualization endpoints contrast enhancement, border delineation, and internal morphology, the percentage of patients scoring higher for paired images compared to pre-contrast images ranged from 93% to 99% for Study 1, and 95% to 97% for Study 2. For both studies, the mean number of lesions detected on paired images exceeded that of the pre-contrast images; 37% for Study 1 and 24% for Study 2.

There were 29% and 11% of patients in which the pre-contrast images detected more lesions for Study 1 and Study 2, respectively. The percentage of patients whose average reader mean score changed by ≤0, up to 1, up to 2, and ≥2 scoring categories presented in Table 6 is shown in Table 8. The categorical improvement of (≤0) represents higher (< 0) or identical (= 0) scores for the pre-contrast read, the categories with scores > 0 represent the magnitude of improvement seen for the paired read.

Table 8: Primary Endpoint Visualization Categorical Improvement for Average Reader Study 1 N=336 Study 2 N=321 Endpoint Categorical Improvement (Paired Pre-Contrast) % Categorical Improvement (Paired Pre-Contrast) % ≤0 > 0 – < 1 1 – < 2 ≥2 ≤0 >0 – < 1 1 – < 2 ≥2 Contrast E… [Excerpted — this section continues on DailyMed.]

🧪 Nonclinical Toxicology 153 words ▾

13 NONCLINICAL TOXICOLOGY

13.1Carcinogenesis, Mutagenesis, Impairment of Fertility Carcinogenesis No carcinogenicity studies of gadobutrol have been conducted. Mutagenesis Gadobutrol was not mutagenic in in vitro reverse mutation tests in bacteria, in the HGPRT (hypoxanthine-guanine phosphoribosyl transferase) test using cultured Chinese hamster V79 cells, or in chromosome aberration tests in human peripheral blood lymphocytes, and was negative in an in vivo micronucleus test in mice after intravenous injection of 0.5 mmol/kg. Impairment of Fertility Gadobutrol had no effect on fertility and general reproductive performance of male and female rats when given in doses 12.2 times the human equivalent dose (based on body surface area).

13.2Animal Toxicology and/or Pharmacology Local intolerance reactions, including moderate irritation associated with infiltration of inflammatory cells was observed after paravenous administration to rabbits, suggesting the possibility of occurrence of local irritation if the contrast medium leaks around veins in a clinical setting [see Warnings and Precautions (5.7) ].

📄 Carcinogenesis, Mutagenesis, Impairment of Fertility 101 words ▾

13.1Carcinogenesis, Mutagenesis, Impairment of Fertility Carcinogenesis No carcinogenicity studies of gadobutrol have been conducted. Mutagenesis Gadobutrol was not mutagenic in in vitro reverse mutation tests in bacteria, in the HGPRT (hypoxanthine-guanine phosphoribosyl transferase) test using cultured Chinese hamster V79 cells, or in chromosome aberration tests in human peripheral blood lymphocytes, and was negative in an in vivo micronucleus test in mice after intravenous injection of 0.5 mmol/kg. Impairment of Fertility Gadobutrol had no effect on fertility and general reproductive performance of male and female rats when given in doses 12.2 times the human equivalent dose (based on body surface area).

📄 Recent Major Changes 14 words ▾

RECENT MAJOR CHANGES Warnings and Precautions, Acute Respiratory Distress Syndrome ( 5.4 ) 3/2025

📄 Package Label / Principal Display Panel 90 words ▾

Dose: 0.1 mL/kg NDC 70710-2064-1 Gadobutrol Injection 7.5 mmol/7.5 mL (1 mmol/mL) For Intravenous Administration Single-Dose Vial. Discard Unused Portion. Sterile Solution Rx only Zydus 7.5 mL Single-dose Vial Label

Dose: 0.1 mL/kg NDC 70710-2065-1 Gadobutrol Injection 10 mmol/10 mL (1 mmol/mL) For Intravenous Administration Single-Dose Vial. Discard Unused Portion. Sterile Solution Rx only Zydus 10 mL Single-dose Vial Label

Dose: 0.1 mL/kg NDC 70710-2066-1 Gadobutrol Injection 15 mmol/15 mL (1 mmol/mL) For Intravenous Administration Single-Dose Vial. Discard Unused Portion. Sterile Solution Rx only Zydus 15 mL Single-dose Vial Label

Source: FDA Structured Product Labeling, mirrored from DailyMed / openFDA. Prefer the government’s original formatting? View this label on DailyMed ↗

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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 form printed on the packaging and shown on DailyMed is the one the FDA registered. Insurance claims use a fixed 11-digit 5-4-2 format, so the short segment is padded with a leading zero and the dashes are dropped. The Identity section at the top of this page lists each form of this code.
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 Zydus Pharmaceuticals USA Inc.. Listing status can change — the directory data on this page refreshes weekly.
Who lists this product with the FDA?
Zydus Pharmaceuticals USA 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.
← 70710-2064-06 · Zydus 70710-2066-06 · Zydus →
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.