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BRIDION sugammadex 100 mg/mL Injection, Solution — NDC 00006-5423-12 package photo
Label image from the product's FDA listing (DailyMed) — may show a different pack size or an older label revision.

BRIDION sugammadex 100 mg/mL Injection, Solution — NDC 0006-5423-12 (Billing 00006-5423-12)

by Merck Sharp & Dohme LLC · 10 VIAL, SINGLE-DOSE in 1 CARTON / 2 mL in 1 VIAL, SINGLE-DOSE

This is a package of BRIDION sugammadex 100 mg/mL Injection, Solution from Merck Sharp & Dohme LLC, marketed since Dec 2015 and currently FDA-listed. It is the main listing for this product, which comes in 2 package sizes.

NDC 00006-5423-12
🏷️ FDA NDC (as labeled) 0006-5423-12 billing pads the labeler segment with a zero
This package
Contains2 mL in 1 vial, single-dose Medicaid pays$32.82 / unit · 12 mo Per package$656.43 / 20 ml · Medicaid Pack sizes2 compare ↓
Main listing for product 0006-5423 · Also comes in: 10 vials 0006-5423-15
Rx only Brand On market Non-controlled ⇄ Compare with another NDC
🗂️ FDA directory synced Oct 8, 2026 · this listing last changed Jul 24, 2026 · sources: openFDA · FDA label (DailyMed) · FDA Orange & Purple Book · First Databank · CMS NADAC, ASP, Medicare & Medicaid · RxNorm
📋 All sources & update times →

This page is curated, coded, and maintained by

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

NDC database record

One package, one record: these facts belong to NDC 0006-5423-12 alone.

Record
FDA NDC Directory package listing · Human prescription drug
Code segments
0006 labeler · 5423 product · 12 package
Package marketed since
Dec 15, 2015
Sample package
No — commercial package
Listing certified through
Dec 31, 2027
Barcode (UPC-A, from the NDC)
3 0006542312 8
Medicaid fills, this package
40,074 prescriptions in the last four reported quarters
FDA record last changed
Jul 24, 2026

Identity & classification

Regulatory identifiers FDA, NLM and CMS codes for this package

FDA NDC (as labeled) 0006-5423-12
Product NDC 0006-5423
11-digit billing NDC 00006542312
NCPDP billing unit ML — per mL (volume)
RxCUI 1726992, 1726997, 1727000, 1727001
UNII ERJ6X2MXV7
Application # NDA022225
SPL Set ID 5171d883-fe8f-482c-97ab-40b00975b64a
Chemical class gamma-Cyclodextrins
DEA schedule Non-controlled
Marketing category NDA
Marketing status On market
FDA listing status Listed (active directory)
Marketing start 2015-12-15
Route INTRAVENOUS
Dosage form INJECTION, SOLUTION
Substance SUGAMMADEX SODIUM
TE code (Orange Book) AP · RLD · RS

Drug-database identifiers Medi-Span GPI and First Databank GCN / HICL / AHFS classification

GPI-14 93000078102020
GPI class Bridion
GCN Seq No 064636
GCN 16001
HICL code 035991
Ingredient (HICL) Sugammadex Sodium
HIC1 code S
Therapeutic class — broad (HIC1) Locomotor System
HIC2 code S7
Therapeutic class — intermediate (HIC2) Affect Primarily Skeletal Muscle
HIC3 code S7D
Therapeutic class — specific (HIC3) Selective Relaxant Binding Agents (Srbas)
AHFS code 91:04.28.00
AHFS class Neuromuscular Blocking Agent Antidote
FDB label name BRIDION 200 MG/2 ML VIAL
FDB brand name Bridion
Legend status F — Federal legend — prescription drug or device
Quick answers
  • GSN (GCN sequence number): 064636
  • GCN: 16001
  • GPI-14 (Medi-Span): 93000078102020
  • HICL (First Databank): 035991
  • AHFS class code: 91:04.28.00
  • RxCUI (RxNorm): 1726992
Why two NDCs? The FDA registers this code as 0006-5423-12 — a 4-4-2 layout, and that's what's printed on the package and shown on DailyMed. For insurance claims, every NDC is standardized to a uniform 11-digit 5-4-2 format by adding a zero to the labeler segment → 00006-5423-12. 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.

RxNorm drug class

This medicine belongs to the Antidotes class.

Drug family (ATC) Antidotes
Where does this data come from?
Therapeutic classes from RxNorm RxClass (U.S. National Library of Medicine) — Established Pharmacologic Class (FDA), ATC drug family (WHO) and mechanism of action, matched by this product’s RxCUI.

Clinical

Label name BRIDION 200 MG/2 ML VIAL Ingredient Sugammadex Sodium
📖 What it is MedlinePlus · NLM

Sugammadex is to reverse the actions of certain neuromuscular (nerve and muscle) blocking medications (drugs used during surgery to assist with mechanical breathing needed to perform the surgery safely). Sugammadex is in a class of medications called neuromuscular blocking agent antidotes. It works by attaching to the neuromuscular blocking medications (i.e., rocuronium or vecuronium) to reduce the amount of active medication available to block the nerves and muscles.

Read the full MedlinePlus article ↗

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 mLPer package
Retail pharmacies payNADAC · weekly Not in the retail survey — common for institutional, discontinued, or low-volume packs.
Medicaid paysCMS SDUD · 12 mo $32.82 $656.43 / 20 ml
Medicare drug plans payPart D · quarterly No Part D plan price is available for this NDC in our data.
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
00006-5423-12 You're viewing this Main listing 10 VIAL, SINGLE-DOSE in 1 CARTON / 2 mL in 1 VIAL, SINGLE-DOSE 2015-12-15 — Active
00006-5423-15 0006-5423-15 10 VIAL, SINGLE-DOSE in 1 CARTON / 5 mL in 1 VIAL, SINGLE-DOSE 2015-12-15 — Active

In Medicaid, this is the most-dispensed pack of this product — about 100% of fills over the last four reported quarters. See all packs ↓

Pack size FAQ

What quantity is in this package?
This package is listed by the FDA — 10 vial, single-dose in 1 carton / 2 ml in 1 vial, single-dose.
What NDC number is used to bill for this package of BRIDION sugammadex 100 mg/mL Injection, Solution?
Use the 11-digit billing form listed in the identifiers section of this page. Pharmacy and medical claims use the 11-digit form; the FDA label may print a shorter form of the same code.

Therapeutic equivalents

ProductLabelerPackNADAC/unitTEStatusPrice vs. this
Bridion 100 mg/mL 71872-7187-01 Medical 1 vial — AP FDA listed —
Bridion 100 mg/mL 84549-0423-12 ProPharma 2 ml — AP FDA listed —
Bridion 100 mg/mLthis 00006-5423-12 Merck 10 vials — AP FDA listed —
Bridion 100 mg/mL 00006-5425-15 Merck 10 vials — AP FDA listed —
Sugammadex 100 mg/mL 31722-0255-10 Camber 10 vials — AP FDA listed —
Sugammadex 100 mg/mL 31722-0254-10 Camber 10 vials — AP FDA listed —
Sugammadex 100 mg/mL 66794-0256-41 Piramal 10 vials — — FDA listed —
Sugammadex 100 mg/mL 66794-0257-41 Piramal 10 vials — — FDA listed —
sugammadex 100 mg/mL 62756-0079-02 Sun 10 vials — AP FDA listed —
sugammadex 100 mg/mL 70069-0893-10 Somerset 10 vials — AP FDA listed —
Sugammadex 100 mg/mL 67457-0970-05 Mylan 10 vials — AP FDA listed —
Sugammadex 100 mg/mL 00641-6270-10 Hikma 10 syringes — AP FDA listed —
Sugammadex 100 mg/mL 70748-0370-02 Lupin 10 vials — AP FDA listed —
Sugammadex 100 mg/mL 70748-0371-02 Lupin 10 vials — AP FDA listed —
Sugammadex 100 mg/mL 67457-0969-02 Mylan 10 vials — AP FDA listed —
sugammadex 100 mg/mL 70069-0892-10 Somerset 10 vials — AP FDA listed —
sugammadex 100 mg/mL 76045-0219-20 Fresenius 24 syringes — AP FDA listed —
sugammadex 100 mg/mL 71872-7382-01 Medical 1 vial — AP FDA listed —
sugammadex 100 mg/mL 55579-0893-10 Solupharm 10 vials — AP FDA listed —
About this product: this is the brand-name version. Some generic versions are approved by the FDA, but we could not confirm current pharmacy availability from our pricing/market data.
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

🏛️
2015
First FDA approval
Dec 2015
📍
2026
Currently FDA-listed
11 years listed
🛡️
2028
Latest patent/protection listed
not a guaranteed launch date
🔒Generic approved by FDA, but pharmacy availability is not confirmed

The FDA lists approved generic versions of this medicine, but that does not always mean a pharmacy can get one today. Patent rules, launch agreements, supply and pricing can affect when generics actually arrive.

🛡️ Latest patent/protection date listed: FDA patent/protection data lists protections through Jun 2028. This may affect when a full generic version becomes widely available, but it is not a guaranteed launch date.
📅 FDA approved Dec 15, 2015 AP TE-rated RLD RS ⏳ ~1.7 yr to latest listed protection

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

Patents & exclusivity — FDA Orange Book
US RE44733 — drug substance (U-1794)
US RE44733 — drug substance (U-1794)
US RE44733*PED — drug product
US RE44733*PED — drug product
Exclusivity NPP
Exclusivity NPP
Exclusivity PED
Exclusivity PED
2015 2017 2019 2021 2023 2025 2027
Today
LOE
Substance patent Formulation patent Method-of-use patent Exclusivity Pediatric +6mo
🏛️FDA exclusivity
FDA-granted marketing protection. It’s separate from patents and may be shorter than patent protection.
🧪Product / substance patents
Patents covering the active ingredient, product, formulation, or related drug features.
🎯Method-of-use patents
Patents covering specific approved uses. These can sometimes be carved out with a “skinny label,” but not always.
🛈 What do these terms mean?
Patent
Legal protection listed in the Orange Book that may delay generic approval or launch. Issued by the U.S. Patent & Trademark Office.
Substance patent
Covers the active drug molecule itself — the hardest to design around. A generic generally can’t launch until it expires.
Formulation (product) patent
Covers a specific formulation or dosage form. A generic can sometimes work around it with a different formulation.
Method-of-use patent
A patent covering one specific approved use of the drug — not necessarily the whole molecule. A generic can sometimes launch with a “skinny label” that carves out the protected use and keeps the others.
Skinny label
A generic label that omits a still-patented use when the FDA allows it — letting a generic reach the market for the unprotected uses.
Exclusivity
FDA-granted marketing protection, separate from patents — e.g. 5-yr new chemical entity, 7-yr orphan drug, or a +6-month pediatric extension.
Paragraph IV
A generic applicant’s formal challenge to a listed patent. It can potentially lead to earlier generic entry, but often involves litigation or a settlement.
RLD / RS
Reference Listed Drug — the brand product the FDA uses as the reference for generic applications. Reference Standard — the product the FDA expects generics to compare against in bioequivalence testing.
TE / AB rating
FDA therapeutic-equivalence rating. An AB rating generally means the FDA considers a generic therapeutically equivalent to — and substitutable for — the brand.
LOE (loss of exclusivity)
The latest patent or exclusivity currently listed — the loss-of-exclusivity / latest-listed-protection date shown on this page. Paragraph-IV challenges and settlements can move the real date earlier; FDA approval and a manufacturer’s decision to market can move it later.

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

Listed patents (4)
PatentTypeUse codeExpires
US RE44733 ↗ Drug substance U-1794 Jan 27, 2026
US RE44733 ↗ Drug substance U-1794 Jan 27, 2026
US RE44733*PED ↗ Drug product — Jul 27, 2026
US RE44733*PED ↗ Drug product — Jul 27, 2026
FDA exclusivity
CodeWhat it grantsExpires
NPPNew Patient PopulationDec 12, 2027
NPPNew Patient PopulationDec 12, 2027
PEDPediatric Exclusivity (+6 months)Jun 12, 2028
PEDPediatric Exclusivity (+6 months)Jun 12, 2028
Common questions
Is there a generic version of BRIDION 200 MG/2 ML VIAL?
Yes — an FDA-approved generic equivalent is listed in the FDA Orange Book for BRIDION 200 MG/2 ML VIAL. See the alternatives section for substitutable, lower-cost products.
The FDA approved a generic — why can’t I get it at my pharmacy yet?
FDA approval and pharmacy availability are two different things. The FDA can approve a generic years before it actually reaches pharmacies, because the brand company may still hold patents or have a settlement that delays the launch. A manufacturer also has to choose to make and sell it, and have supply ready. So a drug can be “FDA-approved generic exists” and still be brand-only at the counter today.
Why do different websites show different generic release dates?
Generic availability is not based on one single date. Some sources use the first exclusivity expiration, some use the last product patent, and others use the latest method-of-use patent. Patent challenges, settlements, licenses, and label carve-outs can also change the real-world launch date. This page shows the underlying Orange Book dates so you can see why estimates may differ.
What does “FDA listed” mean?
It means the product appears in the FDA’s official NDC directory. That’s a good sign a product exists and is intended for the U.S. market, but on its own it does not confirm a pharmacy can fill it today. Where we have recent retail pricing data (NADAC) for a product, we label it “Availability likely” instead.
What does a patent or protection date mean here?
It’s the latest date currently listed in the FDA Orange Book for a patent or exclusivity on the brand product. It can affect when a full generic version becomes widely available — but it is not a guaranteed generic launch date. Generics sometimes arrive earlier (through a settlement or patent challenge) or later (a manufacturer still has to make and sell one).
What does “current Orange Book estimate” mean?
It means we are using the latest patent and exclusivity dates currently listed in the FDA Orange Book. It is not a guaranteed launch date.
Can a generic come out before the last patent expires?
Sometimes. A generic company may challenge a patent, settle with the brand manufacturer, receive a license, or obtain approval with a narrower label that avoids a patented use. In other cases, the last listed protection may delay full-label generic competition.
Can a generic come out after the listed dates?
Yes. Even after patents or exclusivity expire, a generic still needs FDA approval and a manufacturer must choose to market it. Supply, litigation, business decisions, or regulatory issues can delay actual availability.
What is the difference between patents and exclusivity?
Patents are legal protections usually issued by the U.S. Patent and Trademark Office. FDA exclusivity is marketing protection granted by the FDA. They are separate, and either one can affect generic timing.
Why are there multiple patent dates?
One drug can have several patents covering different things: the active ingredient, a formulation, a manufacturing process, or a specific approved use. That is why a page may show several expiration dates instead of one simple generic date.
Built from FDA Orange Book patent and exclusivity data. Dates are refreshed from public FDA data when available; the marker is max(latest patent expiry, latest exclusivity expiry). Paragraph-IV settlements and first-filer 180-day exclusivity can shift the real date; a method-of-use patent may allow an earlier skinny-label generic for non-protected indications. Generic launch timing is an estimate, not a guarantee.
Where does this data come from?
Patents and exclusivity from the FDA Orange Book (small-molecule drugs), refreshed from public FDA data. Generic launch timing is an estimate, not a guarantee.

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 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 55X04QC32I
    A strong alkaline chemical used to adjust and maintain the pH balance of liquid medicines. It helps keep the medicine stable and ensures it stays effective during storage.
  • 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.

3 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

LabelerMerck Sharp & Dohme LLC
Application holderMERCK SHARP AND DOHME LLC A SUB OF MERCK AND CO INC
FDA applicationNDA022225 (NDA)
Labeler code00006
First marketedDec 2015
Product typeHuman Prescription Drug
Portfolio112 products on file

More NDCs from Merck Sharp & Dohme LLC labeler code 00006

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.
🎯 Indications and Usage ⏱️ Dosage and Administration 💊 Dosage Forms and Strengths ⛔ Contraindications ⚠️ Warnings and Cautions 🤒 Adverse Reactions 🔄 Drug Interactions 👥 Use in Specific Populations 🤰 Pregnancy 🧒 Pediatric Use 🧓 Geriatric Use 🆘 Overdosage 🧬 Clinical Pharmacology 🧬 Mechanism of Action 📦 How Supplied / Storage and Handling 📦 Storage and Handling 📋 Description 💬 Information for Patients 🧬 Pharmacokinetics 🧬 Pharmacodynamics 🔬 Clinical Studies 🧪 Nonclinical Toxicology 📄 Carcinogenesis, Mutagenesis, Impairment of Fertility 📄 Package Label / Principal Display Panel
🎯 Indications and Usage 54 words ▾

1 INDICATIONS AND USAGE BRIDION ® is indicated for the reversal of neuromuscular blockade induced by rocuronium bromide and vecuronium bromide in adult and pediatric patients undergoing surgery. BRIDION is indicated for the reversal of neuromuscular blockade induced by rocuronium bromide and vecuronium bromide in adult and pediatric patients undergoing surgery. ( 1 )

⏱️ Dosage and Administration ~3 min read ▾

2 DOSAGE AND ADMINISTRATION Dosing is based on actual body weight ( 2.1 ) Monitor for twitch responses to determine the timing and dose for BRIDION administration. ( 2.1 ) Administer as a single bolus injection. ( 2.1 ) For rocuronium and vecuronium: 4 mg/kg is recommended if spontaneous recovery of the twitch response has reached 1 to 2 post-tetanic counts (PTC) and there are no twitch responses to train-of-four (TOF) stimulation.

( 2.2 ) 2 mg/kg is recommended if spontaneous recovery has reached the reappearance of the second twitch in response to TOF stimulation. ( 2.2 ) For rocuronium only: 16 mg/kg is recommended if there is a clinical need to reverse neuromuscular blockade soon (approximately 3 minutes) after administration of a single dose of 1.2 mg/kg of rocuronium. Immediate reversal in pediatric patients has not been studied.

( 2.2 )

2.1Important Dosing and Administration Information BRIDION dosing is based on actual body weight. BRIDION (sugammadex) injection, for intravenous use, should be administered by trained healthcare providers familiar with the use, actions, characteristics, and complications of neuromuscular blocking agents (NMBA) and neuromuscular block reversal agents. Doses and timing of BRIDION administration should be based on monitoring for twitch responses and the extent of spontaneous recovery that has occurred.

Administer BRIDION intravenously as a single bolus injection. The bolus injection may be given over 10 seconds, into an existing intravenous line. BRIDION has only been administered as a single bolus injection in clinical trials.

From the time of BRIDION administration until complete recovery of neuromuscular function, monitor the patient to assure adequate ventilation and maintenance of a patent airway. Satisfactory recovery should be determined through assessment of skeletal muscle tone and respiratory measurements in addition to the response to peripheral nerve stimulation. The recommended dose of BRIDION does not depend on the anesthetic regimen.

Preparation of dilution for pediatric use: BRIDION 100 mg/mL may be diluted to a concentration of 10 mg/mL, using 0.9% sodium chloride injection, USP, to increase the accuracy of dosing in the pediatric population. To prepare the required dose, aseptically transfer all the contents of the 2 mL vial of BRIDION 2-mL single-dose vials containing 200 mg sugammadex (100 mg/mL) to a bottle (or intravenous bag) containing 18 mL of 0.9% sodium chloride injection, to achieve a final concentration of 10 mg/mL sugammadex. The diluted solution should be used immediately.

BRIDION injection is a single-dose sterile solution without preservatives. Discard any unused portion from the vial.

2.2Recommended Dosing BRIDION can be used to reverse different levels of rocuronium- or vecuronium-induced neuromuscular blockade. For rocuronium and vecuronium: A dose of 4 mg/kg BRIDION is recommended if spontaneous recovery of the twitch response has reached 1 to 2 post-tetanic counts (PTC) and there are no twitch responses to train-of-four (TOF) stimulation following rocuronium- or vecuronium-induced neuromuscular blockade [see Warnings and Precautions (5.8) ]. A dose of 2 mg/kg BRIDION is recommended if spontaneous recovery has reached the reappearance of the second twitch (T 2 ) in response to TOF stimulation following rocuronium- or vecuronium-induced neuromuscular blockade [see Warnings and Precautions (5.8) ].

For rocuronium only: A dose of 16 mg/kg BRIDION is recommended if there is a clinical need to reverse neuromuscular blockade soon (approximately 3 minutes) after administration of a single dose of 1.2 mg/kg of rocuronium. The efficacy of the 16 mg/kg dose of BRIDION following administration of vecuronium has not been studied. Immediate reversal in pediatric patients has not been studied [see Clinical Studies (14.1) ].

2.3Drug Compatibility May inject BRIDION into the intravenous line of a running infusion with the following intravenous solutions: 0.9% sodium… [Excerpted — this section continues on DailyMed.]

💊 Dosage Forms and Strengths 82 words ▾

3 DOSAGE FORMS AND STRENGTHS BRIDION (sugammadex) injection is a sterile, clear, colorless to slightly yellow-brown, non-pyrogenic aqueous solution intended for intravenous infusion. BRIDION is available as follows: 200 mg/2 mL (100 mg/mL) in a single-dose vial for bolus injection 500 mg/5 mL (100 mg/mL), in a single-dose vial for bolus injection 200 mg/2 mL (100 mg/mL) in a single-dose vial for bolus injection ( 3 ) 500 mg/5 mL (100 mg/mL) in a single-dose vial for bolus injection ( 3 )

⛔ Contraindications 68 words ▾

4 CONTRAINDICATIONS BRIDION is contraindicated in patients with known hypersensitivity to sugammadex or any of its components. Hypersensitivity reactions that occurred varied from isolated skin reactions to serious systemic reactions (i.e., anaphylaxis, anaphylactic shock) and have occurred in patients with no prior exposure to sugammadex [see Warnings and Precautions (5.1) , Adverse Reactions (6) ] . Known hypersensitivity to sugammadex or any of its components.

( 4 )

⚠️ Warnings and Cautions ~3 min read ▾

5 WARNINGS AND PRECAUTIONS Anaphylaxis : Be prepared for hypersensitivity reactions (including anaphylactic reactions) and take necessary precautions. ( 5.1 ) Marked Bradycardia : Cases of marked bradycardia, some of which have resulted in cardiac arrest, have been observed within minutes after administration. Monitor for hemodynamic changes and administer anticholinergic agents such as atropine if clinically significant bradycardia is observed.

( 5.2 ) Respiratory Function Monitoring : Ventilatory support is mandatory until adequate spontaneous respiration is restored and the ability to maintain a patent airway is assured. Provide adequate ventilation if neuromuscular blockade persists after BRIDION or recurs following extubation. ( 5.3 , 5.4 ) Waiting Times for Re-Administration of Neuromuscular Blocking Agents : If re-administration of a neuromuscular blocking agent is required after reversal with BRIDION, waiting times should be based on the dose of BRIDION and the renal function of the patient.

Consider use of a nonsteroidal neuromuscular blocking agent. ( 5.5 )

5.1Anaphylaxis and Hypersensitivity Clinicians should be prepared for the possibility of drug hypersensitivity reactions (including anaphylactic reactions) and take the necessary precautions [see Contraindications (4) , Adverse Reactions (6.1) ] . Potentially serious hypersensitivity reactions, including anaphylaxis, have occurred in patients treated with BRIDION. The nature and frequency of anaphylaxis and hypersensitivity associated with BRIDION administration were evaluated in a randomized, double-blind, placebo-controlled, parallel-group, repeat-dose study in which 375 subjects were randomized to receive 3 doses of BRIDION IV with a 5-week washout period: 151 subjects received 4 mg/kg, 148 received 16 mg/kg and 76 received placebo.

The frequency of anaphylaxis for the 299 healthy volunteers treated with intravenous BRIDION was 0.3% (n=1 in the BRIDION 16 mg/kg group on the first dose). Signs and symptoms included conjunctival edema, urticaria, erythema, swelling of the uvula and reduction in peak expiratory flow within 5 minutes of dose administration. The most common hypersensitivity adverse reactions reported were nausea, pruritus and urticaria and showed a dose response relationship, occurring more frequently in the 16 mg/kg group compared to the 4 mg/kg and placebo groups.

Anaphylaxis has also been reported in the post-marketing setting, including at doses less than 16 mg/kg. The most commonly described clinical features in reports of anaphylaxis were dermatologic symptoms (including urticaria, rash, erythema, flushing and skin eruption); and clinically important hypotension often requiring the use of vasopressors for circulatory support. In addition, prolonged hospitalization and/or the use of additional respiratory support until full recovery (re-intubation, prolonged intubation, manual or mechanical ventilation) have been noted in a number of the anaphylaxis reports.

5.2Marked Bradycardia Cases of marked bradycardia, some of which have resulted in cardiac arrest, have been observed within minutes after the administration of BRIDION [see Adverse Reactions (6.2) ] . Patients should be closely monitored for hemodynamic changes during and after reversal of neuromuscular blockade. Treatment with anticholinergic agents, such as atropine, should be administered if clinically significant bradycardia is observed.

5.3Respiratory Function Monitoring During Recovery Ventilatory support is mandatory for patients until adequate spontaneous respiration is restored and the ability to maintain a patent airway is assured. Even if recovery from neuromuscular blockade is complete, other drugs used in the peri- and post-operative period could depress respiratory function and therefore ventilatory support might still be required. Should neuromuscular blockade persist after BRIDION administration or recur following extubation, take appropriate steps to provide adequate ven… [Excerpted — this section continues on DailyMed.]

🤒 Adverse Reactions ~3 min read ▾

6 ADVERSE REACTIONS The following serious adverse reactions are described elsewhere in the labeling: Anaphylaxis and Hypersensitivity [see Contraindications (4) , Warnings and Precautions (5.1) ] Marked Bradycardia [see Warnings and Precautions (5.2) ] Most common adverse reactions (reported in ≥10% of adult patients at a 2, 4, or 16 mg/kg BRIDION dose and higher than the placebo rate): vomiting, pain, nausea, hypotension, and headache. ( 6.1 ) Most common adverse reactions (reported in ≥10% of pediatric patients 2 to <17 years of age at BRIDION doses of 2 or 4 mg/kg) were pain, vomiting, and nausea.

( 6.1 ) Most common adverse reaction (reported in ≥10% of pediatric patients from birth to <2 years of age at BRIDION doses of 2 or 4 mg/kg) was procedural pain. ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Merck Sharp & Dohme LLC at 1-877-888-4231 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch .

6.1Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice. Adult Patients The data described below reflect 2914 subjects exposed to 2, 4, or 16 mg/kg BRIDION and 544 to placebo in pooled Phase 1-3 studies. The population was 18 to 92 years old, 47% male and 53% female, 34% ASA (American Society of Anesthesiologists) Class 1, 51% ASA Class 2, and 14% ASA Class 3, and 82% Caucasian.

Most subjects received a single dose of BRIDION 2 mg/kg or 4 mg/kg. Adverse reactions reported in ≥10% of patients at a 2, 4, or 16 mg/kg BRIDION dose with a rate higher than the placebo rate are: vomiting, pain, nausea, hypotension, and headache. All adverse reactions occurring in ≥2% of subjects treated with BRIDION and more often than placebo for adult subjects who received anesthesia and/or neuromuscular blocking agent in pooled Phase 1 to 3 studies are presented in Table 2.

Table 2: Percent of Subject Exposures in Pooled Phase 1 to 3 Studies with Adverse Reactions Incidence ≥2% Sugammadex Placebo Body System Preferred Term 2 mg/kg (N=895) n (%) 4 mg/kg (N=1921) n (%) 16 mg/kg (N=98) n (%) (N=544) n (%) Injury, poisoning and procedural complications Incision site pain 58 (6) 106 (6) 4 (4) 6 (1) Procedural complication 13 (1) 27 (1) 8 (8) 3 (1) Airway complication of anesthesia 11 (1) 13 (1) 9 (9) 0 Anesthetic complication 8 (1) 14 (1) 9 (9) 1 (<1) Wound hemorrhage 5 (1) 38 (2) 0 8 (1) Recurrence of neuromuscular blockade 0 1 (<1) 2 (2) 0 Gastrointestinal disorders Nausea Combinations of preferred terms are as follows: Nausea includes preferred terms nausea and procedural nausea Vomiting includes preferred terms vomiting and procedural vomiting Abdominal pain includes preferred terms abdominal pain, abdominal pain upper, abdominal discomfort, abdominal pain lower, and epigastric discomfort Pain includes preferred terms pain and procedural pain Red blood cell count decreased includes preferred terms red blood cell count decreased, hemoglobin decreased, and hematocrit decreased Electrocardiogram QT interval abnormal includes preferred terms electrocardiogram QT interval abnormal and electrocardiogram QT interval prolonged Hypertension includes preferred terms hypertension, procedural hypertension, and blood pressure increased Hypotension includes preferred terms hypotension, procedural hypotension, and blood pressure decreased Tachycardia includes preferred terms tachycardia and heart rate increased Bradycardia includes preferred terms bradycardia and heart rate decreased 208 (23) 503 (26) 23 (23) 127 (23) Vomiting 98 (11) 236 (12) 15 (15) 57 (10) Abdominal pain 48 (5) 68 (4) 6 (6) 17 (3) Flatulence 17 (2) 51 (3) 1 (1) 10 (2) Dry mouth 9 (1) 5 (<1) 2 (2) 0 General disorders and administration site conditions Pain 434 (48) 993 (52) 35 (36) 207 (38) Pyrexia 77 (9) 109 (6) 5 (5) 17 (3) Chills 30 (3) 61 (3) 7 (7) 27 (5) N… [Excerpted — this section continues on DailyMed.]

🔄 Drug Interactions ~1 min read ▾

7 DRUG INTERACTIONS Toremifene : Concomitant use can delay recovery. ( 7.2 ) Hormonal contraceptives : Patients must use an additional, non-hormonal method of contraception for 7 days following BRIDION administration. ( 5.6 , 7.3 )

7.1Summary The information reported in sections 7.2 – 7.4 is based on binding affinity between BRIDION and other drugs, preclinical experiments, clinical studies and simulations of a pharmacokinetic-pharmacodynamic (PK-PD) model. Based on these considerations, no clinically significant pharmacodynamic interactions with other drugs are expected, with the exception of toremifene and hormonal contraceptives.

7.2Interactions Potentially Affecting the Efficacy of BRIDION Toremifene For toremifene, which has a relatively high binding affinity for sugammadex and for which relatively high plasma concentrations might be present, some displacement of vecuronium or rocuronium from the complex with BRIDION could occur. The recovery to TOF ratio to 0.9 could therefore be delayed in patients who have received toremifene on the same day of surgery.

7.3Interaction Potentially Affecting the Efficacy of Hormonal Contraceptives In vitro binding studies indicate that BRIDION may bind to progestogen, thereby decreasing progestogen exposure. Therefore, the administration of a bolus dose of BRIDION is considered to be equivalent to missing dose(s) of oral contraceptives containing an estrogen or progestogen. If an oral contraceptive is taken on the same day that BRIDION is administered, the patient must use an additional, non-hormonal contraceptive method or back-up method of contraception (such as condoms and spermicides) for the next 7 days.

In the case of non-oral hormonal contraceptives, the patient must use an additional, non-hormonal contraceptive method or back-up method of contraception (such as condoms and spermicides) for the next 7 days.

7.4Interference with Laboratory Tests BRIDION may interfere with the serum progesterone assay. Interference with this test was observed at sugammadex plasma concentrations of 100 mcg/mL, which may be observed for up to 30 minutes after a 16 mg/kg dose.

👥 Use in Specific Populations ~3 min read ▾

8 USE IN SPECIFIC POPULATIONS Severe Renal Impairment : Not recommended. ( 8.6 )

8.1Pregnancy Risk Summary There are no clinical trial data on BRIDION use in pregnant women to inform any drug-associated risks. The available data from the pharmacovigilance safety database and published literature on BRIDION use in pregnant women are insufficient to identify a drug-associated risk of major birth defects, miscarriage, or adverse maternal or fetal outcomes. In animal reproduction studies, there was no evidence of malformations following daily intravenous administration of sugammadex to rats and rabbits during organogenesis at exposures of up to 6 and 8 times, respectively, the maximum recommended human dose (MRHD) of 16 mg/kg.

However, there was an increase in the incidence of incomplete ossification of the sternebra and reduced fetal body weights in the rabbit study at 8 times the MRHD, which is a dose level in which maternal toxicity was also observed. In a pre- and postnatal development study, sugammadex treatment resulted in an increase in early postnatal loss, which correlated with maternal behavior (increased incidence of pup cannibalism), at exposures equivalent to the MRHD and higher (see Data ) . The background risk of major birth defects and miscarriage for the indicated population are unknown.

However, the background risk in the U.S. general population of major birth defects is 2-4% and of miscarriage is 15-20% of clinically recognized pregnancies. Data Animal Data In an embryofetal development study in rats, pregnant animals received daily intravenous administration of sugammadex at 0, 20, 100, and 500 mg/kg (0.2, 1, and 6 times the MRHD of 16 mg/kg/day, respectively, based on AUC comparison) during organogenesis (Gestational Days 6-17). No treatment-related maternal and embryofetal changes were observed.

In another embryofetal development study, pregnant New Zealand white rabbits received daily intravenous administration of sugammadex at 0, 20, 65, 200 mg/kg (0.6, 2, and 8 times the MRHD, respectively, based on AUC comparison) during organogenesis (Gestational Days 6-18). Fetal body weight decreases (10 and 14%, respectively) were observed in the offspring at maternal doses of 65 mg/kg and 200 mg/kg. In addition, incomplete ossification of sternebra, and unossified 1st metacarpal were noted at a maternal dose of 200 mg/kg/day.

Maternal toxicity was also observed at 200 mg/kg. Considering the observed effects of sugammadex on bone [see Nonclinical Toxicology (13.2) ] , it is possible that these findings may be attributable to drug. There was no evidence of malformations at any dose.

In a prenatal and postnatal development study, pregnant rats were administered sugammadex intravenously at 0, 30, 120, and 500 mg/kg (0.3, 1, and 6 times the MRHD, respectively, based on AUC comparison) from Gestational Day (GD) 6 to Postnatal Day (PND) 21 (corresponding to the beginning of organogenesis through parturition and subsequent pup weaning). Postnatal loss during PND 1-4 was noted across control litters and treated litters from dams receiving sugammadex as a result of pup cannibalization by dams. Overall incidence of affected litters was 2, 1, 4, and 3 litters, respectively, at 0, 30, 120, or 500 mg/kg/day.

The reason for the increased cannibalization is not known. An effect of sugammadex on steroidal hormones and/or pheromones cannot be ruled out. In addition, there were no drug-related effects on parturition in rats during evaluations for prenatal or postnatal development.

8.2Lactation Risk Summary No data are available regarding the presence of sugammadex in human milk, the effects of sugammadex on the breast fed infant, or the effects of sugammadex on milk production. However, sugammadex is present in rat milk (see Data ) . The developmental and health benefits of breastfeeding should be considered along with the mother's clinical need for BRIDION and any potential adverse effects on the breastfed infant from BRIDION or fro… [Excerpted — this section continues on DailyMed.]

🤰 Pregnancy ~2 min read ▾

8.1Pregnancy Risk Summary There are no clinical trial data on BRIDION use in pregnant women to inform any drug-associated risks. The available data from the pharmacovigilance safety database and published literature on BRIDION use in pregnant women are insufficient to identify a drug-associated risk of major birth defects, miscarriage, or adverse maternal or fetal outcomes. In animal reproduction studies, there was no evidence of malformations following daily intravenous administration of sugammadex to rats and rabbits during organogenesis at exposures of up to 6 and 8 times, respectively, the maximum recommended human dose (MRHD) of 16 mg/kg.

However, there was an increase in the incidence of incomplete ossification of the sternebra and reduced fetal body weights in the rabbit study at 8 times the MRHD, which is a dose level in which maternal toxicity was also observed. In a pre- and postnatal development study, sugammadex treatment resulted in an increase in early postnatal loss, which correlated with maternal behavior (increased incidence of pup cannibalism), at exposures equivalent to the MRHD and higher (see Data ) . The background risk of major birth defects and miscarriage for the indicated population are unknown.

However, the background risk in the U.S. general population of major birth defects is 2-4% and of miscarriage is 15-20% of clinically recognized pregnancies. Data Animal Data In an embryofetal development study in rats, pregnant animals received daily intravenous administration of sugammadex at 0, 20, 100, and 500 mg/kg (0.2, 1, and 6 times the MRHD of 16 mg/kg/day, respectively, based on AUC comparison) during organogenesis (Gestational Days 6-17). No treatment-related maternal and embryofetal changes were observed.

In another embryofetal development study, pregnant New Zealand white rabbits received daily intravenous administration of sugammadex at 0, 20, 65, 200 mg/kg (0.6, 2, and 8 times the MRHD, respectively, based on AUC comparison) during organogenesis (Gestational Days 6-18). Fetal body weight decreases (10 and 14%, respectively) were observed in the offspring at maternal doses of 65 mg/kg and 200 mg/kg. In addition, incomplete ossification of sternebra, and unossified 1st metacarpal were noted at a maternal dose of 200 mg/kg/day.

Maternal toxicity was also observed at 200 mg/kg. Considering the observed effects of sugammadex on bone [see Nonclinical Toxicology (13.2) ] , it is possible that these findings may be attributable to drug. There was no evidence of malformations at any dose.

In a prenatal and postnatal development study, pregnant rats were administered sugammadex intravenously at 0, 30, 120, and 500 mg/kg (0.3, 1, and 6 times the MRHD, respectively, based on AUC comparison) from Gestational Day (GD) 6 to Postnatal Day (PND) 21 (corresponding to the beginning of organogenesis through parturition and subsequent pup weaning). Postnatal loss during PND 1-4 was noted across control litters and treated litters from dams receiving sugammadex as a result of pup cannibalization by dams. Overall incidence of affected litters was 2, 1, 4, and 3 litters, respectively, at 0, 30, 120, or 500 mg/kg/day.

The reason for the increased cannibalization is not known. An effect of sugammadex on steroidal hormones and/or pheromones cannot be ruled out. In addition, there were no drug-related effects on parturition in rats during evaluations for prenatal or postnatal development.

🧒 Pediatric Use ~1 min read ▾

8.4Pediatric Use The safety and effectiveness of BRIDION for reversal of neuromuscular blockade induced by rocuronium bromide or vecuronium bromide have been established in pediatric patients from birth and older. Use of BRIDION in these age groups is supported by evidence from adequate and well-controlled studies of BRIDION [see Clinical Pharmacology (12.3) and Clinical Studies (14.1) ]. In pediatric patients, the safety profile is generally consistent with that observed in adults [see Adverse Reactions (6.1) ] .

Juvenile Animal Studies In a bone deposition study, sugammadex concentrations were significantly higher in juvenile rats compared to adult rats (13% vs. 3% of the administered dose, respectively) following a single intravenous (IV) dose at 30 mg/kg (0.3 times the MRHD based on adult AUC comparison). In a juvenile animal bone toxicity study, 7-day old rats were dosed intravenously once daily for 28 days with 0, 30, 120, and 500 mg/kg sugammadex (approximately 0.1, 0.6, and 3 times the MRHD, respectively, by adult AUC comparison).

Sugammadex at 120 and 500 mg/kg decreased ulna and femur bone lengths by approximately 3%, which did not recover after an 8-week treatment-free period. Reversible whitish discoloration and disturbance of enamel formation were also observed in the incisors at these dose levels. In molars, this effect was only observed at 500 mg/kg.

The no-observed-effect-level (NOEL) was 30 mg/kg. In a second juvenile animal bone toxicity study, 7-day old rats were dosed once weekly for 8 weeks with 0, 7.5, 30, and 120 mg/kg (up to 1.2 times the MRHD of 16 mg/kg based on adult AUC comparison). No adverse effects on bone or teeth were noted.

🧓 Geriatric Use ~1 min read ▾

8.5Geriatric Use BRIDION has been administered in a dedicated clinical study to a total 102 geriatric patients that compared the time to recovery from neuromuscular blockade induced by rocuronium (0.6 mg/kg) following administration of 2 mg/kg BRIDION given at the reappearance of T 2 in 65-74 year-olds (N=62) and ≥75 year-olds (N=40) compared with 18-64 year-olds (N=48). The median time to recovery of the TOF (T 4 /T 1 ) ratio to 0.9 in 18-64 year-olds was 2.2 minutes; in 65-74 year-olds it was 2.5 minutes, and in ≥75 year-olds it was 3.6 minutes.

For time to recovery from neuromuscular blockade induced by rocuronium following administration of 4 mg/kg BRIDION given at 1-2 PTCs, results across clinical trials revealed a median recovery of 2.5 minutes for geriatric patients (≥65 years, N=63) versus 2.0 minutes, for adults aged 18-64 years (N=359). Hence no dose adjustment is necessary in geriatric patients with normal organ function [see Dosage and Administration (2.2) ] . This drug is known to be substantially 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, care should be taken in dose selection, and it may be useful to monitor renal function [see Use in Specific Populations (8.6) , Clinical Pharmacology (12.3) ] .

🆘 Overdosage 60 words ▾

10 OVERDOSAGE In premarketing clinical trials, one case of accidental overdose with 40 mg/kg BRIDION was reported without significant effects. BRIDION can be removed using hemodialysis with a high-flux filter, but not with a low-flux filter. Based upon clinical studies, BRIDION concentrations in plasma are reduced with a high-flux filter by about 70% after a 3- to 6-hour dialysis session.

🧬 Clinical Pharmacology ~3 min read ▾

12 CLINICAL PHARMACOLOGY

12.1Mechanism of Action BRIDION is a modified gamma cyclodextrin. It forms a complex with the neuromuscular blocking agents rocuronium and vecuronium, and it reduces the amount of neuromuscular blocking agent available to bind to nicotinic cholinergic receptors in the neuromuscular junction. This results in the reversal of neuromuscular blockade induced by rocuronium and vecuronium.

12.2Pharmacodynamics BRIDION has been administered in doses ranging from 0.5 mg/kg to 16 mg/kg in dose response trials of rocuronium-induced blockade (0.6, 0.9, 1 and 1.2 mg/kg with and without maintenance doses) and vecuronium-induced blockade (0.1 mg/kg with or without maintenance doses) at different time points/depths of block. In these trials a clear dose-response relationship was observed. BRIDION may contain up to 7% of the mono OH-derivative of sugammadex.

In preclinical pharmacology studies, the mono OH-derivative was demonstrated to have ~50% of the affinity as sugammadex for rocuronium and vecuronium and that product with up to 7% of the mono OH-derivative has nearly similar efficacy in reversing rocuronium- or vecuronium-induced blockade. Although sugammadex has greatest affinity for aminosteroid neuromuscular blocking agents such as rocuronium and vecuronium, plasma levels of endogenous or exogenous compounds with a similar steroidal structure, such as some hormones, hormonal contraceptives, and pheromones may also be reduced following administration of sugammadex [see Drug Interactions (7.3) ] .

Cardiac Electrophysiology At a dose 2 times the maximum recommended dose, sugammadex does not prolong the QTc interval to any clinically relevant extent.

12.3Pharmacokinetics The sugammadex pharmacokinetic parameters were calculated from the total sum of non-complex-bound and complex-bound concentrations of sugammadex. Pharmacokinetic parameters as clearance and volume of distribution are assumed to be the same for non-complex-bound and complex-bound sugammadex in anesthetized patients. Distribution The observed steady-state volume of distribution of sugammadex is approximately 11 to 14 liters in adult patients with normal renal function (based on conventional, non-compartmental pharmacokinetic analysis).

Neither sugammadex nor the complex of sugammadex and rocuronium binds to plasma proteins or erythrocytes, as was shown in vitro using male human plasma and whole blood. Sugammadex exhibits linear kinetics in the dosage range of 1 to 16 mg/kg when administered as an IV bolus dose. In nonclinical drug distribution studies, sugammadex is retained in sites of active mineralization, such as bone and teeth, with a mean half-life of 172 and 8 days, respectively [see Use in Specific Populations (8.4) , Nonclinical Toxicology (13.2) ] .

Metabolism In clinical studies, no metabolites of sugammadex have been observed and only renal excretion of the unchanged product was observed as the route of elimination. Elimination In adult anesthetized patients with normal renal function, the elimination half-life (t 1/2 ) of sugammadex is about 2 hours and the estimated plasma clearance is about 88 mL/min (based on compartmental pharmacokinetic analysis). A mass balance study demonstrated that >90% of the dose was excreted within 24 hours.

Ninety-six percent (96%) of the dose was excreted in urine, of which at least 95% could be attributed to unchanged sugammadex. Excretion via feces or expired air was less than 0.02% of the dose. Administration of BRIDION to healthy volunteers resulted in increased renal elimination of rocuronium in complex.

Patients with Renal Impairment Sugammadex is known to be substantially excreted by the kidney. The half-life of sugammadex in patients with mild, moderate and severe renal impairment is 4, 6, and 19 hours, respectively. In one study, exposure to sugammadex was prolonged, leading to 17-fold higher overall exposure in patients with severe renal impairment.

Low concentrations of sugammadex are detectab… [Excerpted — this section continues on DailyMed.]

🧬 Mechanism of Action 55 words ▾

12.1Mechanism of Action BRIDION is a modified gamma cyclodextrin. It forms a complex with the neuromuscular blocking agents rocuronium and vecuronium, and it reduces the amount of neuromuscular blocking agent available to bind to nicotinic cholinergic receptors in the neuromuscular junction. This results in the reversal of neuromuscular blockade induced by rocuronium and vecuronium.

📦 How Supplied / Storage and Handling 110 words ▾

16 HOW SUPPLIED/STORAGE AND HANDLING BRIDION (sugammadex) injection is a clear, colorless to slightly yellow-brown, non-pyrogenic aqueous solution intended for intravenous infusion. BRIDION is available in the following presentations: BRIDION 2-mL single-dose vials containing 200 mg sugammadex (100 mg/mL) Box of 10 NDC 0006-5423-12 BRIDION 5-mL single-dose vials containing 500 mg sugammadex (100 mg/mL) Box of 10 NDC 0006-5423-15, NDC 0006-5425-15 The packaging of this product is not made with natural rubber latex. Store at 25°C (77°F); excursions permitted to 15°C to 30°C (59°F to 86°F) (see USP Controlled Room Temperature).

Protect from light. When not protected from light, the vial should be used within 5 days. Discard unused portion.

📦 Storage and Handling 37 words ▾

Store at 25°C (77°F); excursions permitted to 15°C to 30°C (59°F to 86°F) (see USP Controlled Room Temperature). Protect from light. When not protected from light, the vial should be used within 5 days. Discard unused portion.

📋 Description 203 words ▾

11 DESCRIPTION BRIDION (sugammadex) injection, for intravenous use, contains sugammadex sodium, a modified gamma cyclodextrin chemically designated as 6 A ,6 B ,6 C ,6 D ,6 E ,6 F ,6 G ,6 H -Octakis-S-(2-carboxyethyl)-6 A ,6 B ,6 C ,6 D ,6 E ,6 F ,6 G ,6 H -octathio- γ -cyclodextrin sodium salt (1:8) with a molecular weight of 2178.01. The structural formula is: BRIDION is supplied as a sterile, non-pyrogenic aqueous solution that is clear, colorless to slightly yellow-brown for intravenous injection only. Each mL contains 100 mg sugammadex, which is equivalent to 108.8 mg sugammadex sodium.

The aqueous solution is adjusted to a pH of between 7 and 8 with hydrochloric acid and/or sodium hydroxide. The osmolality of the product is between 300 and 500 mOsmol/kg. BRIDION may contain up to 7 mg/mL of the mono OH-derivative of sugammadex [see Clinical Pharmacology (12.2) ] .

This derivative is chemically designated as 6 A ,6 B ,6 C ,6 D ,6 E ,6 F ,6 G -Heptakis-S-(2-carboxyethyl)-6 A ,6 B ,6 C ,6 D ,6 E ,6 F ,6 G -heptathio- γ -cyclodextrin sodium salt (1:7) with a molecular weight of 2067.90. The structural formula is: Chemical Structure Chemical Structure

💬 Information for Patients 43 words ▾

17 PATIENT COUNSELING INFORMATION Advise females of reproductive potential using hormonal contraceptives that BRIDION may reduce the contraceptive effect . Instruct females to use an additional, non-hormonal method of contraception for the next 7 days following BRIDION administration [see Drug Interactions (7.3) ].

🧬 Pharmacokinetics ~3 min read ▾

12.3Pharmacokinetics The sugammadex pharmacokinetic parameters were calculated from the total sum of non-complex-bound and complex-bound concentrations of sugammadex. Pharmacokinetic parameters as clearance and volume of distribution are assumed to be the same for non-complex-bound and complex-bound sugammadex in anesthetized patients. Distribution The observed steady-state volume of distribution of sugammadex is approximately 11 to 14 liters in adult patients with normal renal function (based on conventional, non-compartmental pharmacokinetic analysis).

Neither sugammadex nor the complex of sugammadex and rocuronium binds to plasma proteins or erythrocytes, as was shown in vitro using male human plasma and whole blood. Sugammadex exhibits linear kinetics in the dosage range of 1 to 16 mg/kg when administered as an IV bolus dose. In nonclinical drug distribution studies, sugammadex is retained in sites of active mineralization, such as bone and teeth, with a mean half-life of 172 and 8 days, respectively [see Use in Specific Populations (8.4) , Nonclinical Toxicology (13.2) ] .

Metabolism In clinical studies, no metabolites of sugammadex have been observed and only renal excretion of the unchanged product was observed as the route of elimination. Elimination In adult anesthetized patients with normal renal function, the elimination half-life (t 1/2 ) of sugammadex is about 2 hours and the estimated plasma clearance is about 88 mL/min (based on compartmental pharmacokinetic analysis). A mass balance study demonstrated that >90% of the dose was excreted within 24 hours.

Ninety-six percent (96%) of the dose was excreted in urine, of which at least 95% could be attributed to unchanged sugammadex. Excretion via feces or expired air was less than 0.02% of the dose. Administration of BRIDION to healthy volunteers resulted in increased renal elimination of rocuronium in complex.

Patients with Renal Impairment Sugammadex is known to be substantially excreted by the kidney. The half-life of sugammadex in patients with mild, moderate and severe renal impairment is 4, 6, and 19 hours, respectively. In one study, exposure to sugammadex was prolonged, leading to 17-fold higher overall exposure in patients with severe renal impairment.

Low concentrations of sugammadex are detectable for at least 48 hours post-dose in patients with severe renal impairment. In a second study comparing subjects with moderate or severe renal impairment to subjects with normal renal function, sugammadex clearance progressively decreased and t 1/2 was progressively prolonged with declining renal function. Exposure was 2-fold and 5-fold higher in subjects with moderate and severe renal impairment, respectively.

Sugammadex concentrations were no longer detectable beyond 7 days post-dose in subjects with severe renal impairment. Geriatric Patients Geriatric patients may have mild or moderate renal impairment. Population pharmacokinetic analysis indicated that, beyond the effects of a decreased creatinine clearance, increased age has limited impact on sugammadex PK parameters [see Use in Specific Populations (8.5 , 8.6) ].

Pediatric Patients The pharmacokinetics of sugammadex in pediatric patients have been evaluated in 2 clinical studies following administration of intravenous doses of 2 or 4 mg/kg sugammadex administered for reversal of moderate or deep neuromuscular blockade, respectively. In one study, sugammadex pharmacokinetic parameters were estimated in pediatric patients 2 to <17 years of age with patients enrolled into 3 age groups (2 to <6, 6 to <12 and 12 to <17 years of age). In a second study, sugammadex pharmacokinetic parameters were estimated in pediatric patients birth to <2 years of age with patients enrolled into 4 age groups (birth to 27 days, 28 days to <3 months, 3 months to <6 months and 6 months to < 2 years).

Sugammadex exposure (AUC 0-inf and C max ) increased in a dose-dependent, linear manner following administration of 2 or 4 mg/kg acros… [Excerpted — this section continues on DailyMed.]

🧬 Pharmacodynamics 184 words ▾

12.2Pharmacodynamics BRIDION has been administered in doses ranging from 0.5 mg/kg to 16 mg/kg in dose response trials of rocuronium-induced blockade (0.6, 0.9, 1 and 1.2 mg/kg with and without maintenance doses) and vecuronium-induced blockade (0.1 mg/kg with or without maintenance doses) at different time points/depths of block. In these trials a clear dose-response relationship was observed. BRIDION may contain up to 7% of the mono OH-derivative of sugammadex.

In preclinical pharmacology studies, the mono OH-derivative was demonstrated to have ~50% of the affinity as sugammadex for rocuronium and vecuronium and that product with up to 7% of the mono OH-derivative has nearly similar efficacy in reversing rocuronium- or vecuronium-induced blockade. Although sugammadex has greatest affinity for aminosteroid neuromuscular blocking agents such as rocuronium and vecuronium, plasma levels of endogenous or exogenous compounds with a similar steroidal structure, such as some hormones, hormonal contraceptives, and pheromones may also be reduced following administration of sugammadex [see Drug Interactions (7.3) ] .

Cardiac Electrophysiology At a dose 2 times the maximum recommended dose, sugammadex does not prolong the QTc interval to any clinically relevant extent.

🔬 Clinical Studies ~3 min read ▾

14 CLINICAL STUDIES

14.1Controlled Clinical Studies Comparative Study of BRIDION versus Neostigmine as a Reversal Agent for Neuromuscular Blockade Induced by Rocuronium or Vecuronium at Reappearance of T 2 (Moderate Blockade) A multicenter, randomized, parallel-group, active-controlled, safety-assessor blinded study comparing BRIDION and neostigmine enrolled 189 patients (87 women and 102 men, 95% were ASA class 1 and 2 and 99% were Caucasian, median weights were 72 kg and 76 kg and median ages were 50 years and 51 years in the rocuronium and vecuronium groups, respectively).

Patients were randomly assigned to the rocuronium or vecuronium group and underwent elective surgical procedures under general anesthesia that required endotracheal intubation and maintenance of neuromuscular blockade. The surgical procedures were mainly endocrine, ocular, ENT, abdominal (gynecological, colorectal, urological), orthopedic, vascular, or dermatological. At the reappearance of T 2 , after the last dose of rocuronium or vecuronium, 2 mg/kg BRIDION or 50 mcg/kg neostigmine was administered in a randomized order as a single bolus injection.

The time from start of administration of BRIDION or neostigmine to recovery of the TOF (T 4 /T 1 ) ratio to 0.9 was assessed. Generally, a T 4 /T 1 ratio ≥0.9 correlates with recovery from neuromuscular blockade. Return of the T 4 /T 1 ratio to 0.9 after the reappearance of T 2 was overall faster with BRIDION 2 mg/kg as compared to neostigmine 50 mcg/kg in the setting of rocuronium or vecuronium-induced neuromuscular blockade (Figures 1 and 2).

Figure 1: Time (Minutes) from Administration of BRIDION or Neostigmine at the Reappearance of T 2 after Rocuronium to Recovery of the T 4 /T 1 Ratio to

0.9Figure 2: Time (Minutes) from Administration of BRIDION or Neostigmine at the Reappearance of T 2 after Vecuronium to Recovery of the T 4 /T 1 Ratio to

0.9Figure 1 Figure 2 Comparative Study of BRIDION versus Neostigmine as a Reversal Agent for Neuromuscular Blockade Induced by Rocuronium or Vecuronium at 1 to 2 PTCs (Deep Blockade) A multicenter, randomized, parallel-group, active-controlled, safety-assessor blinded study comparing BRIDION and neostigmine enrolled 157 patients (86 women and 71 men; 8% ASA class 1, 71% class 2, and 21% class 3; 79% Caucasian; median weights of 81 kg and 84 kg, and median ages of 54 years and 56 years in the rocuronium and vecuronium groups, respectively).

Patients were randomly assigned to the rocuronium or vecuronium group and underwent elective surgical procedures under general anesthesia that required endotracheal intubation and maintenance of neuromuscular blockade. The surgical procedures were mainly abdominal (gynecological, colorectal, urological), orthopedic, reconstructive, or neurological. At 1 to 2 PTCs, after the last dose of rocuronium or vecuronium, 4 mg/kg BRIDION or 70 mcg/kg neostigmine was administered in a randomized order as a single bolus injection.

The time from start of administration of BRIDION or neostigmine to recovery of the TOF (T 4 /T 1 ) ratio to 0.9 was assessed, although neostigmine was not expected to reverse neuromuscular blockade at a depth of 1 to 2 PTCs. Generally, a T 4 /T 1 ratio ≥0.9 correlates with recovery from neuromuscular blockade. Return of the T 4 /T 1 ratio to 0.9 in patients with 1 to 2 PTCs with BRIDION 4 mg/kg had a wider range of recovery times but the median time to recovery was comparable to the study of reversal at T 2 (2.7 minutes with 25 th and 75 th percentiles of 2.1 and 4.3 minutes for rocuronium [N=37], and 3.3 minutes with 25 th and 75 th percentiles of 2.3 and 6.6 minutes for vecuronium [N=47]).

There were 7 and 6 censored observations in the rocuronium and vecuronium groups, respectively. Reversal of Neuromuscular Blockade 3 Minutes after Rocuronium 1.2 mg/kg Time to recovery from neuromuscular blockade induced by succinylcholine compared with recovery from neuromuscular blockade induced by rocuronium followed 3 minu… [Excerpted — this section continues on DailyMed.]

🧪 Nonclinical Toxicology ~2 min read ▾

13 NONCLINICAL TOXICOLOGY

13.1Carcinogenesis, Mutagenesis, Impairment of Fertility Carcinogenesis Long-term animal studies to evaluate the carcinogenic potential of sugammadex have not been conducted. Mutagenesis Sugammadex and its mono OH-derivative tested negatively in in vitro bacterial reverse mutation assays (Ames test), in vitro chromosomal aberration assays in human peripheral blood lymphocytes, and in vivo micronucleus assays in mice and rats. Impairment of Fertility A fertility and early embryonic development study in Sprague-Dawley rats in which male rats were treated daily for 29 days prior to mating and through the mating period and female rats were treated daily for 14 days prior to mating to Day 5 post-coitum via intravenous administration of sugammadex at 20, 100, and 500 mg/kg (0.2, 1, and 6 times the MRHD of 16 mg/kg, respectively, based on AUC comparison) did not show adverse effects on fertility.

13.2Animal Toxicology and/or Pharmacology Bone and teeth retention of sugammadex occurred in rats after intravenous injection, with mean half-lives of 172 and 8 days, respectively. Sugammadex bound to hydroxyapatite in an in vitro study and distributed in the bone formation area where hydroxyapatite is present for mineralization in vivo . In adult rat bone toxicity studies, a single dose of sugammadex at 2000 mg/kg (approximately 24 times the maximum recommended human dose (MRHD) of 16 mg/kg by AUC comparison) administered to adult rats caused a slight increase in bone resorption, but had no effect on teeth color.

No adverse bone effects were seen following a single dose of sugammadex at 500 mg/kg (4 times the MRHD dose of 16 mg/kg based on plasma AUC comparison). In a bone repair study, adult rats were treated with intravenous sugammadex weekly for 6 weeks at 0, 30, 120, and 500 mg/kg (approximately 0.4, 1, and 6 times the MRHD, respectively, by AUC comparison). Based on histological data, high dose animals with post-fracture treatment, showed a statistically significant increase in callus formation and decrease in bone formation, suggesting a potential for a slight delay in the bone healing process.

However, there were no statistically significant effects on bone volume or bone mineral density. In juvenile animal studies, bone and teeth deposition was significantly higher in juvenile rats compared to adults. In addition, sugammadex administered to juvenile rats daily for 4 weeks caused slight bone length decrease (approximately 3%), which did not recover after an 8-week treatment-free period, and reversible whitish discoloration of the teeth at a dose approximately 0.6 times the MRHD, while weekly administration for 8 weeks did not produce similar changes in bone and teeth at doses up to 1.2 times the MRHD [see Use in Specific Populations (8.4) ] .

📄 Carcinogenesis, Mutagenesis, Impairment of Fertility 137 words ▾

13.1Carcinogenesis, Mutagenesis, Impairment of Fertility Carcinogenesis Long-term animal studies to evaluate the carcinogenic potential of sugammadex have not been conducted. Mutagenesis Sugammadex and its mono OH-derivative tested negatively in in vitro bacterial reverse mutation assays (Ames test), in vitro chromosomal aberration assays in human peripheral blood lymphocytes, and in vivo micronucleus assays in mice and rats. Impairment of Fertility A fertility and early embryonic development study in Sprague-Dawley rats in which male rats were treated daily for 29 days prior to mating and through the mating period and female rats were treated daily for 14 days prior to mating to Day 5 post-coitum via intravenous administration of sugammadex at 20, 100, and 500 mg/kg (0.2, 1, and 6 times the MRHD of 16 mg/kg, respectively, based on AUC comparison) did not show adverse effects on fertility.

📄 Package Label / Principal Display Panel 76 words ▾

PRINCIPAL DISPLAY PANEL - 2 mL Vial Carton NDC 0006-5423-12 Bridion ® (sugammadex) Injection 200 mg/2 mL (100 mg/mL) Rx only 10 Single-Dose 2 mL Vials For Intravenous Use Only PRINCIPAL DISPLAY PANEL - 2 mL Vial Carton

PRINCIPAL DISPLAY PANEL - 5 mL Vial Carton NDC 0006-5425-15 Bridion ® (sugammadex) Injection 500 mg/5 mL (100 mg/mL) Rx only 10 Single-Dose 5 mL Vials For Intravenous Use Only PRINCIPAL DISPLAY PANEL - 5 mL Vial Carton

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

Medicaid utilization & spend

📍 This exact package only: Medicaid data is reported per full 11-digit NDC — labeler, product and pack size — so every number here is for this package alone, not the drug overall. Other pack sizes report separately.
💊 Pharmacy benefit only: These are Medicaid outpatient pharmacy claims, billed by NDC. They exclude the medical benefit — clinic- or hospital-administered drugs billed under HCPCS J-codes — so drugs used mostly that way (e.g. Avastin, Lucentis, Keytruda) can look low or missing here. That’s expected, not an error.
📅 Q1 2025 – Q1 2026 · 5 quarters of data
ⓘ The newest quarter is usually incomplete when first published; states restate recent quarters in later CMS releases, so the latest figures typically revise upward. State coverage-policy changes can also shift quarter-to-quarter totals.
Prescriptions last 4 qtrs
40.1K
Units reimbursed last 4 qtrs
310.3K
Gross reimbursed last 4 qtrs
$10.18M
Avg / prescription
$254.12
Avg / unit
$32.8217
Latest quarter Q1 2026
7.7KRx
Fee-for-service vs managed care ⓘ
14% FFS 86% MCO
Fee-for-service · 5,526 Rx Managed care · 34,548 Rx
State Medicaid map
Alaska: no data reported AK Maine: 109 units · 7.8 per 100k residents ME Washington: 302 units · 3.9 per 100k residents WA Idaho: no data reported ID Montana: 899 units · 79.4 per 100k residents MT North Dakota: 406 units · 51.9 per 100k residents ND Minnesota: 622 units · 10.8 per 100k residents MN Wisconsin: no data reported WI Michigan: no data reported MI New York: no data reported NY Vermont: 549 units · 84.9 per 100k residents VT New Hampshire: 4,220 units · 301 per 100k residents NH Oregon: 699 units · 16.5 per 100k residents OR Nevada: no data reported NV Wyoming: no data reported WY South Dakota: 555 units · 60.4 per 100k residents SD Iowa: 1,933 units · 60.3 per 100k residents IA Illinois: no data reported IL Indiana: no data reported IN Ohio: 45,364 units · 385 per 100k residents OH Pennsylvania: 2,830 units · 21.8 per 100k residents PA New Jersey: 2,202 units · 23.7 per 100k residents NJ Massachusetts: 2,076 units · 29.7 per 100k residents MA California: 8,351 units · 21.4 per 100k residents CA Utah: 106 units · 3.1 per 100k residents UT Colorado: no data reported CO Nebraska: no data reported NE Missouri: 5,598 units · 90.3 per 100k residents MO Kentucky: 12,180 units · 269 per 100k residents KY West Virginia: 14,354 units · 811 per 100k residents WV Virginia: 383 units · 4.4 per 100k residents VA Maryland: 939 units · 15.2 per 100k residents MD Connecticut: no data reported CT Rhode Island: no data reported RI Arizona: no data reported AZ New Mexico: 1,898 units · 89.8 per 100k residents NM Kansas: 28 units · 1.0 per 100k residents KS Arkansas: no data reported AR Tennessee: 998 units · 14.0 per 100k residents TN North Carolina: 82 units · 0.8 per 100k residents NC South Carolina: no data reported SC Delaware: 38 units · 3.7 per 100k residents DE Oklahoma: 3,070 units · 75.7 per 100k residents OK Louisiana: 195,637 units · 4,277 per 100k residents LA Mississippi: 1,018 units · 34.6 per 100k residents MS Alabama: no data reported AL Georgia: no data reported GA D.C.: 392 units · 57.7 per 100k residents DC Hawaii: 1,117 units · 77.8 per 100k residents HI Texas: 1,312 units · 4.3 per 100k residents TX Florida: no data reported FL
Units reimbursed · per 100k residents
0.84,277
gray = no data reported ⓘ
Colors are per 100,000 residents, so big states don’t automatically dominate. Tap or hover a state for its actual totals.
Tap or hover a state
…for its Medicaid breakdown
🏆 Top states by units · per 100k residents
1 Louisiana 4,277 /100k
2 West Virginia 811 /100k
3 Ohio 385 /100k
4 New Hampshire 301 /100k
5 Kentucky 269 /100k
6 Missouri 90.3 /100k
7 New Mexico 89.8 /100k
8 Vermont 84.9 /100k
National units — by quarter
💵 About the dollar figures: “reimbursed” is what Medicaid paid pharmacies before confidential manufacturer rebates, so the program’s real net cost is lower than these numbers. Fee-for-service and managed-care claims are combined unless split above. Source: CMS State Drug Utilization Data; per-100k rates use 2023 Census population estimates.

Medicaid utilization by pack size

Medicaid (SDUD) totals over the four most recent reported quarters for every package size of this drug — handy when a specific package (e.g. a starter/titration pack) carries little or no Medicaid volume on its own.
10 vials this page00006-5423-12 40,074 Rx · $10,183,527
10 vials00006-5423-15 No Medicaid data
Drug total (last 4 qtrs): 40,074 Rx · 310,268 units · $10,183,527 gross reimbursed
Tap a pack size to open its page. Source: CMS State Drug Utilization Data, last 4 quarters.

Reported adverse events (FAERS)

Read carefully: FAERS reports are voluntary and unverified. Counts are not incidence, do not establish causation, are subject to reporting bias, and cannot be used to compare one drug to another. Shown for signal context only. Reports for Sugammadex — the ingredient across all brands.

Top reported reactions

Anaphylactic Reaction381
Bradycardia316
Cardiac Arrest217
Anaphylactic Shock211
Bronchospasm200
Hypotension188
Recurrence Of Neuromuscular Blockade128

Age at onset

Neonate9
Infant13
Child18
Adolescent5
Adult214
Elderly80

Reporter sex

3,095 reports
Male · 47%
Female · 52%
Unknown · 0%

Serious outcomes

Hospitalization1,048
Life-threatening916
Death124
Disabling91
Reports over time (by year) — tap or hover for the count & year
2019 2021 2023 2026 345 97
Most recent year is provisional (FAERS lags ~3 months).
Where does this data come from?
Adverse-event reports from the FDA Adverse Event Reporting System (FAERS) via openFDA. FAERS reports are voluntary and unverified — counts are not incidence and don’t establish causation.

About this NDC listing & data coverage

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

Questions about this listing

Why is there no price listed?
The pricing shown on our NDC pages comes from CMS NADAC, a voluntary survey of retail community pharmacy invoices. CMS does not publish a NADAC for every NDC — packages outside the retail survey (institutional and hospital products, bulk packages, discontinued items, and many OTC items) may never receive one. A missing price reflects the survey's scope, not this product's actual cost, and does not mean the product is free or unavailable.
Is the NDC printed on the package the same as the 11-digit billing NDC?
Yes, they identify this exact package in different formats. The 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 Merck Sharp & Dohme LLC. Listing status can change — the directory data on this page refreshes weekly.
Does this product come in other package sizes?
Yes — the FDA directory lists 1 other package presentation of this same product, including 10 vials (00006-5423-15). Each has its own NDC and its own page — see the package list near the top of this page.
Who lists this product with the FDA?
Merck Sharp & Dohme LLC 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.
← 00006-5374-03 · Merck 00006-5424-02 · Merck →
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.