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ELCYS Cysteine Hydrochloride 50 mg/mL Injection, Solution

by Exela Pharma Sciences, LLC · 1 VIAL in 1 CARTON (51754-1008-1) / 50 mL in 1 VIAL
NDC 51754-1008-01
🏷️ FDA NDC (as labeled) 51754-1008-1 billing pads the package segment with a zero
This package
Contains50 mL in 1 vial Pack sizes3 compare ↓
Also comes in: 50 mL 51754-1008-03 25 vials 51754-1008-04
Rx only Brand On market Non-controlled
🗂️ Data synced Jul 24, 2026 · sources: openFDA · FDA label (DailyMed) · FDA Orange & Purple Book · First Databank · CMS NADAC, ASP, Medicare & Medicaid · RxNorm
📋 All sources & update times →

This page is curated, coded, and maintained by

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

⚠️
Other active recalls for Cysteine Hydrochloride (different manufacturers) — 1 · tap to view
These affect other manufacturers’ products for the same ingredient — not necessarily the exact NDC on this page.
Class I · Oct 18, 2023 — Presence of Particulate Matter: Silicone (Exela Pharma Sciences LLC) · FDA recall D-0118-2024
Each entry is an official FDA enforcement report — look up any recall number in the FDA recall database ↗

🆔 Identity & classification

FDA NDC (as labeled) 51754-1008-1
Product NDC 51754-1008
11-digit billing NDC 51754100801
RxCUI 1486165, 2671585
UNII ZT934N0X4W
Application # NDA210660
SPL Set ID 52317b38-b2e6-4a1c-b5b0-43cada0d205e
DEA schedule Non-controlled
Marketing category NDA
Marketing status On market
FDA listing status Listed (active directory)
Marketing start 2023-12-12
Route INTRAVENOUS
Dosage form INJECTION, SOLUTION
Substance CYSTEINE HYDROCHLORIDE
Why two NDCs? The FDA registers this code as 51754-1008-1 — 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 → 51754-1008-01. Same drug, same package — only the format differs.
Where does this data come from?
Identifiers from the FDA openFDA NDC Directory and Structured Product Labeling; RxCUI from RxNorm (NLM); GPI from Medi-Span; GCN / HIC / AHFS / legend from First Databank.

🏭 Manufacturer & labeler

LabelerExela Pharma Sciences, LLC
Application holderEXELA PHARMA SCIENCES LLC
FDA applicationNDA210660 (NDA)
Labeler code51754
First marketedDec 2023
Product typeHuman Prescription Drug
Portfolio24 products on file
The labeler markets the product; the application holder owns the FDA approval. They’re often the same company but can differ (e.g. a repackager or an authorized generic). A mailing address / phone appears here when the manufacturer includes it in the product’s FDA label (not all do).
Where does this data come from?
Labeler, application holder and registered establishment from the FDA openFDA NDC Directory and Drugs@FDA; address/contact from the product’s FDA label.

🩺 Clinical

Supplement & herbal interactions

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

🧪 Inactive Ingredients / Excipients

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

Loading inactive ingredients from the official FDA label in the background. No external source is being called by this page request.
Where does this data come from?
Source: official FDA Structured Product Labeling (SPL) via DailyMed and the openFDA label index. Structured IACT rows and label-wide narrative are kept separate; availability and product-level specificity depend on the submitted label.

Inactive ingredient FAQ

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

💲 Pricing

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

Price systemPer mLPer 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.
Try another pack size: 50 mL 25 vials
Where does this data come from?
NADAC (National Average Drug Acquisition Cost) is the CMS weekly pharmacy-acquisition-cost survey — what pharmacies pay. ASP (Average Sales Price) is the CMS Medicare Part B drug-payment file, published quarterly. Medicaid pays is computed by us from CMS State Drug Utilization Data (total reimbursed ÷ units, trailing 12 months) — gross of rebates and inclusive of dispensing fees, so it reflects what Medicaid paid, not an acquisition cost. Medicare drug plans pay is the median negotiated point-of-sale unit cost across plans listing this NDC in the CMS quarterly Prescription Drug Plan pricing files, before rebates. The VA pays is the federal contract price (FSS, and the statutory Big 4 ceiling where listed) from the VA National Acquisition Center pharmaceutical price file. All are free public government data; each measures a different payer, so the figures are not directly comparable.

🔁 Therapeutic equivalents

ProductLabelerPackNADAC/unitTEStatusPrice vs. this
Elcys 50 mg/mLthis 51754-1008-01 Exela 1 vial — — FDA listed —
About this product: this is the brand-name version. We did not find an FDA-approved generic match for this exact strength, form and route.
Where does this data come from?
Equivalents are other NDCs of the same ingredient, form and route from the openFDA NDC Directory, ranked least-expensive-first by NADAC. Therapeutic-equivalence (AB) ratings come from the FDA Orange Book; biologics use the FDA Purple Book for biosimilar & interchangeable status.

⏳ Availability & generic status

🏛️
2019
First FDA approval
Apr 2019
📍
2026
Currently FDA-listed
7 years listed
🛡️
2039
Latest patent/protection listed
not a guaranteed launch date
🔒No FDA-approved generic found

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

🛡️ Latest patent/protection date listed: FDA patent/protection data lists protections through Jan 2039. This may affect when a full generic version becomes widely available, but it is not a guaranteed launch date.
📅 FDA approved Apr 16, 2019 RLD RS ⏳ ~12.3 yr to latest listed protection

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

Patents & exclusivity — FDA Orange Book
US 11510942 — method of use (U-2752)
US 11969439 — method of use (U-2752)
US 10478453 — method of use (U-2752)
US 10583155 — method of use (U-2752)
US 10653719 — drug product
US 10918662 — drug product
US 10905713 — drug product
US 10905714 — drug product
US 11684636 — drug product
US 10933089 — drug product
US 11826383 — drug product
US 11679125 — drug product
US 11648262 — drug product
US 10912795 — drug product
US 11642370 — drug product
US 11510941 — drug product
2019 2021 2023 2025 2027 2029 2031 2033 2035 2037 2039
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 (16)
PatentTypeUse codeExpires
US 11510942 ↗ Method of use U-2752 Jan 15, 2039
US 11969439 ↗ Method of use U-2752 Jan 15, 2039
US 10478453 ↗ Method of use U-2752 Jan 15, 2039
US 10583155 ↗ Method of use U-2752 Jan 15, 2039
US 10653719 ↗ Drug product — Jan 15, 2039
US 10918662 ↗ Drug product — Jan 15, 2039
US 10905713 ↗ Drug product — Jan 15, 2039
US 10905714 ↗ Drug product — Jan 15, 2039
US 11684636 ↗ Drug product — Jan 15, 2039
US 10933089 ↗ Drug product — Jan 15, 2039
US 11826383 ↗ Drug product — Jan 15, 2039
US 11679125 ↗ Drug product — Jan 15, 2039
US 11648262 ↗ Drug product — Jan 15, 2039
US 10912795 ↗ Drug product — Jan 15, 2039
US 11642370 ↗ Drug product — Jan 15, 2039
US 11510941 ↗ Drug product — Jan 15, 2039
Common questions
Is there a generic version of this drug?
No FDA-approved generic equivalent is currently listed in the FDA Orange Book for this drug. Based on the patents and exclusivity currently listed, the Orange Book estimate is that full-label generic entry may be delayed until Jan 2039 — an estimate, not a guaranteed launch date.
The FDA approved a generic — why can’t I get it at my pharmacy yet?
FDA approval and pharmacy availability are two different things. The FDA can approve a generic years before it actually reaches pharmacies, because the brand company may still hold patents or have a settlement that delays the launch. A manufacturer also has to choose to make and sell it, and have supply ready. So a drug can be “FDA-approved generic exists” and still be brand-only at the counter today.
Why do different websites show different generic release dates?
Generic availability is not based on one single date. Some sources use the first exclusivity expiration, some use the last product patent, and others use the latest method-of-use patent. Patent challenges, settlements, licenses, and label carve-outs can also change the real-world launch date. This page shows the underlying Orange Book dates so you can see why estimates may differ.
What does “FDA listed” mean?
It means the product appears in the FDA’s official NDC directory. That’s a good sign a product exists and is intended for the U.S. market, but on its own it does not confirm a pharmacy can fill it today. Where we have recent retail pricing data (NADAC) for a product, we label it “Availability likely” instead.
What does a patent or protection date mean here?
It’s the latest date currently listed in the FDA Orange Book for a patent or exclusivity on the brand product. It can affect when a full generic version becomes widely available — but it is not a guaranteed generic launch date. Generics sometimes arrive earlier (through a settlement or patent challenge) or later (a manufacturer still has to make and sell one).
What does “current Orange Book estimate” mean?
It means we are using the latest patent and exclusivity dates currently listed in the FDA Orange Book. It is not a guaranteed launch date.
Can a generic come out before the last patent expires?
Sometimes. A generic company may challenge a patent, settle with the brand manufacturer, receive a license, or obtain approval with a narrower label that avoids a patented use. In other cases, the last listed protection may delay full-label generic competition.
Can a generic come out after the listed dates?
Yes. Even after patents or exclusivity expire, a generic still needs FDA approval and a manufacturer must choose to market it. Supply, litigation, business decisions, or regulatory issues can delay actual availability.
What is the difference between patents and exclusivity?
Patents are legal protections usually issued by the U.S. Patent and Trademark Office. FDA exclusivity is marketing protection granted by the FDA. They are separate, and either one can affect generic timing.
Why are there multiple patent dates?
One drug can have several patents covering different things: the active ingredient, a formulation, a manufacturing process, or a specific approved use. That is why a page may show several expiration dates instead of one simple generic date.
Built from FDA Orange Book patent and exclusivity data. Dates are refreshed from public FDA data when available; the marker is max(latest patent expiry, latest exclusivity expiry). Paragraph-IV settlements and first-filer 180-day exclusivity can shift the real date; a method-of-use patent may allow an earlier skinny-label generic for non-protected indications. Generic launch timing is an estimate, not a guarantee.
Where does this data come from?
Patents and exclusivity from the FDA Orange Book (small-molecule drugs), refreshed from public FDA data. Generic launch timing is an estimate, not a guarantee.

🔬 Reported adverse events (FAERS)

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

Top reported reactions

Hallucination5
Pneumonia4
Erythema Multiforme3
Malaise3
Food Craving2
Thirst2
Accidental Exposure1

Age at onset

Adult2
Elderly5

Reporter sex

24 reports
Male · 67%
Female · 33%

Serious outcomes

Hospitalization13
Life-threatening2
Death1
Reports over time (by year) — tap or hover for the count & year
2023 2024 2025 2026 2 0
Most recent year is provisional (FAERS lags ~3 months).
Where does this data come from?
Adverse-event reports from the FDA Adverse Event Reporting System (FAERS) via openFDA. FAERS reports are voluntary and unverified — counts are not incidence and don’t establish causation.

📦 Packaging — all sizes for this product

Package NDCDescription Marketing startStatus
51754-1008-03 10 CARTON in 1 CASE (51754-1008-3) / 1 VIAL in 1 CARTON (51754-1008-1) / 50 mL in 1 VIAL 2023-12-12 Active
51754-1008-04 25 VIAL in 1 CARTON (51754-1008-4) / 50 mL in 1 VIAL 2024-01-01 Discontinued by firm
51754-1008-01 You're viewing this 1 VIAL in 1 CARTON (51754-1008-1) / 50 mL in 1 VIAL 2024-01-01 Active

Pack size FAQ

What quantity is in NDC 51754-1008-01?
NDC 51754-1008-01 is listed by the FDA — 1 vial in 1 carton / 50 ml in 1 vial.
What NDC number is used to bill for this package of ELCYS Cysteine Hydrochloride 50 mg/mL Injection, Solution?
Bill NDC 51754-1008-01 — the 11-digit billing format is 51754100801. Pharmacy and medical claims use the 11-digit form; the FDA label may print a shorter form of the same code.

🧭 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 — Not published for this NDC No photo available yet for this listing.
Inactive ingredients (structured) — Not published for this NDC The labeler did not submit a structured excipient list, or no SPL is available.
NADAC pharmacy acquisition price (CMS) — Not published for this NDC CMS publishes NADAC only for NDCs reported in its retail-pharmacy survey.
Orange Book / therapeutic-equivalence data ✓ Available
HCPCS J-code billing crosswalk — Not published for this NDC Most self-administered / retail products have no J-code — that is normal.
Medicaid utilization (CMS SDUD) — Not published for this NDC CMS reports utilization only for NDCs with Medicaid claims above its privacy threshold.
“Not published” reflects what the public FDA / CMS / NLM sources provide for this exact package code — it is a property of the data feeds, not a judgment about the product.

Questions about this listing

Why is there no price listed?
The pricing shown on our NDC pages comes from CMS NADAC, a voluntary survey of retail community pharmacy invoices. CMS does not publish a NADAC for every NDC — packages outside the retail survey (institutional and hospital products, bulk packages, discontinued items, and many OTC items) may never receive one. A missing price reflects the survey's scope, not this product's actual cost, and does not mean the product is free or unavailable.
Is the NDC printed on the package the same as the 11-digit billing NDC?
Yes, they identify this exact package in different formats. The FDA registers it as 51754-1008-1, which is what is printed on the packaging and shown on DailyMed. Insurance claims use a fixed 11-digit 5-4-2 format, so the short segment is padded with a leading zero: 51754-1008-01, written without dashes as 51754100801. The Identity section at the top of this page lists every form of this code.
What do the three segments of this NDC mean?
In 51754-1008-01, the first segment (51754) is the labeler code FDA assigned to Exela Pharma Sciences, LLC; the middle segment (1008) identifies this specific product — its ingredient, strength, and dosage form; and the last segment (01) identifies this exact package size and type. Together they name one specific package of one specific product.
Is this package still being marketed?
Yes, per the latest FDA NDC Directory data on this page: this package is listed as actively marketed, with no marketing end date reported by Exela Pharma Sciences, 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 2 other package presentations of this same product, including 1 vial (51754-1008-03), 25 vials (51754-1008-04). 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?
Exela Pharma Sciences, 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.

📄 Full prescribing information FDA SPL

The complete FDA label for this product — the official prescribing information, verbatim, section by section. Jump with a chip, search within the label, or expand everything.
🎯 Indications and Usage ⏱️ Dosage and Administration 💊 Dosage Forms and Strengths ⛔ Contraindications ⚠️ Warnings and Cautions 🤒 Adverse Reactions 👥 Use in Specific Populations 🤰 Pregnancy 🧒 Pediatric Use 🧓 Geriatric Use 🆘 Overdosage 🧬 Clinical Pharmacology 🧬 Mechanism of Action 📦 How Supplied / Storage and Handling 📋 Description 💬 Information for Patients
🎯 Indications and Usage 134 words ▾

1 INDICATIONS AND USAGE ELCYS ® is indicated for use as an additive to amino acid solutions to meet the nutritional requirements of newborn infants requiring total parenteral nutrition (TPN); and of adult and pediatric patients with severe liver disease who may have impaired enzymatic processes and require TPN. It can also be added to amino acid solutions to provide a more complete profile of amino acids for protein synthesis. ELCYS ® is a sulfur-containing amino acid indicated to meet the nutritional requirements of newborn infants requiring total parenteral nutrition (TPN); and of adult and pediatric patients with severe liver disease who may have impaired enzymatic processes and require TPN.

It can also be added to amino acid solutions to provide a more complete profile of amino acids for protein synthesis. ( 1 )

⏱️ Dosage and Administration ~3 min read ▾

2 DOSAGE AND ADMINISTRATION • ELCYS ® is for admixing use only. Not for direct intravenous infusion . ( 2.1 ) • PHARMACY BULK PACKAGE: Dispense single-doses to many patients in a pharmacy admixture program.

Use within 4 hours of puncture. ( 2.1 ) • See full prescribing information for information on preparation, administration, instructions for use, dosing considerations, including the recommended dosage in pediatric patients and adults. ( 2.1 , 2.2 , 2.3 , 2.4 , 2.5 )

2.1Important Administration Information Prior to administration, ELCYS® must be diluted and used as an admixture in PN solutions. ELCYS® is not for direct intravenous infusion. The resulting solution is for intravenous infusion into a central or peripheral vein.

The choice of a central or peripheral venous route should depend on the osmolarity of the final infusate. Solutions with osmolarity of 900 mOsm/L or greater must be infused through a central catheter [see Warnings and Precautions ( 5.2 )] . ELCYS ® is supplied as a pharmacy bulk package, and consists of one pharmacy bulk vial which must be diluted prior to intravenous administration [see Dosage andAdministration ( 2.3 )].

As a pharmacy bulk vial, ELCYS ® is intended for dispensing of single doses to many patients. Dispensing from a pharmacy bulk vial should be completed within 4 hours after the vial is penetrated. Do not administer ELCYS ® as a direct, undiluted intravenous injection.

2.2Preparation and Administration Instructions Prior to administration, ELCYS® must be diluted and used as an admixture in PN solutions. ELCYS® is not for direct intravenous infusion. • ELCYS ® is to be prepared only in a suitable work area such as a laminar flow hood (or an equivalent clean air compounding area). The key factor in the preparation is careful aseptic technique to avoid inadvertent touch contamination during mixing of solutions and addition of other nutrients. • ELCYS ® is for addition to amino acid solutions prior to further admixing with dextrose injection using a PN container. • Use a dedicated line for PN solutions. • Intravenous lipid emulsions can be infused concurrently into the same vein as ELCYS ® containing amino acid and dextrose solutions by a Y-connector located near the infusion site; flow rates of each solution should be controlled separately by infusion pumps. • For administration without lipid emulsion, use a 0.22 micron in-line filter. • To prevent air embolism, use a non-vented infusion set or close the vent on a vented set, avoid multiple connections, do not connect flexible containers in series, fully evacuate residual gas in the container prior to administration, do not pressurize the flexible container to increase flow rates, and if administration is controlled by a pumping device, turn off pump before the container runs dry. • If infused with lipid emulsion, do not use administration sets and lines that contain di-2-ethylhexyl phthalate (DEHP).

Administration sets that contain polyvinyl chloride (PVC) components have DEHP as a plasticizer. • Visually inspect the diluted PN solution containing ELCYS ® for particulate matter before admixing, after admixing, and prior to administration. The solution should be clear and there should be no precipitates. A slight yellow color does not alter the quality and efficacy of this product.

2.3Preparation Instructions for Admixing Using a Parenteral Nutrition (PN) Container • Remove ELCYS ® vial from the carton and inspect for particulate matter. • Transfer the required amount of ELCYS ® to an amino acid solution using strict aseptic techniques to avoid microbial contamination. • The amino acid solution containing ELCYS ® can then be used to prepare admixtures in the PN container using strict aseptic techniques. • Amino acids solution containing ELCYS ® may be mixed with dextrose injection. The following proper mixing sequence must be followed to minimize pH related problems: • Transfer dextrose injection to the parental nutrition pooling containe…

💊 Dosage Forms and Strengths 49 words ▾

3 DOSAGE FORMS AND STRENGTHS Injection • Pharmacy Bulk Package: 2500 mg/50mL (50 mg/mL) cysteine hydrochloride, USP in a clear, colorless, sterile solution in a 50 mL vial. Injection • Pharmacy Bulk Package: 2500 mg/50 mL (50 mg/mL) cysteine hydrochloride, USP in a 50 mL vial. ( 3 )

⛔ Contraindications 82 words ▾

4 CONTRAINDICATIONS ELCYS ® is contraindicated in: • Patients with known hypersensitivity to one or more amino acids. • Patients with inborn errors of amino acid metabolism due to risk of severe metabolic or neurologic complications. • Patients with pulmonary edema or acidosis due to low cardiac output. • Hypersensitivity to one or more amino acids ( 4 ) • Inborn errors of amino acid metabolism ( 4 ) • Pulmonary edema or acidosis due to low cardiac output ( 4 )

⚠️ Warnings and Cautions ~3 min read ▾

5 WARNINGS AND PRECAUTIONS • Pulmonary Embolism due to Pulmonary Vascular Precipitates: If signs of pulmonary distress occur, stop the infusion and initiate a medical evaluation. ( 5.1 ) • Vein Damage and Thrombosis: Solutions with osmolarity of 900 mOsm/L or more must be infused through a central catheter. ( 2.1 , 5.2 ) • Increased blood urea nitrogen (BUN): Monitor laboratory parameters and discontinue if exceeds normal postprandial limits and continues to increase.

( 5.3 ) • Acid-Base Imbalance: Monitor laboratory parameters and supplement with electrolytes as needed. ( 5.4 ) • Hepatobiliary Disorders: Monitor liver function parameters and ammonia levels. ( 5.5 ) • Hyperammonemia: Neurocognitive delay possible in infants; monitor blood ammonia levels.

( 5.6 , 8.4 ) • Aluminium Toxicity: Increased risk in patients with renal impairment, including preterm infants. ( 5.7 , 8.4 ) • Monitoring and Laboratory Tests: Monitor fluid and electrolytes, serum osmolarity, blood glucose, kidney and liver function, blood count and coagulation parameters throughout treatment. ( 5.8 )

5.1Pulmonary Embolism due to Pulmonary Vascular Precipitates Pulmonary vascular precipitates causing pulmonary vascular emboli and pulmonary distress have been reported in patients receiving PN. In some fatal cases, pulmonary embolism occurred as a result of calcium phosphate precipitates. Precipitation following passage through an in-line filter and suspected in vivo precipitate formation has also been reported.

If signs of pulmonary distress occur, stop the PN infusion and initiate a medical evaluation. In addition to inspection of the solution [see Dosage and Administration ( 2.1 , 2.2 )], the infusion set and catheter should also periodically be checked for precipitates.

5.2Vein Damage and Thrombosis ELCYS ® must be diluted and used as an admixture in PN solutions. It is not for direct intravenous infusion. Solutions with an osmolarity of 900 mOsm/L or greater must be infused through a central catheter [see Dosage and Administration ( 2.1 )] .

The infusion of hypertonic nutrient injections into a peripheral vein may result in vein irritation, vein damage, and/or thrombosis. The primary complication of peripheral access is venous thrombophlebitis, which manifests as pain, erythema, tenderness or a palpable cord. Remove the catheter as soon as possible, if thrombophlebitis develops.

5.3Increased Blood Urea Nitrogen (BUN) Intravenous infusion of amino acids may induce a rise in blood urea nitrogen (BUN), especially in patients with impaired hepatic or renal function. Appropriate laboratory tests should be performed periodically and infusion discontinued if BUN levels exceed normal postprandial limits and continue to rise. It should be noted that a modest rise in BUN normally occurs as a result of increased protein intake.

Administration of amino acid solutions in the presence of impaired renal function may augment an increasing BUN, as does any protein dietary component.

5.4Acid-Base Imbalance Administration of ELCYS ® may result in metabolic acidosis in preterm infants. Administration of amino acid solutions to a patient with hepatic impairment may result in serum amino acid imbalances, metabolic alkalosis, prerenal azotemia, hyperammonemia, stupor and coma. Frequent clinical evaluation and laboratory determinations are necessary for proper monitoring of acid-base balance during parenteral nutrition therapy.

Significant deviations from normal concentrations may require the use of additional electrolyte supplements.

5.5Hepatobiliary Disorders Hepatobiliary disorders are known to develop in some patients without preexisting liver disease who receive PN, including cholecystitis, cholelithiasis, cholestasis, hepatic steatosis, fibrosis and cirrhosis, possibly leading to hepatic failure. The etiology of these disorders is thought to be multifactorial and may differ between patients. Monitor liver function parameters and ammonia levels. Patients developing si…

🤒 Adverse Reactions 209 words ▾

6 ADVERSE REACTIONS The following serious adverse reactions are discussed in greater detail in other sections of the prescribing information: • Pulmonary embolism due to pulmonary vascular precipitates [see Warnings and Precautions ( 5.1 )] • Vein damage and thrombosis [see Warnings and Precautions ( 5.2 )] • Increased BUN [see Warnings and Precautions ( 5.3 )] • Acid-base imbalance [see Warnings and Precautions ( 5.4 )] • Hepatobiliary disorders [see Warnings and Precautions ( 5.5 )] • Hyperammonemia [see Warnings and Precautions ( 5.6 )] • Aluminum toxicity [see Warnings and Precautions ( 5.7 )] Adverse reactions with the use of cysteine hydrochloride injection were identified in clinical studies or postmarketing reports.

Because some of these reactions were reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure. • Local infusion site reactions, including a warm sensation, erythema, phlebitis and thrombosis at the infusion site • Generalized flushing, fever and nausea Most common adverse reactions are local reactions (warm sensation, erythema, phlebitis and thrombosis at the infusion site), generalized flushing, fever and nausea ( 6 ).

To report SUSPECTED ADVERSE REACTIONS, contact Exela Pharma Sciences, LLC or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

👥 Use in Specific Populations ~2 min read ▾

8 USE IN SPECIFIC POPULATIONS

8.1Pregnancy Risk Summary Appropriate administration of ELCYS ® is not expected to cause major birth defects, miscarriage or adverse maternal or fetal outcomes. Animal reproduction studies have not been conducted with cysteine hydrochloride. The estimated background risk for major birth defects and miscarriage for the indicated populations 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 defect and miscarriage in the clinically recognized pregnancies is 2 to 4% and 15 to 20%, respectively.

8.2Lactation Risk Summary Data available on the effects of cysteine hydrochloride on infants, either directly or through breastmilk, do not suggest a significant risk of adverse events from exposure. Although there are no data on the presence of cysteine hydrochloride in human or animal milk or the effects on milk production, appropriate administration of ELCYS ® is not expected to cause harm to a breastfed infant. The development and health benefits of breastfeeding should be considered along with the mother’s clinical need for ELCYS ® and any potential adverse effects on the breastfed infant from ELCYS ® or from the underlying maternal condition.

8.4Pediatric Use ELCYS ® is approved for use in pediatric patients, from birth to 17 years of age, for use as an additive to amino acid solutions to meet the nutritional requirements of newborn infants, including preterm infants, requiring total parenteral nutrition (TPN) and pediatric patients with severe liver disease who may have impaired enzymatic processes and require TPN . The safety profile for ELCYS ® use in pediatric patients includes risks of acid-base imbalance and hyperammonemia. Acid-base imbalance, including metabolic acidosis, may occur with ELCYS ® administration in preterm infants.

Frequent clinical and laboratory assessments are necessary to monitor and manage fluid balance, electrolyte concentrations, and acid-base balance during parenteral nutrition therapy [see Warnings and Precautions ( 5.4 )] . Hyperammonemia is of special significance in infants (birth to two years of age). This reaction appears to be related to a deficiency of the urea cycle amino acids of genetic or product origin.

It is essential that blood ammonia be measured frequently in infants [see Warnings and Precautions ( 5.6 )]. Because of immature renal function, preterm infants receiving prolonged parenteral nutrition treatment with ELCYS ® may be at higher risk of aluminum toxicity [see Warnings and Precautions ( 5.7 )].

8.5Geriatric Use Clinical studies with ELCYS ® have not been performed to determine whether patients aged 65 and over respond differently from younger patients.

8.6Renal Impairment Monitor patients with impaired renal function receiving PN solutions containing the recommended dosage of ELCYS ® with frequent clinical evaluation and laboratory tests to assess renal function, including serum electrolytes and fluid balance [see Dosage and Administration ( 2.4 ), Warnings and Precautions ( 5.8 )].

8.7Hepatic Impairment Monitor patients with impaired liver function receiving PN solutions containing the recommended dosage of ELCYS ® with frequent clinical evaluation and laboratory tests to assess liver function, such as bilirubin and liver function parameters [see Dosage and Administration ( 2.4 ), Warnings and Precautions ( 5.8 )].

🤰 Pregnancy 93 words ▾

8.1Pregnancy Risk Summary Appropriate administration of ELCYS ® is not expected to cause major birth defects, miscarriage or adverse maternal or fetal outcomes. Animal reproduction studies have not been conducted with cysteine hydrochloride. The estimated background risk for major birth defects and miscarriage for the indicated populations 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 defect and miscarriage in the clinically recognized pregnancies is 2 to 4% and 15 to 20%, respectively.

🧒 Pediatric Use 203 words ▾

8.4Pediatric Use ELCYS ® is approved for use in pediatric patients, from birth to 17 years of age, for use as an additive to amino acid solutions to meet the nutritional requirements of newborn infants, including preterm infants, requiring total parenteral nutrition (TPN) and pediatric patients with severe liver disease who may have impaired enzymatic processes and require TPN . The safety profile for ELCYS ® use in pediatric patients includes risks of acid-base imbalance and hyperammonemia. Acid-base imbalance, including metabolic acidosis, may occur with ELCYS ® administration in preterm infants.

Frequent clinical and laboratory assessments are necessary to monitor and manage fluid balance, electrolyte concentrations, and acid-base balance during parenteral nutrition therapy [see Warnings and Precautions ( 5.4 )] . Hyperammonemia is of special significance in infants (birth to two years of age). This reaction appears to be related to a deficiency of the urea cycle amino acids of genetic or product origin.

It is essential that blood ammonia be measured frequently in infants [see Warnings and Precautions ( 5.6 )]. Because of immature renal function, preterm infants receiving prolonged parenteral nutrition treatment with ELCYS ® may be at higher risk of aluminum toxicity [see Warnings and Precautions ( 5.7 )].

🧓 Geriatric Use 25 words ▾

8.5Geriatric Use Clinical studies with ELCYS ® have not been performed to determine whether patients aged 65 and over respond differently from younger patients.

🆘 Overdosage 35 words ▾

10 OVERDOSAGE In the event of over hydration or solute overload, re-evaluate the patient and institute appropriate corrective measures [see Warnings and Precautions ( 5.3 , 5.4 , 5.5 , 5.7 , 5.8 )] .

🧬 Clinical Pharmacology 59 words ▾

12 CLINICAL PHARMACOLOGY

12.1Mechanism of Action Endogenous cysteine is synthesized from methionine by the enzyme, cystathionase, via the trans-sulfuration pathway, and serves as a precursor substrate for both glutathione and taurine. ELCYS ® provides cysteine to the systemic circulation of patients who require PN and cannot synthesize adequate quantities of cysteine due to insufficient or deficient cystathionase activity.

🧬 Mechanism of Action 56 words ▾

12.1Mechanism of Action Endogenous cysteine is synthesized from methionine by the enzyme, cystathionase, via the trans-sulfuration pathway, and serves as a precursor substrate for both glutathione and taurine. ELCYS ® provides cysteine to the systemic circulation of patients who require PN and cannot synthesize adequate quantities of cysteine due to insufficient or deficient cystathionase activity.

📦 How Supplied / Storage and Handling 79 words ▾

16 HOW SUPPLIED/STORAGE AND HANDLING ELCYS ® is supplied as follows: Pharmacy Bulk Package: 2,500 mg/50 mL (50 mg/mL) of cysteine hydrochloride, USP is a clear, colorless, sterile and nonpyrogenic solution in 50 mL vials packaged as 1 per carton (NDC 51754-1008-1). Store at 20°C to 25°C (68°F to 77°F). [See USP Controlled Room Temperature]. Avoid excessive heat.

Protect from freezing. If accidentally frozen, discard the vial. For storage of admixed solution see Dosage and Administration ( 2.3 ).

📋 Description 161 words ▾

11 DESCRIPTION ELCYS ® (cysteine hydrochloride injection) is a sterile, nonpyrogenic solution for intravenous use. Each 50 mL of ELCYS ® contains 2500 mg of cysteine hydrochloride, USP (equivalent to 345 mg of cysteine) in water for injection. Sodium hydroxide and/or hydrochloric acid are used as needed to adjust the pH.

The pH range is 1.0 to 2.5. The active ingredient is cysteine hydrochloride. Cysteine is a sulfur-containing amino acid.

The chemical name of cysteine hydrochloride is L-cysteine hydrochloride monohydrate and is chemically designated as C 3 H 7 NO 2 S • HCI • H 2 O having a molecular weight of 175.63. Cysteine hydrochloride is a white crystalline powder soluble in water. Cysteine aqueous solution is prone to oxidation when exposed to air, and when mixed with amino acids solutions, cysteine may convert to insoluble cystine which leads to precipitation over time.

It has the following structural formula: ELCYS ® contains no more than 120 mcg/L of aluminum. Structure

💬 Information for Patients 120 words ▾

17 PATIENT COUNSELING INFORMATION Inform patients, caregivers, or home healthcare providers of the following risks of ELCYS ® : • Pulmonary embolism due to pulmonary vascular precipitates [see Warnings and Precautions ( 5.1 )] • Vein damage and thrombosis [see Warnings and Precautions ( 5.2 )] • Increased BUN [see Warnings and Precautions ( 5.3 )] • Acid base imbalance [see Warnings and Precautions ( 5.4 )] • Hepatobiliary disorders [see Warnings and Precautions ( 5.5 )] • Hyperammonemia [see Warnings and Precautions ( 5.6 )] • Aluminum toxicity [see Warnings and Precautions ( 5.7 )] • Monitoring and laboratory tests [see Warnings and Precautions ( 5.8 )] Manufactured and Distributed by: Exela Pharma Sciences, LLC Lenoir, NC 28645 Logo

Source: FDA Structured Product Labeling, mirrored from DailyMed / openFDA. Prefer the government’s original formatting? View this label on DailyMed ↗
← 51754-1007-01 · Exela 51754-1029-01 · EXELA →
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.