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CYSTEINE HYDROCHLORIDE 34.5 mg/mL Injection — NDC 00338-9645-01 package photo
Label image from the product's FDA listing (DailyMed) — may show a different pack size or an older label revision.

CYSTEINE HYDROCHLORIDE 34.5 mg/mL Injection — NDC 0338-9645-01 (Billing 00338-9645-01)

by Baxter Healthcare Corporation · 5 VIAL, SINGLE-DOSE in 1 CARTON / 10 mL in 1 VIAL, SINGLE-DOSE

This is a package of CYSTEINE HYDROCHLORIDE 34.5 mg/mL Injection from Baxter Healthcare Corporation, marketed since Apr 2022 and currently FDA-listed. It is this product's only package size.

NDC 00338-9645-01
🏷️ FDA NDC (as labeled) 0338-9645-01 billing pads the labeler segment with a zero
Rx only Brand On market Non-controlled ⇄ Compare with another NDC
🗂️ FDA directory synced Oct 1, 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 0338-9645-01 alone.

Record
FDA NDC Directory package listing · Human prescription drug
Code segments
0338 labeler · 9645 product · 01 package
Package marketed since
Apr 29, 2022
Sample package
No — commercial package
Listing certified through
Dec 31, 2027
Barcode (UPC-A, from the NDC)
3 0338964501 6
FDA record last changed
Jul 24, 2026
⚠️
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

Regulatory identifiers FDA, NLM and CMS codes for this package

FDA NDC (as labeled) 0338-9645-01
Product NDC 0338-9645
11-digit billing NDC 00338964501
RxCUI 1667993
UNII ZT934N0X4W
Application # NDA212535
SPL Set ID cbf70fc3-14b3-4c17-8de8-acba1e12ac95
DEA schedule Non-controlled
Marketing category NDA
Marketing status On market
FDA listing status Listed (active directory)
Marketing start 2022-04-29
Route INTRAVENOUS
Dosage form INJECTION
Substance CYSTEINE HYDROCHLORIDE
Quick answers
  • RxCUI (RxNorm): 1667993
Why two NDCs? The FDA registers this code as 0338-9645-01 — 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 → 00338-9645-01. 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.

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.

Pricing

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

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

Packaging — all sizes for this product

Package NDCDescription Marketing startMarketing endStatus
00338-9645-01 You're viewing this Main listing 5 VIAL, SINGLE-DOSE in 1 CARTON / 10 mL in 1 VIAL, SINGLE-DOSE 2022-04-29 — Active

Therapeutic equivalents

ProductLabelerPackNADAC/unitTEStatusPrice vs. this
Cysteine Hydrochloride 34.5 mg/mLthis 00338-9645-01 Baxter 5 vials — — FDA listed —
Elcys 10 mg/mL 51754-1007-01 Exela 10 ml — — 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
Dec 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 Mar 2039. This may affect when a full generic version becomes widely available, but it is not a guaranteed launch date.
📅 FDA approved Dec 13, 2019 RLD RS ⏳ ~12.4 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 10543186 — method of use (U-2722)
US 10478453 — method of use (U-2752)
US 10583155 — method of use (U-2752)
US 11510942 — method of use (U-2752)
US 11826383 — drug product
US 10905714 — drug product
US 11045438 — drug product
US 11642370 — drug product
US 10493051 — drug product
US 10918662 — drug product
US 12569514 — drug product
US 10702490 — drug product
US 11648262 — drug product
US 11510941 — drug product
US 11679125 — drug product
US 10653719 — drug product
US 10912795 — drug product
US 10933089 — drug product
US 10905713 — drug product
US 11684636 — 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 (20)
PatentTypeUse codeExpires
US 10543186 ↗ Method of use U-2722 Mar 15, 2039
US 10478453 ↗ Method of use U-2752 Jan 15, 2039
US 10583155 ↗ Method of use U-2752 Jan 15, 2039
US 11510942 ↗ Method of use U-2752 Jan 15, 2039
US 11826383 ↗ Drug product — Jan 15, 2039
US 10905714 ↗ Drug product — Jan 15, 2039
US 11045438 ↗ Drug product — Mar 15, 2039
US 11642370 ↗ Drug product — Jan 15, 2039
US 10493051 ↗ Drug product — Mar 15, 2039
US 10918662 ↗ Drug product — Jan 15, 2039
US 12569514 ↗ Drug product — Jan 15, 2039
US 10702490 ↗ Drug product — Mar 15, 2039
US 11648262 ↗ Drug product — Jan 15, 2039
US 11510941 ↗ Drug product — Mar 2, 2039
US 11679125 ↗ Drug product — Jan 15, 2039
US 10653719 ↗ Drug product — Jan 15, 2039
US 10912795 ↗ Drug product — Jan 15, 2039
US 10933089 ↗ Drug product — Jan 15, 2039
US 10905713 ↗ Drug product — Jan 15, 2039
US 11684636 ↗ 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 Mar 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.

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.

  • 0.006 mL / 1 mL 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

LabelerBaxter Healthcare Corporation
Application holderBAXTER HEALTHCARE CORP
FDA applicationNDA212535 (NDA)
Labeler code00338
First marketedApr 2022
Product typeHuman Prescription Drug
Portfolio283 products on file

More NDCs from Baxter Healthcare Corporation labeler code 00338

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 👥 Use in Specific Populations 🤰 Pregnancy 🧒 Pediatric Use 🆘 Overdosage 🧬 Clinical Pharmacology 🧬 Mechanism of Action 📦 How Supplied / Storage and Handling 📋 Description 💬 Information for Patients 📚 References 📄 Package Label / Principal Display Panel
🎯 Indications and Usage 81 words ▾

1 INDICATIONS AND USAGE Cysteine hydrochloride injection, USP is indicated for use as an additive to amino acids solutions to meet nutritional requirements of neonates (preterm and term infants less than one month of age) requiring total parenteral nutrition. Cysteine hydrochloride injection, USP is a sulfur-containing amino acid indicated for use as an additive to amino acids solutions to meet nutritional requirements of neonates (preterm and term infants less than one month of age) requiring total parenteral nutrition.

( 1 )

⏱️ Dosage and Administration ~3 min read ▾

2 DOSAGE AND ADMINISTRATION • Cysteine hydrochloride injection, USP is for intravenous infusion after dilution and admixing only. ( 2.1 ) • See full prescribing information for information on preparation, administration, and instructions for use. ( 2.1 , 2.2 , 2.3 , 2.4 ) • The recommended dosage in neonates is based upon the recommended daily protein (amino acid) requirements: 22 mg cysteine hydrochloride injection, USP/g amino acids.

The corresponding volume is 0.44 mL cysteine hydrochloride injection, USP/g amino acids. ( 2.5 )

2.1Important Administration Information Cysteine hydrochloride injection, USP is for intravenous infusion after dilution and admixing use only. Prior to administration, cysteine hydrochloride injection, USP must be diluted and used as an admixture in parenteral nutrition solutions. 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) ] .

2.2Preparation and Administration Information • Prior to administration, cysteine hydrochloride injection, USP must be diluted and used as an admixture in parenteral nutrition solutions. • Cysteine hydrochloride injection, USP 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. • Cysteine hydrochloride injection, USP is for addition to amino acid solutions prior to further admixing with dextrose injection using a parenteral nutrition container. • Calcium and phosphate ratios must be considered.

Excess addition of calcium and phosphate, especially in the form of mineral salts, may result in the formation of calcium phosphate precipitates [see Warnings and Precautions (5.1) ] . • Use a dedicated line for parenteral nutrition solutions. • Intravenous lipid emulsions can be infused concurrently into the same vein as cysteine hydrochloride injection, USP-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, 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. • Visually inspect the diluted parenteral nutrition solution containing cysteine hydrochloride injection, USP for particulate matter and discoloration before admixing, after admixing, after removal from refrigeration, 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 Container • Remove cysteine hydrochloride injection, USP vial from the carton and inspect for particulate matter. • Transfer the required amount of cysteine hydrochloride injection, USP to an amino acid solution using strict aseptic techniques to avoid microbial contamination. • The amino acid solution containing cysteine hydrochloride injection, USP can then be used to prepare admixtures in the parenteral nutrition container using strict aseptic techniques. • Amino acids solution containing cysteine hydrochloride injection, USP may be mixed with dextrose injection.

The following proper mixing sequence must be followed to minimize pH related problems: 1… [Excerpted — this section continues on DailyMed.]

💊 Dosage Forms and Strengths 40 words ▾

3 DOSAGE FORMS AND STRENGTHS Injection: 500 mg/10 mL (50 mg/mL) cysteine hydrochloride, USP as a clear, colorless, sterile solution in a single-dose vial. Injection: 500 mg/10 mL (50 mg/mL) cysteine hydrochloride, USP in a single-dose vial. ( 3 )

⛔ Contraindications 84 words ▾

4 CONTRAINDICATIONS Cysteine hydrochloride injection, USP 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 BUN 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 : Neurocognitive delay possible in infants; monitor liver function parameters and ammonia levels. ( 5.5 , 8.4 ) • Aluminum Toxicity : Increased risk in patients with renal impairment, including preterm infants. ( 5.6 , 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.

( 5.7 )

5.1Pulmonary Embolism due to Pulmonary Vascular Precipitates Pulmonary vascular precipitates causing pulmonary vascular emboli and pulmonary distress have been reported in patients receiving parenteral nutrition. 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 parenteral nutrition 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 Cysteine hydrochloride injection, USP must be diluted and used as an admixture in parenteral nutrition solutions. 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 cysteine hydrochloride injection, USP may result in metabolic acidosis in neonates. 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, including neonates, without preexisting liver disease who receive parenteral nutrition, 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. Instances of asymptoma… [Excerpted — this section continues on DailyMed.]

🤒 Adverse Reactions 199 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 Warning and Precautions (5.5) ] • Aluminum toxicity [see Warnings and Precautions (5.6) ] Adverse reactions with the use of cysteine hydrochloride injection were identified in clinical studies or postmarketing reports.

Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to estimate their frequency reliably or to establish a causal relationship to drug exposure. • Metabolic acidosis • 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, nausea, and metabolic acidosis.

( 6 ) To report SUSPECTED ADVERSE REACTIONS, contact Baxter Healthcare Corporation at 1-866-888-2472 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

👥 Use in Specific Populations ~1 min read ▾

8 USE IN SPECIFIC POPULATIONS

8.1Pregnancy Risk Summary Cysteine hydrochloride injection, USP for use as an additive to amino acid solutions to meet nutritional requirements is not indicated for use in adults. Appropriate administration of cysteine hydrochloride injection, USP 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.

8.2Lactation Risk Summary Cysteine hydrochloride injection, USP is used as an additive to amino acid solutions to meet nutritional requirements of neonates requiring total parenteral nutrition and is not indicated for use in adults. There are no data on the presence of cysteine hydrochloride in human or animal milk or the effects on milk production. Data available on the effects of cysteine hydrochloride on infants, either directly or through breastmilk, do not suggest a significant risk of adverse reactions from exposure.

8.4Pediatric Use Cysteine hydrochloride injection, USP is indicated for use as an additive to amino acid solutions to meet the nutritional requirements of neonates, including preterm infants, requiring total parenteral nutrition. The safety profile for cysteine hydrochloride injection, USP use in neonates includes risks of acid-base imbalance and hepatobiliary dysfunction. Acid-base imbalance, including metabolic acidosis, and liver dysfunction may occur with cysteine hydrochloride injection, USP administration in preterm infants.

Frequent clinical and laboratory assessments are necessary to monitor and manage fluid balance, electrolyte concentrations, liver tests, and acid-base balance during parenteral nutrition therapy [see Warnings and Precautions (5.4) ] . Hyperammonemia is of special significance in neonates. 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 during treatment [see Warnings and Precautions (5.5) ] . Because of immature renal function, neonates including preterm infants, receiving prolonged parenteral nutrition with cysteine hydrochloride injection, USP may be at higher risk of aluminum toxicity [see Warnings and Precautions (5.7) ] .

🤰 Pregnancy 60 words ▾

8.1Pregnancy Risk Summary Cysteine hydrochloride injection, USP for use as an additive to amino acid solutions to meet nutritional requirements is not indicated for use in adults. Appropriate administration of cysteine hydrochloride injection, USP 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.

🧒 Pediatric Use 178 words ▾

8.4Pediatric Use Cysteine hydrochloride injection, USP is indicated for use as an additive to amino acid solutions to meet the nutritional requirements of neonates, including preterm infants, requiring total parenteral nutrition. The safety profile for cysteine hydrochloride injection, USP use in neonates includes risks of acid-base imbalance and hepatobiliary dysfunction. Acid-base imbalance, including metabolic acidosis, and liver dysfunction may occur with cysteine hydrochloride injection, USP administration in preterm infants.

Frequent clinical and laboratory assessments are necessary to monitor and manage fluid balance, electrolyte concentrations, liver tests, and acid-base balance during parenteral nutrition therapy [see Warnings and Precautions (5.4) ] . Hyperammonemia is of special significance in neonates. 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 during treatment [see Warnings and Precautions (5.5) ] . Because of immature renal function, neonates including preterm infants, receiving prolonged parenteral nutrition with cysteine hydrochloride injection, USP may be at higher risk of aluminum toxicity [see Warnings and Precautions (5.7) ] .

🆘 Overdosage 31 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 )].

🧬 Clinical Pharmacology 60 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. Cysteine hydrochloride injection, USP provides cysteine to the systemic circulation of neonates who require parenteral nutrition and cannot synthesize adequate quantities of cysteine due to deficient cystathionase activity.

🧬 Mechanism of Action 57 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. Cysteine hydrochloride injection, USP provides cysteine to the systemic circulation of neonates who require parenteral nutrition and cannot synthesize adequate quantities of cysteine due to deficient cystathionase activity.

📦 How Supplied / Storage and Handling 106 words ▾

16 HOW SUPPLIED/STORAGE AND HANDLING Cysteine hydrochloride injection, USP (cysteine hydrochloride injection) is a clear, colorless, sterile and nonpyrogenic solution supplied as follows: 500 mg/10 mL (50 mg/mL) of cysteine hydrochloride, USP in single-dose vials (NDC 0338- 9645-01), packaged as 5 vials per carton (NDC 0338-9645-01) Store cysteine hydrochloride injection, USP at 20°C to 25°C (68°F to 77°F); excursions permitted to 15°C to 30°C (59°F to 86°F) [see USP Controlled Room Temperature]. Protect from light.

Avoid excessive heat. Protect from freezing. If accidentally frozen, discard the vial.

Vial stoppers are not made with natural rubber latex. For storage of admixed solution see Dosage and Administration (2.3)

📋 Description 186 words ▾

11 DESCRIPTION Cysteine hydrochloride injection, USP (cysteine hydrochloride injection) is a sterile, nonpyrogenic solution for intravenous use supplied as 500 mg/10 mL cysteine hydrochloride, USP in a single-dose vial. Each mL of cysteine hydrochloride injection, USP contains 50 mg of cysteine hydrochloride, (equivalent to 34.5 mg of cysteine), and 0.006 mL of hydrochloric acid (6M) in water for injection. Sodium hydroxide and/or hydrochloric acid are used as needed to adjust the pH.

The pH range of cysteine hydrochloride injection, USP is 1.0 to 1.5. The active ingredient is cysteine hydrochloride. The chemical name of cysteine hydrochloride is L-cysteine hydrochloride monohydrate.

Its molecular formula is C 3 H 7 NO 2 S • HCI • H 2 O and molecular weight is 175.63. The chemical structure of L-cysteine hydrochloride monohydrate is depicted below: Cysteine hydrochloride is a white crystalline powder soluble in water. Cysteine is a sulfur-containing amino acid and is prone to oxidation when exposed to air in aqueous solution, which may convert cysteine to insoluble cystine resulting in precipitation over time.

Cysteine hydrochloride injection, USP contains no more than 145 mcg/L of aluminum. Structural Formula

💬 Information for Patients 112 words ▾

17 PATIENT COUNSELING INFORMATION Inform caregivers or home healthcare providers of the following risks of cysteine hydrochloride injection, USP: • 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 Warning and Precautions (5.5) ] • Aluminum toxicity [see Warnings and Precautions (5.6) ] • Monitoring and laboratory tests [see Warnings and Precautions (5.7) ] Manufactured for: Baxter Healthcare Corporation, Deerfield, IL 60015, USA Baxter is a registered trademark of Baxter International Inc.

Rev. 04/22 07-19-00-4043

📚 References 18 words ▾

15 REFERENCES 1. Ayers P. et al. A.S.P.E.N. Parenteral Nutrition Handbook, 2nd ed. 2014 pg. 123 and 124.

📄 Package Label / Principal Display Panel ~2 min read ▾

PACKAGE/LABEL PRINCIPAL DISPLAY PANEL NDC 0338-9645-01 Rx only Cysteine hydrochloride injection, USP 500 mg/10 mL (50 mg/mL) Must be Diluted. For Intravenous Infusion Only Sterile 10 mL Single-Dose Vial Discard Unused Portion Each mL contains: 50 mg cysteine hydrochloride (equivalent to 34.5 mg of cysteine), and 0.006 mL of hydrochloric acid (6M) in water for injection. Sodium hydroxide and/or hydrochloric acid are used as needed to adjust the pH to 1.0 to 1.5.

Contains no more than 145 mcg/l of aluminum. Storage: Store at 20°C to 25°C (68°F to 77°F ), excursions permitted to 15° to 30°C (59°F to 86°F) [see USP Controlled Room Temperature]. Do not freeze.

Recommended Dosage: See prescribing information. Mfd. for Baxter Healthcare Corp Rev 03/22 07-09-00-1048 For Position Box Only LOT: XXXXXX EXP: YYYY-MM-DD NDC 0338-9645-01 Rx Only Cysteine hydrochloride injection, USP 500 mg/10 mL (50 mg/mL) Must be Diluted. For Intravenous Infusion Only 5 x 10 mL Single-Dose Vials – Discard Unused Portion Reserved for 2D barcode GTIN XXXXXXXXXXXXXX SN XXXXXXXXXXXXXX LOT XXXXXX EXP YYY-MD-DD NDC 0338-9645-01 Rx Only Cysteine hydrochloride injection, USP 500 mg/10 mL (50 mg/mL) Must be Diluted.

For Intravenous Infusion Only Contains no more than 145 mcg/L of aluminum Sterile 5 x 10 mL Single-Dose Vials – Discard Unused Portion 07-03-00-0794 Each mL of cysteine hydrochloride injection, USP contains: 50mg of cysteine hydrochloride (equivalent to 34.5 mg of cysteine), and 0.006 mL of hydrochloric acid (6M) in water for injection. Sodium hydroxide or hydrochloric acid are used as needed to adjust the pH. The pH range is 1.0 to 1.5.

Storage: Store at 20°C to 25°C (68°F to 77°F ), excursions permitted to 15°C to 30°C (59°F to 86°F ) [see USP Controlled Room Temperature]. Protect from light. Avoid excessive heat.

Protect from freezing. If accidently frozen, discard the vial. Directions for Use: For single use only.

Discard unused portion of the vial of cysteine hydrochloride injection, USP. Use parenteral nutrition solution containing cysteine hydrochloride injection, USP promptly after mixing. Any storage of the admixture should be under refrigeration at 2°C to 8°C (36°F to 46°F) and limited to brief period of time, no longer than 24 hours.

After removal from refrigeration, inspect for precipitates, use promptly, and complete the infusion within 24 hours. Discard if any precipitates are observed. Discard any remaining admixture.

Protect parenteral nutrition solution from light. Recommended Dosage: See prescribing information. NDC 0338-9645-01 Cysteine hydrochloride injection, USP 500 mg/10 mL (50 mg/mL) Must be Diluted.

For Intravenous Infusion Only Contains no more than 145 mcg/L of aluminum 5 x 10 mL Single-Dose Vials- Discard Unused Portion For Position Only Box Baxter Baxter is a registered trademark of Baxter International Inc. Manufactured for Baxter Healthcare Corporation, Deerfield, IL 60015, USA Rev 03/2022 Representative Container Label Representative Carton Label

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

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 Cysteine hydrochloride — the ingredient across all brands.

Top reported reactions

Parenteral Nutrition Associated Liver Disease50
Cholestasis9
Liver Function Test Abnormal9
Condition Aggravated8
Hallucination5
Bacterial Infection4
Blood Bilirubin Increased4

Age at onset

Neonate51
Infant2
Child1
Adult3
Elderly5

Reporter sex

111 reports
Male · 60%
Female · 40%

Serious outcomes

Hospitalization50
Death6
Disabling1
Reports over time (by year) — tap or hover for the count & year
2023 2024 2025 2026 3 1
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) — 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 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 Baxter Healthcare Corporation. Listing status can change — the directory data on this page refreshes weekly.
Who lists this product with the FDA?
Baxter Healthcare Corporation 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.
← 00338-9644-12 · Baxter 00338-9646-24 · Baxter →
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.