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ISOPROTERENOL 1 mg/5mL Injection, Solution — NDC 69097-0522-35 package photo
Label image from the product's FDA listing (DailyMed) — may show a different pack size or an older label revision.

ISOPROTERENOL 1 mg/5mL Injection, Solution — NDC 69097-522-35 (Billing 69097-0522-35)

by Cipla USA Inc. · 10 AMPULE in 1 CARTON / 5 mL in 1 AMPULE

This is a package of ISOPROTERENOL 1 mg/5mL Injection, Solution from Cipla USA Inc., marketed since Jun 2018 and currently FDA-listed. It is this product's only package size.

NDC 69097-0522-35
🏷️ FDA NDC (as labeled) 69097-522-35 billing pads the product segment with a zero
Rx only Generic 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 →

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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 69097-522-35 alone.

Record
FDA NDC Directory package listing · Human prescription drug
Code segments
69097 labeler · 522 product · 35 package
Package marketed since
Jun 26, 2018
Sample package
No — commercial package
Listing certified through
Dec 31, 2026
Barcode (UPC)
0369097521318, 0369097522353
FDA record last changed
Jul 24, 2026

Identity & classification

Regulatory identifiers FDA, NLM and CMS codes for this package

FDA NDC (as labeled) 69097-522-35
Product NDC 69097-522
11-digit billing NDC 69097052235
NCPDP billing unit ML — per mL (volume)
RxCUI 1667909, 1667915
UNII DIA2A74855
UPC 0369097521318, 0369097522353
Application # ANDA210322
SPL Set ID f724120d-da28-4065-9e05-d7dd6afbb546
Established class (EPC) beta-Adrenergic Agonist
Mechanism of action Adrenergic beta-Agonists
DEA schedule Non-controlled
Marketing category ANDA
Marketing status On market
FDA listing status Listed (active directory)
Marketing start 2018-06-26
Route INTRACARDIAC, INTRAMUSCULAR, INTRAVENOUS, SUBCUTANEOUS
Dosage form INJECTION, SOLUTION
Substance ISOPROTERENOL HYDROCHLORIDE

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

GPI-14 44201040102005
GPI class Isoproterenol HCl
GCN Seq No 004941
GCN 19490
HICL code 002053
Ingredient (HICL) Isoproterenol Hcl
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 12:12.08.04
AHFS class Non-Selective Beta-Adrenergic Agonists
FDB label name ISOPROTERENOL 1 MG/5 ML AMPUL
FDB brand name Isoproterenol Hcl
Legend status F — Federal legend — prescription drug or device
Quick answers
  • GSN (GCN sequence number): 004941
  • GCN: 19490
  • GPI-14 (Medi-Span): 44201040102005
  • HICL (First Databank): 002053
  • AHFS class code: 12:12.08.04
  • RxCUI (RxNorm): 1667909
Why two NDCs? The FDA registers this code as 69097-522-35 — a 5-3-2 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 product segment → 69097-0522-35. 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 beta-Adrenergic Agonist class.

Pharmacologic class beta-Adrenergic Agonist
Drug family (ATC) Adrenergic and dopaminergic agents, Non-selective beta-adrenoreceptor agonists, Non-selective beta-adrenoreceptor agonists
How it works Adrenergic beta-Agonists
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 ISOPROTERENOL 1 MG/5 ML AMPUL Ingredient Isoproterenol Hcl

Supplement & herbal interactions

🌿 Drug–supplement interaction checker →
2
Nutrient depletion considerations

Isoproterenol may be associated with lower levels of 2 nutrients — worth a chat with your pharmacist, not a cause for alarm.

🧪 Full Isoproterenol nutrient depletion report →
An association is not a deficiency. Educational only — don't start or stop anything without professional guidance.
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
69097-0522-35 You're viewing this Main listing 10 AMPULE in 1 CARTON / 5 mL in 1 AMPULE 2018-06-26 — Active

Therapeutic equivalents

ProductLabelerPackNADAC/unitTEStatusPrice vs. this
Isoproterenol Hydrochloride .2 mg/mL 00548-9502-00 Amphastar 10 vials — AP FDA listed —
Isoproterenol hydrochloride .2 mg/mL 10702-0364-51 KVK-Tech, 10 vials — AP FDA listed —
Isoproterenol Hydrochloride .2 mg/mL 14789-0015-05 Nexus 10 vials — AP FDA listed —
Isoproterenol Hydrochloride .2 mg/mL 23155-0661-41 Heritage 10 vials — AP FDA listed —
Isoproterenol Hydrochloride .2 mg/mL 25021-0324-01 Sagent 10 vials — AP FDA listed —
Isoproterenol Hydrochloride .2 mg/mL 42571-0330-80 Micro 10 ampules — AP FDA listed —
Isoproterenol Hydrochloride 1 mg/5mL 55150-0317-10 Eugia 10 ampules — — FDA listed —
isoproterenol hydrochloride 1 mg/5mL 68083-0586-10 Gland 10 vials — AP FDA listed —
Isoproterenol 1 mg/5mLthis 69097-0522-35 Cipla 10 ampules — — FDA listed —
Isoproterenol Hydrochloride .2 mg/mL 69918-0735-10 Nordic 10 vials — AP FDA listed —
Isoproterenol Hydrochloride 1 mg/5mL 70121-1605-07 Amneal 10 vials — AP FDA listed —
Isoproterenol Hydrochloride .2 mg/mL 72485-0113-10 Armas 10 ampules — AP FDA listed —
Isoproterenol Hydrochloride .2 mg/mL 83634-0303-01 Avenacy, 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
Jun 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.

What it looks like

Color White
One label can cover several strengths, so colors may be combined — always confirm a loose pill against the dispensed prescription label or a pharmacist.
Where does this data come from?
Physical description (imprint, shape, color, scoring, coating) from this product’s FDA Structured Product Labeling (SPL), mirrored from DailyMed / openFDA.

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

LabelerCipla USA Inc.
Application holderCIPLA LTD
FDA applicationANDA210322 (ANDA)
Labeler code69097
First marketedJun 2018
Product typeHuman Prescription Drug
Portfolio222 products on file

More NDCs from Cipla USA Inc. labeler code 69097

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 💊 Dosage Forms and Strengths ⛔ Contraindications ⚠️ Warnings and Cautions 🤒 Adverse Reactions 🔄 Drug Interactions 👥 Use in Specific Populations 🆘 Overdosage 🧬 Clinical Pharmacology 📦 How Supplied / Storage and Handling 📋 Description 🧪 Nonclinical Toxicology 📄 Carcinogenesis, Mutagenesis, Impairment of Fertility 📄 Package Label / Principal Display Panel
🎯 Indications and Usage 67 words ▾

1 INDICATIONS AND USAGE Isoproterenol hydrochloride injection is indicated: To improve hemodynamic status in patients in distributive shock and shock due to reduced cardiac output For bronchospasm occurring during anesthesia Isoproterenol hydrochloride injection is a beta-adrenergic agonist indicated: To improve hemodynamic status in patients in distributive shock and shock due to reduced cardiac output ( 1 ) For treatment of bronchospasm occurring during anesthesia ( 1 )

⏱️ Dosage and Administration ~1 min read ▾

2 DOSAGE AND ADMINISTRATION Initiate Isoproterenol hydrochloride injection at the lowest recommended dose and increase gradually based on patient response ( 2.2 ) Recommended initial dosage: Shock: 0.5 mcg to 5 mcg per minute as an intravenous infusion ( 2.2 ) Bronchospasm: 10 mcg to 20 mcg intravenous injection ( 2.2 )

2.1General Considerations Inspect visually for particulate matter and discoloration prior to administration, whenever solution and container permit. Do not use if the injection is pinkish or darker than slightly yellow or contains a precipitate. Discard any unused portion. Diluted solution should be used immediately. Unused material should be discarded.

2.2Recommended Dosage Dosage should generally be started at the lowest recommended dose and increased gradually based on patient response. Recommended dosage for adults with shock and hypoperfusion states: Route of Administration Preparation of Dilution† Infusion Rate†† Intravenous infusion Dilute 5 mL (1 mg) in 500 mL of 5% Dextrose Injection, USP 0.5 mcg to 5 mcg per minute (0.25 mL to 2.5 mL of diluted solution) †Concentrations up to 10 times greater have been used when limitation of volume is essential. ††Rates over 30 mcg per minute have been used in advanced stages of shock.

Adjust the rate of infusion based on heart rate, central venous pressure, systemic blood pressure, and urine flow. If the heart rate exceeds 110 beats per minute, consider decreasing or temporarily discontinuing the infusion. Recommended dosage for adults with bronchospasm occurring during anesthesia: Route of Administration Preparation of Dilution Initial Dose Subsequent Dose Bolus intravenous injection Dilute 1 mL (0.2 mg) to 10 mL with Sodium Chloride Injection, USP, or 5% Dextrose Injection, USP 10 mcg to 20 mcg (0.5 mL to 1 mL of diluted solution) The initial dose may be repeated when necessary There are no well-controlled studies in children to establish appropriate dosing; however, the American Heart Association recommends an initial infusion rate of 0.1 mcg/kg/min, with the usual range being 0.1 mcg/kg/min to 1 mcg/kg/min.

💊 Dosage Forms and Strengths 53 words ▾

3 DOSAGE FORMS AND STRENGTHS Injection solution: single dose, clear glass ampules containing isoproterenol in a clear, colorless to practically colorless solution; 1 mL containing 0.2 mg/1 mL (0.2 mg/mL) 5 mL containing 1 mg/5 mL (0.2 mg/mL) Injection: 0.2 mg/mL and 1 mg/5 mL (0.2 mg/mL) single dose vial ( 3 )

⛔ Contraindications 37 words ▾

4 CONTRAINDICATIONS Isoproterenol hydrochloride injection is contraindicated in patients with: tachycardia ventricular arrhythmias angina pectoris Isoproterenol hydrochloride injection is contraindicated in patients with: Tachycardia ( 4 ) Ventricular arrhythmias ( 4 ) Angina pectoris ( 4 )

⚠️ Warnings and Cautions 124 words ▾

5 WARNINGS AND PRECAUTIONS Cardiac arrhythmias and ischemia may be induced by isoproterenol ( 5.1 ) Sulfite: Isoproterenol hydrochloride injection contains metabisulfite, which may cause allergic reaction ( 5.2 )

5.1Cardiac Arrhythmias and Ischemia Isoproterenol may induce cardiac arrhythmias and myocardial ischemia in patients, especially patients with coronary artery disease, or cardiomyopathy.

5.2Allergic Reactions associated with Sulfite Isoproterenol hydrochloride injection contains sodium metabisulfite, which may cause mild to severe allergic reactions including anaphylaxis or asthmatic episodes, particularly in patients with a history of allergies. However, the presence of metabisulfite in this product should not preclude its use for treatment in emergency situations, even if the patient is sulfite-sensitive, as the alternatives to using isoproterenol in a life-threatening situation may not be satisfactory.

🤒 Adverse Reactions 106 words ▾

6 ADVERSE REACTIONS The following adverse reactions have been associated with use of isoproterenol. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to estimate their frequency reliably or to establish a causal relationship to drug exposure. Nervous system disorders: Nervousness, headache, dizziness, visual blurring Cardiovascular: Tachycardia, tachyarrhythmias, palpitations, angina, ventricular arrhythmias, Adams-Stokes attacks, pulmonary edema Respiratory: Dyspnea Other: Flushing of the skin, sweating, mild tremors, pallor, nausea Common adverse reactions with isoproterenol include tachycardia and palpitations (6) To report SUSPECTED ADVERSE REACTIONS, contact Cipla Limited, India at 1- 866 -604 -3268 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

🔄 Drug Interactions 201 words ▾

7 DRUG INTERACTIONS Table 1. Clinically Relevant Interactions with Isoproterenol Epinephrine Clinical Impact Both drugs are direct cardiac stimulants, and their combined effects may induce serious arrhythmias upon simultaneous administration. Intervention Isoproterenol hydrochloride injection and epinephrine should not be administered simultaneously.

Drugs that may potentiate clinical response of Isoproterenol Clinical Impact The effects of isoproterenol may be potentiated by tricyclic antidepressants, monoamine oxidase inhibitors, levothyroxine sodium, and certain antihistamines, notably chlorpheniramine, tripelennamine, and diphenhydramine. Intervention Monitor hemodynamic parameters in patients who concurrently are taking tricyclic antidepressants, monoamine oxidase inhibitors, levothyroxine sodium and certain antihistamines. Adjust doses appropriately.

Drugs that may reduce clinical response of Isoproterenol Clinical Impact The cardiostimulating and bronchodilating effects of isoproterenol are antagonized by beta-adrenergic blocking drugs, such as propranolol. Intervention Monitor for hemodynamic response and relief of bronchospasm and adjust dose appropriately. Do not administer Isoproterenol hydrochloride injection and epinephrine simultaneously due to combined effects may induce serious arrhythmias ( 7) ) Concomitant use of tricyclic antidepressants, monoamine oxidase inhibitors, levothyroxine sodium and certain antihistamines; hemodynamic parameters may potentiate a clinical response of isoproterenol ( 7 ) Beta-adrenergic blocking drugs may reduce cardiostimulating and bronchodilating effects of isoproterenol ( 7 ) See 17 for PATIENT COUNSELING INFORMATION.

👥 Use in Specific Populations ~2 min read ▾

8 USE IN SPECIFIC POPULATIONS

8.1Pregnancy Risk Summary Prolonged experience with isoproterenol use in pregnant women over several decades, based on published literature, do not identify a drug associated risk of major birth defects, miscarriage or adverse maternal or fetal outcomes. However, there are risks to the mother and fetus associated with isoproterenol use during labor or delivery (see Clinical Considerations). The estimated background risk of 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 United States 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 Hypotension associated with shock is a medical emergency in pregnancy which can be fatal if left untreated.

Delaying treatment in pregnant women with hypotension associated with shock 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 isoproterenol on the fetus. Labor and Delivery Isoproterenol usually inhibits spontaneous or oxytocin induced contractions of the pregnant human uterus and may delay the second stage of labor.

Avoid isoproterenol during the second stage of labor. Avoid isoproterenol in obstetrics when maternal blood pressure exceeds 130/80 mmHg. Although isoproterenol may improve maternal hypotension associated with shock, it may result in uterine vasoconstriction, decreased uterine blood flow, uterine atony with hemorrhage, and fetal anoxia.

8.2Lactation Risk Summary There is no information regarding the presence of isoproterenol in milk or the effects of isoproterenol on the breastfed infant or on milk production. However, due to its short half-life, isoproterenol exposure is expected to be very low in the breastfed infant.

8.4Pediatric Use Safety and efficacy of isoproterenol in pediatric patients have not been established. Intravenous infusions of isoproterenol in refractory asthmatic children at rates of 0.05-2.7 µg/kg/min have caused clinical deterioration, myocardial necrosis, congestive heart failure and death. The risks of cardiac toxicity appear to be increased by some factors [acidosis, hypoxemia, coadministration of corticosteroids, coadministration of methylxanthines (theophylline, theobromine) or aminophylline] that are especially likely to be present in these patients.

If I.V. isoproterenol is used in children with refractory asthma, patient monitoring must include continuous assessment of vital signs, frequent electrocardiography, and daily measurements of cardiac enzymes, including CPK-MB.

8.5Geriatric Use Clinical studies of isoproterenol did not include sufficient numbers of subjects aged 65 and over to determine whether they respond differently from younger subjects in clinical circumstances. There are, however, some data that suggest that elderly healthy or hypertensive patients are less responsive to beta-adrenergic stimulation than are younger subjects. In general, dose selection for elderly patients 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 diseases or other drug therapy.

🆘 Overdosage 50 words ▾

10 OVERDOSAGE Overdosage of isoproterenol can cause tachycardia or other arrhythmias, palpitations, angina, hypotension, or hypertension. In case of overdosage, reduce the rate of administration or discontinue isoproterenol hydrochloride injection until patient's condition stabilizes. Monitor blood pressure, pulse, respiration, and EKG. It is not known whether isoproterenol hydrochloride is dialyzable.

🧬 Clinical Pharmacology ~1 min read ▾

12 CLINICAL PHARMACOLOGY

12.1Mechanism of Action Isoproterenol is a potent nonselective beta-adrenergic agonist with very low affinity for alpha-adrenergic receptors.

12.2Pharmacodynamics Intravenous infusion of isoproterenol in man lowers peripheral vascular resistance, primarily in skeletal muscle but also in renal and mesenteric vascular beds. Diastolic pressure falls. Renal blood flow is decreased in normotensive subjects but is increased markedly in shock.

Systolic blood pressure may remain unchanged or rise, although mean arterial pressure typically falls. Cardiac output is increased because of the positive inotropic and chronotropic effects of the drug in the face of diminished peripheral vascular resistance. Isoproterenol relaxes almost all varieties of smooth muscle when the tone is high, but this action is most pronounced on bronchial and gastrointestinal smooth muscle.

It prevents or relieves bronchoconstriction, but tolerance to this effect develops with overuse of the drug. In man, isoproterenol causes less hyperglycemia than does epinephrine. Isoproterenol and epinephrine are equally effective in stimulating the release of free fatty acids and energy production.

12.3Pharmacokinetics Absorption Isoproterenol is readily absorbed when given parenterally or as an aerosol. Elimination Isoproterenol is metabolized primarily in the liver and other tissues by COMT. Isoproterenol is a relatively poor substrate for MAO and is not taken up by sympathetic neurons to the same extent as are epinephrine and norepinephrine.

The duration of action of isoproterenol may therefore be longer than that of epinephrine but is still brief.

📦 How Supplied / Storage and Handling 121 words ▾

16 HOW SUPPLIED/STORAGE AND HANDLING Isoproterenol Hydrochloride Injection, USP is a sterile, clear colorless to practically colorless solution. Each mL contains 0.2 mg of isoproterenol hydrochloride, USP. NDC Number Container Concentration Fill Quantity 69097-521-31 Single-dose ampul 0.2 mg/mL 1 mL 25 ampuls per carton 69097-522-35 Single-dose ampul 1 mg/5 mL (0.2 mg/mL) 5 mL 10 ampuls per carton Protect from light.

Keep in opaque container until used. Store at 20º to 25ºC (68º to 77ºF). [See USP Controlled Room Temperature.] Do not use if the injection is pinkish or darker than slightly yellow or contains a precipitate. Discard unused portion.

Manufactured by: Gland Pharma Limited, India. Manufactured for: Cipla USA, Inc. 10 Independence Boulevard, Suite 300 Warren, NJ 07059 Revised: 11/2023

📋 Description 139 words ▾

11 DESCRIPTION Isoproterenol hydrochloride is 3,4-Dihydroxy-α-[(isopropylamino)methyl] benzyl alcohol hydrochloride, a beta-adrenergic agonist and a synthetic sympathomimetic amine that is structurally related to epinephrine. The molecular formula is C 11 H 17 NO 3 ·HCl. It has a molecular weight of 247.72 and the following structural formula: Isoproterenol hydrochloride is a racemic compound.

Each milliliter of the sterile solution contains: Isoproterenol hydrochloride, USP 0.2 mg Edetate disodium USP (EDTA) 0.2 mg Sodium citrate, dihydrate USP 2.07 mg Citric acid, anhydrous USP 2.5 mg Sodium chloride USP 7.0 mg Hydrochloric acid NF q.s to adjust pH Sodium hydroxide NF q.s to adjust pH Water for Injection USP q.s to 1.0 mL The pH is adjusted between 2.5 and 4.5 with hydrochloric acid NF and/or sodium hydroxide NF. The sterile solution is nonpyrogenic and can be administered by the intravenous route. Image

🧪 Nonclinical Toxicology 56 words ▾

13 NONCLINICAL TOXICOLOGY

13.1Carcinogenesis, Mutagenesis, Impairment of Fertility Long-term studies in animals to evaluate the carcinogenic potential of isoproterenol hydrochloride have not been done. Mutagenic potential and effect on fertility have not been determined. There is no evidence from human experience that isoproterenol hydrochloride injection may be carcinogenic or mutagenic or that it impairs fertility.

📄 Carcinogenesis, Mutagenesis, Impairment of Fertility 53 words ▾

13.1Carcinogenesis, Mutagenesis, Impairment of Fertility Long-term studies in animals to evaluate the carcinogenic potential of isoproterenol hydrochloride have not been done. Mutagenic potential and effect on fertility have not been determined. There is no evidence from human experience that isoproterenol hydrochloride injection may be carcinogenic or mutagenic or that it impairs fertility.

📄 Package Label / Principal Display Panel 61 words ▾

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL NDC 69097-522-35 Rx Only Isoproterenol Hydrochloride Injection, USP 1 mg/5 mL (0.2 mg/mL) Intravenous, Subcutaneous, Intramuscular or Intracardiac Use Only. 5 mL ampul x 10 ampuls per carton Cipla NDC 69097-521-31 Rx Only Isoproterenol Hydrochloride Injection, USP 0.2 mg/mL Intravenous, Subcutaneous, Intramuscular or Intracardiac Use Only. 5 mL ampul x 25 ampuls per carton Cipla carton-5ml carton-1ml

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
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) — 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.
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 Cipla USA Inc.. Listing status can change — the directory data on this page refreshes weekly.
Who lists this product with the FDA?
Cipla USA 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.
← 69097-0521-31 · Cipla 69097-0526-03 · Cipla →
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.