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METHSCOPOLAMINE BROMIDE 2.5 mg Tablet, 100-count — NDC 72319-0029-04 package photo

METHSCOPOLAMINE BROMIDE 2.5 mg Tablet, 100-count

by i3 Pharmaceuticals, LLC · 100 TABLET in 1 BOTTLE (72319-029-04)
NDC 72319-0029-04
🏷️ FDA NDC (as labeled) 72319-029-04 billing pads the product segment with a zero
This package
Contains100-count Cost per ea$0.5506 NADAC Per package$55.06 / 100 tablets Pack sizes2 compare ↓
Also priced by: Part D plans $1.18/unit — full pricing hub ↓
Also comes in: 1000 tablets 72319-0029-06
Rx only Generic On market Non-controlled
🗂️ Data synced Jul 24, 2026 · sources: openFDA · FDA label (DailyMed) · FDA Orange & Purple Book · First Databank · CMS NADAC, ASP, Medicare & Medicaid · RxNorm
📋 All sources & update times →

This page is curated, coded, and maintained by

Compiled from public FDA, CMS, DailyMed, NADAC, and related drug data sources. Editorial policy

🆔 Identity & classification

FDA NDC (as labeled) 72319-029-04
Product NDC 72319-029
11-digit billing NDC 72319002904
NCPDP billing unit EA — each (per item)
RxCUI 314088, 403914
UNII RTN51LK7WL
Application # ANDA216786
SPL Set ID 14c0c030-e96d-4a5e-95ff-02dd78a46be3
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 2024-12-18
Route ORAL
Dosage form TABLET
Substance METHSCOPOLAMINE BROMIDE
GPI-14 49102060100305
GCN Seq No 004842
GCN 18861
HICL code 013809
Ingredient (HICL) Methscopolamine Bromide
HIC1 code J
Therapeutic class — broad (HIC1) Autonomic Nervous System
HIC2 code J2
Therapeutic class — intermediate (HIC2) Anticholinergics
HIC3 code J2A
Therapeutic class — specific (HIC3) Belladonna Alkaloids
AHFS code 12:08.08.00
AHFS class Antimuscarinics/Antispasmodics
FDB label name METHSCOPOLAMINE BROM 2.5 MG TB
FDB brand name Methscopolamine Bromide
Legend status F — Federal legend — prescription drug or device
TE code (Orange Book) AA · RLD · RS
Why two NDCs? The FDA registers this code as 72319-029-04 — 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 → 72319-0029-04. 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) Belladonna alkaloids, semisynthetic, quaternary ammonium compounds, 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.

🏭 Manufacturer & labeler

Labeleri3 Pharmaceuticals, LLC
Application holderNE RX PHARMA LLC
FDA applicationANDA216786 (ANDA)
Labeler code72319
First marketedDec 2024
Product typeHuman Prescription Drug
Portfolio19 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.

🩺 Clinical

Label name METHSCOPOLAMINE BROM 2.5 MG TB Ingredient Methscopolamine Bromide
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.

💊 What it looks like

Color white
ShapeOval
ImprintS16
Size12 mm
ScoringNot scored
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 OP1R32D61U
    Microcrystalline cellulose is a purified form of cellulose, a natural fiber from plant sources. It acts as a binder and filler in tablets and capsules, helping hold ingredients together and give the medicine its shape and size.
  • UNII 70097M6I30
    Magnesium stearate is a salt made from magnesium and stearic acid, a fatty substance. It's used in tablets and capsules as a lubricant and glidant to help ingredients flow smoothly during manufacturing and prevent sticking.
  • UNII ETJ7Z6XBU4
    Silicon dioxide is a naturally occurring mineral used as a glidant and anti-caking agent. It helps powder ingredients flow smoothly and prevents clumping during manufacturing and storage.
  • UNII O8232NY3SJ
    A plant-based carbohydrate derived from corn kernels. It acts as a filler to add bulk, a binder to hold ingredients together, and a disintegrant to help the tablet break apart in your stomach for absorption.

4 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.

💲 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 eaPer package
Retail pharmacies payNADAC · weekly $0.551 $55.06 / 100 tablets
Medicaid paysCMS SDUD · 12 mo No recent Medicaid claims on file for this NDC — rare and low-volume NDCs are suppressed in the public data.
Medicare drug plans payPart D · Q2 2026 $1.18 $117.75 / 100 tablets
NADAC price history (per ea) — tap or hover for the price & month
Dec 2025 Feb 2026 May 2026 Aug 2026 $0.772 $0.551
▼ Down 29% over the last 9 months.
Where does this data come from?
NADAC (National Average Drug Acquisition Cost) is the CMS weekly pharmacy-acquisition-cost survey — what pharmacies pay. ASP (Average Sales Price) is the CMS Medicare Part B drug-payment file, published quarterly. Medicaid pays is computed by us from CMS State Drug Utilization Data (total reimbursed ÷ units, trailing 12 months) — gross of rebates and inclusive of dispensing fees, so it reflects what Medicaid paid, not an acquisition cost. Medicare drug plans pay is the median negotiated point-of-sale unit cost across plans listing this NDC in the CMS quarterly Prescription Drug Plan pricing files, before rebates. The VA pays is the federal contract price (FSS, and the statutory Big 4 ceiling where listed) from the VA National Acquisition Center pharmaceutical price file. All are free public government data; each measures a different payer, so the figures are not directly comparable.

🔁 Therapeutic equivalents

ProductLabelerPackNADAC/unitTEStatusPrice vs. this
Methscopolamine Bromide 2.5 mg 51991-0191-01 Breckenridge 100 tablets $0.551 AA Availability likely —
Methscopolamine Bromide 2.5 mgthis 72319-0029-04 i3 100 tablets $0.551 AA Availability likely —
Methscopolamine Bromide 2.5 mg 76385-0100-01 Unichem 100 tablets $0.551 AA Availability likely —
Methscopolamine Bromide 2.5 mg 43063-0740-01 PD-Rx 100 tablets — AA FDA listed —
Methscopolamine Bromide 2.5 mg 72162-2471-01 Bryant 100 tablets — AA 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

🏛️
2024
On the market since
Dec 2024
📍
2026
Currently FDA-listed
2 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.

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

Medicare Part D (outpatient prescription) spending for Methscopolamine Bromide — the program that covers self-administered drugs. 3 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 Methscopolamine 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
$129.8K
Claims incl. refills
1K
Beneficiaries
671
Spend / beneficiary
$193.49
Spend / claim
$129.05
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.

📦 Packaging — all sizes for this product

Package NDCDescription Per unit Per pack Marketing startStatus
72319-0029-04 You're viewing this 100 TABLET in 1 BOTTLE (72319-029-04) $0.5506 / ea $55.06 2024-12-18 Active
72319-0029-06 1000 TABLET in 1 BOTTLE (72319-029-06) — — 2024-12-18 Active

You're viewing the smallest of 2 pack sizes for this product.

Pack size FAQ

What quantity is in NDC 72319-0029-04?
NDC 72319-0029-04 is a 100-count package — 100 tablet in 1 bottle.
What is the difference between NDC 72319-0029-04 and NDC 72319-0029-06?
Both are METHSCOPOLAMINE BROMIDE 2.5 mg Tablet — the drug itself is identical. NDC 72319-0029-04 is the 100-count package, while NDC 72319-0029-06 is the 1000 tablets package.
What NDC number is used to bill for this package of METHSCOPOLAMINE BROMIDE 2.5 mg Tablet?
Bill NDC 72319-0029-04 — the 11-digit billing format is 72319002904. Pharmacy and medical claims use the 11-digit form; the FDA label may print a shorter form of the same code.

Prices are the latest CMS NADAC pharmacy acquisition cost per NDC; per-pack figures are per-unit × pack quantity, shown only when the pack is denominated in the same measure NADAC prices.

📄 Full prescribing information FDA SPL

The complete FDA label for this product — the official prescribing information, verbatim, section by section. Jump with a chip, search within the label, or expand everything.
🎯 Indications and Usage ⏱️ Dosage and Administration ⛔ Contraindications ⚠️ Warnings 🤒 Adverse Reactions 🔄 Drug Interactions 🤰 Pregnancy 🧒 Pediatric Use 🆘 Overdosage 🧬 Clinical Pharmacology 📦 How Supplied / Storage and Handling 📋 Description 💬 Information for Patients
🎯 Indications and Usage 36 words ▾

INDICATIONS AND USAGE Adjunctive therapy for the treatment of peptic ulcer. METHSCOPOLAMINE BROMIDE HAS NOT BEEN SHOWN TO BE EFFECTIVE IN CONTRIBUTING TO THE HEALING OF PEPTIC ULCER, DECREASING THE RATE OF RECURRENCE OR PREVENTING COMPLICATIONS.

⏱️ Dosage and Administration ~1 min read ▾

DOSAGE AND ADMINISTRATION The average dosage of Methscopolamine Bromide Tablets is 2.5 mg one-half hour before meals and 2.5 to 5 mg at bedtime. A starting dose of 12.5 mg daily will be clinically effective in most patients without the production of appreciable side effects. If the patient is experiencing symptoms such as severe abdominal pain or cramping which demand prompt relief, the drug may be started on a daily dosage of 20 mg, administered in doses of 5 mg one- half hour before meals and at bedtime.

If very unpleasant side effects develop promptly, the daily dosage should be reduced. If neither symptomatic relief nor side effects appear, the daily dosage may be increased. Some patients have tolerated 30 mg daily with no unpleasant reactions.

Patients whose dosage has been reduced to eliminate or modify side effects often continue to show adequate response both subjectively in relief of symptoms and objectively as measured by antisecretory effects. The ultimate aim of therapy is to arrive at a dosage which provides maximal clinical effectiveness with a minimum of unpleasant side effects. Many patients report no side effects on a dosage which gives complete relief of symptoms.

On the other hand, some patients have reported severe side effects without appreciable symptomatic relief. Such patients must be considered unsuited for this therapy. Usually they have been or will prove to be similarly intolerant to other anticholinergic drugs.

If methscopolamine bromide is to be used in a patient who gives a history of such intolerance, it should be started at a low dosage.

⛔ Contraindications 68 words ▾

CONTRAINDICATIONS Glaucoma; obstructive uropathy (e.g., bladder neck obstruction due to prostatic hypertrophy); obstructive disease of the gastrointestinal tract (e.g., pyloroduodenal stenosis); paralytic ileus; intestinal atony of the elderly or debilitated patient; unstable cardiovascular status in acute hemorrhage; severe ulcerative colitis; toxic megacolon complicating ulcerative colitis; myasthenia gravis. Methscopolamine Bromide Tablets, 2.5 mg and 5 mg is contraindicated in patients who are hypersensitive to methscopolamine bromide or related drugs.

⚠️ Warnings 105 words ▾

WARNINGS In the presence of high environmental temperature, heat prostration (fever and heat stroke due to decreased sweating) can occur with drug use. Diarrhea may be an early symptom of incomplete intestinal obstruction, especially in patients with ileostomy or colostomy. In this instance treatment with this drug would be inappropriate and possibly harmful.

Methscopolamine bromide may produce drowsiness or blurred vision. The patient should be cautioned regarding activities requiring mental alertness such as operating a motor vehicle or other machinery or performing hazardous work while taking this drug. With overdosage, a curare-like action may occur, i.e., neuromuscular blockade leading to muscular weakness and possible paralysis.

🤒 Adverse Reactions 90 words ▾

ADVERSE REACTIONS The following adverse reactions have been observed, but there is not enough data to support an estimate of frequency. Cardiovascular : Tachycardia, palpitation. Allergic : Severe allergic reaction or drug idiosyncrasies including anaphylaxis.

CNS : Headaches, nervousness, mental confusion, drowsiness, dizziness. Special Senses : Blurred vision, dilation of the pupil, cycloplegia, increased ocular tension, loss of taste. Renal : Urinary hesitancy and retention.

Gastrointestinal : Nausea, vomiting, constipation, bloated feeling. Dermatologic : Decreased sweating, urticaria and other dermal manifestations. Miscellaneous : Xerostomia, weakness, insomnia, impotence, suppression of lactation.

🔄 Drug Interactions 33 words ▾

4. Drug interactions Additive anticholinergic effects may result from concomitant use with antipsychotics, tricyclic antidepressants, and other drugs with anticholinergic effects. Concomitant administration with antacids may interfere with the absorption of methscopolamine bromide.

🤰 Pregnancy 50 words ▾

6. Pregnancy Teratogenic effects Animal reproduction studies have not been conducted with methscopolamine bromide. It is also not known whether methscopolamine bromide can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. Methscopolamine bromide should be given to a pregnant woman only if clearly needed.

🧒 Pediatric Use 12 words ▾

8. Pediatric use Safety and efficacy in children have not been established.

🆘 Overdosage 165 words ▾

OVERDOSAGE The symptoms of overdosage with Methscopolamine Bromide Tablets, 2.5 mg and 5 mg progress from intensification of the usual side effects to CNS disturbances (from restlessness and excitement to psychotic behavior), circulatory changes (flushing, fall in blood pressure, circulatory failure), respiratory failure, paralysis, and coma. Measures to be taken are (1) induction of emesis and (2) injection of physostigmine 0.5 to 2 mg intravenously, and repeated as necessary up to a total of 5 mg. Fever may be treated symptomatically (alcohol sponging, ice packs).

Excitement of a degree which demands attention may be managed with sodium thiopental 2% solution given slowly intravenously or chloral hydrate (100 to 200 mL of a 2% solution) by rectal infusion. In the event of progression of the curare-like effect to paralysis of the respiratory muscles, artificial respiration should be instituted and maintained until effective respiratory action returns. The oral LD 50 in rats is 1,352 to 2,617 mg/kg.

No data is available on the dialyzability of methscopolamine bromide.

🧬 Clinical Pharmacology 58 words ▾

CLINICAL PHARMACOLOGY Methscopolamine bromide is an anticholinergic agent which possesses most of the pharmacologic actions of that drug class. These include reduction in volume and total acid content of gastric secretion, inhibition of gastrointestinal motility, inhibition of salivary excretion, dilation of the pupil and inhibition of accommodation with resulting blurring of vision. Large doses may result in tachycardia.

📦 How Supplied / Storage and Handling 123 words ▾

HOW SUPPLIED Methscopolamine Bromide Tablets, USP 2.5 mg are available as white to off-white, round shaped biconvex tablets debossed "S15" on one side of the tablet and plain on the other side, in the following package size: Bottles of 100 (NDC 72319-029-04) Bottles of 1000 (NDC 72319-029-06) Methscopolamine Bromide Tablets, USP 5 mg are available as white to off-white, oval shaped biconvex tablets, debossed "S16" on one side of the tablet and plain on the other side, in the following package size: Bottles of 60 (NDC 72319-030-02) Bottles of 1000 (NDC 72319-030-06) Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature].

Dispense in a tight, light- resistant container. KEEP THIS AND ALL MEDICATIONS OUT OF THE REACH OF CHILDREN.

📋 Description 144 words ▾

DESCRIPTION Methscopolamine Bromide Tablets, USP 2.5 mg and 5 mg contain methscopolamine bromide USP, an anticholinergic, which occurs as white crystals, or as a white odorless crystalline powder. Methscopolamine bromide melts at about 225°C with decomposition. The drug is freely soluble in water, slightly soluble in alcohol, and insoluble in acetone and in chloroform.

The chemical name for methscopolamine bromide is 3-Oxa-9-azoniatricyclo [3.3.1.0 2,4 ]nonane, 7-(3-hydroxy-1-oxo-2-phenylpropoxy)-9, 9-dimethyl-, bromide, [7(s)-(1α, 2β, 4β, 5α, 7β)]- and the molecular weight is 398.30. The structural formula is represented below: Methscopolamine Bromide Tablets, USP 2.5 mg for oral administration contain 2.5 mg of methscopolamine bromide USP. Methscopolamine Bromide Tablets, USP 5 mg for oral administration contain 5 mg of methscopolamine bromide USP.

Inactive ingredients: microcrystalline cellulose NF, pregelatinized starch NF, colloidal silicon dioxide NF, magnesium stearate NF. Contains no lactose. FDA approved impurity specifications differs from the USP. methscopolamine-structure

💬 Information for Patients 9 words ▾

2. Information for patient See statement under WARNINGS .

Source: FDA Structured Product Labeling, mirrored from DailyMed / openFDA. Prefer the government’s original formatting? View this label on DailyMed ↗
← 72319-0028-01 · i3 72319-0030-02 · i3 →
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.