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Norepinephrine 16 ug/mL Solution — NDC 81298-9659-03 package photo
Label image from the product's FDA listing (DailyMed) — may show a different pack size or an older label revision.

Norepinephrine 16 ug/mL Solution — NDC 81298-9659-3 (Billing 81298-9659-03)

by Long Grove Pharmaceuticals, LLC · 10 POUCH in 1 BOX / 1 BAG in 1 POUCH / 250 mL in 1 BAG

This is a package of Norepinephrine 16 ug/mL Solution from Long Grove Pharmaceuticals, LLC, marketed since Feb 2024 and currently FDA-listed. It is this product's only package size.

NDC 81298-9659-03
🏷️ FDA NDC (as labeled) 81298-9659-3 billing pads the package 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 81298-9659-3 alone.

Record
FDA NDC Directory package listing · Human prescription drug
Code segments
81298 labeler · 9659 product · 3 package
Package marketed since
Feb 2, 2024
Sample package
No — commercial package
Listing certified through
Dec 31, 2026
Barcode (UPC-A, from the NDC)
3 8129896593 7
FDA record last changed
Jul 24, 2026
⚠️
Other active recalls for Norepinephrine Bitartrate (different manufacturers) — 1 · tap to view
These affect other manufacturers’ products for the same ingredient — not necessarily the exact NDC on this page.
Class II · Jan 23, 2024 — Incorrect product concentration on the overwrap label: The overwrap label incorrectly identified the product strength as 4 mg / 250 mL; however, the primary bag label correctly identified the product strength as 8 mg / 250 mL. (Baxter Healthcare Corporation) · FDA recall D-0336-2024
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) 81298-9659-3
Product NDC 81298-9659
11-digit billing NDC 81298965903
NCPDP billing unit ML — per mL (volume)
RxCUI 2475337, 2475340, 2619579
UNII IFY5PE3ZRW
Application # NDA214628
SPL Set ID 759807dd-61a8-4f6f-8bf5-f6ee773c81bc
Established class (EPC) Catecholamine
Chemical class Catecholamines
DEA schedule Non-controlled
Marketing category NDA
Marketing status On market
FDA listing status Listed (active directory)
Marketing start 2024-02-02
Route INTRAVENOUS
Dosage form SOLUTION
Substance NOREPINEPHRINE BITARTRATE

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

GCN Seq No 065223
GCN 24137
HICL code 036346
Ingredient (HICL) Norepinephrine Bit/0.9 % Nacl
HIC1 code J
Therapeutic class — broad (HIC1) Autonomic Nervous System
HIC2 code J5
Therapeutic class — intermediate (HIC2) Adrenergics
HIC3 code J5A
Therapeutic class — specific (HIC3) Adrenergic Agents,Catecholamines
AHFS code 12:12.12.00
AHFS class Alpha- And Beta-Adrenergic Agonists
FDB label name NOREPINEPHR 4 MG/250-0.9% NACL
FDB brand name Norepinephrine Bitar-0.9% Nacl
Legend status F — Federal legend — prescription drug or device
Quick answers
  • GSN (GCN sequence number): 065223
  • GCN: 24137
  • HICL (First Databank): 036346
  • AHFS class code: 12:12.12.00
  • RxCUI (RxNorm): 2475337
Why two NDCs? The FDA registers this code as 81298-9659-3 — a 5-4-1 layout, and that's what's printed on the package and shown on DailyMed. For insurance claims, every NDC is standardized to a uniform 11-digit 5-4-2 format by adding a zero to the package segment → 81298-9659-03. 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 Catecholamine class.

Pharmacologic class Catecholamine
Drug family (ATC) Adrenergic and dopaminergic agents
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 NOREPINEPHR 4 MG/250-0.9% NACL Ingredient Norepinephrine Bit/0.9 % Nacl
📖 What it is MedlinePlus · NLM

Norepinephrine is used to increase low blood pressure. Norepinephrine is in a class of medications called adrenergic agents. It works by constricting blood vessels in the body and improving the pumping action of the heart.

Read the full MedlinePlus article ↗
📗 Our plain-language guide HelloPharmacist
  • It raises blood pressure when it has dropped dangerously low, such as in severe, sudden hypotension. It is given in a hospital setting. Some older product labels also list use as a...
  • It is given through an IV drip into a large vein by trained staff. Your team adjusts the rate to your blood pressure and lowers it slowly when it's time to stop.
  • The most common ones are high blood pressure, slow heart rate, anxiety, headache and trouble breathing. Tell your nurse right away about pain, swelling or skin changes at the IV si...
  • Yes. MAO inhibitors, linezolid and tricyclic antidepressants can cause severe, prolonged high blood pressure. It can also raise blood sugar, so diabetes medicines may need adjustin...
📖 Read our full Norepinephrine guide →

Supplement & herbal interactions

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

Pricing

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

Price systemPer 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
81298-9659-03 You're viewing this Main listing 10 POUCH in 1 BOX / 1 BAG in 1 POUCH / 250 mL in 1 BAG 2024-02-02 — Active

Therapeutic equivalents

ProductLabelerPackNADAC/unitTEStatusPrice vs. this
Norepinephrine Bitartrate 4 mg/250mL 00338-0040-20 Baxter 250 ml — — FDA listed —
Norepinephrine Bitartrate 4 mg/250mL 00338-0112-20 Baxter 250 ml — — FDA listed —
Norepinephrine Bitartrate In Sodium Chloride .016 mg/mL 44567-0640-10 WG 250 ml — — FDA listed —
Norepinephrine 16 ug/mLthis 81298-9659-03 Long 10 pouches — — FDA listed —
About this product: this is the brand-name version. Some generic versions are approved by the FDA, but we could not confirm current pharmacy availability from our pricing/market data.
Where does this data come from?
Equivalents are other NDCs of the same ingredient, form and route from the openFDA NDC Directory, ranked least-expensive-first by NADAC. Therapeutic-equivalence (AB) ratings come from the FDA Orange Book; biologics use the FDA Purple Book for biosimilar & interchangeable status.

Availability & generic status

🏛️
2022
First FDA approval
Oct 2022
📍
2026
Currently FDA-listed
4 years listed
🛡️
2038
Latest patent/protection listed
not a guaranteed launch date
🔒Generic approved by FDA, but pharmacy availability is not confirmed

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

🛡️ Latest patent/protection date listed: FDA patent/protection data lists protections through Jan 2038. This may affect when a full generic version becomes widely available, but it is not a guaranteed launch date.
📅 FDA approved Oct 6, 2022 RLD RS ⏳ ~11.3 yr to latest listed protection

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

Patents & exclusivity — FDA Orange Book
US 11413259 — method of use (U-3461)
US 11413259 — method of use (U-3461)
US 11413259 — method of use (U-3461)
US 10420735 — method of use (U-3461)
US 10420735 — method of use (U-3461)
US 10420735 — method of use (U-3461)
US 10226436 — method of use (U-3461)
US 10226436 — method of use (U-3461)
US 10226436 — method of use (U-3461)
US 10568850 — drug product
US 12245996 — drug product
US 10159657 — drug product
US 10568850 — drug product
US 12245996 — drug product
US 10568850 — drug product
US 10159657 — drug product
US 11602508 — drug product
US 10159657 — drug product
US 12245996 — drug product
US 11602508 — drug product
US 11602508 — drug product
2022 2024 2026 2028 2030 2032 2034 2036 2038
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 (21)
PatentTypeUse codeExpires
US 11413259 ↗ Method of use U-3461 Jan 30, 2038
US 11413259 ↗ Method of use U-3461 Jan 30, 2038
US 11413259 ↗ Method of use U-3461 Jan 30, 2038
US 10420735 ↗ Method of use U-3461 Jan 30, 2038
US 10420735 ↗ Method of use U-3461 Jan 30, 2038
US 10420735 ↗ Method of use U-3461 Jan 30, 2038
US 10226436 ↗ Method of use U-3461 Jan 30, 2038
US 10226436 ↗ Method of use U-3461 Jan 30, 2038
US 10226436 ↗ Method of use U-3461 Jan 30, 2038
US 10568850 ↗ Drug product — Jan 30, 2038
US 12245996 ↗ Drug product — Jan 30, 2038
US 10159657 ↗ Drug product — Jan 30, 2038
US 10568850 ↗ Drug product — Jan 30, 2038
US 12245996 ↗ Drug product — Jan 30, 2038
US 10568850 ↗ Drug product — Jan 30, 2038
US 10159657 ↗ Drug product — Jan 30, 2038
US 11602508 ↗ Drug product — Jan 30, 2038
US 10159657 ↗ Drug product — Jan 30, 2038
US 12245996 ↗ Drug product — Jan 30, 2038
US 11602508 ↗ Drug product — Jan 30, 2038
US 11602508 ↗ Drug product — Jan 30, 2038
Common questions
Is there a generic version of NOREPINEPHR 4 MG/250-0.9% NACL?
Yes — an FDA-approved generic equivalent is listed in the FDA Orange Book for NOREPINEPHR 4 MG/250-0.9% NACL. See the alternatives section for substitutable, lower-cost products.
The FDA approved a generic — why can’t I get it at my pharmacy yet?
FDA approval and pharmacy availability are two different things. The FDA can approve a generic years before it actually reaches pharmacies, because the brand company may still hold patents or have a settlement that delays the launch. A manufacturer also has to choose to make and sell it, and have supply ready. So a drug can be “FDA-approved generic exists” and still be brand-only at the counter today.
Why do different websites show different generic release dates?
Generic availability is not based on one single date. Some sources use the first exclusivity expiration, some use the last product patent, and others use the latest method-of-use patent. Patent challenges, settlements, licenses, and label carve-outs can also change the real-world launch date. This page shows the underlying Orange Book dates so you can see why estimates may differ.
What does “FDA listed” mean?
It means the product appears in the FDA’s official NDC directory. That’s a good sign a product exists and is intended for the U.S. market, but on its own it does not confirm a pharmacy can fill it today. Where we have recent retail pricing data (NADAC) for a product, we label it “Availability likely” instead.
What does a patent or protection date mean here?
It’s the latest date currently listed in the FDA Orange Book for a patent or exclusivity on the brand product. It can affect when a full generic version becomes widely available — but it is not a guaranteed generic launch date. Generics sometimes arrive earlier (through a settlement or patent challenge) or later (a manufacturer still has to make and sell one).
What does “current Orange Book estimate” mean?
It means we are using the latest patent and exclusivity dates currently listed in the FDA Orange Book. It is not a guaranteed launch date.
Can a generic come out before the last patent expires?
Sometimes. A generic company may challenge a patent, settle with the brand manufacturer, receive a license, or obtain approval with a narrower label that avoids a patented use. In other cases, the last listed protection may delay full-label generic competition.
Can a generic come out after the listed dates?
Yes. Even after patents or exclusivity expire, a generic still needs FDA approval and a manufacturer must choose to market it. Supply, litigation, business decisions, or regulatory issues can delay actual availability.
What is the difference between patents and exclusivity?
Patents are legal protections usually issued by the U.S. Patent and Trademark Office. FDA exclusivity is marketing protection granted by the FDA. They are separate, and either one can affect generic timing.
Why are there multiple patent dates?
One drug can have several patents covering different things: the active ingredient, a formulation, a manufacturing process, or a specific approved use. That is why a page may show several expiration dates instead of one simple generic date.
Built from FDA Orange Book patent and exclusivity data. Dates are refreshed from public FDA data when available; the marker is max(latest patent expiry, latest exclusivity expiry). Paragraph-IV settlements and first-filer 180-day exclusivity can shift the real date; a method-of-use patent may allow an earlier skinny-label generic for non-protected indications. Generic launch timing is an estimate, not a guarantee.
Where does this data come from?
Patents and exclusivity from the FDA Orange Book (small-molecule drugs), refreshed from public FDA data. Generic launch timing is an estimate, not a guarantee.

Inactive Ingredients / Excipients

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

💡 Tap an ingredient (hover on desktop) to see what it is and why it’s used.

  • UNII 7FLD91C86K
    Edetate disodium is a chemical compound that binds and removes certain metal ions. In medicines, it acts as a preservative and stabilizer by preventing metals like calcium from interfering with the product's shelf life and consistency.
  • 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 451W47IQ8X
    Sodium chloride is common table salt. It's used in medicines as a buffer to maintain proper pH, as a filler to add bulk, or to adjust the osmotic balance in liquid formulations.
  • 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.

5 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

LabelerLong Grove Pharmaceuticals, LLC
Application holderLONG GROVE PHARMACEUTICALS LLC
FDA applicationNDA214628 (NDA)
Labeler code81298
First marketedFeb 2024
Product typeHuman Prescription Drug
Portfolio14 products on file

More NDCs from Long Grove Pharmaceuticals, LLC labeler code 81298

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

Full prescribing information FDA SPL

The complete FDA label for this product — the official prescribing information, verbatim, section by section. Very long sections are excerpted here and marked; the full text is on DailyMed (linked in the sources below). Jump with a chip, search within the label, or expand everything.
🎯 Indications and Usage ⏱️ Dosage and Administration 💊 Dosage Forms and Strengths ⛔ Contraindications ⚠️ Warnings and Cautions 🤒 Adverse Reactions 🔄 Drug Interactions 👥 Use in Specific Populations 🤰 Pregnancy 🧒 Pediatric Use 🧓 Geriatric Use 🆘 Overdosage 🧬 Clinical Pharmacology 🧬 Mechanism of Action 📦 How Supplied / Storage and Handling 📋 Description 💬 Information for Patients 🧬 Pharmacokinetics 🧬 Pharmacodynamics 🧪 Nonclinical Toxicology 📄 Carcinogenesis, Mutagenesis, Impairment of Fertility 📄 Package Label / Principal Display Panel
🎯 Indications and Usage 46 words ▾

1 INDICATIONS AND USAGE Norepinephrine in Sodium Chloride Injection is indicated to raise blood pressure in adult patients with severe, acute hypotension. Norepinephrine in Sodium Chloride Injection is a catecholamine indicated for restoration of blood pressure in adult patients with acute hypotensive states. ( 1 )

⏱️ Dosage and Administration ~2 min read ▾

2 DOSAGE AND ADMINISTRATION No further dilution prior to infusion is required ( 2.1 ) Initial intravenous infusion rate of 8 to 12 mcg per minute, adjust the rate of flow to establish and maintain a low to normal blood pressure (usually 80 to 100 mm Hg) sufficient to maintain the circulation of vital organs ( 2.2 ) The average maintenance dose ranges from 2 to 4 mcg per minute. ( 2.2 )

2.1Important Dosage and Administration Instructions Correct Hypovolemia Address hypovolemia before initiation of Norepinephrine in Sodium Chloride Injection therapy. If the patient does not respond to therapy, suspect occult hypovolemia [see Warnings and Precautions ( 5.1 )] . Administration Infuse Norepinephrine in Sodium Chloride Injection into a large vein.

Avoid infusions into the veins of the leg in the elderly or in patients with occlusive vascular disease of the legs [see Warnings and Precautions ( 5.1 )] . Avoid using a catheter-tie-in technique. Inspect parenteral drug products for particulate matter and discoloration prior to use, whenever solution and container permit.

Do not open the aluminum foil pouch until time of use. The premixed, ready-to-use infusion bag has a single port for insertion of the infusion set only. Do not use this port to remove content from the bag or add another medication.

Once the infusion bag has been connected to the infusion set, it is stable for 24 hours for intermittent or continuous use, as long as the bag stays connected to the infusion set. Discontinuation When discontinuing the infusion, reduce the flow rate gradually. Avoid abrupt withdrawal.

Single dose only. Discard unused portion.

2.2Dosage After an initial dose of 8 to 12 mcg per minute via intravenous infusion, assess patient response and adjust dosage to maintain desired hemodynamic effect. Monitor blood pressure every two minutes or continuously until the desired hemodynamic effect is achieved, and then monitor blood pressure every five minutes for the duration of the infusion. Recommended Average Maintenance Dosage: Typical maintenance intravenous dosage is 2 to 4 mcg per minute.

2.3Drug Incompatibilities Avoid contact with iron salts and alkalizing and oxidizing agents. Whole blood or plasma, if indicated to increase blood volume, should be administered separately.

💊 Dosage Forms and Strengths 101 words ▾

3 DOSAGE FORMS AND STRENGTHS Injection: Norepinephrine is a clear, colorless sterile solution in the premixed, ready-to-use single dose intravenous infusion bags available as: 4 mg/250 mL (16 mcg/mL) of norepinephrine in 0.9% Sodium Chloride 8 mg/250 mL (32 mcg/mL) of norepinephrine in 0.9% Sodium Chloride 16 mg/250 mL (64 mcg/mL) of norepinephrine in 0.9% Sodium Chloride Injection: in a single dose infusion bags with - 4 mg/250 mL (16 mcg/mL) of norepinephrine in 0.9% Sodium Chloride - 8 mg/250 mL (32 mcg/mL) of norepinephrine in 0.9% Sodium Chloride - 16 mg/250 mL (64 mcg/mL) of norepinephrine in 0.9% Sodium Chloride

⛔ Contraindications 7 words ▾

4 CONTRAINDICATIONS None. None. ( 4 )

⚠️ Warnings and Cautions ~2 min read ▾

5 WARNINGS AND PRECAUTIONS Tissue Ischemia : Avoid extravasation into tissues, which can cause local necrosis ( 5.1 ) Hypotension After Abrupt Discontinuation : Sudden cessation of the infusion rate may result in marked hypotension. Reduce the Norepinephrine in Sodium Chloride Injection infusion rate gradually. ( 5.2 ) Cardiac Arrhythmias : Norepinephrine in Sodium Chloride Injection may cause arrhythmias.

Monitor cardiac function in patients with underlying heart disease. ( 5.3 )

5.1Tissue Ischemia Administration of Norepinephrine in Sodium Chloride Injection to patients who are hypotensive from hypovolemia can result in severe peripheral and visceral vasoconstriction, decreased renal perfusion and reduced urine output, tissue hypoxia, lactic acidosis, and reduced systemic blood flow despite “normal” blood pressure. Address hypovolemia prior to initiating Norepinephrine in Sodium Chloride Injection [see Dosage and Administration ( 2.1 )] . Avoid Norepinephrine in Sodium Chloride Injection in patients with mesenteric or peripheral vascular thrombosis, as this may increase ischemia and extend the area of infarction.

Gangrene of the extremities has occurred in patients with occlusive or thrombotic vascular disease or who received prolonged or high dose infusions. Monitor for changes to the skin of the extremities in susceptible patients. Extravasation of Norepinephrine in Sodium Chloride Injection may cause necrosis and sloughing of surrounding tissue.

To reduce the risk of extravasation, infuse into a large vein, check the infusion site frequently for free flow, and monitor for signs of extravasation [see Dosage and Administration ( 2.1 )] . Emergency Treatment of Extravasation To prevent sloughing and necrosis in areas in which extravasation has occurred, infiltrate the ischemic area as soon as possible, using a syringe with a fine hypodermic needle with 5 to 10 mg of phentolamine mesylate in 10 mL to 15 mL of 0.9% Sodium Chloride Injection in adults. Sympathetic blockade with phentolamine causes immediate and conspicuous local hyperemic changes if the area is infiltrated within 12 hours.

5.2Hypotension after Abrupt Discontinuation Sudden cessation of the infusion rate may result in marked hypotension. When discontinuing the infusion, gradually reduce the Norepinephrine in Sodium Chloride Injection infusion rate while expanding blood volume with intravenous fluids.

5.3Cardiac Arrhythmias Norepinephrine in Sodium Chloride Injection elevates intracellular calcium concentrations and may cause arrhythmias, particularly in the setting of hypoxia or hypercarbia. Perform continuous cardiac monitoring of patients with arrhythmias.

🤒 Adverse Reactions 108 words ▾

6 ADVERSE REACTIONS The following adverse reactions are described in greater detail in other sections: Tissue Ischemia [see Warnings and Precautions ( 5.1 )] Hypotension [see Warnings and Precautions ( 5.2 )] Cardiac Arrhythmias [see Warnings and Precautions ( 5.3 )] The most common adverse reactions are hypertension and bradycardia. The following adverse reactions can occur: Nervous system disorders: Anxiety, headache Respiratory disorders: Respiratory difficulty, pulmonary edema Most common adverse reactions are ischemic injury, bradycardia, anxiety, transient headache, respiratory difficulty, and extravasation necrosis at injection site.

( 6 ) To report SUSPECTED ADVERSE REACTIONS, contact Long Grove Pharmaceuticals LLC at 1-855-642-2594 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch .

🔄 Drug Interactions 201 words ▾

7 DRUG INTERACTIONS Monoamine oxidase inhibitors (MAOI) or antidepressants of the triptyline or imipramine types may result in hypertension. ( 7.1 ) Cyclopropane and halothane anesthetics increase cardiac autonomic irritability. ( 7.4 )

7.1MAO-Inhibiting Drugs Co-administration of Norepinephrine in Sodium Chloride Injection with monoamine oxidase (MAO) inhibitors or other drugs with MAO-inhibiting properties (e.g., linezolid) can cause severe, prolonged hypertension. If administration of Norepinephrine in Sodium Chloride Injection cannot be avoided in patients who recently have received any of these drugs and in whom, after discontinuation, MAO activity has not yet sufficiently recovered, monitor for hypertension.

7.2Tricyclic Antidepressants Co-administration of Norepinephrine in Sodium Chloride Injection with tricyclic antidepressants (including amitriptyline, nortriptyline, protriptyline, clomipramine, desipramine, imipramine) can cause severe, prolonged hypertension. If administration of Norepinephrine in Sodium Chloride Injection cannot be avoided in these patients, monitor for hypertension.

7.3Antidiabetics Norepinephrine in Sodium Chloride Injection can decrease insulin sensitivity and raise blood glucose. Monitor glucose and consider dosage adjustment of antidiabetic drugs.

7.4Halogenated Anesthetics Concomitant use of Norepinephrine in Sodium Chloride Injection with halogenated anesthetics (e.g., cyclopropane, desflurane, enflurane, isoflurane, and sevoflurane) may lead to ventricular tachycardia or ventricular fibrillation. Monitor cardiac rhythm in patients receiving concomitant halogenated anesthetics.

👥 Use in Specific Populations ~3 min read ▾

8 USE IN SPECIFIC POPULATIONS Elderly patients may be at greater risk of developing adverse reactions. ( 8.5 )

8.1Pregnancy Risk Summary Limited published data consisting of a small number of case reports and multiple small trials involving the use of norepinephrine in pregnant women at the time of delivery have not identified an increased risk of major birth defects, miscarriage or adverse maternal or fetal outcomes. There are risks to the mother and fetus from hypotension associated with septic shock, myocardial infarction and stroke which are medical emergencies in pregnancy and can be fatal if left untreated (see Clinical Considerations ) .

In animal reproduction studies, using high doses of intravenous norepinephrine resulted in lowered maternal placental blood flow. Clinical relevance to changes in the human fetus is unknown since the average maintenance dose is ten times lower (see Data ) . Increased fetal reabsorptions were observed in pregnant hamsters after receiving daily injections at approximately 2 times the maximum recommended dose on a mg/m 2 basis for four days during organogenesis (see Data ) .

The estimated background risk for major birth defects and miscarriage for the indicated population is unknown. All pregnancies have a background risk of birth defect, loss, or other adverse outcomes. In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2-4% and 15-20%, respectively.

Clinical Considerations Disease-associated maternal and/or embryo/fetal risk Hypotension associated with septic shock, myocardial infarction, and stroke are medical emergencies in pregnancy which can be fatal if left untreated. Delaying treatment in pregnant women with hypotension associated with septic shock, myocardial infarction and stroke may increase the risk of maternal and fetal morbidity and mortality. Life-sustaining therapy for the pregnant woman should not be withheld due to potential concerns regarding the effects of norepinephrine on the fetus.

Data Animal Data A study in pregnant sheep receiving high doses of intravenous norepinephrine (40 mcg/min, at approximately 10 times the average maintenance dose of 2-4 mcg/min in human, on a mg/kg basis) exhibited a significant decrease in maternal placental blood flow. Decreases in fetal oxygenation, urine and lung liquid flow were also observed. Norepinephrine administration to pregnant rats on Gestation Day 16 or 17 resulted in cataract production in rat fetuses.

In hamsters, an increased number of resorptions (29.1% in study group vs. 3.4% in control group), fetal microscopic liver abnormalities and delayed skeletal ossification were observed at approximately 2 times the maximum recommended intramuscular or subcutaneous dose (on a mg/m 2 basis at a maternal subcutaneous dose of 0.5 mg/kg/day from Gestation Day 7-10).

8.2Lactation Risk Summary There are no data on the presence of norepinephrine in either human or animal milk, the effects on the breastfed infant, or the effects on milk production. Clinically relevant exposure to the infant is not expected based on the short half-life and poor oral bioavailability of norepinephrine.

8.4Pediatric Use Safety and effectiveness in pediatric patients have not been established.

8.5Geriatric Use Clinical studies of Norepinephrine in Sodium Chloride Injection did not include sufficient numbers of subjects aged 65 and over to determine whether they respond differently from younger subjects. Other reported clinical experience has not identified differences in responses between the elderly and younger patients. In general, dose selection for an elderly patient should be cautious, usually starting at the low end of the dosing range, reflecting the greater frequency of decreased hepatic, renal, or cardiac function, and of concomitant disease or other drug therapy.

Avoid administration of Norepinephrine in Sodium Chloride Injection into the veins in the leg i… [Excerpted — this section continues on DailyMed.]

🤰 Pregnancy ~2 min read ▾

8.1Pregnancy Risk Summary Limited published data consisting of a small number of case reports and multiple small trials involving the use of norepinephrine in pregnant women at the time of delivery have not identified an increased risk of major birth defects, miscarriage or adverse maternal or fetal outcomes. There are risks to the mother and fetus from hypotension associated with septic shock, myocardial infarction and stroke which are medical emergencies in pregnancy and can be fatal if left untreated (see Clinical Considerations ) .

In animal reproduction studies, using high doses of intravenous norepinephrine resulted in lowered maternal placental blood flow. Clinical relevance to changes in the human fetus is unknown since the average maintenance dose is ten times lower (see Data ) . Increased fetal reabsorptions were observed in pregnant hamsters after receiving daily injections at approximately 2 times the maximum recommended dose on a mg/m 2 basis for four days during organogenesis (see Data ) .

The estimated background risk for major birth defects and miscarriage for the indicated population is unknown. All pregnancies have a background risk of birth defect, loss, or other adverse outcomes. In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2-4% and 15-20%, respectively.

Clinical Considerations Disease-associated maternal and/or embryo/fetal risk Hypotension associated with septic shock, myocardial infarction, and stroke are medical emergencies in pregnancy which can be fatal if left untreated. Delaying treatment in pregnant women with hypotension associated with septic shock, myocardial infarction and stroke may increase the risk of maternal and fetal morbidity and mortality. Life-sustaining therapy for the pregnant woman should not be withheld due to potential concerns regarding the effects of norepinephrine on the fetus.

Data Animal Data A study in pregnant sheep receiving high doses of intravenous norepinephrine (40 mcg/min, at approximately 10 times the average maintenance dose of 2-4 mcg/min in human, on a mg/kg basis) exhibited a significant decrease in maternal placental blood flow. Decreases in fetal oxygenation, urine and lung liquid flow were also observed. Norepinephrine administration to pregnant rats on Gestation Day 16 or 17 resulted in cataract production in rat fetuses.

In hamsters, an increased number of resorptions (29.1% in study group vs. 3.4% in control group), fetal microscopic liver abnormalities and delayed skeletal ossification were observed at approximately 2 times the maximum recommended intramuscular or subcutaneous dose (on a mg/m 2 basis at a maternal subcutaneous dose of 0.5 mg/kg/day from Gestation Day 7-10).

🧒 Pediatric Use 13 words ▾

8.4Pediatric Use Safety and effectiveness in pediatric patients have not been established.

🧓 Geriatric Use 112 words ▾

8.5Geriatric Use Clinical studies of Norepinephrine in Sodium Chloride Injection did not include sufficient numbers of subjects aged 65 and over to determine whether they respond differently from younger subjects. Other reported clinical experience has not identified differences in responses between the elderly and younger patients. In general, dose selection for an elderly patient should be cautious, usually starting at the low end of the dosing range, reflecting the greater frequency of decreased hepatic, renal, or cardiac function, and of concomitant disease or other drug therapy.

Avoid administration of Norepinephrine in Sodium Chloride Injection into the veins in the leg in elderly patients [see Warnings and Precautions ( 5.1 )] .

🆘 Overdosage 44 words ▾

10 OVERDOSAGE Overdosage with Norepinephrine in Sodium Chloride Injection may result in headache, severe hypertension, reflex bradycardia, marked increase in peripheral resistance, and decreased cardiac output. In case of accidental overdosage, discontinue Norepinephrine in Sodium Chloride Injection until the condition of the patient stabilizes.

🧬 Clinical Pharmacology ~1 min read ▾

12 CLINICAL PHARMACOLOGY

12.1Mechanism of Action Norepinephrine is a peripheral vasoconstrictor (alpha-adrenergic action) and an inotropic stimulator of the heart and dilator of coronary arteries (beta-adrenergic action).

12.2Pharmacodynamics The primary pharmacodynamic effects of norepinephrine are cardiac stimulation and vasoconstriction. Cardiac output is generally unaffected, although it can be decreased, and total peripheral resistance is also elevated. The elevation in resistance and pressure result in reflex vagal activity, which slows the heart rate and increases stroke volume.

The elevation in vascular tone or resistance reduces blood flow to the major abdominal organs as well as to skeletal muscle. Coronary blood flow is substantially increased secondary to the indirect effects of alpha stimulation. After intravenous administration, a pressor response occurs rapidly and reaches steady state within 5 minutes.

The pharmacologic actions of norepinephrine are terminated primarily by uptake and metabolism in sympathetic nerve endings. The pressor action stops within 1-2 minutes after the infusion is discontinued.

12.3Pharmacokinetics Absorption Following intravenous administration, the steady state plasma concentration is achieved in 5 min. Distribution Plasma protein binding of norepinephrine is approximately 25%. It is mainly bound to plasma albumin and to a smaller extent to prealbumin and alpha 1-acid glycoprotein. The volume of distribution is

8.8L. Norepinephrine localizes mainly in sympathetic nervous tissue. It crosses the placenta but not the blood-brain barrier. Elimination The mean half-life of norepinephrine is approximately 2.4 min. The average metabolic clearance is

3.1L/min. Metabolism Norepinephrine is metabolized in the liver and other tissues by a combination of reactions involving the enzymes catechol-O-methyltransferase (COMT) and MAO. The major metabolites are normetanephrine and 3-methoxy-4-hydroxy mandelic acid (vanillylmandelic acid, VMA), both of which are inactive.

Other inactive metabolites include 3-methoxy-4-hydroxyphenylglycol, 3,4-dihydroxymandelic acid, and 3,4-dihydroxyphenylglycol. Excretion Noradrenaline metabolites are excreted in urine primarily as sulphate conjugates and, to a lesser extent, as glucuronide conjugates. Only small quantities of norepinephrine are excreted unchanged.

🧬 Mechanism of Action 25 words ▾

12.1Mechanism of Action Norepinephrine is a peripheral vasoconstrictor (alpha-adrenergic action) and an inotropic stimulator of the heart and dilator of coronary arteries (beta-adrenergic action).

📦 How Supplied / Storage and Handling 127 words ▾

16 HOW SUPPLIED/STORAGE AND HANDLING Norepinephrine in Sodium Chloride Injection (norepinephrine bitartrate) is supplied as a clear, colorless sterile solution in a 250 mL non-PVC infusion bag with single function connector system consisting of a port and cap, packaged individually in an aluminum foil pouch with an oxygen scavenger. Supplied as: Unit of Sale Concentration Package Size NDC 81298-9659-3 4 mg/250 mL (16 mcg/mL) 10 bags NDC 81298-9655-3 8 mg/250 mL (32 mcg/mL) 10 bags NDC 81298-9658-3 16 mg/250 mL (64 mcg/mL) 10 bags 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.

Once the overwrap is removed, the bag can be stored at room temperature for up to 45 days.

📋 Description 138 words ▾

11 DESCRIPTION Norepinephrine (sometimes referred to as l-arterenol/Levarterenol or l-norepinephrine) is a catecholamine which differs from epinephrine by the absence of a methyl group on the nitrogen atom. Chemically, Norepinephrine Bitartrate is (-)-α-(aminomethyl)-3,4-dihydroxybenzyl alcohol tartrate (1:1) (salt) monohydrate (molecular weight 337.3 g/mol) and has the following structural formula: Norepinephrine in Sodium Chloride Injection is a clear, colorless, single dose sterile solution supplied as a ready-to-use intravenous infusion bag for intravenous use and does not require further dilution.

Each mL contains the equivalent of 16 or 32 or 64 micrograms of norepinephrine base supplied as 31.90 or 63.80 or 127.6 micrograms per mL of norepinephrine bitartrate monohydrate. In addition, each mL of solution contains 0.01 mg edetate disodium dihydrate as a metal chelator and 9.0 mg sodium chloride for isotonicity. It has a pH of 3.5 to 4.5.

Figure

💬 Information for Patients 41 words ▾

17 PATIENT COUNSELING INFORMATION Risk of Tissue Damage Advise the patient, family, or caregiver to report signs of extravasation urgently [see Warnings and Precautions ( 5.1 )] . Manufactured for: Long Grove Pharmaceuticals, LLC Rosemont, IL 60018 Rev. 10/2024 076273002 R01

🧬 Pharmacokinetics 158 words ▾

12.3Pharmacokinetics Absorption Following intravenous administration, the steady state plasma concentration is achieved in 5 min. Distribution Plasma protein binding of norepinephrine is approximately 25%. It is mainly bound to plasma albumin and to a smaller extent to prealbumin and alpha 1-acid glycoprotein. The volume of distribution is

8.8L. Norepinephrine localizes mainly in sympathetic nervous tissue. It crosses the placenta but not the blood-brain barrier. Elimination The mean half-life of norepinephrine is approximately 2.4 min. The average metabolic clearance is

3.1L/min. Metabolism Norepinephrine is metabolized in the liver and other tissues by a combination of reactions involving the enzymes catechol-O-methyltransferase (COMT) and MAO. The major metabolites are normetanephrine and 3-methoxy-4-hydroxy mandelic acid (vanillylmandelic acid, VMA), both of which are inactive.

Other inactive metabolites include 3-methoxy-4-hydroxyphenylglycol, 3,4-dihydroxymandelic acid, and 3,4-dihydroxyphenylglycol. Excretion Noradrenaline metabolites are excreted in urine primarily as sulphate conjugates and, to a lesser extent, as glucuronide conjugates. Only small quantities of norepinephrine are excreted unchanged.

🧬 Pharmacodynamics 128 words ▾

12.2Pharmacodynamics The primary pharmacodynamic effects of norepinephrine are cardiac stimulation and vasoconstriction. Cardiac output is generally unaffected, although it can be decreased, and total peripheral resistance is also elevated. The elevation in resistance and pressure result in reflex vagal activity, which slows the heart rate and increases stroke volume.

The elevation in vascular tone or resistance reduces blood flow to the major abdominal organs as well as to skeletal muscle. Coronary blood flow is substantially increased secondary to the indirect effects of alpha stimulation. After intravenous administration, a pressor response occurs rapidly and reaches steady state within 5 minutes.

The pharmacologic actions of norepinephrine are terminated primarily by uptake and metabolism in sympathetic nerve endings. The pressor action stops within 1-2 minutes after the infusion is discontinued.

🧪 Nonclinical Toxicology 18 words ▾

13 NONCLINICAL TOXICOLOGY

13.1Carcinogenesis, Mutagenesis, Impairment of Fertility Carcinogenesis, mutagenesis, and fertility studies have not been performed.

📄 Carcinogenesis, Mutagenesis, Impairment of Fertility 15 words ▾

13.1Carcinogenesis, Mutagenesis, Impairment of Fertility Carcinogenesis, mutagenesis, and fertility studies have not been performed.

📄 Package Label / Principal Display Panel 150 words ▾

Principal Display Panel – 4 mg Pouch Label NDC: 81298- 9659 -1 Rx only 1 x 250 mL Norepinephrine in 0.9% Sodium Chloride injection 4 mg per 250 mL (16 mcg/mL) Keep in sealed overwrap until time of use. LONG GROVE PHARMACEUTICALS™ Principal Display Panel – 4 mg Pouch Label

Principal Display Panel – 8 mg Pouch Label NDC: 81298- 9655 -1 Rx only 1 x 250 mL Norepinephrine in 0.9% Sodium Chloride injection 8 mg per 250 mL (32 mcg/mL) Keep in sealed overwrap until time of use. LONG GROVE PHARMACEUTICALS™ Principal Display Panel – 8 mg Pouch Label

Principal Display Panel – 16 mg Pouch Label NDC: 81298- 9658 -1 Rx only 1 x 250 mL Norepinephrine in 0.9% Sodium Chloride injection 16 mg per 250 mL (64 mcg/mL) Keep in sealed overwrap until time of use. LONG GROVE PHARMACEUTICALS™ Principal Display Panel – 16 mg Pouch 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 Norepinephrine (this brand).

Top reported reactions

Hypotension1,304
Acute Kidney Injury899
Multiple Organ Dysfunction Syndrome857
Condition Aggravated819
Toxicity To Various Agents726
Sepsis724
Cardiogenic Shock667

Reporter sex

13,044 reports

Serious outcomes

Hospitalization6,998
Life-threatening3,911
Disabling541
Reports over time (by year) — tap or hover for the count & year
2019 2021 2023 2026 1,590 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 ✓ 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 Long Grove Pharmaceuticals, LLC. Listing status can change — the directory data on this page refreshes weekly.
Who lists this product with the FDA?
Long Grove Pharmaceuticals, LLC is the labeler of record for this NDC — the company under whose FDA-assigned code the package is listed. The labeler may be the manufacturer itself or a distributor marketing the product under its own code.
Do I need a prescription for this product?
This NDC is listed with FDA as a prescription product, so it is dispensed under a prescriber's order. Your pharmacist can tell you whether any over-the-counter forms of the same medication exist.
This page identifies an FDA-listed package (the NDC) and reports public regulatory and pricing data about the listing. It is reference information, not a medical recommendation — talk to your pharmacist or prescriber about your own medication.
Where does this data come from?
Listing facts (marketing category, packager status, marketing dates) from the FDA openFDA NDC Directory; label availability from DailyMed; pricing coverage from CMS NADAC; equivalence scope from the FDA Orange Book.
← 81298-9658-03 · Long 81313-0001-01 · AMERICAN →
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.