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Ipratropium Bromide .5 mg/2.5mL Solution, 30 pouches — NDC 60687-0394-83 package photo
Label image from the product's FDA listing (DailyMed) — may show a different pack size or an older label revision.

Ipratropium Bromide .5 mg/2.5mL Solution, 30 pouches — NDC 60687-394-83 (Billing 60687-0394-83)

by American Health Packaging · 30 POUCH in 1 CARTON / 1 AMPULE in 1 POUCH / 2.5 mL in 1 AMPULE

This is a package of 30 pouches of Ipratropium Bromide .5 mg/2.5mL Solution from American Health Packaging, marketed since Jan 2019 and currently FDA-listed; retail pharmacies pay about $0.1122 per mL (NADAC). It is this product's only package size.

NDC 60687-0394-83
🏷️ FDA NDC (as labeled) 60687-394-83 billing pads the product segment with a zero
Rx only Generic On market Non-controlled ⇄ Compare with another NDC
🗂️ FDA directory synced Oct 8, 2026 · this listing last changed Jul 24, 2026 · sources: openFDA · FDA label (DailyMed) · FDA Orange & Purple Book · First Databank · CMS NADAC, ASP, Medicare & Medicaid · RxNorm
📋 All sources & update times →

NDC database record

One package, one record: these facts belong to NDC 60687-394-83 alone.

Record
FDA NDC Directory package listing · Human prescription drug
Code segments
60687 labeler · 394 product · 83 package
Package marketed since
Jan 7, 2019
Sample package
No — commercial package
Listing certified through
Dec 31, 2026
Barcode (UPC-A, from the NDC)
3 6068739483 1
Medicaid fills, this package
7,783 prescriptions in the last four reported quarters
FDA record last changed
Jul 24, 2026

Identity & classification

Regulatory identifiers FDA, NLM and CMS codes for this package

FDA NDC (as labeled) 60687-394-83
Product NDC 60687-394
11-digit billing NDC 60687039483
NCPDP billing unit ML — per mL (volume)
RxCUI 836358
UNII J697UZ2A9J
Application # ANDA075693
SPL Set ID 8927f392-4c88-4ac1-a934-c444ecf6b2c8
Established class (EPC) Anticholinergic
Mechanism of action Cholinergic Antagonists
DEA schedule Non-controlled
Marketing category ANDA
Marketing status On market
FDA listing status Listed (active directory)
Marketing start 2019-01-07
Route RESPIRATORY (INHALATION)
Dosage form SOLUTION
Substance IPRATROPIUM BROMIDE
TE code (Orange Book) AN · RLD · RS

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

GPI-14 44100030102020
GPI class Ipratropium Bromide
GCN Seq No 021700
GCN 42235
HICL code 000057
Ingredient (HICL) Ipratropium Bromide
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 B60
Therapeutic class — specific (HIC3) Anticholinergics, Orally Inhaled Short Acting
AHFS code 12:08.08.00
AHFS class Antimuscarinics/Antispasmodics
FDB label name IPRATROPIUM BR 0.02% SOLN
FDB brand name Ipratropium Bromide
Legend status F — Federal legend — prescription drug or device
Quick answers
  • GSN (GCN sequence number): 021700
  • GCN: 42235
  • GPI-14 (Medi-Span): 44100030102020
  • HICL (First Databank): 000057
  • AHFS class code: 12:08.08.00
  • RxCUI (RxNorm): 836358
Why two NDCs? The FDA registers this code as 60687-394-83 — 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 → 60687-0394-83. 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 Anticholinergic class.

Pharmacologic class Anticholinergic
Drug family (ATC) Other nasal preparations, Anticholinergics
How it works Cholinergic Antagonists
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 IPRATROPIUM BR 0.02% SOLN Ingredient Ipratropium Bromide
📖 What it is MedlinePlus · NLM

Ipratropium oral inhalation is used to prevent wheezing, shortness of breath, coughing, and chest tightness 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). Ipratropium is in a class of medications called bronchodilators. It works by relaxing and opening the air passages to the lungs to make breathing easier.

Read the full MedlinePlus article ↗
📗 Our plain-language guide HelloPharmacist
  • No, the ipratropium inhaler (like Atrovent HFA) is a maintenance medicine — it's meant to be used regularly every day to keep your airways open, not as a rescue inhaler during a su...
  • My doctor gave me an ipratropium inhaler — can I use it when I have a sudden asthma attack?
  • It depends on why you're using it. For a common cold, safety and effectiveness have only been established for up to 4 days. For seasonal allergies (hay fever), it's been studied fo...
  • The nasal spray helps my runny nose, but can I keep using it past a week?
📖 Read our full Ipratropium guide →
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 $0.112 $8.42 / 75 ml
Medicaid paysCMS SDUD · 12 mo $0.4111 $30.83 / 75 ml
Medicare drug plans payPart D · Q2 2026 $0.1185 $8.89 / 75 ml
Medicare Part B allowsASP · J7644 $0.444 / J7644 unit —
NADAC price history (per mL) — tap or hover for the price & month
Sep 2022 Feb 2024 Apr 2026 Sep 2026 $0.116 $0.058
▲ Up 88% over the last 16 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)60687-394-83
11-digit billing NDC60687-0394-83
Format5-3-2 as registered → padded to 5-4-2 for billing (zero added to the product segment)
HCPCS J-codeJ7644
DescriptorIPRATROPIUM BROMIDE, INHALATION SOLUTION, FDA-APPROVED FINAL PRODUCT, NON-COMPOUNDED, ADMINISTERED THROUGH DME, UNIT DOSE FORM, PER MILLIGRAM
Billing units / pkg0.2 units
How the units are derivedThis package is 2.5 ML; the HCPCS unit is 1 MG, so one package = 0.2 billing units.
Medicare Part B spend (2026 (Q1))$193,055 · 12,953 claims · $14.90 per claim (all NDCs under J7644)
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
60687-0394-83 You're viewing this Main listing 30 POUCH in 1 CARTON / 1 AMPULE in 1 POUCH / 2.5 mL in 1 AMPULE 2018-12-26 — Active

Therapeutic equivalents

ProductLabelerPackNADAC/unitTEStatusPrice vs. this
Ipratropium Bromide .5 mg/2.5mL 47335-0706-49 Sun 5 pouches $0.095 — FDA listed save 15%
Ipratropium Bromide .5 mg/2.5mL 00378-7970-52 Mylan 1 pouch $0.104 AN Availability likely save 7%
Ipratropium Bromide .5 mg/2.5mL 64980-0640-02 Rising 1 pouch $0.104 AN Availability likely save 7%
Ipratropium Bromide .5 mg/2.5mL 00487-9801-01 Nephron 30 pouches $0.112 AN Availability likely —
Ipratropium Bromide .5 mg/2.5mLthis 60687-0394-83 American 30 pouches $0.112 AN Availability likely —
Ipratropium Bromide .5 mg/2.5mL 76204-0100-01 Ritedose 30 pouches $0.112 AN Availability likely —
Ipratropium Bromide .5 mg/2.5mL 62135-0830-84 Chartwell 6 pouches $0.114 AN Availability likely +1%
Ipratropium Bromide .5 mg/2.5mL 50090-0668-00 A-S 1 pouch — AN FDA listed —
Ipratropium Bromide .5 mg/2.5mL 50090-6373-00 A-S 25 pouches — AN FDA listed —
Ipratropium Bromide .5 mg/2.5mL 55154-2134-05 Cardinal 5 pouches — AN FDA listed —
Ipratropium bromide .5 mg/2.5mL 65862-0905-03 Aurobindo 30 pouches — AN FDA listed —
Ipratropium Bromide .5 mg/2.5mL 67296-2246-01 Redpharm 1 pouch — AN FDA listed —
Ipratropium Bromide .5 mg/2.5mL 68071-3769-02 NuCare 25 ampules — AN FDA listed —
Ipratropium Bromide .5 mg/2.5mL 55154-4411-05 Cardinal 5 pouches — 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

🏛️
2019
On the market since
Jan 2019
📍
2026
Currently FDA-listed
7 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.

🧪 Avoiding an ingredient? See Ipratropium inactive ingredients by manufacturer: every current product's list side by side, so you can ask your pharmacy for the version that does not list it.

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

  • UNII QTT17582CB
    A strong acid used to adjust and maintain the proper pH level in liquid medicines, ensuring stability and preventing breakdown of active ingredients.
  • UNII 451W47IQ8X
    Sodium chloride is common table salt. It's used in medicines as a buffer to maintain proper pH, as a filler to add bulk, or to adjust the osmotic balance in liquid formulations.
  • UNII 059QF0KO0R
    Water is a liquid solvent that dissolves and mixes ingredients together in liquid medicines, syrups, and injections. It helps distribute the active drug evenly throughout the product.

3 inactive ingredients listed in the exact product block matched to this NDC.

Where does this data come from?
Data sourced from official FDA Structured Product Labeling (SPL) via DailyMed — ingredient classCode="IACT" elements from the exact product block matched by this NDC. Label-section narrative from DailyMed / the openFDA label index is shown separately when available.

Inactive ingredient FAQ

Are inactive ingredients the same for every manufacturer?
No. Inactive ingredients can differ by manufacturer, dosage form, strength, and package / product version.
Why might an inactive ingredient be missing?
Some SPLs do not provide a complete structured inactive-ingredient list, and older or unusual labels may only include the information in narrative text.
Can inactive ingredients matter?
Yes. They can matter for allergies, intolerances, dyes, gluten / lactose concerns, preservatives, and formulation differences — but confirm with a pharmacist or the manufacturer when it’s clinically important.

Manufacturer & labeler

LabelerAmerican Health Packaging
Application holderTHE RITEDOSE CORP
FDA applicationANDA075693 (ANDA)
Labeler code60687
First marketedJan 2019
Product typeHuman Prescription Drug
Portfolio674 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 38 words ▾

INDICATIONS AND USAGE Ipratropium Bromide Inhalation Solution administered either alone or with other bronchodilators, especially beta adrenergics, is indicated as a bronchodilator for maintenance treatment of bronchospasm associated with chronic obstructive pulmonary disease, including chronic bronchitis and emphysema.

⏱️ Dosage and Administration 92 words ▾

DOSAGE AND ADMINISTRATION The usual dosage of ipratropium bromide inhalation solution is 500 mcg (1 Unit-Dose Vial) administered three to four times a day by oral nebulization, with doses 6 to 8 hours apart. Ipratropium bromide inhalation solution unit-dose vials contain 500 mcg ipratropium bromide, USP anhydrous in 2.5 mL normal saline. Ipratropium bromide inhalation solution can be mixed in the nebulizer with albuterol or metaproterenol if used within one hour.

Drug stability and safety of Ipratropium Bromide Inhalation Solution when mixed with other drugs in a nebulizer have not been established.

⛔ Contraindications 21 words ▾

CONTRAINDICATIONS Ipratropium bromide is contraindicated in known or suspected cases of hypersensitivity to ipratropium bromide, or to atropine and its derivatives.

⚠️ Warnings 92 words ▾

WARNINGS The use of ipratropium bromide inhalation solution as a single agent for the relief of bronchospasm in acute COPD exacerbation has not been adequately studied. Drugs with faster onset of action may be preferable as initial therapy in this situation. Combination of ipratropium bromide and beta agonists has not been shown to be more effective than either drug alone in reversing the bronchospasm associated with acute COPD exacerbation.

Immediate hypersensitivity reactions may occur after administration of ipratropium bromide, as demonstrated by rare cases of urticaria, angioedema, rash, bronchospasm and oropharyngeal edema.

🤒 Adverse Reactions ~2 min read ▾

ADVERSE REACTIONS Adverse reaction information concerning ipratropium bromide inhalation solution is derived from 12-week active-controlled clinical trials. Additional information is derived from foreign post-marketing experience and the published literature. All adverse events, regardless of drug relationship, reported by three percent or more patients in the 12-week controlled clinical trials appear in the table below.

Additional adverse reactions reported in less than three percent of the patients treated with ipratropium bromide include tachycardia, palpitations, eye pain, urinary retention, urinary tract infection and urticaria. Cases of precipitation or worsening of narrow-angle glaucoma, mydriasis, and acute eye pain have been reported. Lower respiratory adverse reactions (bronchitis, dyspnea and bronchospasm) were the most common events leading to discontinuation of ipratropium bromide therapy in the 12-week trials.

Headache, mouth dryness and aggravation of COPD symptoms are more common when the total daily dose of ipratropium bromide equals or exceeds 2,000 mcg. Allergic-type reactions such as skin-rash, angioedema of tongue, lips and face, urticaria, laryngospasm and anaphylactic reaction have been reported. Many of the patients had a history of allergies to other drugs and/or foods.

All Adverse Events, from a Double-blind, Parallel, 12-week Study of patients with COPD All adverse events, regardless of drug relationship, reported by three percent or more patients in the 12-week controlled clinical trials. PERCENT OF PATIENTS Ipratropium Metaproterenol Ipratropium/ Metaproterenol Albuterol Ipratropium/ Albuterol (500 mcg t.i.d.) (15 mg t.i.d.) (500 mcg t.i.d./ 15 mg t.i.d.) (2.5 mg t.i.d.) (500 mcg t.i.d./ 2.5 mg t.i.d.) n = 219 n = 212 n = 108 n = 205 n = 100 Body as a Whole-General Disorders Headache 6.4 5.2 6.5 6.3

9.0Pain 4.1 3.3 0.9 2.9

5.0Influenza-like symptoms 3.7 4.7 6.5 0.5

1.0Back Pain 3.2 1.9 1.9 2.4

0.0Chest Pain 3.2 4.2 5.6 2.0

1.0Cardiovascular Disorders Hypertension/Hypertension Aggravated 0.9 1.9 0.9 1.5

4.0Central & Peripheral Nervous System Dizziness 2.3 3.3 1.9 3.9

4.0Insomnia 0.9 0.5 4.6 1.0

1.0Tremor 0.9 7.1 8.3 1.0

0.0Nervousness 0.5 4.7 6.5 1.0

1.0Gastrointestinal System Disorders Mouth Dryness 3.2 0.0 1.9 2.0

3.0Nausea 4.1 3.8 1.9 2.9

2.0Constipation 0.9 0.0 3.7 1.0

1.0Musculo-skeletal System Disorders Arthritis 0.9 1.4 0.9 0.5

3.0Respiratory System Disorders (Lower) Coughing 4.6 8.0 6.5 5.4

6.0Dyspnea 9.6 13.2 16.7 12.7

9.0Bronchitis 14.6 24.5 15.7 16.6

20.0Bronchospasm 2.3 2.8 4.6 5.4

5.0Sputum Increased 1.4 1.4 4.6 3.4

0.0Respiratory Disorder 0.0 6.1 6.5 2.0

4.0Respiratory System Disorders (Upper) Upper Respiratory Tract Infection 13.2 11.3 9.3 12.2

16.0Pharyngitis 3.7 4.2 5.6 2.9

4.0Rhinitis 2.3 4.2 1.9 2.4

0.0Sinusitus 2.3 2.8 0.9 5.4 4.0

🔄 Drug Interactions 40 words ▾

Drug Interactions Ipratropium bromide has been shown to be a safe and effective bronchodilator when used in conjunction with beta adrenergic bronchodilators. Ipratropium bromide has also been used with other pulmonary medications, including methylxanthines and corticosteroids, without adverse drug interactions.

🤰 Pregnancy 98 words ▾

Pregnancy TERATOGENIC EFFECTS Pregnancy Category B Oral reproduction studies performed in mice, rats and rabbits at doses of 10, 100, and 125 mg/kg respectively, and inhalation reproduction studies in rats and rabbits at doses of 1.5 and 1.8 mg/kg (or approximately 38 and 45 times the recommended human daily dose) respectively, have demonstrated no evidence of teratogenic effects as a result of ipratropium bromide. However, no adequate or well-controlled studies have been conducted in pregnant women. Because animal reproduction studies are not always predictive of human response, ipratropium bromide should be used during pregnancy only if clearly needed.

🧒 Pediatric Use 18 words ▾

Pediatric Use Safety and effectiveness in the pediatric population below the age of 12 have not been established.

🆘 Overdosage 66 words ▾

OVERDOSAGE Acute systemic overdosage by inhalation solution is unlikely since ipratropium bromide is not well absorbed after inhalation at up to four-fold the recommended dose, or after oral administration at up to forty-fold the recommended dose. The oral LD 50 of ipratropium bromide ranged between 1001 and 2010 mg/kg in mice; between 1667 and 4000 mg/kg in rats; and between 400 and 1300 mg/kg in dogs.

🧬 Clinical Pharmacology ~2 min read ▾

CLINICAL PHARMACOLOGY Ipratropium bromide is an anticholinergic (parasympatholytic) agent that, 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 (cyclic GMP) that are caused by interaction of acetylcholine with the muscarinic receptor on bronchial smooth muscle. The bronchodilation following inhalation of ipratropium bromide is primarily a local, site-specific effect, not a systemic one.

Much of an administered dose is swallowed but not absorbed, as shown by fecal excretion studies. Following nebulization of a 2 mg dose, a mean 7% of the dose was absorbed into the systemic circulation either from the surface of the lung or from the gastrointestinal tract. The half-life of elimination is about 1.6 hours after intravenous administration.

Ipratropium bromide is minimally (0 to 9% in vitro ) bound to plasma albumin and a 1 -acid glycoproteins. It is partially metabolized. Autoradiographic studies in rats have shown that ipratropium bromide does not penetrate the blood-brain barrier.

Ipratropium bromide has not been studied in patients with hepatic or renal insufficiency. It should be used with caution in those patient populations. In controlled 12-week studies in patients with bronchospasm associated with chronic obstructive pulmonary disease (chronic bronchitis and emphysema) significant improvements in pulmonary function (FEV 1 increases of 15% or more) occurred within 15 to 30 minutes, reached a peak in 1 to 2 hours, and persisted for periods of 4 to 5 hours in the majority of patients, with about 25% to 38% of the patients demonstrating increases of 15% or more for at least 7 to 8 hours.

Continued effectiveness of ipratropium bromide inhalation solution was demonstrated throughout the 12-week period. In addition, significant increases in forced vital capacity (FVC) have been demonstrated. However, ipratropium bromide did not consistently produce significant improvement in subjective symptom scores nor in quality of life scores over the 12-week duration of study.

Additional controlled 12-week studies were conducted to evaluate the safety and effectiveness of ipratropium bromide inhalation solution administered concomitantly with the beta adrenergic bronchodilator solutions metaproterenol and albuterol compared with the administration of each of the beta agonists alone. Combined therapy produced significant additional improvement in FEV 1 and FVC. On combined therapy, the median duration of 15% improvement in FEV 1 was 5 to 7 hours, compared with 3 to 4 hours in patients receiving a beta agonist alone.

📦 How Supplied / Storage and Handling 67 words ▾

HOW SUPPLIED Ipratropium Bromide Inhalation Solution Unit Dose Vial is supplied as a 0.02% clear, colorless solution containing 2.5 mL. NDC 60687-394-83, 30 vials per carton / 1 vial per foil pouch Each vial is made from a low density polyethylene (LDPE) resin. Vials are supplied in a foil pouch. Store between 59°F (15°C) and 86°F (30°C). Protect from light. Store unused vials in the foil pouch.

📦 Storage and Handling 17 words ▾

Store between 59°F (15°C) and 86°F (30°C). Protect from light. Store unused vials in the foil pouch.

📋 Description 126 words ▾

DESCRIPTION The active ingredient, ipratropium bromide monohydrate, USP, 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. Ipratropium Bromide Monohydrate C 20 H 30 BrNO 3 •H 2 O Mol. Wt.

430.4 Ipratropium bromide is a white crystalline substance, freely soluble in water and lower alcohols. It is a quaternary ammonium compound and thus exists in an ionized state in aqueous solutions. It is relatively insoluble in non-polar media.

Ipratropium Bromide Inhalation Solution is administered by oral inhalation with the aid of a nebulizer. It contains ipratropium bromide, USP 0.02% (anhydrous basis) in a sterile, preservative-free, isotonic saline solution, pH-adjusted to 3.4 (3 to 4) with hydrochloric acid. Chemical Structure

💬 Information for Patients 122 words ▾

Information for Patients Patients should be advised that temporary blurring of vision, precipitation or worsening of narrow-angle glaucoma or eye pain may result if the solution comes into direct contact with the eyes. Use of a nebulizer with mouthpiece rather than face mask may be preferable, to reduce the likelihood of the nebulizer solution reaching the eyes. Patients should be advised that ipratropium bromide inhalation solution can be mixed in the nebulizer with albuterol or metaproterenol if used within one hour.

Drug stability and safety of Ipratropium Bromide Inhalation Solution when mixed with other drugs in a nebulizer have not been established. Patients should be reminded that ipratropium bromide inhalation solution should be used consistently as prescribed throughout the course of therapy.

⚠️ Precautions ~2 min read ▾

PRECAUTIONS General Ipratropium bromide should be used with caution in patients with narrow-angle glaucoma, prostatic hypertrophy or bladder-neck obstruction. Information for Patients Patients should be advised that temporary blurring of vision, precipitation or worsening of narrow-angle glaucoma or eye pain may result if the solution comes into direct contact with the eyes. Use of a nebulizer with mouthpiece rather than face mask may be preferable, to reduce the likelihood of the nebulizer solution reaching the eyes.

Patients should be advised that ipratropium bromide inhalation solution can be mixed in the nebulizer with albuterol or metaproterenol if used within one hour. Drug stability and safety of Ipratropium Bromide Inhalation Solution when mixed with other drugs in a nebulizer have not been established. Patients should be reminded that ipratropium bromide inhalation solution should be used consistently as prescribed throughout the course of therapy.

Drug Interactions Ipratropium bromide has been shown to be a safe and effective bronchodilator when used in conjunction with beta adrenergic bronchodilators. Ipratropium bromide has also been used with other pulmonary medications, including methylxanthines and corticosteroids, without adverse drug interactions. Carcinogenesis, Mutagenesis, Impairment of Fertility Two-year oral carcinogenicity studies in rats and mice have revealed no carcinogenic potential at dietary doses up to 6 mg/kg/day of ipratropium bromide.

Results of various mutagenicity studies (Ames test, mouse dominant lethal test, mouse micronucleus test and chromosome aberration of bone marrow in Chinese hamsters) were negative. Fertility of male or female rats at oral doses up to 50 mg/kg/day was unaffected by ipratropium bromide administration. At doses above 90 mg/kg increased resorption and decreased conception rates were observed.

Pregnancy TERATOGENIC EFFECTS Pregnancy Category B Oral reproduction studies performed in mice, rats and rabbits at doses of 10, 100, and 125 mg/kg respectively, and inhalation reproduction studies in rats and rabbits at doses of 1.5 and 1.8 mg/kg (or approximately 38 and 45 times the recommended human daily dose) respectively, have demonstrated no evidence of teratogenic effects as a result of ipratropium bromide. However, no adequate or well-controlled studies have been conducted in pregnant women. Because animal reproduction studies are not always predictive of human response, ipratropium bromide should be used during pregnancy only if clearly needed.

Nursing Mothers It is not known whether ipratropium bromide is excreted in human milk. Although lipid-insoluble quaternary bases pass into breast milk, it is unlikely that ipratropium bromide would reach the infant to a significant extent, especially when taken by inhalation since ipratropium bromide is not well absorbed systemically after inhalation or oral administration. However, because many drugs are excreted in human milk, caution should be exercised when ipratropium bromide is administered to a nursing woman.

Pediatric Use Safety and effectiveness in the pediatric population below the age of 12 have not been established.

🍼 Nursing Mothers 76 words ▾

Nursing Mothers It is not known whether ipratropium bromide is excreted in human milk. Although lipid-insoluble quaternary bases pass into breast milk, it is unlikely that ipratropium bromide would reach the infant to a significant extent, especially when taken by inhalation since ipratropium bromide is not well absorbed systemically after inhalation or oral administration. However, because many drugs are excreted in human milk, caution should be exercised when ipratropium bromide is administered to a nursing woman.

📄 Carcinogenesis, Mutagenesis, Impairment of Fertility 85 words ▾

Carcinogenesis, Mutagenesis, Impairment of Fertility Two-year oral carcinogenicity studies in rats and mice have revealed no carcinogenic potential at dietary doses up to 6 mg/kg/day of ipratropium bromide. Results of various mutagenicity studies (Ames test, mouse dominant lethal test, mouse micronucleus test and chromosome aberration of bone marrow in Chinese hamsters) were negative. Fertility of male or female rats at oral doses up to 50 mg/kg/day was unaffected by ipratropium bromide administration.

At doses above 90 mg/kg increased resorption and decreased conception rates were observed.

📄 Patient Package Insert ~1 min read ▾

Patient's Instructions for Use Ipratropium Bromide Inhalation Solution 0.02% Read complete instructions carefully before using. Twist open the top of one unit dose vial and squeeze the contents into the nebulizer reservoir. (Figure 1).

2. Connect the nebulizer reservoir to the mouthpiece or face mask (Figure 2). 3.

Connect the nebulizer to the compressor. 4. Sit in a comfortable, upright position; place the mouthpiece in your mouth (Figure 3) or put on the face mask and turn on the compressor.

If a face mask is used, care should be taken to avoid leakage around the mask as temporary blurring of vision, pupil enlargement, precipitation or worsening of narrow angle glaucoma, or eye pain may occur if the solution comes into direct contact with the eyes. 5. Breathe as calmly, deeply, and evenly as possible until no more mist is formed in the nebulizer chamber (about 5 to 15 minutes).

At this point, the treatment is finished. 6. Clean the nebulizer (see manufacturer's instructions).

Note: Use only as directed by your physician. More frequent administration or higher doses are not recommended. Ipratropium Bromide Inhalation Solution can be mixed in the nebulizer with albuterol or metaproterenol if used within one hour but not with other drugs.

Drug stability and safety of Ipratropium Bromide Inhalation Solution when mixed with other drugs in the nebulizer have not been established. Store between 59°F (15°C) and 86°F (30°). Protect from light.

Store unused vials in the foil pouch. ADDITIONAL INSTRUCTIONS: __________________________________________________________________________________________________ Figure 1 Figure 2 Figure 3

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

Package/Label Display Panel – Carton – 0.5 mg per 2.5 mL NDC 60687- 394 -83 Ipratropium Bromide Inhalation Solution, 0.02% 0.5 mg/2.5 mL 30 x 2.5 mL Sterile Unit-Dose Vials, each in a foil pouch. Rx Only FOR ORAL INHALATION ONLY INGREDIENTS: Each low density polyethylene vial contains: 2.5 mL Ipratropium Bromide 0.02%, preservative free, isotonic sterile aqueous solution containing sodium chloride. Adjusted to pH 3.4 (3 to 4) with hydrochloric acid.

Usual Dosage: See accompanying prescribing information. Store between 15º and 30ºC (59º and 86ºF). Protect from light.

Rx Only ATTENTION PHARMACIST: Detach "Patient's Instructions For Use" from package insert and dispense with solution. Manufactured by: The Ritedose Corporation, Columbia, SC 29203 Distributed by: American Health Packaging, Columbus, OH 43217 0.5 mg/2.5 mL Ipratropium Bromide Inhalation Solution Carton

Package/Label Display Panel – Pouch – 0.5 mg per 2.5 mL NDC 60687-394-79 Ipratropium Bromide Inhalation Solution 0.02% (0.5 mg/vial) FOR ORAL INHALATION ONLY Each low density polyethylene vial contains: 2.5 mL Ipratropium Bromide 0.02%, preservative free, isotonic sterile aqueous solution containing sodium chloride. Adjusted to pH 3.4 (3 to 4) with hydrochloric acid. Usual Dosage: See accompanying prescribing information.

Store between 15º and 30ºC (59º and 86ºF). Protect from light. ATTENTION PHARMACIST: Detach "Patient's Instructions For Use" from package insert and dispense with solution.

Rx Only STERILE One 2.5 mL Unit-Dose Vial Manufactured by: The Ritedose Corporation Columbia, SC 29203 Distributed by: American Health Packaging Columbus, OH 43217 RPFP0221 Ipratropium Bromide Inhalation Solution Foil Label

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

Medicaid utilization & spend

📍 This exact package only: Medicaid data is reported per full 11-digit NDC — labeler, product and pack size — so every number here is for this package alone, not the drug overall. Other pack sizes report separately.
💊 Pharmacy benefit only: These are Medicaid outpatient pharmacy claims, billed by NDC. They exclude the medical benefit — clinic- or hospital-administered drugs billed under HCPCS J-codes — so drugs used mostly that way (e.g. Avastin, Lucentis, Keytruda) can look low or missing here. That’s expected, not an error.
📅 Q1 2025 – Q1 2026 · 5 quarters of data
ⓘ The newest quarter is usually incomplete when first published; states restate recent quarters in later CMS releases, so the latest figures typically revise upward. State coverage-policy changes can also shift quarter-to-quarter totals.
Prescriptions last 4 qtrs
7.8K
Units reimbursed last 4 qtrs
305.6K
Gross reimbursed last 4 qtrs
$125.6K
Avg / prescription
$16.14
Avg / unit
$0.4111
Latest quarter Q1 2026
2.2KRx
Medicaid pays / mL
$0.4111
gross reimbursed
vs
NADAC / mL
$0.1122
acquisition cost
=
Spread
+$0.2989
+266% vs cost
What Medicaid paid per mL (before rebates; includes the pharmacy’s dispensing fee) compared with NADAC — the average price pharmacies pay to buy the drug. A positive spread means Medicaid reimbursed more than the purchase price, before manufacturer rebates.
Fee-for-service vs managed care ⓘ
18% FFS 82% MCO
Fee-for-service · 1,403 Rx Managed care · 6,380 Rx
State Medicaid map
Alaska: no data reported AK Maine: no data reported ME Washington: 11,840 units · 152 per 100k residents WA Idaho: 940 units · 47.9 per 100k residents ID Montana: no data reported MT North Dakota: no data reported ND Minnesota: no data reported MN Wisconsin: no data reported WI Michigan: 5,288 units · 52.7 per 100k residents MI New York: 17,701 units · 90.4 per 100k residents NY Vermont: no data reported VT New Hampshire: no data reported NH Oregon: no data reported OR Nevada: no data reported NV Wyoming: no data reported WY South Dakota: no data reported SD Iowa: 1,188 units · 37.0 per 100k residents IA Illinois: 14,463 units · 115 per 100k residents IL Indiana: 572 units · 8.3 per 100k residents IN Ohio: 15,659 units · 133 per 100k residents OH Pennsylvania: 21,343 units · 165 per 100k residents PA New Jersey: no data reported NJ Massachusetts: 1,691 units · 24.2 per 100k residents MA California: 100,818 units · 259 per 100k residents CA Utah: no data reported UT Colorado: 360 units · 6.1 per 100k residents CO Nebraska: 660 units · 33.4 per 100k residents NE Missouri: 12,400 units · 200 per 100k residents MO Kentucky: 7,100 units · 157 per 100k residents KY West Virginia: no data reported WV Virginia: 6,635 units · 76.1 per 100k residents VA Maryland: 16,890 units · 273 per 100k residents MD Connecticut: no data reported CT Rhode Island: no data reported RI Arizona: 3,855 units · 51.9 per 100k residents AZ New Mexico: 58 units · 2.7 per 100k residents NM Kansas: no data reported KS Arkansas: 2,625 units · 85.6 per 100k residents AR Tennessee: no data reported TN North Carolina: 12,040 units · 111 per 100k residents NC South Carolina: 1,350 units · 25.1 per 100k residents SC Delaware: no data reported DE Oklahoma: no data reported OK Louisiana: no data reported LA Mississippi: 522 units · 17.8 per 100k residents MS Alabama: 2,190 units · 42.9 per 100k residents AL Georgia: 19,493 units · 177 per 100k residents GA D.C.: 480 units · 70.7 per 100k residents DC Hawaii: no data reported HI Texas: 6,214 units · 20.4 per 100k residents TX Florida: 21,248 units · 94.0 per 100k residents FL
Units reimbursed · per 100k residents
2.7273
gray = no data reported ⓘ
Colors are per 100,000 residents, so big states don’t automatically dominate. Tap or hover a state for its actual totals.
Tap or hover a state
…for its Medicaid breakdown
🏆 Top states by units · per 100k residents
1 Maryland 273 /100k
2 California 259 /100k
3 Missouri 200 /100k
4 Georgia 177 /100k
5 Pennsylvania 165 /100k
6 Kentucky 157 /100k
7 Washington 152 /100k
8 Ohio 133 /100k
National units — by quarter
💵 About the dollar figures: “reimbursed” is what Medicaid paid pharmacies before confidential manufacturer rebates, so the program’s real net cost is lower than these numbers. Fee-for-service and managed-care claims are combined unless split above. Source: CMS State Drug Utilization Data; per-100k rates use 2023 Census population estimates.

Medicare Part D spend CMS · PART D · 2026 (Q1)

Medicare Part D (outpatient prescription) spending for Ipratropium Bromide — the program that covers self-administered drugs. 13 manufacturers.
⚠️ Drug-level data: CMS publishes Part D spending by drug, not by NDC — these figures combine every manufacturer, strength and package size sold under the name Ipratropium Bromide. That’s a different level of aggregation than the Medicaid card above, which is specific to this exact 11-digit NDC (pack size included), so the two aren’t directly comparable.
Period
Total Part D spend
$19.15M
Claims incl. refills
666.7K
Beneficiaries
481.7K
Spend / beneficiary
$39.75
Spend / claim
$28.72
Trend by period
💵 About the dollar figures: spending is what Part D plans paid before confidential manufacturer rebates, so the program’s real net cost is lower. A blank patient count means fewer than 11 people — CMS hides counts that small to protect privacy. Source: CMS Medicare Quarterly Part D Spending by Drug (data.cms.gov), updated quarterly.
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.