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Hetastarch in Sodium Chloride 6 g/100mL Injection, Solution — NDC 0409-7248-03 (Billing 00409-7248-03)

by Hospira, Inc. · 12 CONTAINER in 1 CASE / 500 mL in 1 CONTAINER

This is a package of Hetastarch in Sodium Chloride 6 g/100mL Injection, Solution from Hospira, Inc., marketed since Feb 2005 and currently FDA-listed. It is this product's only package size.

NDC 00409-7248-03
🏷️ FDA NDC (as labeled) 0409-7248-03 billing pads the labeler segment with a zero
Rx only Generic 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
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Compiled from public FDA, CMS, DailyMed, NADAC, and related drug data sources. Editorial policy

NDC database record

One package, one record: these facts belong to NDC 0409-7248-03 alone.

Record
FDA NDC Directory package listing · Human prescription drug
Code segments
0409 labeler · 7248 product · 03 package
Package marketed since
Feb 28, 2005
Sample package
No — commercial package
Listing certified through
Dec 31, 2027
Barcode (UPC-A, from the NDC)
3 0409724803 2
FDA record last changed
Jul 24, 2026

Identity & classification

Regulatory identifiers FDA, NLM and CMS codes for this package

FDA NDC (as labeled) 0409-7248-03
Product NDC 0409-7248
11-digit billing NDC 00409724803
NCPDP billing unit ML — per mL (volume)
RxCUI 310757
UNII 875Y4127EA
Application # BA740193
SPL Set ID d64f961a-3e1f-4b04-cf83-604474af2775
Established class (EPC) Plasma Volume Expander
Mechanism of action Osmotic Activity
Physiologic effect Increased Intravascular Volume
Chemical class Starch
DEA schedule Non-controlled
Marketing category ANDA
Marketing status On market
FDA listing status Listed (active directory)
Marketing start 2005-02-28
Route INTRAVENOUS
Dosage form INJECTION, SOLUTION
Substance HETASTARCH

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

GPI-14 85300010202020
GPI class Hetastarch-NaCl
GCN Seq No 006342
GCN 88080
HICL code 002737
Ingredient (HICL) Hetastarch In 0.9 % Nacl
HIC1 code M
Therapeutic class — broad (HIC1) Blood
HIC2 code M0
Therapeutic class — intermediate (HIC2) Blood And Blood Replacement Preparations
HIC3 code M0D
Therapeutic class — specific (HIC3) Plasma Expanders
AHFS code 40:12.00.00
AHFS class Replacement Preparations
FDB label name HETASTARCH 6%-0.9% NACL BAG
FDB brand name Hetastarch-0.9% Nacl
Legend status F — Federal legend — prescription drug or device
Quick answers
  • GSN (GCN sequence number): 006342
  • GCN: 88080
  • GPI-14 (Medi-Span): 85300010202020
  • HICL (First Databank): 002737
  • AHFS class code: 40:12.00.00
  • RxCUI (RxNorm): 310757
Why two NDCs? The FDA registers this code as 0409-7248-03 — 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 → 00409-7248-03. 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 Plasma Volume Expander class.

Pharmacologic class Plasma Volume Expander
Drug family (ATC) Blood substitutes and plasma protein fractions
How it works Osmotic Activity
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 HETASTARCH 6%-0.9% NACL BAG Ingredient Hetastarch In 0.9 % Nacl

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 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
00409-7248-03 You're viewing this Main listing 12 CONTAINER in 1 CASE / 500 mL in 1 CONTAINER 2005-02-28 — Active

Therapeutic equivalents

ProductLabelerPackNADAC/unitTEStatusPrice vs. this
Hextend 6 g/100mL 00409-1555-54 Hospira, 500 ml — — FDA listed —
Hetastarch in Sodium Chloride 6 g/100mLthis 00409-7248-03 Hospira, 500 ml — — FDA listed —
6% Hetastarch In 0.9% Sodium Chloride 6 g/100mL 51662-1317-01 HF 500 ml — — FDA listed —
About this product: this is a generic version of the medicine. FDA equivalence ratings are shown when available, and other versions are listed above, least expensive first.
Where does this data come from?
Equivalents are other NDCs of the same ingredient, form and route from the openFDA NDC Directory, ranked least-expensive-first by NADAC. Therapeutic-equivalence (AB) ratings come from the FDA Orange Book; biologics use the FDA Purple Book for biosimilar & interchangeable status.

Availability & generic status

🏛️
2005
On the market since
Feb 2005
📍
2026
Currently FDA-listed
21 years listed
🔓
·
Generic on the market
this product is a generic
✅This is a generic drug

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

Where does this data come from?
Patents and exclusivity from the FDA Orange Book (small-molecule drugs), refreshed from public FDA data. Generic launch timing is an estimate, not a guarantee.

Inactive Ingredients / Excipients

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

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.

Manufacturer & labeler

LabelerHospira, Inc.
FDA applicationBA740193 (ANDA)
Labeler code00409
First marketedFeb 2005
Product typeHuman Prescription Drug
Portfolio317 products on file

More NDCs from Hospira, Inc. labeler code 00409

The labeler markets the product; the application holder owns the FDA approval. They’re often the same company but can differ (e.g. a repackager or an authorized generic). A mailing address / phone appears here when the manufacturer includes it in the product’s FDA label (not all do).
Where does this data come from?
Labeler, application holder and registered establishment from the FDA openFDA NDC Directory and Drugs@FDA; address/contact from the product’s FDA label.

Full prescribing information FDA SPL

The complete FDA label for this product — the official prescribing information, verbatim, section by section. Very long sections are excerpted here and marked; the full text is on DailyMed (linked in the sources below). Jump with a chip, search within the label, or expand everything.
🚨 Boxed Warning 🎯 Indications and Usage ⏱️ Dosage and Administration 💊 Dosage Forms and Strengths ⛔ Contraindications ⚠️ Warnings and Cautions 🤒 Adverse Reactions 🔄 Drug Interactions 👥 Use in Specific Populations 🤰 Pregnancy 🧒 Pediatric Use 🧬 Clinical Pharmacology 🧬 Mechanism of Action 📦 How Supplied / Storage and Handling 📋 Description 🍼 Nursing Mothers 🧬 Pharmacokinetics 🧬 Pharmacodynamics 🔬 Clinical Studies 🧪 Nonclinical Toxicology 📄 Carcinogenesis, Mutagenesis, Impairment of Fertility 📚 References 📄 Package Label / Principal Display Panel
🚨 Boxed Warning 126 words ▾

WARNING: MORTALITY; KIDNEY INJURY; COAGULOPATHY • Use of hydroxyethyl starch (HES) products, including 6% Hetastarch in 0.9% Sodium Chloride Injection, increases risk of o Mortality o Kidney injury ( 5.1 ) o Coagulopathy ( 5.2 ) • DO NOT use HES products, including 6% Hetastarch in 0.9% Sodium Chloride Injection, unless adequate alternative treatment is unavailable. ( 1 ) WARNING: MORTALITY; KIDNEY INJURY; COAGULOPATHY See full prescribing information for complete boxed warning. • Use of hydroxyethyl starch (HES) products, including 6% Hetastarch in 0.9% Sodium Chloride Injection, increases risk of o Mortality o Kidney injury ( 5.1 ) o Coagulopathy ( 5.2 ) • DO NOT use HES products, including 6% Hetastarch in 0.9% Sodium Chloride Injection, unless adequate alternative treatment is unavailable.

( 1 )

🎯 Indications and Usage 142 words ▾

1 INDICATIONS AND USAGE 6% Hetastarch in 0.9% Sodium Chloride Injection is indicated in the treatment of hypovolemia when plasma volume expansion is desired in settings where adequate alternative treatment is unavailable. It is not a substitute for blood or plasma. The adjunctive use of 6% Hetastarch in 0.9% Sodium Chloride Injection in leukapheresis has also been shown to be safe and efficacious in improving the harvesting and increasing the yield of granulocytes by centrifugal means. • 6% Hetastarch in 0.9% Sodium Chloride Injection is a hetastarch indicated for treatment of hypovolemia when plasma volume expansion is desired in settings where adequate alternative treatment is unavailable.

( 1 ) • 6% Hetastarch in 0.9% Sodium Chloride Injection in leukapheresis has shown to be safe and efficacious in improving the harvesting and increasing the yield of granulocytes by centrifugal means. ( 1 )

⏱️ Dosage and Administration ~3 min read ▾

2 DOSAGE AND ADMINISTRATION Dosage for Acute Use in Plasma Volume Expansion 6% Hetastarch in 0.9% Sodium Chloride Injection is administered by intravenous infusion only. Total dosage and rate of infusion depend upon the amount of blood or plasma lost and the resultant hemoconcentration. For intravenous use only.

Recommended Dosage Dose Adults ( 2.1 ) 500 to 1000 mL Leukapheresis ( 2.2 ) 250 to 700 mL of 6% Hetastarch in 0.9% Sodium Chloride Injection with citrate anticoagulant is added to the input line of the centrifugation apparatus.

2.1Adults The amount usually administered is 500 to 1000 mL. Doses of more than 1500 mL per day for the typical 70 kg patient (approximately 20 mL per kg of body weight) are usually not required. Higher doses have been reported in postoperative and trauma patients where severe blood loss has occurred [see Warnings and Precautions (5) ].

2.2Leukapheresis 250 to 700 mL of 6% Hetastarch in 0.9% Sodium Chloride Injection with citrate anticoagulant is administered by aseptic addition to the input line of the centrifugation apparatus at a ratio of 1:8 to 1:13 to venous whole blood. The 6% Hetastarch in 0.9% Sodium Chloride Injection and citrate should be thoroughly mixed to assure effective anticoagulation of blood as it flows through the leukapheresis machine.

2.3Direction for use for 6% Hetastarch in 0.9% Sodium Chloride Injection • Do not use plastic container in series connection. If administration is controlled by a pumping device, care must be taken to discontinue pumping action before the container runs dry or air embolism may result. If administration is not controlled by a pumping device, refrain from applying excessive pressure (>300mmHg) causing distortion to the container such as wringing or twisting.

Such handling could result in breakage of the container. • Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration whenever solution and container permit. Use only if solution is clear and container and seals are intact. • Intended for intravenous administration using sterile equipment. It is recommended that intravenous administration apparatus be replaced at least once every 24 hours. • Withdraw or expel all air from the bag through the medication port prior to infusion if administration is by pressure infusion. • For single use only.

The solution contains no bacteriostat, antimicrobial agent or added buffers (except for pH adjustment) and is intended only for single-dose injection. When smaller doses are required the unused portion should be discarded. CAUTION: Before administering to the patient, review these directions: Visual Inspection • Do not remove the plastic infusion container from its overwrap until immediately before use. • Inspect each container.

Read the label. Ensure solution is the one ordered and is within the expiration date. • Invert container and carefully inspect the solution in good light for cloudiness, haze, or particulate matter. • Any container which is suspect should not be used. To Open 1.

Tear overwrap down at notch and remove solution container. 2. Check for minute leaks by squeezing solution container firmly.

3. If any leaks are found, discard solution as sterility may be impaired. Preparation for Administration 1.

Remove plastic protector from sterile set port at bottom of container. 2. Attach administration set.

Refer to complete directions accompanying set. When stored at room temperature, 6% Hetastarch in 0.9% Sodium Chloride Injection admixtures of 500–560 mL with citrate concentrations up to 2.5% were compatible for 24 hours. The safety and compatibility of additives other than citrate have not been established.

💊 Dosage Forms and Strengths 33 words ▾

3 DOSAGE FORMS AND STRENGTHS Single-dose container: • 30 g hetastarch in 500 mL of 0.9% sodium chloride injection. • 30 g hetastarch in 500 mL 0.9% sodium chloride injection. ( 3 )

⛔ Contraindications 41 words ▾

4 CONTRAINDICATIONS Do not use HES products, including 6% Hetastarch in 0.9% Sodium Chloride Injection, unless adequate alternative treatment is unavailable. • Do not use HES products, including 6% Hetastarch in 0.9% Sodium Chloride Injection, unless adequate alternative treatment is unavailable.

⚠️ Warnings and Cautions ~3 min read ▾

5 WARNINGS AND PRECAUTIONS • Avoid use in patients with pre-existing renal dysfunction ( 5.1 ) • Increased risk of mortality and acute kidney injury (AKI) in critically ill patients, including patients with sepsis; surgical patients; and blunt trauma patients ( 5.1 ) • Discontinue use of 6% Hetastarch in 0.9% Sodium Chloride Injection at the first sign of renal injury ( 5.1 ) • Continue to monitor renal function for at least 90 days as use of RRT has been reported up to 90 days after administration of HES products, including 6% Hetastarch in 0.9% Sodium Chloride Injection ( 5.1 ) • 6% Hetastarch in 0.9% Sodium Chloride Injection is not recommended for use as a cardiac bypass pump prime, while the patient is on cardiopulmonary bypass, or in the immediate period after the pump has been discontinued because of the risk of increasing coagulation abnormalities and bleeding in patients whose coagulation status is already impaired.

Discontinue use of 6% Hetastarch in 0.9% Sodium Chloride Injection at first sign of coagulopathy ( 5.2 ) • Monitor liver function in patients receiving HES products, including 6% Hetastarch in 0.9% Sodium Chloride Injection ( 5.2 )

5.1Mortality and Renal Dysfunction • Critically ill patients, including patients with sepsis, are at increased risk of mortality and acute kidney injury (AKI), including need for renal replacement therapy (RRT) • Surgery patients are at increased risk of mortality and AKI • Blunt trauma patients are at increased risk of mortality and AKI • Avoid use in patients with pre-existing renal dysfunction • Discontinue use of 6% Hetastarch in 0.9% Sodium Chloride Injection at the first sign of renal injury • Continue to monitor renal function for at least 90 days as use of RRT has been reported up to 90 days after administration of HES products, including 6% Hetastarch in 0.9% Sodium Chloride Injection

5.2Coagulopathy • 6% Hetastarch in 0.9% Sodium Chloride Injection is not recommended for use as a cardiac bypass pump prime, while the patient is on cardiopulmonary bypass, or in the immediate period after the pump has been discontinued because of the risk of increasing coagulation abnormalities and bleeding in patients whose coagulation status is already impaired. Monitor the coagulation status of surgery patients, as excess bleeding has been reported with HES solutions in this population. Discontinue use of 6% Hetastarch in 0.9% Sodium Chloride Injection at first sign of coagulopathy 1–2 6% Hetastarch in 0.9% Sodium Chloride Injection has not been adequately evaluated to establish its safety in uses over extended periods other than leukapheresis.

6% Hetastarch in 0.9% Sodium Chloride Injection has been associated with coagulation abnormalities in conjunction with an acquired, reversible von Willebrand's-like syndrome and/or Factor VIII deficiency when used over a period of days. Replacement therapy should be considered if a severe Factor VIII deficiency is identified. If a coagulopathy develops, it may take several days to resolve.

Certain conditions may affect the safe use of 6% Hetastarch in 0.9% Sodium Chloride Injection on a chronic basis. For example, in patients with subarachnoid hemorrhage where 6% Hetastarch in 0.9% Sodium Chloride Injection is used repeatedly over a period of days for the prevention of cerebral vasospasm, significant clinical bleeding may occur. Intracranial bleeding resulting in death has been reported.

3 Slight declines in platelet counts and hemoglobin levels have been observed in donors undergoing repeated leukapheresis procedures using 6% Hetastarch in 0.9% Sodium Chloride Injection due to the volume expanding effects of hetastarch and to the collection of platelets and erythrocytes. Hemoglobin levels usually return to normal within 24 hours. Hemodilution by 6% Hetastarch in 0.9% Sodium Chloride Injection may also result in 24 hour declines of total protein, albumin, calcium, and fibrinogen levels.

Regular and frequent clinical evaluation and complete blo… [Excerpted — this section continues on DailyMed.]

🤒 Adverse Reactions ~3 min read ▾

6 ADVERSE REACTIONS Serious adverse reactions reported in postmarket clinical trials include increased mortality and AKI (including need for RRT) in critically ill subjects, including subjects with sepsis, and surgical subjects. Clinical trials have also shown increased mortality and AKI in blunt trauma subjects. Increased coagulopathy was reported in surgical subjects.

Most common adverse reactions are hypersensitivity, coagulopathy, hemodilution, circulatory overload and metabolic acidosis. • Most common adverse reactions are hypersensitivity, coagulopathy, hemodilution, circulatory overload and metabolic acidosis. ( 6.2 ) To report SUSPECTED ADVERSE REACTIONS, contact Hospira, Inc. at 1-800-441-4100 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. (Note: All of the studies listed below used licensed HES products except for reference 4.) A randomized controlled trial (N=804) in severe sepsis patients using HES product (not approved in the U.S.) reported increased mortality (relative risk, 1.17; 95% CI, 1.01 to 1.36; p=0.03) and RRT (relative risk, 1.35; 95% CI, 1.01 to 1.80; p=0.04) in the HES treatment arm.

4 Another randomized controlled trial (N=196) using different HES in severe sepsis patients reported no difference in mortality (relative risk, 1.20; 95% CI, 0.83 to 1.74; p=0.33) and a trend for RRT (relative risk, 1.83; 95% CI, 0.93 to 3.59; p=0.06) in HES patients. 5 A randomized controlled trial (N=7000) using different HES in a heterogeneous patient population consisting of critically ill adult patients admitted to the ICU reported no difference in mortality (relative risk, 1.06; 95% CI, 0.96 to 1.18; p=0.26) but increased use of RRT (relative risk, 1.21; 95% CI, 1.00 to 1.45; p=0.04) in HES patients.

6 In a retrospective study of adult patients (N=1442) undergoing pulmonary or esophageal surgery who were prophylactically fluid restricted during the procedure, 74 developed AKI (5.1%) within the first 72 hours postoperatively. Fluid restriction neither increased nor was a risk factor for AKI. AKI occurred more often when HES products were administered to patients with decreased renal function or having >2 risk factors with normal renal function, whereas restriction of crystalloid was unrelated to AKI, regardless of preoperative renal function.

12 In a retrospective case series of high-risk adult vascular surgery patients (N=796) receiving fluid therapy during a vascular surgery procedure, logistic regression analysis using prespecified confounding variables or suspected risk factors for AKI showed that intraoperative administration of an HES product was associated with increased likelihood of 30-day mortality and need for RRT, compared with use of crystalloids alone. 13 In a retrospective study of adult subjects undergoing elective noncardiac surgery, patients (N=14,680) receiving an HES product and crystalloid were propensity-matched with patients (N=14,680) receiving only crystalloid.

After controlling for potential confounding variables, odds of experiencing AKI of severe intensity with HES was 21% greater than with crystalloid alone. In addition, AKI risk increased as a function of HES volume. 14 In a prospective observational study assessing the impact of HES products on recipient renal graft outcomes in brain-dead organ donors, data were obtained on 986 kidneys transplanted from 529 donors.

Kidneys from donors who received HES had a higher rate of delayed graft function in recipient subjects (41% versus 31%). After accounting for the propensity of donors to receive HES products, HES product administration was independently associated with an increased risk of delayed graft function in recipients. A dose response relatio… [Excerpted — this section continues on DailyMed.]

🔄 Drug Interactions 72 words ▾

7 DRUG INTERACTIONS 6% Hetastarch in 0.9% Sodium Chloride Injection should be used with caution in patients who have been anticoagulated with other drugs that negatively influence the coagulation system. • The safety and compatibility of other additives have not been established. • Use with caution with drugs that negatively influence the coagulation system. ( 7 ) • The safety and compatibility of other additives have not been established. ( 7 )

👥 Use in Specific Populations ~1 min read ▾

8 USE IN SPECIFIC POPULATIONS

8.1Pregnancy Hetastarch has been shown to have an embryocidal effect on New Zealand rabbits when given intravenously over the entire organogenesis period in a daily dose 1/2 times the maximum recommended therapeutic human dose (1500 mL) and on BD rats when given intraperitoneally, from the 16th to the 21st day of pregnancy, in a daily dose 2.3 times the maximum recommended therapeutic human dose. When hetastarch was administered to New Zealand rabbits, BD rats, and swiss mice with intravenous daily doses of 2 times, 1/3 times, and 1 times the maximum recommended therapeutic human dose respectively over several days during the period of gestation, no evidence of teratogenicity was evident.

There are no adequate and well-controlled studies in pregnant women. 6% Hetastarch in 0.9% Sodium Chloride Injection should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus.

8.3Nursing Mothers It is not known whether hetastarch is excreted in human milk. Because many drugs are excreted in human milk, caution should be exercised when 6% Hetastarch in 0.9% Sodium Chloride Injection is administered to a nursing woman.

8.4Pediatric Use The safety and effectiveness of hetastarch in pediatric patients have not been established. Adequate, well-controlled clinical trials to establish the safety and effectiveness of 6% Hetastarch in 0.9% Sodium Chloride Injection in pediatric patients have not been conducted.

🤰 Pregnancy 145 words ▾

8.1Pregnancy Hetastarch has been shown to have an embryocidal effect on New Zealand rabbits when given intravenously over the entire organogenesis period in a daily dose 1/2 times the maximum recommended therapeutic human dose (1500 mL) and on BD rats when given intraperitoneally, from the 16th to the 21st day of pregnancy, in a daily dose 2.3 times the maximum recommended therapeutic human dose. When hetastarch was administered to New Zealand rabbits, BD rats, and swiss mice with intravenous daily doses of 2 times, 1/3 times, and 1 times the maximum recommended therapeutic human dose respectively over several days during the period of gestation, no evidence of teratogenicity was evident.

There are no adequate and well-controlled studies in pregnant women. 6% Hetastarch in 0.9% Sodium Chloride Injection should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus.

🧒 Pediatric Use 41 words ▾

8.4Pediatric Use The safety and effectiveness of hetastarch in pediatric patients have not been established. Adequate, well-controlled clinical trials to establish the safety and effectiveness of 6% Hetastarch in 0.9% Sodium Chloride Injection in pediatric patients have not been conducted.

🧬 Clinical Pharmacology ~1 min read ▾

12 CLINICAL PHARMACOLOGY

12.1Mechanism of Action The plasma volume expansion produced by 6% Hetastarch in 0.9% Sodium Chloride Injection approximates that of 5% Albumin (Human). Intravenous infusion of 6% Hetastarch in 0.9% Sodium Chloride Injection results in expansion of plasma volume.

12.2Pharmacodynamics 6% Hetastarch in 0.9% Sodium Chloride Injection results in expansion of plasma volume that decreases over the succeeding 24 to 36 hours. The degree of plasma volume expansion and improvement in hemodynamic state depend upon the patient's intravascular status.

12.3Pharmacokinetics Hetastarch molecules below 50,000 molecular weight are rapidly eliminated by renal excretion. A single dose of approximately 500 mL of 6% Hetastarch in 0.9% Sodium Chloride Injection (approximately 30 g) results in elimination in the urine of approximately 33% of the dose within 24 hours. This is a variable process but generally results in an intravascular hetastarch concentration of less than 10% of the total dose injected by two weeks.

A study of the biliary excretion of 6% Hetastarch in 0.9% Sodium Chloride Injection in 10 healthy males accounted for less than 1% of the dose over a 14 day period. The hydroxyethyl group is not cleaved by the body but remains intact and attached to glucose units when excreted. Significant quantities of glucose are not produced as hydroxyethylation prevents complete metabolism of the smaller polymers.

The addition of hetastarch to whole blood increases the erythrocyte sedimentation rate. Therefore, 6% Hetastarch in 0.9% Sodium Chloride Injection is used to improve the efficiency of granulocyte collection by centrifugal means.

🧬 Mechanism of Action 39 words ▾

12.1Mechanism of Action The plasma volume expansion produced by 6% Hetastarch in 0.9% Sodium Chloride Injection approximates that of 5% Albumin (Human). Intravenous infusion of 6% Hetastarch in 0.9% Sodium Chloride Injection results in expansion of plasma volume.

📦 How Supplied / Storage and Handling 86 words ▾

16 HOW SUPPLIED/STORAGE AND HANDLING 6% Hetastarch in 0.9% Sodium Chloride Injection is supplied sterile and nonpyrogenic in 500 mL single-dose flexible plastic containers. Unit of Sale Concentration NDC 0409-7248-03 Case containing 12 Flexible Plastic Containers 30 g Hetastarch/500 mL (6 g Hetastarch/100 mL) Exposure of pharmaceutical products to heat should be minimized. Avoid excessive heat.

Protect from freezing. Store at 20 to 25°C (68 to 77°F). [See USP Controlled Room Temperature.] Rx only Distributed by Hospira, Inc., Lake Forest, IL 60045 USA LAB-1287-6.0 Hospira logo

📋 Description ~2 min read ▾

11 DESCRIPTION 6% Hetastarch in 0.9% Sodium Chloride Injection is a sterile, nonpyrogenic solution for intravenous administration. Each 100 mL contains: Hetastarch............................................................................ 6 g Sodium Chloride, USP........................................................

0.9g Water for Injection, USP..................................................... qs pH adjusted with Sodium Hydroxide, NF if necessary Concentration of Electrolytes (mEq/L): Sodium (Na + ) 154, Chloride (Cl - ) 154 (not including ions for pH adjustment). pH: 5.5 (3.5 to 7.0) Total osmolar concentration is 308 mOsmol/liter (calc). Hetastarch is a synthetic colloid derived from a waxy starch composed almost entirely of amylopectin. Hydroxyethyl ether groups are introduced into the glucose units of the starch, and the resultant material is hydrolyzed to yield a product with a molecular weight suitable for use as a plasma volume expander and erythrocyte sedimenting agent.

The molar substitution is approximately 0.75 which means hetastarch has an average of approximately 75 hydroxyethyl groups for every 100 glucose units. The weight average molecular weight is approximately 670,000 with a range of 550,000 to 800,000 and with at least 80% of the polymers falling within the range of 20,000 to 2,500,000. Hydroxyethyl groups are attached by ether linkage primarily at C-2 of the glucose unit and to a lesser extent at C-3 and C-6.

The polymer resembles glycogen, and the polymerized D-glucose units are joined primarily by α-1,4 linkages with occasional α-1,6 branching linkages. The degree of branching is approximately 1:20 which means that there is one 1–6 branch for every 20 glucose monomer units. The chemical name for hetastarch is hydroxyethyl starch.

The structural formula is as follows: Amylopectin derivative in which R 2 , R 3 , and R 6 are H or CH 2 CH 2 OH, or R 6 is a branching point in the starch polymer connected through a 1-6 linkage to additional alpha-D-glucopyranosyl units. Hetastarch is an artificial colloid pharmacologically classified as a plasma volume expander; 0.9% Sodium Chloride Injection is a fluid and electrolyte replenisher. 6% Hetastarch in 0.9% Sodium Chloride Injection is a clear, pale yellow to amber solution.

Exposure to prolonged adverse storage conditions may result in a change to a turbid deep brown or the formation of a crystalline precipitate. Do not use the solution if these conditions are evident. The flexible plastic container is fabricated from a specially formulated polyvinylchloride.

Water can permeate from inside the container into the overwrap but not in amounts sufficient to affect the solution significantly. Solutions in contact with the plastic container may leach out certain chemical components from the plastic in very small amounts; however, biological testing was supportive of the safety of the plastic container materials. Exposure to temperatures above 25°C/77°F during transport and storage will lead to minor losses in moisture content.

Higher temperatures lead to greater losses. It is unlikely that these minor losses will lead to clinically significant changes within the expiration period. structural formula hetastarch

🍼 Nursing Mothers 40 words ▾

8.3Nursing Mothers It is not known whether hetastarch is excreted in human milk. Because many drugs are excreted in human milk, caution should be exercised when 6% Hetastarch in 0.9% Sodium Chloride Injection is administered to a nursing woman.

🧬 Pharmacokinetics 170 words ▾

12.3Pharmacokinetics Hetastarch molecules below 50,000 molecular weight are rapidly eliminated by renal excretion. A single dose of approximately 500 mL of 6% Hetastarch in 0.9% Sodium Chloride Injection (approximately 30 g) results in elimination in the urine of approximately 33% of the dose within 24 hours. This is a variable process but generally results in an intravascular hetastarch concentration of less than 10% of the total dose injected by two weeks.

A study of the biliary excretion of 6% Hetastarch in 0.9% Sodium Chloride Injection in 10 healthy males accounted for less than 1% of the dose over a 14 day period. The hydroxyethyl group is not cleaved by the body but remains intact and attached to glucose units when excreted. Significant quantities of glucose are not produced as hydroxyethylation prevents complete metabolism of the smaller polymers.

The addition of hetastarch to whole blood increases the erythrocyte sedimentation rate. Therefore, 6% Hetastarch in 0.9% Sodium Chloride Injection is used to improve the efficiency of granulocyte collection by centrifugal means.

🧬 Pharmacodynamics 41 words ▾

12.2Pharmacodynamics 6% Hetastarch in 0.9% Sodium Chloride Injection results in expansion of plasma volume that decreases over the succeeding 24 to 36 hours. The degree of plasma volume expansion and improvement in hemodynamic state depend upon the patient's intravascular status.

🔬 Clinical Studies ~2 min read ▾

14 CLINICAL STUDIES Surgical Patients Comparative Studies In randomized, controlled, comparative studies of 6% Hetastarch in 0.9% Sodium Chloride Injection (n=92) and Albumin (n=85) in surgical patients, no patient in either treatment group had a bleeding complication and no significant difference was found in the amount of blood loss between the treatment groups. 7-10 Pediatric Postoperative Volume Expander Study In one small double-blind study, 47 infants, children, and adolescents (ages 1 year to 15.5 years) scheduled for repair of congenital heart disease with moderate hypothermia were randomized to receive either 6% Hetastarch in 0.9% Sodium Chloride Injection or Albumin as a postoperative volume expander during the first 24 hours after surgery.

Thirty-eight children required colloid replacement therapy, of which 20 children received 6% Hetastarch in 0.9% Sodium Chloride Injection. No differences were found in the coagulation parameters or in the amount of replacement fluids required in the children receiving 20 mL/kg or less of either colloid replacement therapy. In children who received greater than 20 mL/kg of 6% Hetastarch in 0.9% Sodium Chloride Injection, an increase in prothrombin time was demonstrated (p=0.006).

11 There were no neonates included in this study [see Use in Specific Populations (8.4) ]. Adult Critically Ill Studies Three randomized controlled trials (RCTs) followed critically ill adult patients treated with different HES products for 90 days. One trial (N=804) in severe sepsis patients using HES product (not approved in the U.S.) reported increased mortality (relative risk, 1.17; 95% CI, 1.01 to 1.36; p=0.03) and RRT (relative risk, 1.35; 95% CI, 1.01 to 1.80; p=0.04) in the HES treatment arm.

4 Another trial (N=196) using different HES in severe sepsis patients reported no difference in mortality (relative risk,1.20; 95% CI, 0.83 to 1.74; p=0.33) and a trend for RRT (relative risk, 1.83; 95% CI, 0.93 to 3.59; p=0.06) in HES patients. 5 A third trial (N=7000) using different HES in a heterogeneous patient population consisting of critically ill adult patients admitted to the ICU reported no difference in mortality (relative risk, 1.06; 95% CI, 0.96 to 1.18; p=0.26) but increased use of RRT (relative risk, 1.21; 95% CI, 1.00 to 1.45; p=0.04) in HES patients.

6

🧪 Nonclinical Toxicology 24 words ▾

13 NONCLINICAL TOXICOLOGY

13.1Carcinogenesis, Mutagenesis, Impairment of Fertility Long-term studies of animals have not been performed to evaluate the carcinogenic potential of hetastarch.

📄 Carcinogenesis, Mutagenesis, Impairment of Fertility 21 words ▾

13.1Carcinogenesis, Mutagenesis, Impairment of Fertility Long-term studies of animals have not been performed to evaluate the carcinogenic potential of hetastarch.

📚 References ~3 min read ▾

15 REFERENCES 1. Knutson JE., et al., Does Intraoperative Hetastarch Administration Increase Blood Loss and Transfusion Requirements After Cardiac Surgery? Anesthesia Analg ., 2000;90:801–7.

2. Cope JT., et al., Intraoperative Hetastarch Infusion Impairs Hemostasis After Cardiac Operations. The Annals of Thoracic Surgery , 1997;63:78–83.

3. Damon L., Intracranial Bleeding During Treatment with Hydroxyethyl Starch. New England Journal of Medicine , 1987;317(15):964–965.

4. Perner A, et al., Hydroxyethyl starch 130/0.42 versus Ringer's acetate in severe sepsis patients. The New England Journal of Medicine , 2012 July 12;367(2):124–34.

5. Guidet B, et al., Assessment of hemodynamic efficacy and safety of 6% hydroxyethyl starch 130/0.4 vs 0.9% NaCl fluid replacement in patients with severe sepsis: The CRYSTMAS Study. Critical Care , 2012 May 24;16(3):R94.

6. Myburgh JA, et al., Hydroxyethyl starch or saline for fluid resuscitation in intensive care. The New England Journal of Medicine , 2012 November 15;367(20):1901–11.

7. Diehl J., et al., Clinical Comparison of Hetastarch and Albumin in Postoperative Cardiac Patients. The Annals of Thoracic Surgery , 1982;34(6):674–679.

8. Gold M., et al., Comparison of Hetastarch to Albumin for Perioperative Bleeding in Patients Undergoing Abdominal Aortic Aneurysm Surgery. Annals of Surgery , 1990;211(4):482–485.

9. Kirklin J., et al., Hydroxyethyl Starch versus Albumin for Colloid Infusion Following Cardiopulmonary Bypass in Patients Undergoing Myocardial Revascularization. The Annals of Thoracic Surgery , 1984;37(1):40–46.

10. Moggio RA., et al., Hemodynamic Comparison of Albumin and Hydroxyethyl Starch in Postoperative Cardiac Surgery Patients. Critical Care Medicine , 1983;11(12):943–945.

11. Brutocao D., et al., Comparison of Hetastarch with Albumin for Postoperative Volume Expansion in Children After Cardiopulmonary Bypass. Journal of Cardiothoracic and Vascular Anesthesia , 1996;10(3):348–351.

12. Ahn HJ, Kim JA, Lee AR, et al. The risk of acute kidney injury from fluid restriction and hydroxyethyl starch in thoracic surgery.

Anesth Analg 2016; 122(1):186–193. 13. Green RS, Butler MB, Hicks SD, et al.

Effect of hydroxyethyl starch on outcomes in high-risk vascular surgery patients: A retrospective analysis. J Cardiothorac Vasc Anesth 2016; 30(4):967–72. 14.

Kashy BK, Podolyak A, Makarova N, et al. Effect of hydroxyethyl starch on postoperative kidney function in patients having noncardiac surgery. Anesthesiology 2014; 121 (4):730–9.

15. Patel MS, Niemann CU, Sally MB, et al. The impact of hydroxyethyl starch use in deceased organ donors on the development of delayed graft function in kidney transplant recipients: A Propensity-Adjusted Analysis.

Am J of Transplant 2015; 15 (8):2152–8. 16. Rasmussen KC, Johansson PI, Højskov M, et al.

Hydroxyethyl starch reduces coagulation competence and increases blood loss during major surgery: results from a randomized controlled trial. Ann Surg 2014; 259 (2):249–54. 17.

Bayer O, Schwarzkopf D, Doenst T, et al. Perioperative fluid therapy with tetrastarch and gelatin in cardiac surgery — a prospective sequential analysis. Crit Care Med 2013; 41(11):2532–42.

18. Lagny MG, Roediger L, Koch JN, et al. Hydroxyethyl starch 130/0.4 and the risk of acute kidney injury after cardiopulmonary bypass: A single-center retrospective study.

J of Cardiothorac and Vasc Anesth 2016: 30(4):869–75. 19. Wilkes MM, Navickis RJ.

Postoperative renal replacement therapy after hydroxyethyl starch infusion: a meta-analysis of randomized trials. Neth J Crit Care 2014; 18:4–9. 20.

Allen CJ, Valle EJ, Jouria JM, et al. Differences between blunt and penetrating trauma after resuscitation with HES. J Trauma Acute Care Surg 2014; 77(6):859–64.

21. Eriksson M, Brattström O, Mårtensson J, et al. Acute kidney injury following severe trauma: Risk factors and long-term outcome.

J Trauma Acute Care Surg 2015; 79(3):407–12.

📄 Package Label / Principal Display Panel ~1 min read ▾

PRINCIPAL DISPLAY PANEL - 500 mL Bag 500 mL NDC 0409-7248-13 6% HETASTARCH in 0.9% Sodium Chloride Injection For intravenous use only EACH 100 mL CONTAINS HETASTARCH, 6 g AND SODIUM CHLORIDE 0.9 g IN WATER FOR INJECTION. MAY CONTAIN SODIUM HYDROXIDE FOR pH ADJUSTMENT. ELECTROLYTES (mEq/L): SODIUM 154, CHLORIDE 154.

308 mOsmol/LITER (calc). pH 5.5 (3.5 TO 7.0). IF ADMINISTRATION IS BY PRESSURE INFUSION, ALL AIR SHOULD BE WITHDRAWN OR EXPELLED FROM THE BAG THROUGH THE MEDICATION PORT PRIOR TO INFUSION. STERILE, NONPYROGENIC.

SINGLE-DOSE CONTAINER. DISCARD UNUSED PORTION. USE ONLY IF SOLUTION IS CLEAR.

USUAL DOSAGE: SEE INSERT. STORE AT 20 TO 25°C (68 TO 77°F). [SEE USP CONTROLLED ROOM TEMPERATURE.] PROTECT FROM FREEZING. SEE INSERT.

DO NOT INTRODUCE ADDITIVES INTO THIS CONTAINER Rx ONLY 3 V CONTAINS DEHP DISTRIBUTED BY HOSPIRA, INC., LAKE FOREST, IL 60045 USA Hospira IM-4487 14477801 PRINCIPAL DISPLAY PANEL - 500 mL Bag

PRINCIPAL DISPLAY PANEL - 500 mL Bag Overwrap 2 HDPE TO OPEN TEAR AT NOTCH DO NOT REMOVE FROM OVERWRAP UNTIL READY FOR USE. AFTER REMOVING THE OVERWRAP, CHECK FOR MINUTE LEAKS BY SQUEEZING CONTAINER FIRMLY. IF LEAKS ARE FOUND, DISCARD SOLUTION AS STERILITY MAY BE IMPAIRED.

RECOMMENDED STORAGE: ROOM TEMPERATURE (25°C). AVOID EXCESSIVE HEAT. PROTECT FROM FREEZING.

SEE INSERT. IM-4498 Not Made With Natural Rubber Latex 14622100 PRINCIPAL DISPLAY PANEL - 500 mL Bag Overwrap

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 Hetastarch in Sodium Chloride (this brand).

Top reported reactions

Bradycardia34
Hypotension33
Live Birth32
Stevens-johnson Syndrome14
Toxic Epidermal Necrolysis13
Rash10
Drug Interaction9

Age at onset

Neonate1
Adolescent1
Adult10
Elderly2

Reporter sex

0 reports

Serious outcomes

Hospitalization54
Life-threatening34
Death25
Disabling1
Reports over time (by year) — tap or hover for the count & year
2019 2021 2023 2026 18 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.

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.
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“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 Hospira, Inc.. Listing status can change — the directory data on this page refreshes weekly.
Who lists this product with the FDA?
Hospira, Inc. is the labeler of record for this NDC — the company under whose FDA-assigned code the package is listed. The labeler may be the manufacturer itself or a distributor marketing the product under its own code.
Do I need a prescription for this product?
This NDC is listed with FDA as a prescription product, so it is dispensed under a prescriber's order. Your pharmacist can tell you whether any over-the-counter forms of the same medication exist.
This page identifies an FDA-listed package (the NDC) and reports public regulatory and pricing data about the listing. It is reference information, not a medical recommendation — talk to your pharmacist or prescriber about your own medication.
Where does this data come from?
Listing facts (marketing category, packager status, marketing dates) from the FDA openFDA NDC Directory; label availability from DailyMed; pricing coverage from CMS NADAC; equivalence scope from the FDA Orange Book.
← 00409-7101-02 · Hospira, 00409-7299-25 · Hospira, →
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.