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Ipratropium Bromide 21 ug Spray — NDC 69238-2016-03 package photo
Label image from the product's FDA listing (DailyMed) — may show a different pack size or an older label revision.

Ipratropium Bromide 21 ug Spray — NDC 69238-2016-3 (Billing 69238-2016-03)

by Amneal Pharmaceuticals NY LLC · 1 BOTTLE, SPRAY in 1 CARTON / 345 SPRAY in 1 BOTTLE, SPRAY

This is a package of Ipratropium Bromide 21 ug Spray from Amneal Pharmaceuticals NY LLC, marketed since Aug 2022 and currently FDA-listed; retail pharmacies pay about $0.3678 per mL (NADAC). It is this product's only package size.

NDC 69238-2016-03
🏷️ FDA NDC (as labeled) 69238-2016-3 billing pads the package 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 →

Identity & classification

Regulatory identifiers FDA, NLM and CMS codes for this package

FDA NDC (as labeled) 69238-2016-3
Product NDC 69238-2016
11-digit billing NDC 69238201603
NCPDP billing unit ML — per mL (volume)
RxCUI 1797833
UNII J697UZ2A9J
UPC 0369238201635
Application # ANDA215104
SPL Set ID 61820346-29d9-4864-b8f4-4a198b8ac594
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 2022-08-18
Route NASAL
Dosage form SPRAY
Substance IPRATROPIUM BROMIDE
TE code (Orange Book) AB · RLD · RS

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

GPI-14 42300040102010
GCN Seq No 024457
GCN 42239
HICL code 000057
Ingredient (HICL) Ipratropium Bromide
HIC1 code Q
Therapeutic class — broad (HIC1) Ear/Eye/Nose/Rectum/Topical/Vagina/Other
HIC2 code Q7
Therapeutic class — intermediate (HIC2) Nasal Preparations
HIC3 code Q7A
Therapeutic class — specific (HIC3) Nose Preparations, Miscellaneous (Rx)
AHFS code 52:92.00.00
AHFS class Eent Drugs, Miscellaneous
FDB label name IPRATROPIUM 0.03% SPRAY
FDB brand name Ipratropium Bromide
Legend status F — Federal legend — prescription drug or device
Quick answers
  • GSN (GCN sequence number): 024457
  • GCN: 42239
  • GPI-14 (Medi-Span): 42300040102010
  • HICL (First Databank): 000057
  • AHFS class code: 52:92.00.00
  • RxCUI (RxNorm): 1797833
Why two NDCs? The FDA registers this code as 69238-2016-3 — a 5-4-1 layout, and that's what's printed on the package and shown on DailyMed. For insurance claims, every NDC is standardized to a uniform 11-digit 5-4-2 format by adding a zero to the package segment → 69238-2016-03. Same drug, same package — only the format differs.
Where does this data come from?
Identifiers from the FDA openFDA NDC Directory and Structured Product Labeling; RxCUI from RxNorm (NLM); GPI from Medi-Span; GCN / HIC / AHFS / legend from First Databank.

RxNorm drug class

This medicine belongs to the 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 0.03% SPRAY Ingredient Ipratropium Bromide
📖 What it is MedlinePlus · NLM

Ipratropium nasal spray is available in two strengths that are used to treat different conditions. Ipratropium nasal spray 0.06% is used to relieve a runny nose caused by the common cold or seasonal allergies (hay fever) in adults and children age 5 and older. Ipratropium nasal spray 0.03% is used to relieve a runny nose caused by year-round allergic and nonallergic rhinitis (runny nose and stuffiness) in adults and children age 6 and older. Ipratropium nasal spray does not relieve nasal congestion, sneezing, or postnasal drip caused by these conditions. Ipratropium nasal spray is in a class o...

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 $0.368 —
Medicaid paysCMS SDUD · 12 mo $0.8348 —
Medicare drug plans payPart D · Q2 2026 $0.6490 —
NADAC price history (per mL) — tap or hover for the price & month
Dec 2023 Jan 2026 May 2026 Sep 2026 $0.706 $0.349
▼ Down 40% over the last 13 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.

Packaging — all sizes for this product

Package NDCDescription Marketing startMarketing endStatus
69238-2016-03 You're viewing this Main listing 1 BOTTLE, SPRAY in 1 CARTON / 345 SPRAY in 1 BOTTLE, SPRAY 2022-08-18 — Active

Therapeutic equivalents

ProductLabelerPackNADAC/unitTEStatusPrice vs. this
Ipratropium Bromide 21 ug 00054-0045-44 Hikma 1 bottle $0.368 AB Availability likely —
Ipratropium Bromide 21 ug 16714-0526-01 NORTHSTAR 1 bottle $0.368 AB Availability likely —
Ipratropium Bromide 21 ug 60505-0826-01 Apotex 1 bottle $0.368 AB Availability likely —
Ipratropium Bromide 21 ugthis 69238-2016-03 Amneal 1 bottle $0.368 AB Availability likely —
Ipratropium Bromide 21 ug 70748-0336-01 Lupin 1 bottle $0.368 AB Availability likely —
Ipratropium Bromide 21 ug 72888-0149-38 Advagen 1 bottle $0.368 AB Availability likely —
Ipratropium bromide 21 ug 24208-0398-30 Bausch 1 bottle $0.420 AB FDA listed +14%
Ipratroprium Bromide 21 ug 68682-0398-30 Oceanside 1 bottle — AB FDA listed —
Ipratropium Bromide 21 ug 72162-2143-03 Bryant 1 bottle — AB 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

🏛️
2022
On the market since
Aug 2022
📍
2026
Currently FDA-listed
4 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.

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

  • UNII F5UM2KM3W7
    Benzalkonium chloride is a chemical compound that works as a preservative and antimicrobial agent in medications. It prevents bacterial and fungal growth in liquid formulations to keep the product safe during storage and use.
  • UNII 7FLD91C86K
    Edetate disodium is a chemical compound that binds and removes certain metal ions. In medicines, it acts as a preservative and stabilizer by preventing metals like calcium from interfering with the product's shelf life and consistency.
  • UNII QTT17582CB
    A strong acid used to adjust and maintain the proper pH level in liquid medicines, ensuring stability and preventing breakdown of active ingredients.
  • UNII 451W47IQ8X
    Sodium chloride is common table salt. It's used in medicines as a buffer to maintain proper pH, as a filler to add bulk, or to adjust the osmotic balance in liquid formulations.
  • UNII 55X04QC32I
    A strong alkaline chemical used to adjust and maintain the pH balance of liquid medicines. It helps keep the medicine stable and ensures it stays effective during storage.
  • UNII 059QF0KO0R
    Water is a liquid solvent that dissolves and mixes ingredients together in liquid medicines, syrups, and injections. It helps distribute the active drug evenly throughout the product.

6 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

LabelerAmneal Pharmaceuticals NY LLC
Application holderAMNEAL PHARMACEUTICALS LLC
FDA applicationANDA215104 (ANDA)
Labeler code69238
First marketedAug 2022
Product typeHuman Prescription Drug
Portfolio372 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. Very long sections are excerpted here and marked; the full text is on DailyMed (linked in the sources below). Jump with a chip, search within the label, or expand everything.
🎯 Indications and Usage 53 words ▾

INDICATIONS AND USAGE Ipratropium Bromide Nasal Solution 0.03% is indicated for the symptomatic relief of rhinorrhea associated with allergic and nonallergic perennial rhinitis in adults and children age 6 years and older. Ipratropium Bromide Nasal Solution 0.03% does not relieve nasal congestion, sneezing, or postnasal drip associated with allergic or nonallergic perennial rhinitis.

⏱️ Dosage and Administration 116 words ▾

DOSAGE AND ADMINISTRATION The recommended dose of Ipratropium Bromide Nasal Solution 0.03% is two sprays (42 mcg) per nostril two or three times daily (total dose 168 to 252 mcg/day) for the symptomatic relief of rhinorrhea associated with allergic and nonallergic perennial rhinitis in adults and children age 6 years and older. Optimum dosage varies with the response of the individual patient. Initial pump priming requires seven sprays of the pump.

If used regularly as recommended, no further priming is required. If not used for more than 24 hours, the pump will require two sprays, or if not used for more than seven days, the pump will require seven sprays to reprime. Avoid spraying into eyes.

⛔ Contraindications 27 words ▾

CONTRAINDICATIONS Ipratropium Bromide Nasal Solution 0.03% is contraindicated in patients with a history of hypersensitivity to atropine or its derivatives, or to any of the other ingredients.

⚠️ Warnings 45 words ▾

WARNINGS Immediate hypersensitivity reactions may occur after administration of ipratropium bromide, as demonstrated by urticaria, angioedema, rash, bronchospasm, anaphylaxis, and oropharyngeal edema. If such a reaction occurs, therapy with Ipratropium Bromide Nasal Solution 0.03% should be stopped at once and alternative treatment should be considered.

🤒 Adverse Reactions ~3 min read ▾

ADVERSE REACTIONS Adverse reaction information on Ipratropium Bromide Nasal Solution 0.03% in patients with perennial rhinitis was derived from four multicenter, vehicle-controlled clinical trials involving 703 patients (356 patients on Ipratropium Bromide Nasal Solution 0.03% and 347 patients on vehicle), and a one-year, open-label, follow-up trial. In three of the trials, patients received Ipratropium Bromide Nasal Solution 0.03% three times daily, for eight weeks. In the other trial, Ipratropium Bromide Nasal Solution 0.03% was given to patients two times daily for four weeks.

Of the 285 patients who entered the open-label, follow-up trial, 232 were treated for 3 months, 200 for 6 months, and 159 up to one year. The majority (>86%) of patients treated for one year were maintained on 42 mcg per nostril, two or three times daily, of Ipratropium Bromide Nasal Solution 0.03%. Table 1 shows adverse events, and the frequency that these adverse events led to the discontinuation of treatment, reported for patients who received Ipratropium Bromide Nasal Solution 0.03% at the recommended dose of 42 mcg per nostril, or vehicle two or three times daily for four or eight weeks.

Only adverse events reported with an incidence of at least 2.0% in the Ipratropium Bromide Nasal Solution 0.03% group and higher in the Ipratropium Bromide Nasal Solution 0.03% group than in the vehicle group are shown. Table 1 % of Patients Reporting Events + Ipratropium Bromide Nasal Solution 0.03% (n=356) Vehicle Control (n=347) Incidence % Discontinued % Incidence % Discontinued % Headache 9.8 0.6 9.2

0.0Upper respiratory tract infection 9.8 1.4 7.2

1.4Epistaxis 1 9.0 0.3 4.6

0.3Rhinitis* Nasal dryness 5.1 0.0 0.9

0.3Nasal irritation 2 2.0 0.0 1.7

0.6Other nasal symptoms 3 3.1 1.1 1.7

0.3Pharyngitis 8.1 0.3 4.6

0.0Nausea 2.2 0.3 0.9 0.0 + This table includes adverse events which occurred at an incidence rate of at least 2.0% in the Ipratropium Bromide Nasal Solution 0.03%group and more frequently in the Ipratropium Bromide Nasal Solution 0.03%group than in the vehicle group. 1 Epistaxis reported by 7.0% of Ipratropium Bromide Nasal Solution 0.03%patients and 2.3% of vehicle patients, blood-tinged mucus by 2.0% of Ipratropium Bromide Nasal Solution 0.03%patients and 2.3% of vehicle patients. 2 Nasal irritation includes reports of nasal itching, nasal burning, nasal irritation, and ulcerative rhinitis.

3 Other nasal symptoms include reports of nasal congestion, increased rhinorrhea, increased rhinitis, posterior nasal drip, sneezing, nasal polyps, and nasal edema. * All events are listed by their WHO term; rhinitis has been presented by descriptive terms for clarification. Ipratropium Bromide Nasal Solution 0.03% was well tolerated by most patients. The most frequently reported nasal adverse events were transient episodes of nasal dryness or epistaxis.

These adverse events were mild or moderate in nature, none was considered serious, none resulted in hospitalization and most resolved spontaneously or following a dose reduction. Treatment for nasal dryness and epistaxis was required infrequently (2% or less) and consisted of local application of pressure or a moisturizing agent (e.g., petroleum jelly or saline nasal spray). Patient discontinuation for epistaxis or nasal dryness was infrequent in both the controlled (0.3% or less) and one-year, open-label (2% or less) trials.

There was no evidence of nasal rebound (i.e., a clinically significant increase in rhinorrhea, posterior nasal drip, sneezing or nasal congestion severity compared to baseline) upon discontinuation of double-blind therapy in these trials. Adverse events reported by less than 2% of the patients receiving Ipratropium Bromide Nasal Solution 0.03% during the controlled clinical trials or during the open-label follow-up trial, which are potentially related to Ipratropium Bromide Nasal Solution 0.03% local effects or systemic anticholinergic effects include: dry mouth/throat, dizziness, ocu… [Excerpted — this section continues on DailyMed.]

🆘 Overdosage 124 words ▾

OVERDOSAGE Acute overdosage by intranasal administration is unlikely since ipratropium bromide is not well absorbed systemically after intranasal or oral administration. Following administration of a 20 mg oral dose (equivalent to ingesting more than four bottles of Ipratropium Bromide Nasal Solution 0.03%) to 10 male volunteers, no change in heart rate or blood pressure was noted. Following a 2 mg intravenous infusion over 15 minutes to the same 10 male volunteers, plasma ipratropium concentrations of 22 to 45 ng/mL were observed (>100 times the concentrations observed following intranasal administration).

Following intravenous infusion these 10 volunteers had a mean increase of heart rate of 50 bpm and less than 20 mmHg change in systolic or diastolic blood pressure at the time of peak ipratropium levels.

🧬 Clinical Pharmacology ~3 min read ▾

CLINICAL PHARMACOLOGY Mechanism of Action Ipratropium bromide is an anticholinergic (parasympatholytic) agent which, based on animal studies, appears to inhibit vagally-mediated reflexes by antagonizing the action of acetylcholine, the transmitter agent released at the neuromuscular junctions in the lung. In humans, ipratropium bromide has antisecretory properties and, when applied locally, inhibits secretions from the serous and seromucous glands lining the nasal mucosa. Ipratropium bromide is a quaternary amine that minimally crosses the nasal and gastrointestinal membranes and the blood-brain barrier, resulting in a reduction of the systemic anticholinergic effects (e.g., neurologic, ophthalmic, cardiovascular, and gastrointestinal effects) that are seen with tertiary anticholinergic amines.

Pharmacokinetics Absorption: Ipratropium bromide is poorly absorbed into the systemic circulation following oral administration (2% to 3%). Less than 20% of an 84 mcg per nostril dose was absorbed from the nasal mucosa of normal volunteers, induced-cold patients, or perennial rhinitis patients. Distribution: Ipratropium bromide is minimally bound (0% to 9% in vitro ) to plasma albumin and α 1 -acid glycoprotein.

Its blood/plasma concentration ratio was estimated to be about 0.89. Studies in rats have shown that ipratropium bromide does not penetrate the blood-brain barrier. Metabolism: Ipratropium bromide is partially metabolized to ester hydrolysis products, tropic acid and tropane.

These metabolites appear to be inactive based on in vitro receptor affinity studies using rat brain tissue homogenates. Elimination: After intravenous administration of 2 mg ipratropium bromide to 10 healthy volunteers, the terminal half-life of ipratropium was approximately 1.6 hours. The total body clearance and renal clearance were estimated to be 2,505 and 1,019 mL/min, respectively.

The amount of the total dose excreted unchanged in the urine (Ae) within 24 hours was approximately one-half of the administered dose. Pediatrics: Following administration of 42 mcg of ipratropium bromide per nostril two or three times a day in perennial rhinitis patients 6 to 18 years old, the mean amounts of the total dose excreted unchanged in the urine (8.6% to 11.1%) were higher than those reported in adult volunteers or adult perennial rhinitis patients (3.7% to 5.6%). Plasma ipratropium concentrations were relatively low (ranging from undetectable up to 0.49 ng/mL).

No correlation of the amount of the total dose excreted unchanged in the urine (Ae) with age or gender was observed in the pediatric population. Special Populations: Gender does not appear to influence the absorption or excretion of nasally administered ipratropium bromide. The pharmacokinetics of ipratropium bromide have not been studied in patients with hepatic or renal insufficiency or in the elderly.

Drug-Drug Interactions: No specific pharmacokinetic studies were conducted to evaluate potential drug-drug interactions. Pharmacodynamics In two single-dose trials (n=17), doses up to 336 mcg of ipratropium bromide did not significantly affect pupillary diameter, heart rate, or systolic/diastolic blood pressure. Similarly, in patients with induced-colds, Ipratropium Bromide Nasal Solution 0.06% (84 mcg/nostril four times a day), had no significant effects on pupillary diameter, heart rate or systolic/diastolic blood pressure.

Two nasal provocation trials in perennial rhinitis patients (n=44) using ipratropium bromide nasal spray showed a dose dependent increase in inhibition of methacholine induced nasal secretion with an onset of action within 15 minutes (time of first observation). Controlled clinical trials demonstrated that intranasal fluorocarbon-propelled ipratropium bromide does not alter physiologic nasal functions (e.g., sense of smell, ciliary beat frequency, mucociliary clearance, or the air conditioning capacity of the nose).

Clinical Trials The clinical trials for Ipratropium Bromide Nasal So… [Excerpted — this section continues on DailyMed.]

📦 How Supplied / Storage and Handling 156 words ▾

HOW SUPPLIED Ipratropium Bromide Nasal Solution 0.03% is a clear, colorless solution supplied in a white high density polyethylene (HDPE) bottle fitted with a white colored metered nasal spray pump, a green safety clip to prevent accidental discharge of the spray, and a clear plastic dust cap. It contains 31.1 g of product formulation, 345 sprays, each delivering 21 mcg of ipratropium bromide, USP per spray (70 μL), or 28 days of therapy at the maximum recommended dose (two sprays per nostril three times a day) (NDC 69238-2016-3).

Store tightly closed at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature]. Avoid freezing. Keep out of reach of children.

Do not spray in the eyes. Address medical inquiries to: www.amneal.com or 1-877-835-5472. Patients should be reminded to read and follow the accompanying “Patient’s Instructions for Use” , which should be dispensed with the product.

Distributed by: Amneal Pharmaceuticals LLC Bridgewater, NJ 08807 Rev. 04-2022-01

📋 Description 162 words ▾

DESCRIPTION The active ingredient in Ipratropium Bromide Nasal Solution is ipratropium bromide, USP (as the monohydrate). It is an anticholinergic agent 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. The structural formula is: C 20 H 30 BrNO 3 •H 2 O ipratropium bromide, USP Mol.

Wt. 430.4 Ipratropium bromide, USP is a white or almost white crystalline substance, freely soluble in methanol, soluble in water, sparingly soluble in ethanol, and insoluble in non-polar media. In aqueous solution, it exists in an ionized state as a quaternary ammonium compound.

Ipratropium Bromide Nasal Solution 0.03% is a metered-dose, manual pump spray unit which delivers 21 mcg ipratropium bromide, USP (on an anhydrous basis) per spray (70 μL) in an isotonic, aqueous solution with pH adjusted to 4.7. It also contains benzalkonium chloride, edetate disodium, sodium chloride, sodium hydroxide, hydrochloric acid, and purified water. Each bottle contains 345 sprays.

Structural Formula

⚠️ Precautions ~3 min read ▾

PRECAUTIONS General Effects Seen with Anticholinergic Drugs: Ipratropium Bromide Nasal Solution 0.03% should be used with caution in patients with narrow-angle glaucoma, prostatic hyperplasia, or bladder neck obstruction, particularly if they are receiving an anticholinergic by another route. Use in Hepatic or Renal Disease: Ipratropium Bromide Nasal Solution 0.03% has not been studied in patients with hepatic or renal insufficiency. It should be used with caution in those patient populations.

Information for Patients Patients should be advised that temporary blurring of vision, precipitation or worsening of narrow-angle glaucoma, mydriasis, increased intraocular pressure, acute eye pain or discomfort, visual halos or colored images in association with red eyes from conjunctival and corneal congestion may result if Ipratropium Bromide Nasal Solution 0.03% comes into direct contact with the eyes. Patients should be instructed to avoid spraying Ipratropium Bromide Nasal Solution 0.03% in or around their eyes.

Patients who experience eye pain, blurred vision, excessive nasal dryness, or episodes of nasal bleeding should be instructed to contact their doctor. To ensure proper dosing, patients should be advised not to alter the size of the nasal spray opening. Patients should be reminded to carefully read and follow the accompanying Patient's Instructions for Use .

Since dizziness, accommodation disorder, mydriasis, and blurred vision may occur with use of Ipratropium Bromide Nasal Solution 0.03%, patients should be cautioned about engaging in activities requiring balance and visual acuity such as driving a car or operating appliances, machinery, etc. Drug Interactions No controlled clinical trials were conducted to investigate potential drug-drug interactions. There is potential for an additive interaction with other concomitantly administered medications with anticholinergic properties including Ipratropium Bromide for oral inhalation.

Carcinogenesis, Mutagenesis, Impairment of Fertility Two-year oral carcinogenicity studies in rats and mice have revealed no carcinogenic activity at doses up to 6 mg/kg. This dose corresponds in rats and mice to approximately 190 and 95 times the maximum recommended daily intranasal dose in adults, respectively, and approximately 110 and 55 times the maximum recommended daily intranasal dose in children, respectively, on a mg/m 2 basis. 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 (approximately 1,600 times the maximum recommended daily intranasal dose in adults on a mg/m 2 basis) was unaffected by ipratropium bromide administration. At an oral dose of 500 mg/kg (approximately 16,000 times the maximum recommended daily intranasal dose in adults on a mg/m 2 basis), ipratropium bromide produced a decrease in the conception rate. Pregnancy Teratogenic Effects: Pregnancy Category B.

There are no adequate and well-controlled studies for Ipratropium Bromide Nasal Solution 0.03% in pregnant women. Because animal reproduction studies are not always predictive of human response, Ipratropium Bromide Nasal Solution 0.03% should be used during pregnancy only if clearly needed. Oral reproduction studies were performed at ipratropium doses of 10 mg/kg in mice, 1,000 mg/kg in rats and 125 mg/kg in rabbits.

These doses correspond, in each species, respectively, to approximately 160, 32,000, and 8,000 times the maximum recommended daily intranasal dose (MRDID) in adults on a mg/m 2 basis. Inhalation reproduction studies were conducted in rats and rabbits at doses of 1.5 and 1.8 mg/kg, respectively, (approximately 50 and 120 times, respectively, the MRDID in adults on a mg/m 2 basis). These studies demonstrated no evidence of teratogenic effects as a result of ipratropium bromide.

At oral doses 90 mg/kg and above in rat… [Excerpted — this section continues on DailyMed.]

📖 Instructions for Use ~3 min read ▾

Patient's Instructions for Use Ipratropium Bromide Nasal Solution 0.03%, Nasal Spray, 21 mcg/spray Read complete instructions carefully before using. In order to ensure proper dosing, do not attempt to change the size of the spray opening. Ipratropium Bromide Nasal Solution 0.03% is indicated for the symptomatic relief of rhinorrhea (runny nose) associated with allergic and nonallergic perennial rhinitis in adults and children age 6 years and older.

Ipratropium Bromide Nasal Solution 0.03% does not relieve nasal congestion, sneezing, or postnasal drip associated with allergic or nonallergic perennial rhinitis. Read complete instructions carefully and use only as directed. To Use: 1.

Remove the clear plastic dust cap and the green safety clip from the nasal spray pump (Figure 1). The safety clip prevents the accidental discharge of the spray in your pocket or purse. 2.

The nasal spray pump must be primed before Ipratropium Bromide Nasal Solution 0.03% is used for the first time. To prime the pump, hold the bottle with your thumb at the base and your index and middle fingers on the white shoulder area. Make sure the bottle points upright and away from your eyes.

Press your thumb firmly and quickly against the bottle seven times (Figure 2). The pump is now primed and can be used. Your pump should not have to be reprimed unless you have not used the medication for more than 24 hours; repriming the pump will only require two sprays.

If you have not used your nasal spray for more than seven days, repriming the pump will require seven sprays. 3. Before using Ipratropium Bromide Nasal Solution 0.03%, blow your nose gently to clear your nostrils if necessary.

4. Close one nostril by gently placing your finger against the side of your nose, tilt your head slightly forward and, keeping the bottle upright, insert the nasal tip into the other nostril (Figure 3). Point the tip toward the back and outer side of the nose.

5. Press firmly and quickly upwards with the thumb at the base while holding the white shoulder portion of the pump between your index and middle fingers. Following each spray, sniff deeply and breathe out through your mouth.

6. After spraying the nostril and removing the unit, tilt your head backwards for a few seconds to let the spray spread over the back of the nose. 7.

Repeat steps 4 through 6 in the same nostril. 8. Repeat steps 4 through 7 in the other nostril (i.e., two sprays per nostril).

9. Replace the clear plastic dust cap and safety clip. 10.

At some time before the medication is completely used up, you should consult your physician or pharmacist to determine whether a refill is needed. You should not take extra doses or stop using Ipratropium Bromide Nasal Solution 0.03% without consulting your physician. To Clean: If the nasal tip becomes clogged, remove the clear plastic dust cap and safety clip.

Hold the nasal tip under running, warm tap water (Figure 4) for about a minute. Dry the nasal tip, reprime the nasal spray pump (step 2 above), and replace the plastic dust cap and safety clip. Caution: Ipratropium Bromide Nasal Solution 0.03% is intended to relieve your rhinorrhea (runny nose) with regular use.

It is therefore important that you use Ipratropium Bromide Nasal Solution 0.03% as prescribed by your physician. For most patients, some improvement in runny nose is usually apparent during the first full day of treatment with Ipratropium Bromide Nasal Solution 0.03%. Some patients may require up to two weeks of treatment to obtain maximum benefit.

Do not spray Ipratropium Bromide Nasal Solution 0.03% in your eyes. Should this occur, immediately flush your eye with cool tap water for several minutes. If you accidentally spray Ipratropium Bromide Nasal Solution 0.03% in your eyes, you may experience a temporary blurring of vision, visual halos or colored images in association with red eyes from conjunctival and corneal congestion, development or worsening of narrow-angle glaucoma, pupil dilation, or acute eye… [Excerpted — this section continues on DailyMed.]

📄 Package Label / Principal Display Panel 5 words ▾

PRINCIPAL DISPLAY PANEL Label Carton

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
4.5K
Units reimbursed last 4 qtrs
142.9K
Gross reimbursed last 4 qtrs
$119.3K
Avg / prescription
$26.58
Avg / unit
$0.8348
Latest quarter Q1 2026
108Rx
Medicaid pays / mL
$0.8348
gross reimbursed
vs
NADAC / mL
$0.3678
acquisition cost
=
Spread
+$0.4670
+127% 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 ⓘ
69% FFS 31% MCO
Fee-for-service · 3,103 Rx Managed care · 1,386 Rx
State Medicaid map
Alaska: no data reported AK Maine: no data reported ME Washington: 1,680 units · 21.5 per 100k residents WA Idaho: no data reported ID Montana: 360 units · 31.8 per 100k residents MT North Dakota: no data reported ND Minnesota: 1,200 units · 20.9 per 100k residents MN Wisconsin: 690 units · 11.7 per 100k residents WI Michigan: 2,370 units · 23.6 per 100k residents MI New York: 19,710 units · 101 per 100k residents NY Vermont: no data reported VT New Hampshire: no data reported NH Oregon: 3,420 units · 80.8 per 100k residents OR Nevada: no data reported NV Wyoming: no data reported WY South Dakota: no data reported SD Iowa: 750 units · 23.4 per 100k residents IA Illinois: no data reported IL Indiana: 600 units · 8.7 per 100k residents IN Ohio: 5,160 units · 43.8 per 100k residents OH Pennsylvania: 6,870 units · 53.0 per 100k residents PA New Jersey: 2,670 units · 28.7 per 100k residents NJ Massachusetts: 540 units · 7.7 per 100k residents MA California: 72,451 units · 186 per 100k residents CA Utah: 450 units · 13.2 per 100k residents UT Colorado: 1,500 units · 25.5 per 100k residents CO Nebraska: no data reported NE Missouri: 1,350 units · 21.8 per 100k residents MO Kentucky: 1,110 units · 24.5 per 100k residents KY West Virginia: 780 units · 44.1 per 100k residents WV Virginia: 3,420 units · 39.2 per 100k residents VA Maryland: 6,780 units · 110 per 100k residents MD Connecticut: 870 units · 24.1 per 100k residents CT Rhode Island: no data reported RI Arizona: no data reported AZ New Mexico: 360 units · 17.0 per 100k residents NM Kansas: no data reported KS Arkansas: 420 units · 13.7 per 100k residents AR Tennessee: 630 units · 8.8 per 100k residents TN North Carolina: 1,410 units · 13.0 per 100k residents NC South Carolina: no data reported SC Delaware: 390 units · 37.8 per 100k residents DE Oklahoma: no data reported OK Louisiana: 480 units · 10.5 per 100k residents LA Mississippi: 420 units · 14.3 per 100k residents MS Alabama: no data reported AL Georgia: 930 units · 8.4 per 100k residents GA D.C.: no data reported DC Hawaii: no data reported HI Texas: 1,920 units · 6.3 per 100k residents TX Florida: no data reported FL
Units reimbursed · per 100k residents
6.3186
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 California 186 /100k
2 Maryland 110 /100k
3 New York 101 /100k
4 Oregon 80.8 /100k
5 Pennsylvania 53.0 /100k
6 West Virginia 44.1 /100k
7 Ohio 43.8 /100k
8 Virginia 39.2 /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.