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Urimar-T Caps methenamine, sodium phosphate, monobasic, monohydrate, phenyl salicylate, methylene blue, and hyoscyamine sulfate 120 mg; 40.8 mg; 36.2 mg; 10.8 mg; .12 mg Capsule, 60-count — NDC 28595-0224-60 package photo
Label image from the product's FDA listing (DailyMed) — may show a different pack size or an older label revision.

Urimar-T Caps methenamine, sodium phosphate, monobasic, monohydrate, phenyl salicylate, methylene blue, and hyoscyamine sulfate 120 mg; 40.8 mg; 36.2 mg; 10.8 mg; .12 mg Capsule, 60-count — NDC 28595-224-60 (Billing 28595-0224-60)

by Allegis Pharmaceuticals, LLC · 60 CAPSULE in 1 BOTTLE

This is a package of 60 capsules of Urimar-T Caps methenamine, sodium phosphate, monobasic, monohydrate, phenyl salicylate, methylene blue, and hyoscyamine sulfate 120 mg; 40.8 mg; 36.2 mg; 10.8 mg; .12 mg Capsule from Allegis Pharmaceuticals, LLC, marketed since Jun 2023 and currently FDA-listed. It is this product's only package size.

NDC 28595-0224-60
🏷️ FDA NDC (as labeled) 28595-224-60 billing pads the product segment with a zero
Rx only On market Non-controlled ⇄ Compare with another NDC
🗂️ FDA directory synced Oct 8, 2026 · this listing last changed Aug 27, 2026 · sources: openFDA · FDA label (DailyMed) · FDA Orange & Purple Book · First Databank · CMS NADAC, ASP, Medicare & Medicaid · RxNorm
📋 All sources & update times →

This page is curated, coded, and maintained by

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

NDC database record

One package, one record: these facts belong to NDC 28595-224-60 alone.

Record
FDA NDC Directory package listing · Human prescription drug
Code segments
28595 labeler · 224 product · 60 package
Package marketed since
Jun 28, 2023
Sample package
No — commercial package
Listing certified through
Dec 31, 2026
Billing quantity
60 EA per package
Barcode (UPC)
0328595224602
FDA record last changed
Aug 27, 2026

Identity & classification

Regulatory identifiers FDA, NLM and CMS codes for this package

FDA NDC (as labeled) 28595-224-60
Product NDC 28595-224
11-digit billing NDC 28595022460
NCPDP billing unit EA — each (per item)
RxCUI 2637557, 2640308
UNII J50OIX95QV, 593YOG76RN, 28A37T47QO, T42P99266K, F2R8V82B84
UPC 0328595224602
SPL Set ID cf7c3d65-11d2-49cd-b207-8ccc6a221fe0
Established class (EPC) Oxidation-Reduction Agent
Mechanism of action Oxidation-Reduction Activity
DEA schedule Non-controlled
Marketing category UNAPPROVED DRUG OTHER
Marketing status On market
FDA listing status Listed (active directory)
Marketing start 2023-06-28
Route ORAL
Dosage form CAPSULE
Substance METHENAMINE; SODIUM PHOSPHATE, MONOBASIC, MONOHYDRATE; PHENYL SALICYLATE; METHYLENE BLUE; HYOSCYAMINE SULFATE

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

GPI-14 16992005200130
GCN Seq No 085037
GCN 54476
HICL code 034934
Ingredient (HICL) Meth/Meblue/Sod Phos/Psal/Hyos
HIC1 code W
Therapeutic class — broad (HIC1) Anti-Infecting Agents
HIC2 code W2
Therapeutic class — intermediate (HIC2) Antibacterials
HIC3 code W2G
Therapeutic class — specific (HIC3) Antibiotic, Antibacterial, Misc.
AHFS code 08:36.00.00
AHFS class Urinary Anti-Infectives
FDB label name URIMAR-T CAPSULE
FDB brand name Urimar-T
Legend status F — Federal legend — prescription drug or device
Quick answers
  • GSN (GCN sequence number): 085037
  • GCN: 54476
  • GPI-14 (Medi-Span): 16992005200130
  • HICL (First Databank): 034934
  • AHFS class code: 08:36.00.00
  • RxCUI (RxNorm): 2637557
Why two NDCs? The FDA registers this code as 28595-224-60 — 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 → 28595-0224-60. 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 Belladonna alkaloids, tertiary amines class.

Drug family (ATC) Belladonna alkaloids, tertiary amines
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 URIMAR-T CAPSULE Ingredient Meth/Meblue/Sod Phos/Psal/Hyos
🧪 What is this product?

Urimar-T Caps is an oral capsule containing six active ingredients commonly combined in urinary tract products. Methenamine functions as an antimicrobial agent in the urinary system, while sodium phosphate helps maintain urine acidity. Phenyl salicylate and methylene blue are typically included for their antimicrobial properties in urinary formulations. Hyoscyamine sulfate is an anticholinergic agent commonly used to reduce urinary urgency and discomfort. This product is marketed without an approved FDA application.

Supplement & herbal interactions

🌿 Drug–supplement interaction checker →
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 eachPer 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.
ℹ️
No price is published for this exact package yet. CMS surveys NADAC per package size, so a different pack of the same drug often has one.
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
28595-0224-60 You're viewing this Main listing 60 CAPSULE in 1 BOTTLE 2023-06-28 — Active

Therapeutic equivalents

ProductLabelerPackNADAC/unitTEStatusPrice vs. this
Urimar-T Caps 120 mg/1; 40.8 mg/1; 36.2 mg/1; 10.8 mg/1; .12 mgthis 28595-0224-60 Allegis 60 capsules — — FDA listed —
Mb Caps 120 mg/1; 40.8 mg/1; 36.2 mg/1; 10.8 mg/1; .12 mg 28595-0299-60 Allegis 60 capsules — — FDA listed —
About this product: other versions of the same ingredient, strength and form are listed above, least expensive first, with FDA equivalence ratings where available.
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

🏛️
2023
On the market since
Jun 2023
📍
2026
Currently FDA-listed
3 years listed
🔒
·
No generic listed yet
brand only
ℹ️No FDA-approved generic found

We did not find an FDA-approved generic match for this exact strength, form and route.

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 blue
ShapeCapsule
Imprint224
Size19 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 2S7830E561
    Crospovidone is a synthetic polymer derived from povidone. It acts as a disintegrant, helping the tablet or capsule break apart quickly in the stomach so the active ingredient can be absorbed.
  • UNII H3R47K3TBD
    FD&C Blue No. 1 is a synthetic blue dye approved for use in foods and medicines. It serves as a colorant to give the medication its distinctive appearance and help with product identification.
  • UNII PN2ZH5LOQY
    A synthetic red dye approved by the FDA for use in foods, medicines, and cosmetics. It serves as a colorant to make tablets, capsules, and liquids visually distinctive for product identification.
  • UNII 2G86QN327L
    Gelatin is a protein derived from animal collagen, commonly used in medicines as a gelling agent and capsule material. It helps create soft or hard capsule shells that hold and release medication, and can also thicken liquid formulations.
  • UNII EWQ57Q8I5X
    Lactose monohydrate is a natural sugar derived from milk. It serves as a filler and binder in tablets and capsules, helping create the proper size, texture, and consistency of the medicine.
  • 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 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 3WJQ0SDW1A
    Polyethylene glycol is a synthetic liquid or solid polymer used in medicines as a solvent, lubricant, and humectant. It helps dissolve active ingredients, reduces friction during manufacturing, and retains moisture in the final product.
  • UNII 15FIX9V2JP
    Titanium dioxide is a bright white mineral powder commonly used as a colorant and opacifying agent. It makes pills and tablets white or lighter in color and helps make coatings non-transparent.

9 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

LabelerAllegis Pharmaceuticals, LLC
Labeler code28595
First marketedJun 2023
Product typeHuman Prescription Drug
Portfolio10 products on file

More NDCs from Allegis Pharmaceuticals, LLC labeler code 28595

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 ⏱️ Dosage and Administration ⛔ Contraindications ⚠️ Warnings 🤒 Adverse Reactions 🔄 Drug Interactions 🤰 Pregnancy 🧒 Pediatric Use 🧓 Geriatric Use 🆘 Overdosage 🧬 Clinical Pharmacology 📦 How Supplied / Storage and Handling 📦 Storage and Handling 📋 Description ⚠️ Precautions 🍼 Nursing Mothers 🔒 Drug Abuse and Dependence 📄 Package Label / Principal Display Panel
🎯 Indications and Usage 46 words ▾

INDICATIONS AND USAGE URIMAR-T™ CAPS is indicated for the treatment of symptoms of irritative voiding. Indicated for the relief of local symptoms, such as inflammation, hypermotility, and pain, which accompany lower urinary tract infections. Indicated for the relief of urinary tract symptoms caused by diagnostic procedures.

⏱️ Dosage and Administration 38 words ▾

DOSAGE AND ADMINISTRATION Adults: One capsule orally 4 times per day followed by liberal fluid intake. Pediatric: Dosage must be individualized by physician for older children. Not recommended for use in children six years of age or younger.

⛔ Contraindications 64 words ▾

CONTRAINDICATIONS URIMAR-T™ CAPS is contraindicated in patients with a hypersensitivity to any of the ingredients. Risk-benefit should be considered when the following medical problems exist: Cardiac disease (especially cardiac arrhythmias, congestive heart failure, coronary heart disease, and mitral stenosis); gastrointestinal tract obstructive disease; glaucoma; myasthenia gravis; acute urinary retention may be precipitated in obstructive uropathy (such as bladder neck obstruction due to prostatic hypertrophy).

⚠️ Warnings 45 words ▾

WARNINGS Do not exceed recommended dosage. If rapid pulse, dizziness, or blurring of vision occurs, discontinue use immediately . KEEP THIS AND ALL MEDICATIONS OUT OF THE REACH OF CHILDREN. IN CASE OF ACCIDENTAL OVERDOSE, SEEK PROFESSIONAL ASSISTANCE OR CONTACT A POISON CONTROL CENTER IMMEDIATELY.

🤒 Adverse Reactions 118 words ▾

ADVERSE REACTIONS Cardiovascular - rapid pulse, flushing Central Nervous System - blurred vision, dizziness, drowsiness Respiratory - shortness of breath or troubled breathing Genitourinary - difficult micturition, acute urinary retention Gastrointestinal - dry mouth, nausea and vomiting Serious allergic reactions to this drug are rare. Seek immediate medical attention if you notice symptoms of a serious allergic reaction, including itching, rash, severe dizziness, swelling or trouble breathing. This medication can cause urine and sometimes stools to turn blue to blue-green.

This effect is harmless and will subside after medication is stopped. Call your doctor or physician for medical advice about side effects. To report SUSPECTED ADVERSE REACTIONS, contact Allegis Pharmaceuticals, LLC at 1-866-633-9033, or FDA at 1-800-FDA-1088, www.fda.gov/medwatch.

🔄 Drug Interactions ~3 min read ▾

DRUG INTERACTIONS Drug Interactions Although the exact mechanism of this drug interaction is unknown, methylene blue inhibits the action of monoamine oxidase A— an enzyme responsible for breaking down serotonin in the brain. It is believed that when methylene blue is given to patients taking serotonergic psychiatric medications, high levels of serotonin can build up in the brain, causing toxicity. This is referred to as Serotonin Syndrome.

Signs and symptoms of Serotonin Syndrome include mental changes (confusion, hyperactivity, memory problems), muscle twitching, excessive sweating, shivering or shaking, diarrhea, trouble with coordination, and/or fever. Additional Information for Healthcare Professionals Methylene blue can interact with serotonergic psychiatric medications and cause serious CNS toxicity. In emergency situations requiring life-threatening or urgent treatment with methylene blue (as described above), the availability of alternative interventions should be considered and the benefit of methylene blue treatment should be weighed against the risk of serotonin toxicity.

If methylene blue must be administered to a patient receiving a serotonergic drug, the serotonergic drug must be immediately stopped, and the patient should be closely monitored for emergent symptoms of CNS toxicity for two weeks (five weeks if fluoxetine [Prozac] was taken), or until 24 hours after the last dose of methylene blue, whichever comes first. In non-emergency situations when non-urgent treatment with methylene blue is contemplated and planned, the serotonergic psychiatric medication should be stopped to allow its activity in the brain to dissipate.

Most serotonergic psychiatric drugs should be stopped at least 2 weeks in advance of methylene blue treatment. Fluoxetine (Prozac), which has a longer half-life compared to similar drugs, should be stopped at least 5 weeks in advance. Treatment with the serotonergic psychiatric medication may be resumed 24 hours after the last dose of methylene blue.

Serotonergic psychiatric medications should not be started in a patient receiving methylene blue. Wait until 24 hours after the last dose of methylene blue before starting the antidepressant. Educate your patients to recognize the symptoms of serotonin toxicity or CNS toxicity and advise them to contact a healthcare professional immediately if they experience any symptoms while taking serotonergic psychiatric medications or methylene blue.

As a result of hyoscyamine's effects on gastrointestinal motility and gastric emptying, absorption of other oral medications may be decreased during concurrent use with this combination medication. Urinary alkalizers and thiazide diuretics May cause the urine to become alkaline reducing the effectiveness of methenamine by inhibiting its conversion to formaldehyde. Antimuscarinics Concurrent use may intensify antimuscarinic effects of hyoscyamine because of secondary antimuscarinic activities of these medications.

Antacids/antidiarrheals Concurrent use may reduce absorption of hyoscyamine resulting in decreased therapeutic effectiveness. Concurrent use with antacids may cause urine to become alkaline reducing the effectiveness of methenamine by inhibiting its conversion to formaldehyde. Doses of these medications should be spaced 1 hour apart from doses of hyoscyamine.

Antimyasthenics Concurrent use with hyoscyamine may further reduce intestinal motility, therefore, caution is recommended. Ketoconazole and hyoscyamine may cause increased gastrointestinal pH. Concurrent administration with hyoscyamine may result in marked reduction in the absorption of ketoconazole.

Patients should be advised to take this combination at least 2 hours after ketoconazole. Monoamine oxidase (MAO) inhibitors Concurrent use with hyoscyamine may intensify antimuscarinic side effects. Opioid (narcotic) analgesics may result in increased risk of severe constipation.

Sulfonamides These drugs may precipitate with formaldehyde in the urine… [Excerpted — this section continues on DailyMed.]

🤰 Pregnancy 57 words ▾

Pregnancy Reproduction (FDA Pregnancy Category C) Hyoscyamine and methenamine cross the placenta. Studies have not been done in either animals or humans. It is not known whether URIMAR-T™ CAPS can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. URIMAR-T™ CAPS should be given to a pregnant woman only if clearly needed.

🧒 Pediatric Use 16 words ▾

Pediatric Infants and young children are especially susceptible to the toxic effect of the belladonna alkaloids.

🧓 Geriatric Use 25 words ▾

Geriatric Use with caution in elderly patients as they may respond to the usual doses of the belladonna alkaloids with excitement, agitation, drowsiness, or confusion.

🆘 Overdosage 79 words ▾

OVERDOSAGE Emesis or gastric lavage. Slow intravenous administration of physostigmine in doses of 1 to 4 mg (0.5 to 1 mg in children) repeated as needed in one to two hours to reverse severe antimuscarinic symptoms. Administration of small doses of diazepam to control excitement and seizures.

Artificial respiration with oxygen if needed for respiratory depression. Adequate hydration. Symptomatic treatment as necessary.

If overdose is suspected, contact the poison control center at 1-800-222-1222, or your local emergency room immediately.

🧬 Clinical Pharmacology ~1 min read ▾

CLINICAL PHARMACOLOGY METHENAMINE degrades in an acidic urine environment releasing formaldehyde which provides bactericidal or bacteriostatic action. It is well absorbed from the gastrointestinal tract. 70 to 90% reaches the urine unchanged at which point it is hydrolyzed if the urine is acidic.

Within 24 hours it is almost completely (90%) excreted; of this amount at pH 5, approximately 20% is formaldehyde. Protein binding - some formaldehyde is bound to substances in the urine and surrounding tissues. Methenamine is freely distributed to body tissue and fluids but is not clinically significant as it does not hydrolyze at a pH greater than 6.8.

SODIUM PHOSPHATE MONOBASIC an acidifier, helps to maintain an acid pH in the urine necessary for the degradation of methenamine. PHENYL SALICYLATE releases salicylate, a mild analgesic for pain. METHYLENE BLUE possesses weak antiseptic properties.

It is well absorbed by the gastrointestinal tract and is rapidly reduced to leukomethylene blue which is stabilized in some combination form in the urine. 75% is excreted unchanged. HYOSCYAMINE SULFATE is a parasympatholytic drug which relaxes smooth muscles and thus produces an antispasmotic effect.

It is well absorbed from the gastrointestinal tract and is rapidly distributed throughout the body tissues. Most is excreted in the urine within 12 hours, 13% to 50% being unchanged. Protein binding for hyoscyamine sulfate is moderate and biotransformation is hepatic.

📦 How Supplied / Storage and Handling 80 words ▾

HOW SUPPLIED Urimar-T™ CAPS are light blue capsules imprinted with 224, available in bottles of 60 capsules, (NDC: 28595-224-60), and sample capsules of 1 (NDC: 28595-224-99). STORAGE Store in a cool, dry place at controlled room temperature 15° to 30°C (59° to 86°F). Keep container tightly closed.

Protect from moisture and direct sunlight. Dispense in a tight, light-resistant container as defined in the USP/NF with a child resistant closure. WARNING: Keep this and all drugs out of reach of children.

📦 Storage and Handling 114 words ▾

STORAGE Store in a cool, dry place at controlled room temperature 15° to 30°C (59° to 86°F). Keep container tightly closed. Protect from moisture and direct sunlight. Dispense in a tight, light-resistant container as defined in the USP/NF with a child resistant closure. WARNING: Keep this and all drugs out of reach of children.

STORAGE Store in a cool, dry place at controlled room temperature 15 ° to 30 ° C (59 ° to 86 ° F). Keep container tightly closed. Protect from moisture and direct sunlight. Dispense in a tight, light-resistant container as defined in the USP/NF with a child resistant closure. WARNING: Keep this and all drugs out of reach of children.

📋 Description 50 words ▾

DESCRIPTION URIMAR-T™ CAPS for oral administration. Each capsule contains: Methenamine 120 mg Sodium Phosphate Monobasic 40.8 mg Phenyl Salicylate 36.2 mg Methylene Blue 10.8 mg Hyoscyamine Sulfate 0.12 mg Inactive ingredients: lactose monohydrate, polyethylene glycol, crospovidone, magnesium stearate, silicified microcrystalline cellulose, FD&C Blue #1, FD&C Red #3, titanium dioxide, gelatin.

⚠️ Precautions 199 words ▾

PRECAUTIONS URIMAR-T ™ CAPS contains methylene blue and should NOT be taken with serotonergic psychiatric medications. Cross sensitivity and/or related problems Patients intolerant of other belladonna alkaloids or other salicylates may be intolerant of this medication also. Delay in gastric emptying could complicate the management of gastric ulcers.

Pregnancy Reproduction (FDA Pregnancy Category C) Hyoscyamine and methenamine cross the placenta. Studies have not been done in either animals or humans. It is not known whether URIMAR-T™ CAPS can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity.

URIMAR-T™ CAPS should be given to a pregnant woman only if clearly needed. Nursing mothers Methenamine and traces of hyoscyamine are excreted in breast milk. Caution should be exercised when URIMAR-T™ CAPS are administered to a nursing mother.

Prolonged use There have been no studies to establish the safety of prolonged use in humans. No known long-term animal studies have been performed to evaluate carcinogenic potential. Pediatric Infants and young children are especially susceptible to the toxic effect of the belladonna alkaloids.

Geriatric Use with caution in elderly patients as they may respond to the usual doses of the belladonna alkaloids with excitement, agitation, drowsiness, or confusion.

🍼 Nursing Mothers 25 words ▾

Nursing mothers Methenamine and traces of hyoscyamine are excreted in breast milk. Caution should be exercised when URIMAR-T™ CAPS are administered to a nursing mother.

🔒 Drug Abuse and Dependence 32 words ▾

Drug Abuse And Dependence A dependence on the use of URIMAR-T™ CAPS has not been reported and due to the nature of its ingredients, abuse of URIMAR T™ CAPS is not expected.

📄 Package Label / Principal Display Panel 12 words ▾

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

About this NDC listing & data coverage

Finished prescription product Marketed without an FDA application

Listed without an FDA application

This product's marketing category indicates it is marketed without an approved FDA application (no NDA, ANDA, or BLA on file). Having an NDC does not by itself establish FDA approval — the NDC Directory is a listing system, not an approval decision. Approval-linked data such as Orange Book therapeutic-equivalence ratings therefore does not apply.

What data is (and isn’t) available for this NDC — tap to expand
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) ✓ 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 — Not published for this NDC Most self-administered / retail products have no J-code — that is normal.
Medicaid utilization (CMS SDUD) — Not published for this NDC CMS reports utilization only for NDCs with Medicaid claims above its privacy threshold.
“Not published” reflects what the public FDA / CMS / NLM sources provide for this exact package code — it is a property of the data feeds, not a judgment about the product.

Questions about this listing

Is this NDC FDA-approved?
An NDC listing does not by itself establish FDA approval — the NDC Directory records that a product is listed with FDA, not that it was reviewed and approved. This listing's marketing category is "Unapproved Drug Other". Products approved under an application carry an NDA, ANDA, or BLA number.
Why is there no price listed?
The pricing shown on our NDC pages comes from CMS NADAC, a voluntary survey of retail community pharmacy invoices. CMS does not publish a NADAC for every NDC — packages outside the retail survey (institutional and hospital products, bulk packages, discontinued items, and many OTC items) may never receive one. A missing price reflects the survey's scope, not this product's actual cost, and does not mean the product is free or unavailable.
Is the NDC printed on the package the same as the 11-digit billing NDC?
Yes, they identify this exact package in different formats. The form printed on the packaging and shown on DailyMed is the one the FDA registered. Insurance claims use a fixed 11-digit 5-4-2 format, so the short segment is padded with a leading zero and the dashes are dropped. The Identity section at the top of this page lists each form of this code.
Is this package still being marketed?
Yes, per the latest FDA NDC Directory data on this page: this package is listed as actively marketed, with no marketing end date reported by Allegis Pharmaceuticals, LLC. Listing status can change — the directory data on this page refreshes weekly.
Who lists this product with the FDA?
Allegis Pharmaceuticals, LLC is the labeler of record for this NDC — the company under whose FDA-assigned code the package is listed. The labeler may be the manufacturer itself or a distributor marketing the product under its own code.
Do I need a prescription for this product?
This NDC is listed with FDA as a prescription product, so it is dispensed under a prescriber's order. Your pharmacist can tell you whether any over-the-counter forms of the same medication exist.
This page identifies an FDA-listed package (the NDC) and reports public regulatory and pricing data about the listing. It is reference information, not a medical recommendation — talk to your pharmacist or prescriber about your own medication.
Where does this data come from?
Listing facts (marketing category, packager status, marketing dates) from the FDA openFDA NDC Directory; label availability from DailyMed; pricing coverage from CMS NADAC; equivalence scope from the FDA Orange Book.
← 28595-0120-12 · Allegis 28595-0299-60 · Allegis →
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.