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Ipratropium Bromide and Albuterol Sulfate .5 mg/3mL; 3 mg/3mL Solution — NDC 62135-831-84 (Billing 62135-0831-84)

by Chartwell RX, LLC · 6 POUCH in 1 CARTON / 5 VIAL, SINGLE-DOSE in 1 POUCH / 3 mL in 1 VIAL, SINGLE-DOSE

This is a package of Ipratropium Bromide and Albuterol Sulfate .5 mg/3mL; 3 mg/3mL Solution from Chartwell RX, LLC, marketed since Dec 2007 and currently FDA-listed; retail pharmacies pay about $0.0812 per mL (NADAC). It is this product's only package size.

NDC 62135-0831-84
🏷️ FDA NDC (as labeled) 62135-831-84 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 Aug 27, 2026 · sources: openFDA · FDA label (DailyMed) · FDA Orange & Purple Book · First Databank · CMS NADAC, ASP, Medicare & Medicaid · RxNorm
📋 All sources & update times →

NDC database record

One package, one record: these facts belong to NDC 62135-831-84 alone.

Record
FDA NDC Directory package listing · Human prescription drug
Code segments
62135 labeler · 831 product · 84 package
Package marketed since
Jan 25, 2024
Sample package
No — commercial package
Listing certified through
Dec 31, 2026
Barcode (UPC)
0362135831844
FDA record last changed
Aug 27, 2026

Identity & classification

Regulatory identifiers FDA, NLM and CMS codes for this package

FDA NDC (as labeled) 62135-831-84
Product NDC 62135-831
11-digit billing NDC 62135083184
NCPDP billing unit ML — per mL (volume)
RxCUI 1437702
UNII J697UZ2A9J, 021SEF3731
UPC 0362135831844
Application # ANDA076749
SPL Set ID b444478a-10ce-484f-9039-6383dfb8161e
Established class (EPC) Anticholinergic; beta2-Adrenergic Agonist
Mechanism of action Adrenergic beta2-Agonists; Cholinergic Antagonists
DEA schedule Non-controlled
Marketing category ANDA
Marketing status On market
FDA listing status Listed (active directory)
Marketing start 2007-12-31
Route RESPIRATORY (INHALATION)
Dosage form SOLUTION
Substance IPRATROPIUM BROMIDE; ALBUTEROL SULFATE
TE code (Orange Book) AN · RLD · RS

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

GPI-14 44209902012015
GCN Seq No 048018
GCN 13456
HICL code 009040
Ingredient (HICL) Ipratropium/Albuterol Sulfate
HIC1 code B
Therapeutic class — broad (HIC1) Respiratory System
HIC2 code B6
Therapeutic class — intermediate (HIC2) Drugs Affecting The Trachea And Bronchi (Cont3)
HIC3 code B62
Therapeutic class — specific (HIC3) Beta-Adrenergic And Anticholinergic Combo, Inhaled
AHFS code 12:08.08.00
AHFS class Antimuscarinics/Antispasmodics
FDB label name IPRAT-ALBUT 0.5-3(2.5) MG/3 ML
FDB brand name Ipratropium-Albuterol
Legend status F — Federal legend — prescription drug or device
Quick answers
  • GSN (GCN sequence number): 048018
  • GCN: 13456
  • GPI-14 (Medi-Span): 44209902012015
  • HICL (First Databank): 009040
  • AHFS class code: 12:08.08.00
  • RxCUI (RxNorm): 1437702
Why two NDCs? The FDA registers this code as 62135-831-84 — 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 → 62135-0831-84. 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 beta2-Adrenergic Agonist class.

Pharmacologic class beta2-Adrenergic Agonist
Drug family (ATC) Selective beta-2-adrenoreceptor agonists, Selective beta-2-adrenoreceptor agonists
How it works Adrenergic beta2-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 IPRAT-ALBUT 0.5-3(2.5) MG/3 ML Ingredient Ipratropium/Albuterol Sulfate
📖 What it is MedlinePlus · NLM

The combination of albuterol and ipratropium is used to prevent wheezing, difficulty breathing, chest tightness, and coughing in people with chronic obstructive pulmonary disease (COPD; a group of diseases that affect the lungs and airways) such as chronic bronchitis (swelling of the air passages that lead to the lungs) and emphysema (damage to the air sacs in the lungs). Albuterol and ipratropium combination is used by people whose symptoms have not been controlled by a single inhaled medication. Albuterol and ipratropium are in a class of medications called bronchodilators. Albuterol and ipr...

Read the full MedlinePlus article ↗
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 $0.081 $7.31 / 90 ml
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 · Q2 2026 $0.1058 $9.52 / 90 ml
Medicare Part B allowsASP · J7620 $0.201 / J7620 unit —
NADAC price history (per mL) — tap or hover for the price & month
Dec 2025 Feb 2026 May 2026 Aug 2026 $0.091 $0.081
▼ Down 10% over the last 9 months.
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.

Billing & reimbursement

FDA NDC (as labeled)62135-831-84
11-digit billing NDC62135-0831-84
Format5-3-2 as registered → padded to 5-4-2 for billing (zero added to the product segment)
HCPCS J-codeJ7620
DescriptorALBUTEROL, UP TO 2.5 MG AND IPRATROPIUM BROMIDE, UP TO 0.5 MG, FDA-APPROVED FINAL PRODUCT, NON-COMPOUNDED, ADMINISTERED THROUGH DME
Billing units / pkg0.33 units
Medicare Part B spend (2026 (Q1))$1,748,401 · 105,195 claims · $16.62 per claim (all NDCs under J7620)
Crosswalk sourcePDAC NDC-HCPCS crosswalk (DME MAC / DMEPOS)
Where does this data come from?
The HCPCS J-code crosswalk comes from the CMS ASP NDC-HCPCS crosswalk and the DMEPDAC (DME MAC) NDC-HCPCS crosswalk — free public CMS data. Billing units are derived from the code’s descriptor and the package amount.

Packaging — all sizes for this product

Package NDCDescription Marketing startMarketing endStatus
62135-0831-84 You're viewing this Main listing 6 POUCH in 1 CARTON / 5 VIAL, SINGLE-DOSE in 1 POUCH / 3 mL in 1 VIAL, SINGLE-DOSE 2024-01-25 — Active

Therapeutic equivalents

ProductLabelerPackNADAC/unitTEStatusPrice vs. this
Ipratropium Bromide and Albuterol Sulfate .5 mg/3mL; 2.5 mg/3mL 00378-9671-30 Mylan 1 pouch $0.079 AN Availability likely save 3%
Ipratropium Bromide and Albuterol Sulfate .5 mg/3mL; 3 mg/3mL 00487-0201-01 Nephron 30 pouches $0.079 AN Availability likely save 3%
Ipratropium Bromide and Albuterol Sulfate .5 mg/3mL; 2.5 mg/3mL 47335-0756-49 Sun 6 pouches $0.079 AN Availability likely save 3%
Ipratropium Bromide And Albuterol Sulfate 2.5 mg/3mL; .5 mg/3mL 60687-0405-83 American 30 pouches $0.079 AN Availability likely save 3%
Ipratropium Bromide and Albuterol Sulfate .5 mg/3mL; 3 mg/3mL 64980-0645-03 Rising 30 pouches $0.079 AN Availability likely save 3%
Ipratropium Bromide and Albuterol Sulfate 2.5 mg/3mL; .5 mg/3mL 69097-0173-53 Cipla 6 pouches $0.079 AN Availability likely save 3%
Ipratropium Bromide and Albuterol Sulfate .5 mg/3mL; 2.5 mg/3mL 69097-0840-53 Cipla 30 pouches $0.079 AN Availability likely save 3%
Ipratropium Bromide And Albuterol Sulfate 2.5 mg/3mL; .5 mg/3mL 76204-0600-01 Ritedose 30 pouches $0.079 AN Availability likely save 3%
Ipratropium Bromide and Albuterol Sulfate .5 mg/3mL; 3 mg/3mLthis 62135-0831-84 Chartwell 6 pouches $0.081 AN Availability likely —
Ipratropium Bromide And Albuterol Sulfate 2.5 mg/3mL; .5 mg/3mL 50090-1382-00 A-S 30 vials — AN FDA listed —
Ipratropium Bromide and Albuterol Sulfate .5 mg/3mL; 3 mg/3mL 50090-1669-00 A-S 30 vials — AN FDA listed —
Ipratropium Bromide And Albuterol Sulfate 2.5 mg/3mL; .5 mg/3mL 60429-0975-30 Golden 1 pouch — AN FDA listed —
Ipratropium Bromide and Albuterol Sulfate 2.5 mg/3mL; .5 mg/3mL 65862-0906-03 Aurobindo 30 pouches — — FDA listed —
Ipratropium Bromide and Albuterol Sulfate .5 mg/3mL; 3 mg/3mL 68788-8103-03 Preferred 30 pouches — AN FDA listed —
Ipratropium Bromide and Albuterol Sulfate .5 mg/3mL; 3 mg/3mL 71205-0051-15 Proficient 15 pouches — AN FDA listed —
Ipratropium Bromide and Albuterol Sulfate .5 mg/3mL; 2.5 mg/3mL 71205-0726-15 Proficient 1 pouch — AN 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

🏛️
2007
On the market since
Dec 2007
📍
2026
Currently FDA-listed
19 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

LabelerChartwell RX, LLC
Application holderNEPHRON PHARMACEUTICALS CORP
FDA applicationANDA076749 (ANDA)
Labeler code62135
First marketedDec 2007
Product typeHuman Prescription Drug
Portfolio521 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 27 words ▾

INDICATIONS AND USAGE Ipratropium Bromide and Albuterol Sulfate Inhalation Solution is indicated for the treatment of bronchospasm associated with COPD in patients requiring more than one bronchodilator.

⏱️ Dosage and Administration ~1 min read ▾

DOSAGE AND ADMINISTRATION The recommended dose of Ipratropium Bromide and Albuterol Sulfate Inhalation Solution is one 3 mL vial administered 4 times per day via nebulization with up to 2 additional 3 mL doses allowed per day, if needed. Safety and efficacy of additional doses or increased frequency of administration of Ipratropium Bromide and Albuterol Sulfate Inhalation Solution beyond these guidelines has not been studied and the safety and efficacy of extra doses of albuterol sulfate or ipratropium bromide in addition to the recommended doses of Ipratropium Bromide and Albuterol Sulfate Inhalation Solution have not been studied.

The use of Ipratropium Bromide and Albuterol Sulfate Inhalation Solution can be continued as medically indicated to control recurring bouts of bronchospasm. If a previously effective regimen fails to provide the usual relief, medical advice should be sought immediately, as this is often a sign of worsening COPD, which would require reassessment of therapy. A Pari-LC-Plus™ nebulizer (with face mask or mouthpiece) connected to a PRONEB™ compressor was used to deliver Ipratropium Bromide and Albuterol Sulfate Inhalation Solution to each patient in one U.S. clinical study.

The safety and efficacy of Ipratropium Bromide and Albuterol Sulfate Inhalation Solution delivered by other nebulizers and compressors have not been established. Ipratropium Bromide and Albuterol Sulfate Inhalation Solution should be administered via jet nebulizer connected to an air compressor with an adequate air flow, equipped with a mouthpiece or suitable face mask.

⛔ Contraindications 28 words ▾

CONTRAINDICATIONS Ipratropium Bromide and Albuterol Sulfate Inhalation Solution is contraindicated in patients with a history of hypersensitivity to any of its components, or to atropine and its derivatives.

⚠️ Warnings ~1 min read ▾

WARNINGS PARADOXICAL BRONCHOSPASM In the clinical study of Ipratropium Bromide and Albuterol Sulfate Inhalation Solution, paradoxical bronchospasm was not observed. However, paradoxical bronchospasm has been observed with both inhaled ipratropium bromide and albuterol products and can be life-threatening. If this occurs, Ipratropium Bromide and Albuterol Sulfate Inhalation Solution should be discontinued immediately and alternative therapy instituted.

DO NOT EXCEED RECOMMENDED DOSE Fatalities have been reported in association with excessive use of inhaled products containing sympathomimetic amines and with the home use of nebulizers. CARDIOVASCULAR EFFECTS Ipratropium Bromide and Albuterol Sulfate Inhalation Solution, like other beta-adrenergic agonists, can produce a clinically significant cardiovascular effect in some patients as measured by pulse rate, blood pressure, and/or symptoms. Although such effects are uncommon for Ipratropium Bromide and Albuterol Sulfate Inhalation Solution at recommended doses, if they occur, the drug may need to be discontinued.

In addition, beta-agonists have been reported to produce ECG changes, such as flattening of the T-wave, prolongation of the QTc interval, and ST segment depression. The clinical significance of these findings is unknown. Therefore, Ipratropium Bromide and Albuterol Sulfate Inhalation Solution, like other sympathomimetic amines, should be used with caution in patients with cardiovascular disorders, especially coronary insufficiency, cardiac arrhythmias, and hypertension.

IMMEDIATE HYPERSENSITIVITY REACTIONS Immediate hypersensitivity reactions to albuterol and/or ipratropium bromide may occur after the administration of Ipratropium Bromide and Albuterol Sulfate Inhalation Solution as demonstrated by rare cases of urticaria, angioedema, rash, pruritis, oropharyngeal edema, bronchospasm, and anaphylaxis.

🤒 Adverse Reactions ~1 min read ▾

ADVERSE REACTIONS Adverse reaction information concerning Ipratropium Bromide and Albuterol Sulfate Inhalation Solution was derived from the 12-week controlled clinical trial. ADVERSE EVENTS OCCURRING IN ≥ 1% OF ≥ 1 TREATMENT GROUP(S) AND WHERE THE COMBINATION TREATMENT SHOWED THE HIGHEST PERCENTAGE Body System COSTART Term Albuterol n (%) Ipratropium n (%) lpratropium Bromide and Albuterol Sulfate n (%) NUMBER OF PATIENTS 761 754 765 N (%) Patients with AE 327 (43.0) 329 (43.6) 367 (48.0) BODY AS A WHOLE Pain 8 (1.1) 4 (0.5) 10 (1.3) Pain chest 11 (1 .4) 14 (1.9) 20 (2.6) DIGESTIVE Diarrhea 5 (0.7) 9 (1.2) 14 (1.8) Dyspepsia 7 (0.9) 8 (1.1) 10 (1.3) Nausea 7 (0.9) 6 (0.8) 11 (1.4) MUSCULO-SKELETAL Cramps Leg 8 (1.1) 6 (0.8) 11 (1.4) RESPIRATORY Bronchitis 11 (1 .4) 13 (1.7) 13(1.7) Lung Disease 36 (4.7) 34 (4.5) 49 (6.4) Pharyngitis 27 (3.5) 27 (3.6) 34 (4.4) Pneumonia 7 (0.9) 8 (1.1) 10 (1.3) UROGENITAL Infection urinary tract 3 (0.4) 9 (1.2) 12(1.6) Additional adverse reactions reported in more than 1% of patients treated with Ipratropium Bromide and Albuterol Sulfate Inhalation Solution included constipation and voice alterations.

In the clinical trial, there was a 0.3% incidence of possible allergic-type reactions, including skin rash, pruritis, and urticaria. Additional information derived from the published literature on the use of albuterol sulfate and ipratropium bromide singly or in combination includes precipitation or worsening of narrow-angle glaucoma, acute eye pain, blurred vision, mydriasis, paradoxical bronchospasm, wheezing, exacerbation of COPD symptoms, drowsiness, aching, flushing, upper respiratory tract infection, palpitations, taste perversion, elevated heart rate, sinusitis, back pain, sore throat and metabolic acidosis.

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

🆘 Overdosage ~1 min read ▾

OVERDOSAGE The effects of overdosage with Ipratropium Bromide and Albuterol Sulfate Inhalation Solution are expected to be related primarily to albuterol sulfate, since ipratropium bromide is not well absorbed systemically after oral or aerosol administration. The expected symptoms with overdosage are those of excessive beta-adrenergic stimulation and/or occurrence or exaggeration of symptoms such as seizures, angina, hypertension or hypotension, tachycardia with rates up to 200 beats per minute, arrhythmia, nervousness, headache, tremor, dry mouth, palpitation, nausea, dizziness, fatigue, malaise, insomnia, and exaggeration of pharmacological effects listed in ADVERSE REACTIONS .

Hypokalemia may also occur. As with all sympathomimetic aerosol medications, cardiac arrest and even death may be associated with abuse of Ipratropium Bromide and Albuterol Sulfate Inhalation Solution. Treatment consists of discontinuation of Ipratropium Bromide and Albuterol Sulfate Inhalation Solution together with appropriate symptomatic therapy.

The judicious use of a cardioselective beta-receptor blocker may be considered, bearing in mind that such medication can produce bronchospasm. There is insufficient evidence to determine if dialysis is beneficial for overdosage of Ipratropium Bromide and Albuterol Sulfate Inhalation Solution. The oral median lethal dose of albuterol sulfate in mice is greater than 2000 mg/kg (approximately 540 times the maximum recommended daily inhalation dose of Ipratropium Bromide and Albuterol Sulfate Inhalation Solution on a mg/m 2 basis).

The subcutaneous median lethal dose of albuterol sulfate in mature rats and small young rats is approximately 450 and 2000 mg/kg, respectively (approximately 240 and 1100 times the maximum recommended daily inhalation dose of Ipratropium Bromide and Albuterol Sulfate Inhalation Solution on a mg/m 2 basis, respectively). The inhalation median lethal dose has not been determined in animals. The oral median lethal dose of ipratropium bromide in mice, rats and dogs is greater than 1000 mg/kg, approximately 1700 mg/kg and approximately 400 mg/kg, respectively (approximately 1400, 4600, and 3600 times the maximum recommended daily inhalation dose in adults on a mg/m 2 basis, respectively).

🧬 Clinical Pharmacology ~2 min read ▾

CLINICAL PHARMACOLOGY Ipratropium Bromide and Albuterol Sulfate Inhalation Solution is a combination of the β 2-adrenergic bronchodilator, albuterol sulfate, and the anticholinergic bronchodilator, ipratropium bromide. Mechanism of Action Albuterol sulfate The prime action of β-adrenergic drugs is to stimulate adenyl cyclase, the enzyme that catalyzes the formation of cyclic-3’,5’-adenosine monophosphate (cAMP) from adenosine triphosphate (ATP). The cAMP thus formed mediates the cellular responses.

In vitro studies and in vivo pharmacologic studies have demonstrated that albuterol has a preferential effect on β 2-adrenergic receptors compared with isoproterenol. While it is recognized that β 2-adrenergic receptors are the predominant receptors in bronchial smooth muscle, recent data indicated that 10% to 50% of the β-receptors in the human heart may be β 2-receptors. The precise function of these receptors, however, is not yet established.

Albuterol has been shown in most controlled clinical trials to have more effect on the respiratory tract, in the form of bronchial smooth muscle relaxation, than isoproterenol at comparable doses while producing fewer cardiovascular effects. Controlled clinical studies and other clinical experience have shown that inhaled albuterol, like other β-adrenergic agonist drugs, can produce a significant cardiovascular effect in some patients. Ipratropium bromide Ipratropium bromide is an anticholinergic (parasympatholytic) agent, which blocks the muscarinic receptors of acetylcholine, and, based on animal studies, appears to inhibit vagally mediated reflexes by antagonizing the action of acetylcholine, the transmitter agent released from the vagus nerve.

Anticholinergics prevent the increases in intracellular concentration of cyclic guanosine monophosphate (cGMP), resulting from the interaction of acetylcholine with the muscarinic receptors of bronchial smooth muscle. Ipratropium Bromide and Albuterol Sulfate Inhalation Solution Ipratropium Bromide and Albuterol Sulfate Inhalation Solution is expected to maximize the response to treatment in patients with chronic obstructive pulmonary disease (COPD) by reducing bronchospasm through two distinctly different mechanisms: sympathomimetic (albuterol sulfate) and anticholinergic / parasympatholytic (ipratropium bromide).

Simultaneous administration of both an anticholinergic and a β 2-sympathomimetic is designed to produce greater bronchodilation effects than when either drug is utilized alone at its recommended dosage. Pharmacokinetics Albuterol sulfate Albuterol sulfate is longer acting than isoproterenol in most patients by any route of administration, because it is not a substrate for the cellular uptake processes for catecholamines nor for the metabolism of catechol-O-methyl transferase. Instead the drug is conjugatively metabolized to albuterol 4’-O - sulfate.

Ipratropium bromide The bronchodilation following inhalation of ipratropium is primarily a local, site-specific effect, not a systemic one. Much of an inhaled dose is swallowed as shown by fecal excretion studies. Following nebulization of a 1 mg dose to healthy volunteers, a mean of 4% of the dose was excreted unchanged in the urine.

Ipratropium bromide is minimally (0% to 9% in vitro ) bound to plasma albumin and α 1–acid glycoproteins. It is partially metabolized to inactive ester hydrolysis products. Following intravenous administration, approximately one-half is excreted unchanged in the urine.

The half-life of elimination is about 1.6 hours after intravenous administration. Ipratropium bromide that reaches the systemic circulation is reportedly removed by the kidneys rapidly at a rate that exceeds the glomerular filtration rate. The pharmacokinetics of Ipratropium Bromide and Albuterol Sulfate Inhalation Solution or ipratropium bromide have not been studied in the elderly and in patients with hepatic or renal insufficiency (see PRECAUTIONS ).

Ipratropium Bromide and Albuterol Sulfate In…

📦 How Supplied / Storage and Handling 97 words ▾

HOW SUPPLIED Ipratropium Bromide and Albuterol Sulfate Inhalation Solution is supplied as a 3 mL sterile solution for nebulization in sterile low-density polyethylene unit-dose vials. Store vials in pouch until time of use. Supplied in cartons as listed below.

NDC 62135-831-84: 6 foil pouches, each containing 5 vials, total 30 vials per carton Storage and Handling PROTECT FROM LIGHT. The unit-dose vial should remain stored in the protective foil pouch until time of use. Store between 2° and 25° C (36° and 77° F).

Protect from light. Rx Only Manufactured for: Chartwell RX, LLC. Congers, NY 10920

📋 Description ~2 min read ▾

DESCRIPTION The active components in Ipratropium Bromide and Albuterol Sulfate Inhalation Solution are albuterol sulfate and ipratropium bromide. Albuterol sulfate is a salt of racemic albuterol and a relatively selective β 2-adrenergic bronchodilator chemically described as α 1-[( tert -Butylamino) methyl]-4-hydroxy- m -xylene- α,α′-diol sulfate (2:1) (salt). It has a molecular weight of 576.7 and the empirical formula is (C 13 H 21 NO 3 ) 2 •H 2 SO 4 .

It is a white crystalline powder, soluble in water and slightly soluble in ethanol. The World Health Organization’s recommended name for albuterol base is salbutamol. Ipratropium bromide is an anticholinergic bronchodilator chemically described as 8-azoniabicyclo[3.2.1]-octane,3-(3-hydroxy-1-oxo-2-phenylpropoxy)-8-methyl-8-(1-methylethyl)-, bromide, monohydrate (endo,syn)-, (±)-; a synthetic quaternary ammonium compound, chemically related to atropine.

It has a molecular weight of 430.4 and the empirical formula is C 20 H 30 BrNO 3 •H 2 O. It is a white crystalline substance, freely soluble in water and lower alcohols, and insoluble in lipophilic solvents such as ether, chloroform, and fluorocarbons. Each 3 mL vial of Ipratropium Bromide and Albuterol Sulfate Inhalation Solution contains 3 mg (0.1%) of albuterol sulfate (equivalent to 2.5 mg (0.083%) of albuterol base) and 0.5 mg (0.017%) of ipratropium bromide in an isotonic, sterile, aqueous solution containing sodium chloride and hydrochloric acid to adjust to pH 4.

Ipratropium Bromide and Albuterol Sulfate Inhalation Solution is a clear, colorless solution. It does not require dilution prior to administration by nebulization. For Ipratropium Bromide and Albuterol Sulfate Inhalation Solution, like all other nebulized treatments, the amount delivered to the lungs will depend on patient factors, the jet nebulizer utilized, and compressor performance.

Using the Pari-LC-Plus™ nebulizer (with face mask or mouthpiece) connected to a PRONEB™ compressor system, under in vitro conditions, the mean delivered dose from the mouth piece (% nominal dose) was approximately 46% of albuterol and 42% of ipratropium bromide at a mean flow rate of

3.6L/min. The mean nebulization time was 15 minutes or less. Ipratropium Bromide and Albuterol Sulfate Inhalation Solution should be administered from jet nebulizers at adequate flow rates, via face masks or mouthpieces (see DOSAGE AND ADMINISTRATION ). image description image description

💬 Patient Medication Information ~3 min read ▾

PATIENT INFORMATION Ipratropium Bromide 0.5 mg and Albuterol Sulfate 3 mg* Inhalation Solution *Equivalent to 2.5 mg albuterol base Prescription Only. Read the patient information that comes with Ipratropium Bromide 0.5 mg and Albuterol Sulfate 3 mg before you start using it and each time you get a refill. There may be new information.

This leaflet does not take the place of talking with your doctor about your medical condition or your treatment. What is Ipratropium Bromide 0.5 mg and Albuterol Sulfate 3 mg? Ipratropium Bromide 0.5 mg and Albuterol Sulfate 3 mg is a combination of two medicines called bronchodilators.

Ipratropium Bromide 0.5 mg and Albuterol Sulfate 3 mg contains albuterol sulfate, which is a beta-adrenergic agonist, and ipratropium bromide, which is an anticholinergic. These two medicines work together to help open the airways in your lungs. Ipratropium Bromide 0.5 mg and Albuterol Sulfate 3 mg is used to help treat airway narrowing (bronchospasm) that happens with chronic obstructive pulmonary disease (COPD) in adult patients who need to use more than one bronchodilator medicine.

Who should not use Ipratropium Bromide 0.5 mg and Albuterol Sulfate 3mg? Do not use Ipratropium Bromide 0.5 mg and Albuterol Sulfate 3 mg if you: Are allergic to any of the ingredients in Ipratropium Bromide 0.5 mg and Albuterol Sulfate 3 mg or to atropine. The active ingredients are albuterol sulfate and ipratropium bromide.

See the end of this leaflet for a complete list of ingredients in Ipratropium Bromide 0.5 mg and Albuterol Sulfate 3 mg. Ipratropium Bromide 0.5 mg and Albuterol Sulfate 3 mg has not been studied in patients younger than 18 years of age. What should I tell my doctor before I start using Ipratropium Bromide 0.5 mg and Albuterol Sulfate 3 mg?

Tell your doctor about all of your conditions, including if you: Have heart problems. This includes coronary artery disease and heart rhythm problems. Have high blood pressure Have diabetes Have or had seizures Have a thyroid problem called hyperthyroidism Have an eye problem called narrow-angle glaucoma Have liver or kidney problems Have problems urinating due to bladder-neck blockage or an enlarged prostate (men) Are pregnant or planning to become pregnant.

It is not known if Ipratropium Bromide 0.5 mg and Albuterol Sulfate 3 mg can harm your unborn baby. You and your doctor will have to decide if Ipratropium Bromide 0.5 mg and Albuterol Sulfate 3 mg is right for you during a pregnancy. Are breastfeeding.

It is not known if Ipratropium Bromide 0.5 mg and Albuterol Sulfate 3 mg passes into your milk or if it can harm your baby. You and your doctor should decide whether you should take Ipratropium Bromide 0.5 mg and Albuterol Sulfate 3 mg or breastfeed, but not both. Tell your doctor about all the medicines you take including prescription and non-prescription medicines, vitamins and herbal supplements.

Ipratropium Bromide 0.5 mg and Albuterol Sulfate 3 mg and other medicines can interact. This may cause serious side effects. Especially tell your doctor if you take: Other medicines that contain anticholinergics such as ipratropium bromide.

This also includes medicines used for Parkinson’s disease. Other medicines that contain beta-agonists such as albuterol sulfate. These are usually used to treat airway narrowing (bronchospasm).

Medicines called beta-blockers. These are usually used for high blood pressure or heart problems. Medicines called “water pills” (diuretics).

Medicines for depression called monoamine oxidase inhibitors (MAOIs) or tricyclic antidepressants. Ask your doctor or pharmacist if you are not sure if you take any of these types of medicines. Know the medicines you take.

Keep a list of them and show it to your doctor and pharmacists when you get a new medicine. How should I use Ipratropium Bromide 0.5 mg and Albuterol Sulfate 3 mg? Read the Patient’s Instructions for Use that you get with your prescription.

Talk to your doctor or pharmacist if you have any qu…

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