Provocholine methacholine chloride 100 mg/100mg Powder, For Solution
🆔 Identity & classification
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💲 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 system | Per mL | Per package |
|---|---|---|
| Retail pharmacies payNADAC · weekly | Not in the retail survey — common for institutional, discontinued, or low-volume packs. | |
| Medicaid paysCMS SDUD · 12 mo | No recent Medicaid claims on file for this NDC — rare and low-volume NDCs are suppressed in the public data. | |
| Medicare drug plans payPart D · quarterly | No Part D plan price is available for this NDC in our data. | |
| Medicare Part B allowsASP · J7674 | $1.942 / J7674 unit | — |
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🧾 Billing & reimbursement
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🔁 Therapeutic equivalents
| Product | Labeler | Pack | NADAC/unit | TE | Status | Price vs. this |
|---|---|---|---|---|---|---|
| Provocholine 100 mg/100mgthis 64281-0100-06 | Methapharm | 6 vials | — | — | FDA listed | — |
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We did not find an FDA-approved generic match for this exact strength, form and route.
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📦 Packaging — all sizes for this product
| Package NDC | Description | Marketing start | Status |
|---|---|---|---|
| 64281-0100-06 You're viewing this | 6 VIAL, GLASS in 1 BOX (64281-100-06) / 100 mg in 1 VIAL, GLASS (64281-100-00) | 2013-03-27 | Active |
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| NDC identity (package / product / labeler codes) | ✓ Available |
| Labeler | ✓ Available |
| Product & package description | ✓ Available |
| Marketing category & status | ✓ Available |
| Active ingredient / dosage form / route | ✓ Available |
| FDA label (SPL via DailyMed) | ✓ Available |
| Package photos | ✓ Available |
| Inactive ingredients (structured) | — Not published for this NDC The labeler did not submit a structured excipient list, or no SPL is available. |
| NADAC pharmacy acquisition price (CMS) | — Not published for this NDC CMS publishes NADAC only for NDCs reported in its retail-pharmacy survey. |
| Orange Book / therapeutic-equivalence data | — Not published for this NDC Applies only to products approved under an NDA/ANDA; many listings are out of scope. |
| HCPCS J-code billing crosswalk | ✓ Available |
| Medicaid utilization (CMS SDUD) | — Not published for this NDC CMS reports utilization only for NDCs with Medicaid claims above its privacy threshold. |
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📄 Full prescribing information FDA SPL
🚨 Boxed Warning ▾
WARNING: SEVERE BRONCHOCONSTRICTION WARNING: SEVERE BRONCHOCONSTRICTION Severe bronchoconstriction can result from Provocholine administration (including the lowest dose). The use of Provocholine is contraindicated in pediatric and adult patients with baseline FEV1 < 60% predicted or adults with FEV1 <
1.5L. Because of the potential for severe bronchoconstriction, the use of Provocholine in patients with clinically apparent asthma or wheezing is not recommended [ see Warnings and Precautions (5.1) ]. Emergency equipment and medication should be immediately available to treat acute respiratory distress.
If severe bronchoconstriction occurs, reverse immediately with a rapid-acting inhaled bronchodilator agent (β-agonist) [ see Warnings and Precautions (5.1) ]. If baseline spirometry is not performed or is measured inaccurately, the initial FEV1 may be underestimated. In this situation, decreases in FEV1 may not be detected after administration of escalating Provocholine doses, which may result in administration of unnecessary higher doses and an increased risk for excessive bronchoconstriction [ see Warnings and Precautions (5.1) ].
WARNING: SEVERE BRONCHOCONSTRICTION See full prescribing information for complete boxed warning. Severe bronchoconstriction can result from Provocholine administration (including the lowest dose) (5.1) Use of Provocholine is contraindicated in pediatric and adult patients with baseline FEV1 < 60% predicted or adults with FEV1 <
1.5L (5.1) Use of Provocholine is not recommended in patients with clinically apparent asthma or wheezing (5.1) If severe bronchoconstriction occurs, reverse immediately with a rapid-acting inhaled bronchodilator agent (β-Agonist) (5.1)
🎯 Indications and Usage ▾
1 INDICATIONS AND USAGE Provocholine, used in a methacholine challenge test, is indicated for the diagnosis of bronchial airway hyperreactivity in adults and pediatric patients five years of age and older who do not have clinically apparent asthma. Provocholine, a cholinergic agonist used in a methacholine challenge test, is indicated for the diagnosis of bronchial airway hyperreactivity in adults and pediatric patients five years of age and older who do not have clinically apparent asthma (1)
⏱️ Dosage and Administration ▾
2 DOSAGE AND ADMINISTRATION The methacholine challenge test should be conducted in a pulmonary function laboratory or clinic, by adequately trained personnel, for safety and accuracy (2.1) Determine baseline FEV1 values to assess whether a patient is able to undergo the methacholine challenge test (2.1) See the Full Prescribing Information for the required reconstitution and dilution procedures prior to use (2.2). Recommended dosage(s) of Provocholine in the Methacholine Challenge Test is administration of increasing strengths of Provocholine solution via nebulization (2.3) Administer using either the 5-Breath Dosimeter Dosing Method or the 1-Minute Tidal Breathing Dosing Method with the doubling or quadrupling stepwise protocols (2.4, 2.5) See the full Prescribing Information for administration of inhaled β-agonist after Methacholine Challenge Test (2.6) See the Full Prescribing Information for the interpretation of the results and calculation of hyperresponsiveness (2.7)
2.1Preparation and Administration Overview Provocholine powder for inhalation solution requires reconstitution and dilution prior to use [see Dosage and Administration (2.2)]. Provocholine inhalation solution in a ready-to-use kit does not require reconstitution and/ or silution prior to use. Provocholine inhalation solution 16 mg/mL in a single-dose vial requires dilution prior to use [see Dosage and Administration (2.2)] .
For safety and accuracy, administer Provocholine during a methacholine challenge test in a pulmonary function laboratory or clinic, by an adequately trained personnel. Only healthcare providers trained in and thoroughly familiar with all aspects of the test’s technique and management of respiratory distress should perform the test. Emergency medication and equipment should be immediately available to treat acute respiratory distress.
Consider Provocholine use in patients on chronic asthma drugs if the accuracy of the asthma diagnosis is in doubt. In these patients, only administer Provocholine if spirometry is normal after supervised withdrawal of the asthma drugs. Provocholine is not recommended for use in patients with clinically apparent asthma or wheezing.
Before starting a methacholine challenge test, baseline spirometry must be performed. For a patient to be able to undergo the test, he or she must present with baseline FEV 1 (Forced Expiratory Volume in 1 second) greater than or equal to 60% of the predicted value (in adults and children) and greater than or equal to
1.5L (in adults). Provocholine is contraindicated in adult and pediatric patients with baseline FEV1 < 60% predicted or in adults with FEV 1 <
1.5L [see Contraindications (4) and Warnings and Precautions (5.1)]. At commencement of the methacholine challenge test and prior to administration of Provocholine, a post-diluent FEV 1 must be measured following nebulization of the diluent or base solution (contains no methacholine chloride) [ see Dosage and Administration (2.4, 2.5)]. Administer Provocholine by oral inhalation, with or without food, using either the 5-Breath Dosimeter Dosing Method or the 1-Minute Tidal Breathing Dosing Method with the dose doubling or quadrupling protocols [see Dosage and Administration (2.3, 2.4, 2.5)].
Discard any unused solution from the nebulizer after each administration. The methacholine challenge test is considered positive if there is a reduction of FEV 1 of 20% or more from the post-diluent FEV 1 . The test should be stopped at this point.
Calculate and record the FEV 1 reduction value before starting the test [see Dosage and Administration (2.3, 2.4, 2.5)]. After the methacholine challenge test with Provocholine, administer an inhaled β-agonist to expedite the return of the FEV 1 to baseline and to relieve any discomfort the patient may experience. Most patients revert to normal pulmonary function within 10 to 20 minutes following administration of an inhaled β-agonist [see Dosage and Administration (2.6)].
2.2 Reconstitution an…
💊 Dosage Forms and Strengths ▾
3 DOSAGE FORMS AND STRENGTHS • For inhalation solution: 100 mg of methacholine chloride crystalline powder, white to off-white in color in amber glass vials (powder is reconstituted and then diluted prior to administration) • Inhalation solution ready-to-use (sterile): Contain the following strengths of methacholine chloride in a clear, colorless solution. i. 3 mL base solution (contains no methacholine chloride) ii. 0.0625 mg/mL (0.1875 mg/ 3 mL) of methacholine chloride iii.
0.25mg/mL (0.75 mg/ 3 mL) of methacholine chloride iv. 1 mg/mL (3 mg/ 3 mL) of methacholine chloride v. 4 mg/mL (12 mg/ 3 mL) of methacholine chloride vi.
16 mg/mL (48 mg/ 3 mL) of methacholine chloride • Inhalation solution (in a single-dose vial): 16 mg/mL (48 mg/ 3 mL) of methacholine chloride in a clear, colorless solution in a 3 mL plastic single-dose vial with a twist-off cap. • For inhalation solution: 100 mg of methacholine chloride powder in amber glass vial (3) • Inhalation solutions: o Ready-to-use-kit: base solution (contains no methacholine chloride), 0.0625 mg/mL (0.1875 mg/3 mL), 0.25 mg/mL (0.75 mg/3 mL), 1 mg/mL (3 mg/ 3mL), 4 mg/mL (12 mg/3 mL), and 16 mg/mL (48 mg/3 mL) of methacholine chloride (3) o Single-dose vial: 16 mg/mL (48 mg/3 mL) of methacholine chloride (3) -----------------------------
⛔ Contraindications ▾
4 CONTRAINDICATIONS Provocholine is contraindicated in patients with: Hypersensitivity to methacholine or other parasympathomimetic agents. Reactions have included rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing. Baseline FEV 1 < 60% predicted (adults or pediatric patients) or <1.5 L (adults) hypersensitivity to methacholine chloride or other parasympathomimetic agents (4) Baseline FEV 1 <60% predicted (adults or pediatric patients) or <1.5 L (adults) (4)
⚠️ Warnings and Cautions ▾
5 WARNINGS AND PRECAUTIONS . Risk of Severe Bronchoconstriction: Severe bronchoconstriction can result from Provocholine administration. Do not use Provocholine in pediatric and adult patients with baseline FEV1 <60% predicted or adults with FEV1 <1.5 L.
Not recommended in patients with clinically apparent asthma or wheezing. If severe bronchoconstriction occurs, reverse with administration of rapid-acting inhaled β2-agonist. (5.1) • Bronchoconstriction from Inadvertent Exposure: Healthcare provider and any other personnel involved in the administration of the methacholine challenge test should take precautions to avoid inadvertent inhalation of Provocholine powder and nebulized aerosol (5.2) • Risk in Patients with Coexisting Diseases and Conditions: Provocholine not recommended for patients with uncontrolled hypertension, aortic aneurysm, or history of myocardial infarction or stroke diseases.
Consider the benefits and potential risk for use of Provocholine in patients with conditions that could be adversely affected by a cholinergic agent. (5.3)
5.1Risk of Severe Bronchoconstriction Severe bronchoconstriction can result from Provocholine administration (including the lowest dose). The use of Provocholine is contraindicated in pediatric and adult patients with baseline FEV 1 < 60% predicted or adults with FEV 1 <
1.5L. Emergency equipment and medication should be immediately available to treat acute respiratory distress. Because of the potential for severe bronchoconstriction, the use of Provocholine in patients with clinically apparent asthma or wheezing is not recommended.
If severe bronchoconstriction occurs, reverse immediately by the administration of a rapid-acting inhaled β-agonist. If baseline spirometry is not performed or is measured inaccurately, the initial FEV 1 may be underestimated. In this situation, decreases in FEV 1 may not be detected after escalating Provocholine doses, which may result in administration of unnecessary higher doses and an increase in the risk for excessive bronchoconstriction.
5.2Bronchoconstriction from Inadvertent Exposure to Healthcare Providers Administering Provocholine The supplied Provocholine powder or the Provocholine nebulized aerosol may cause bronchoconstriction in healthcare providers administering Provocholine in a methacholine challenge test. Healthcare providers and any other personnel involved in the administration of Provocholine should take the following precautionary steps: Do not inhale the supplied Provocholine powder Do not handle the Provocholine powder if you have asthma or hay fever.
Apply a low resistance filter to expiratory ports of dosing apparatus, as necessary, to prevent Provocholine release in the room air
5.3Risk in Patients with Coexisting Diseases and Conditions Provocholine is not recommended for patients with uncontrolled hypertension, aortic aneurysm, or history of myocardial infarction or stroke diseases. Patients with epilepsy, vagotonia, peptic ulcer disease, thyroid disease, urinary tract obstruction or other condition that could be adversely affected by a cholinergic agent should undergo methacholine challenge only if the healthcare practitioner considers the benefit to the individual outweighs the potential risks.
🤒 Adverse Reactions ▾
6 ADVERSE REACTIONS The following adverse reactions associated with the use of Provocholine were identified in clinical studies or post marketing reports. Because some of these reactions were 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. Respiratory System: Bronchospasm (includes symptoms such as chest tightness, cough or wheezing).
Less Common Adverse Reactions: Headache, throat irritation, light-headedness and itching. Adverse reactions are bronchoconstriction, headache, throat irritation, light-headedness, and itching (6) To report SUSPECTED ADVERSE REACTIONS, contact Methapharm at 1-866-701-4636 or call FDA at 1-800-FDA-1088 or visit www.fda.gov/medwatch
🔄 Drug Interactions ▾
7 DRUG INTERACTIONS Beta-Adrenergic Blockers The use of beta-adrenergic blockers may impair reversal of Provocholine-caused bronchoconstriction. Beta-Agonists, Anticholinergics, and Theophylline Beta-agonists, anticholinergics, and theophylline inhibit the response of airways to Provocholine; therefore, hold these drugs before Provocholine use for the following duration: • Short-acting β-agonists (e.g., albuterol): 6 hours • Long-acting β-agonists (e.g., salmeterol): 36 hours • Short-acting anti-cholinergics (e.g., ipratropium): 12 hours • Long-acting anti-cholinergics (e.g., tiotropium): ≥168 hours • Oral theophylline: 12-48 hours Oral or Inhaled Corticosteroids, and Inhaled Cromoglycate Regular use of oral or inhaled corticosteroids and inhaled cromoglycate may acutely decrease bronchial responsiveness to Provocholine.
However, these drugs may be continued with Provocholine use. Beta-Adrenergic Blockers : May impair reversal of Provocholine-caused bronchoconstriction (7) Beta-Agonists, Anticholinergics, and Theophylline : Inhibit response to Provocholine; therefore, hold these drugs prior to Provocholine use (7) Oral or Inhaled Corticosteroids, and Inhaled Cromyoglycate : May decrease response to Provocholine (7)
👥 Use in Specific Populations ▾
8 USE IN SPECIFIC POPULATIONS . Pregnancy: Provocholine is not recommended (8.1)
8.1Pregnancy Risk Summary The available data from published literature on Provocholine use in pregnant women are insufficient to evaluate for a drug-associated risk of major birth defects, miscarriage, or adverse maternal or fetal outcomes. Animal reproduction studies evaluating effects of methacholine chloride on embryofetal development have not been conducted. Diagnosis of bronchial airway hyperreactivity with bronchoprovocation challenge is not recommended for pregnant women because of the potential for hypoxia in the fetus.
If bronchial airway hyperreactivity is suspected, consider trial of empiric treatment. The estimated background risk of major birth defects and miscarriage for the indicated population is unknown. All pregnancies have a background risk of birth defect, loss, or other adverse outcomes.
In the United States general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2 to 4% and 15 to 20%, respectively.
8.2Lactation Risk Summary There are no available data on the presence of methacholine chloride in human milk, the effect on the breastfed infant, or the effect on milk production. The developmental and health benefits of breastfeeding should be considered along with the mother’s clinical need for Provocholine and any potential adverse effects on the breastfed infant from Provocholine or from the underlying maternal condition.
8.4Pediatric Use The safety and effectiveness of Provocholine used in a methacholine challenge test, has been established for the diagnosis of bronchial airway hyperreactivity in pediatric patients 5 years of age and older who do not have clinically apparent asthma. The safety and effectiveness of Provocholine have not been established in pediatric patients younger than 5 years of age.
8.5Geriatric Use The diagnosis of bronchial airway hyperreactivity is largely performed in pediatric and younger adult patients. Clinical studies of Provocholine did not include patients 65 years of age or older.
🤰 Pregnancy ▾
8.1Pregnancy Risk Summary The available data from published literature on Provocholine use in pregnant women are insufficient to evaluate for a drug-associated risk of major birth defects, miscarriage, or adverse maternal or fetal outcomes. Animal reproduction studies evaluating effects of methacholine chloride on embryofetal development have not been conducted. Diagnosis of bronchial airway hyperreactivity with bronchoprovocation challenge is not recommended for pregnant women because of the potential for hypoxia in the fetus.
If bronchial airway hyperreactivity is suspected, consider trial of empiric treatment. The estimated background risk of major birth defects and miscarriage for the indicated population is unknown. All pregnancies have a background risk of birth defect, loss, or other adverse outcomes.
In the United States general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2 to 4% and 15 to 20%, respectively.
🧒 Pediatric Use ▾
8.4Pediatric Use The safety and effectiveness of Provocholine used in a methacholine challenge test, has been established for the diagnosis of bronchial airway hyperreactivity in pediatric patients 5 years of age and older who do not have clinically apparent asthma. The safety and effectiveness of Provocholine have not been established in pediatric patients younger than 5 years of age.
🧓 Geriatric Use ▾
8.5Geriatric Use The diagnosis of bronchial airway hyperreactivity is largely performed in pediatric and younger adult patients. Clinical studies of Provocholine did not include patients 65 years of age or older.
🧬 Clinical Pharmacology ▾
12 CLINICAL PHARMACOLOGY .
12.1Mechanism of Action Methacholine chloride is a cholinergic agonist. Bronchial smooth muscle contains significant parasympathetic (cholinergic) innervation. Methacholine chloride agonizes the muscarinic receptors which eventually induce bronchoconstriction.
12.2Pharmacodynamics After oral inhalation of Provocholine, patients with asthma are more sensitive to Provocholine-induced bronchoconstriction than are healthy subjects. This difference in response is the pharmacological basis for Provocholine in the methacholine challenge test.
12.3Pharmacokinetics There are no metabolic and pharmacokinetic data available on methacholine chloride.
🧬 Mechanism of Action ▾
12.1Mechanism of Action Methacholine chloride is a cholinergic agonist. Bronchial smooth muscle contains significant parasympathetic (cholinergic) innervation. Methacholine chloride agonizes the muscarinic receptors which eventually induce bronchoconstriction.
📦 How Supplied / Storage and Handling ▾
16 HOW SUPPLIED/STORAGE AND HANDLING Provocholine (methacholine chloride) for Inhalation Solution: Powder: 100 mg of methacholine chloride as a white to off-white powder in amber glass vial. Each carton contains six vials (NDC 64281-100-06). Store the supplied powder at 59°F to 86°F (15°C to 30°C).
Provocholine (methacholine chloride) Inhalation Solution: Provocholine Inhalation Solution Ready-to-use kits are supplied in two formats: 1. Each carton contains six sterile ready-to-use kits (NDC: 64281-110-06). Each sterile ready-to-use kit (NDC 64281-110-05) contains six plastic vials with twist-off cap.
Each vial contains 3 mL of different strengths of methacholine chloride in a clear, colorless solution as follows: a) base solution (contains no methacholine chloride) (NDC 64281-111-00) b) 0.0625 mg/mL (0.1875 mg/3 mL) (NDC 64281-112-00) c) 0.25 mg/mL (0.75 mg/3 mL) (NDC 64281-113-00) d) 1 mg/mL (3 mg/3 mL) (NDC 64281-114-00) e) 4 mg/mL (12 mg/3 mL) (NDC 64281-115-00) f) 16 mg/mL (48 mg/3 mL) (NDC 64281-116-00) 2. Each carton contains six sterile ready-to-use kits (NDC: 64281-110-06). Each sterile ready-to-use kit (NDC 64281-110-05) contains six foil pouches.
Each foil pouch contains a 3 mL plastic vial (with twist-off cap) of different strengths of methacholine chloride in a clear, colorless solution as follows: g) base solution (contains no methacholine chloride) (NDC 64281-111-00) h) 0.0625 mg/mL (0.1875 mg/3 mL) (NDC 64281-112-00) i) 0.25 mg/mL (0.75 mg/3 mL) (NDC 64281-113-00) j) 1 mg/mL (3 mg/3 mL) (NDC 64281-114-00) k) 4 mg/mL (12 mg/3 mL) (NDC 64281-115-00) l) 16 mg/mL (48 mg/3 mL) (NDC 64281-116-00) Provocholine Inhalation Solution Single-dose Vial: 16 mg/mL of methacholine chloride in a clear, colorless solution in a 3 mL plastic single-dose vial with twist-off cap in two formats: 1.
Each outer carton contains two inner cartons (NDC 64281-116-12). Each inner carton contains six vials of 16 mg/mL solution (NDC 64281-116-06). 2.
Each carton contains three foil pouches each containing cards of four plastic 3 mL vials containing 16 mg/mL of methacholine chloride (NDC 64281-116-12). Store ready-to-use kits and single-dose vials between 15°C to 25°C (59°F to 77°F). Use immediately upon opening the vial.
📋 Description ▾
11 DESCRIPTION Methacholine chloride, the active ingredient of Provocholine, is a parasympathomimetic (cholinergic) bronchoconstrictor agent. Provocholine (methacholine chloride) powder for solution is administered by oral inhalation. Chemically, methacholine chloride (the active ingredient) is 1-propanaminium, 2-(acetyloxy)-N,N,N,-trimethyl-, chloride.
It is a white to practically white deliquescent compound, soluble in water, alcohol and chloroform and insoluble in ether. Aqueous solutions are neutral to litmus. Methacholine chloride has an empirical formula of C 8 H 18 ClNO 2 , a molecular weight of 195.69, and the following structural formula: Provocholine (methacholine chloride) for Inhalation Solution: Each vial of Provocholine contains 100 mg of methacholine chlodide powder Provocholine (methacholine chloride) Inhalation Solution: • Ready-to-use kit (sterile): Plastic vials with twist-off cap containing 3 mL of the following strengths of methacholine chloride solution.
Each solution also contains the following inactive ingredients: sodium acetate trihydrate, sodium chloride, water for injection. Glacial acetic acid is added to adjust pH. a) base solution (contains no methacholine chloride) b) 0.0625 mg/mL (0.1875 mg/3 mL) c) 0.25 mg/mL (0.75 mg/3 mL) d) 1 mg/mL (3 mg/3 mL) e) 4 mg/mL (12 mg/3 mL) f) 16 mg/mL (48 mg/3 mL) • Single-dose plastic vial with twist off cap containing 16 mg/mL (48 mg/3mL) of methacholine chloride solution. Solution also contains the following inactive ingredients: sodium acetate trihydrate, sodium chloride, and water for injection.
Glacial acetic acid is added to adjust pH. structure
💬 Information for Patients ▾
17 PATIENT COUNSELING INFORMATION Risk of Severe Bronchoconstriction Inform the patient or caregiver that severe bronchoconstriction can result from Provocholine administration [see Warnings and Precautions (5.1)] . Methapharm, Inc. 8230 210th Street #109 Boca Raton, FL, USA 33433 For more information visit www.methapharmrespiratory.com, email [email protected] or call 1-833-887-7686. ® Provocholine is a registered trademark of Methapharm Inc.
Revision: July 2026 methapharm