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Norepinephrine Bitartrate 1 mg/mL Injection, Solution, Concentrate — NDC 70121-1576-7 (Billing 70121-1576-07)

by Amneal Pharmaceuticals LLC · 10 VIAL in 1 CARTON / 4 mL in 1 VIAL

This is a package of Norepinephrine Bitartrate 1 mg/mL Injection, Solution, Concentrate from Amneal Pharmaceuticals LLC, no longer marketed (first marketed Dec 2018), no longer in the FDA NDC Directory. It is this product's only package size.

NDC 70121-1576-07
🏷️ FDA NDC (as labeled) 70121-1576-7 billing pads the package segment with a zero
Rx only Generic Discontinued Non-controlled ⚠ Discontinued by firm ⇄ 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

⚠️
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 ↗
⚠️
Excluded from the active FDA NDC Directory. The labeler reported this product as discontinued, so it is excluded from the active NDC Directory. The listing was last certified through Sep 2026. A label may still appear on DailyMed, but the NDC is no longer in the current FDA NDC Directory. Search the FDA NDC Directory ↗

Identity & classification

Regulatory identifiers FDA, NLM and CMS codes for this package

FDA NDC (as labeled) 70121-1576-7
Product NDC 70121-1576
11-digit billing NDC 70121157607
NCPDP billing unit ML — per mL (volume)
RxCUI 242969
UNII IFY5PE3ZRW
UPC 0370121157618
Application # ANDA210839
SPL Set ID 256264b1-ddf6-42b7-8a09-194fffea65e2
Established class (EPC) Catecholamine
Chemical class Catecholamines
DEA schedule Non-controlled
Marketing category ANDA
Marketing status Discontinued
FDA listing status Discontinued by firm (certified through Sep 2026)
Marketing start 2018-12-17
Route INTRAVENOUS
Dosage form INJECTION, SOLUTION, CONCENTRATE
Substance NOREPINEPHRINE BITARTRATE

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

GPI-14 38000090102010
GPI class Norepinephrine Bitartrate
GCN Seq No 028633
GCN 00476
HICL code 002051
Ingredient (HICL) Norepinephrine Bitartrate
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 NOREPINEPHRINE 4 MG/4 ML VIAL
FDB brand name Norepinephrine Bitartrate
Legend status F — Federal legend — prescription drug or device
Quick answers
  • GSN (GCN sequence number): 028633
  • GCN: 00476
  • GPI-14 (Medi-Span): 38000090102010
  • HICL (First Databank): 002051
  • AHFS class code: 12:12.12.00
  • RxCUI (RxNorm): 242969
Why two NDCs? The FDA registers this code as 70121-1576-7 — 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 → 70121-1576-07. 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 NOREPINEPHRINE 4 MG/4 ML VIAL Ingredient Norepinephrine Bitartrate
📖 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
70121-1576-07 You're viewing this Main listing 10 VIAL in 1 CARTON / 4 mL in 1 VIAL 2018-12-17 — Discontinued by firm

Therapeutic equivalents

ProductLabelerPackNADAC/unitTEStatusPrice vs. this
Norepinephrine Bitartrate 1 mg/mL 00143-9318-10 Hikma 10 vials — AP FDA listed —
Levophed 1 mg/mL 00409-0161-10 Hospira, 10 vials — AP FDA listed —
Levophed 1 mg/mL 00409-3375-04 Hospira, 10 vials — AP FDA listed —
Norepinephrine Bitartrate 1 mg/mL 00781-3755-95 Sandoz 10 vials — AP FDA listed —
Norepinephrine Bitartrate 1 mg/mL 25021-0316-04 Sagent 10 vials — AP FDA listed —
Norepinephrine bitartrate 1 mg/mL 31722-0372-32 Camber 10 vials — AP FDA listed —
Norepinephrine bitartrate 1 mg/mL 36000-0162-10 Baxter 10 ampules — AP Discontinued —
Norepinephrine Bitartrate 1 mg/mL 43066-0997-10 Baxter 10 vials — AP FDA listed —
Norepinephrine Bitartrate 1 mg/mL 47335-0615-44 Sun 10 vials — — FDA listed —
Levophed(R) Norepinephrine Bitartrate 1 mg/mL 51662-1315-01 HF 4 ml — AP FDA listed —
Norepinephrine Bitartrate 1 mg/mL 51662-1528-01 HF 4 ml — AP FDA listed —
Norepinephrine Bitartrate 1 mg/mL 51991-0983-17 Breckenridge 10 vials — AP FDA listed —
Norepinephrine Bitartrate 1 mg/mL 63323-0940-04 Fresenius 10 vials — AP FDA listed —
Norepinephrine Bitartrate 1 mg/mL 64980-0630-41 Rising 10 vials — AP FDA listed —
Norepinephrine Bitartrate 1 mg/mL 65145-0133-10 Caplin 10 vials — AP FDA listed —
Norepinephrine Bitartrate 1 mg/mL 65219-0140-04 Fresenius 10 vials — AP FDA listed —
Norepinephrine bitartrate 1 mg/mL 67457-0852-04 Mylan 10 vials — AP FDA listed —
Norepinephrine bitartrate 1 mg/mL 68083-0437-10 Gland 10 vials — AP FDA listed —
Norepinephrine Bitartrate 1 mg/mLthis 70121-1576-07 Amneal 10 vials — — Discontinued —
Norepinephrine Bitartrate 1 mg/mL 70377-0121-12 BIOCON 10 vials — AP FDA listed —
Norepinephrine Bitartrate 1 mg/mL 71288-0439-05 Meitheal 10 vials — AP FDA listed —
Norepinephrine Bitartrate 1 mg/mL 71839-0143-10 BE 10 vials — AP FDA listed —
Norepinephrine bitartrate 1 mg/mL 72078-0002-04 Mylan 10 vials — AP FDA listed —
norepinephrine bitartrate 1 mg/mL 72205-0241-07 Novadoz 10 vials — AP FDA listed —
Norepinephrine Bitartrate 1 mg/mL 72572-0481-10 Civica, 10 vials — AP FDA listed —
Norepinephrine Bitartrate 1 mg/mL 72603-0180-10 NorthStar 10 vials — AP FDA listed —
norepinephrine bitartrate 1 mg/mL 83634-0307-04 Avenacy, 10 vials — AP FDA listed —
Norepinephrine Bitartrate 1 mg/mL 83854-0017-10 Anthea 10 vials — AP 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

🏛️
2018
On the market since
Dec 2018
📍
2026
Currently FDA-listed
8 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

LabelerAmneal Pharmaceuticals LLC
Application holderAMNEAL EU LTD
FDA applicationANDA210839 (ANDA)
Labeler code70121
First marketedDec 2018
Product typeHuman Prescription Drug
Portfolio490 products on file
The labeler markets the product; the application holder owns the FDA approval. They’re often the same company but can differ (e.g. a repackager or an authorized generic). A mailing address / phone appears here when the manufacturer includes it in the product’s FDA label (not all do).
Where does this data come from?
Labeler, application holder and registered establishment from the FDA openFDA NDC Directory and Drugs@FDA; address/contact from the product’s FDA label.

Full prescribing information FDA SPL

The complete FDA label for this product — the official prescribing information, verbatim, section by section. Jump with a chip, search within the label, or expand everything.
🎯 Indications and Usage ⏱️ Dosage and Administration ⛔ Contraindications ⚠️ Warnings 🤒 Adverse Reactions 🔄 Drug Interactions 🤰 Pregnancy 🧒 Pediatric Use 🧓 Geriatric Use 🆘 Overdosage 🧬 Clinical Pharmacology 📦 How Supplied / Storage and Handling 📋 Description
🎯 Indications and Usage 38 words ▾

INDICATIONS AND USAGE For blood pressure control in certain acute hypotensive states (e.g., pheochromocytomectomy, sympathectomy, poliomyelitis, spinal anesthesia, myocardial infarction, septicemia, blood transfusion, and drug reactions). As an adjunct in the treatment of cardiac arrest and profound hypotension.

⏱️ Dosage and Administration ~3 min read ▾

DOSAGE AND ADMINISTRATION Norepinephrine bitartrate injection is a concentrated, potent drug which must be diluted in dextrose containing solutions prior to infusion. An infusion of norepinephrine bitartrate injection should be given into a large vein ( see PRECAUTIONS ). Restoration of Blood Pressure in Acute Hypotensive States Blood volume depletion should always be corrected as fully as possible before any vasopressor is administered.

When, as an emergency measure, intraaortic pressures must be maintained to prevent cerebral or coronary artery ischemia, norepinephrine bitartrate injection can be administered before and concurrently with blood volume replacement. Diluent: Norepinephrine bitartrate injection should be diluted in 5 percent dextrose injection or 5 percent dextrose and sodium chloride injections. These dextrose containing fluids are protection against significant loss of potency due to oxidation.

Administration in saline solution alone is not recommended. Whole blood or plasma, if indicated to increase blood volume, should be administered separately (for example, by use of a Y-tube and individual containers if given simultaneously). Average Dosage: Add the content of the vial (4 mg/4 mL) of norepinephrine bitartrate injection to 1,000 mL of a 5 percent dextrose containing solution.

Each mL of this dilution contains 4 mcg of the base of norepinephrine bitartrate. Give this solution by intravenous infusion. Insert a plastic intravenous catheter through a suitable bore needle well advanced centrally into the vein and securely fixed with adhesive tape, avoiding, if possible, a catheter tie-in technique as this promotes stasis.

An IV drip chamber or other suitable metering device is essential to permit an accurate estimation of the rate of flow in drops per minute. After observing the response to an initial dose of 2 mL to 3 mL (from 8 mcg to 12 mcg of base) per minute, adjust the rate of flow to establish and maintain a low normal blood pressure (usually 80 mm Hg to 100 mm Hg systolic) sufficient to maintain the circulation to vital organs. In previously hypertensive patients, it is recommended that the blood pressure should be raised no higher than 40 mm Hg below the preexisting systolic pressure.

The average maintenance dose ranges from 0.5 mL to 1 mL per minute (from 2 mcg to 4 mcg of base). High Dosage: Great individual variation occurs in the dose required to attain and maintain an adequate blood pressure. In all cases, dosage of norepinephrine bitartrate injection should be titrated according to the response of the patient.

Occasionally much larger or even enormous daily doses (as high as 68 mg base or 17 vials) may be necessary if the patient remains hypotensive, but occult blood volume depletion should always be suspected and corrected when present. Central venous pressure monitoring is usually helpful in detecting and treating this situation. Fluid Intake: The degree of dilution depends on clinical fluid volume requirements.

If large volumes of fluid (dextrose) are needed at a flow rate that would involve an excessive dose of the pressor agent per unit of time, a solution more dilute than 4 mcg per mL should be used. On the other hand, when large volumes of fluid are clinically undesirable, a concentration greater than 4 mcg per mL may be necessary. Duration of Therapy: The infusion should be continued until adequate blood pressure and tissue perfusion are maintained without therapy.

Infusions of norepinephrine bitartrate injection should be reduced gradually, avoiding abrupt withdrawal. In some of the reported cases of vascular collapse due to acute myocardial infarction, treatment was required for up to six days. Adjunctive Treatment in Cardiac Arrest Infusions of norepinephrine bitartrate injection are usually administered intravenously during cardiac resuscitation to restore and maintain an adequate blood pressure after an effective heartbeat and ventilation have been established by other means. [Norepi…

⛔ Contraindications 198 words ▾

CONTRAINDICATIONS Norepinephrine should not be given to patients who are hypotensive from blood volume deficits except as an emergency measure to maintain coronary and cerebral artery perfusion until blood volume replacement therapy can be completed. If norepinephrine bitartrate injection is continuously administered to maintain blood pressure in the absence of blood volume replacement, the following may occur: severe peripheral and visceral vasoconstriction, decreased renal perfusion and urine output, poor systemic blood flow despite “normal” blood pressure, tissue hypoxia, and lactate acidosis.

Norepinephrine should also not be given to patients with mesenteric or peripheral vascular thrombosis (because of the risk of increasing ischemia and extending the area of infarction) unless, in the opinion of the attending physician, the administration of norepinephrine bitartrate injection is necessary as a life-saving procedure. Cyclopropane and halothane anesthetics increase cardiac autonomic irritability and therefore seem to sensitize the myocardium to the action of intravenously administered epinephrine or norepinephrine.

Hence, the use of norepinephrine during cyclopropane and halothane anesthesia is generally considered contraindicated because of the risk of producing ventricular tachycardia or fibrillation. The same type of cardiac arrhythmias may result from the use of norepinephrine bitartrate injection in patients with profound hypoxia or hypercarbia.

⚠️ Warnings 80 words ▾

WARNINGS Norepinephrine should be used with extreme caution in patients receiving monoamine oxidase inhibitors (MAOI) or antidepressants of the triptyline or imipramine types, because severe, prolonged hypertension may result. Norepinephrine bitartrate injection contains sodium metabisulfite, a sulfite that may cause allergic-type reactions including anaphylactic symptoms and life-threatening or less severe asthmatic episodes in certain susceptible people. The overall prevalence of sulfite sensitivity in the general population is unknown.

Sulfite sensitivity is seen more frequently in asthmatic than in nonasthmatic people.

🤒 Adverse Reactions 176 words ▾

ADVERSE REACTIONS The following reactions can occur: Body As A Whole: Ischemic injury due to potent vasoconstrictor action and tissue hypoxia. Cardiovascular System: Bradycardia, probably as a reflex result of a rise in blood pressure, arrhythmias. Nervous System: Anxiety, transient headache.

Respiratory System: Respiratory difficulty. Skin and Appendages: Extravasation necrosis at injection site. Prolonged administration of any potent vasopressor may result in plasma volume depletion which should be continuously corrected by appropriate fluid and electrolyte replacement therapy.

If plasma volumes are not corrected, hypotension may recur when norepinephrine is discontinued, or blood pressure may be maintained at the risk of severe peripheral and visceral vasoconstriction (e.g., decreased renal perfusion) with diminution in blood flow and tissue perfusion with subsequent tissue hypoxia and lactic acidosis and possible ischemic injury. Gangrene of extremities has been rarely reported. Overdoses or conventional doses in hypersensitive persons (e.g., hyperthyroid patients) cause severe hypertension with violent headache, photophobia, stabbing retrosternal pain, pallor, intense sweating, and vomiting.

To report SUSPECTED ADVERSE REACTIONS, contact Amneal Biosciences at 1-855-266-3251 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

🔄 Drug Interactions 98 words ▾

Drug Interactions: Cyclopropane and halothane anesthetics increase cardiac autonomic irritability and therefore seem to sensitize the myocardium to the action of intravenously administered epinephrine or norepinephrine. Hence, the use of norepinephrine during cyclopropane and halothane anesthesia is generally considered contraindicated because of the risk of producing ventricular tachycardia or fibrillation. The same type of cardiac arrhythmias may result from the use of norepinephrine in patients with profound hypoxia or hypercarbia.

Norepinephrine should be used with extreme caution in patients receiving monoamine oxidase inhibitors (MAOI) or antidepressants of the triptyline or imipramine types, because severe, prolonged hypertension may result.

🤰 Pregnancy 46 words ▾

Pregnancy Category C: Animal reproduction studies have not been conducted with norepinephrine. It is also not known whether norepinephrine can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. Norepinephrine should be given to a pregnant woman only if clearly needed.

🧒 Pediatric Use 12 words ▾

Pediatric Use: Safety and effectiveness in pediatric patients has not been established.

🧓 Geriatric Use 102 words ▾

Geriatric Use: Clinical studies of norepinephrine 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.

Norepinephrine infusions should not be administered into the veins in the leg in elderly patients (see PRECAUTIONS , General ).

🆘 Overdosage 42 words ▾

OVERDOSAGE Overdosage with norepinephrine may result in headache, severe hypertension, reflex bradycardia, marked increase in peripheral resistance, and decreased cardiac output. In case of accidental overdosage, as evidenced by excessive blood pressure elevation, discontinue norepinephrine until the condition of the patient stabilizes.

🧬 Clinical Pharmacology 25 words ▾

CLINICAL PHARMACOLOGY Norepinephrine functions as a peripheral vasoconstrictor (alpha-adrenergic action) and as an inotropic stimulator of the heart and dilator of coronary arteries (beta-adrenergic action).

📦 How Supplied / Storage and Handling 103 words ▾

HOW SUPPLIED Norepinephrine Bitartrate Injection, USP is a clear, colorless or practically colorless to slightly yellow color liquid and supplied in 4 mL single-dose vial. Each mL contains norepinephrine bitartrate, USP equivalent to norepinephrine 1 mg. It is available as follows: 4 mg/4 mL (1 mg/mL) 10 x 4 mL Single-Dose Vials in a Carton: NDC 70121-1576-7 Store at 20° to 25°C (68° to 77°F); excursions permitted between 15° to 30°C (59° to 86°F) [see USP Controlled Room Temperature].

Protect from light. Manufactured by: Amneal Pharmaceuticals Pvt. Ltd.

Parenteral Unit Ahmedabad 382213, INDIA Distributed by: Amneal Biosciences LLC Bridgewater, NJ 08807 Rev. 05-2018-00

📋 Description 182 words ▾

DESCRIPTION Norepinephrine (sometimes referred to as l-arterenol/Levarterenol or l-norepinephrine ) is a sympathomimetic amine which differs from epinephrine by the absence of a methyl group on the nitrogen atom. Norepinephrine Bitartrate is (-)-α-(aminomethyl)-3,4-dihydroxybenzyl alcohol tartrate (1:1) (salt) monohydrate and has the following structural formula: Norepinephrine bitartrate, USP is a white to faintly grey powder with a molecular formula of C 8 H 11 NO 3 •C 4 H 6 O 6 •H 2 O, and a molecular weight of 337.28 g/mol.

It is freely soluble in water, slightly soluble in alcohol, practically insoluble in chloroform and in ether. Norepinephrine bitartrate injection, USP is a clear, colorless or practically colorless to slightly yellow color liquid and supplied in sterile aqueous solution in the form of the bitartrate salt to be administered by intravenous infusion following dilution. Each mL contains the equivalent of 1 mg base of norepinephrine, sodium chloride for isotonicity, and not more than 0.2 mg of sodium metabisulfite as an antioxidant.

It has a pH of 3 to 4.5. The air in the vials has been displaced by nitrogen gas. 10

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

About this NDC listing & data coverage

Finished prescription product No longer marketed (per FDA listing data)
What data is (and isn’t) available for this NDC — tap to expand
NDC identity (package / product / labeler codes) ✓ Available
Labeler ✓ Available
Product & package description ✓ Available
Marketing category & status ✓ Available
Active ingredient / dosage form / route ✓ Available
FDA label (SPL via DailyMed) ✓ Available
Package photos — Not published for this NDC No photo available yet for this listing.
Inactive ingredients (structured) — Not published for this NDC The labeler did not submit a structured excipient list, or no SPL is available.
NADAC pharmacy acquisition price (CMS) — Not published for this NDC CMS publishes NADAC only for NDCs reported in its retail-pharmacy survey.
Orange Book / therapeutic-equivalence data — Not published for this NDC Applies only to products approved under an NDA/ANDA; many listings are out of scope.
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.
What does the discontinued status mean for this NDC?
The labeler reported a marketing end date (or the listing was delisted), so this specific package is no longer actively marketed. Remaining stock may still be dispensed for a time, and the NDC stays valid for historical records and claims — but data feeds (pricing, labeling) typically stop updating for it. Other package sizes or other manufacturers' versions of the same medication may still be marketed — see the equivalents section where available.
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.
Who lists this product with the FDA?
Amneal 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.
← 70121-1574-01 · Amneal 70121-1577-05 · Amneal →
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.