Digenyx Hyoscyamine Sulfate 0.125 mg .125 mg Tablet, 30-count
🆔 Identity & classification
Where does this data come from?
🏷️ RxNorm drug class
This medicine belongs to the Belladonna alkaloids, tertiary amines class.
Where does this data come from?
🏭 Manufacturer & labeler
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🩺 Clinical
Hyoscyamine is used to control symptoms associated with disorders of the gastrointestinal (GI) tract. It works by decreasing the motion of the stomach and intestines and the secretion of stomach fluids, including acid. Hyoscyamine is also used in the treatment of bladder spasms, peptic ulcer disease, diverticulitis, colic, irritable bowel syndrome, cystitis, and pancreatitis. Hyoscyamine may also be used to treat certain heart conditions, to control the symptoms of Parkinson's disease and rhinitis (runny nose), and to reduce excess saliva production.
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💊 What it looks like
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🧪 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.
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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.
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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.
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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.
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UNII 5856J3G2A2
A starch-based powder made from potatoes and processed with sodium. It acts as a disintegrant, helping the tablet or capsule break apart quickly in the stomach so the medicine can be absorbed.
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UNII 4ELV7Z65AP
Stearic acid is a fatty acid derived from plant or animal sources. It acts as a binder and lubricant in tablets and capsules, helping them hold together and flow smoothly during manufacturing.
5 inactive ingredients listed in the exact product block matched to this NDC.
Where does this data come from?
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
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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 each | 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. | |
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🔁 Therapeutic equivalents
| Product | Labeler | Pack | NADAC/unit | TE | Status | Price vs. this |
|---|---|---|---|---|---|---|
| Hyoscyamine Sulfate TAB .125 mg 42192-0340-01 | Acella | 100 tablets | $0.152 | — | Availability likely | — |
| Hyoscyamine sulfate .125 mg 62135-0512-12 | Chartwell | 120 tablets | $0.152 | — | Availability likely | — |
| Hyoscyamine Sulfate .125 mg 62559-0421-01 | ANI | 100 tablets | $0.152 | — | Availability likely | — |
| Oscimin .125 mg 68047-0252-01 | Larken | 100 tablets | $0.152 | — | Availability likely | — |
| Levsin .125 mg 68220-0112-10 | Viatris | 100 tablets | $2.657 | — | Availability likely | — |
| Hyoscyamine Sulfate .125 mg 00615-8537-39 | NCS | 30 tablets | — | — | FDA listed | — |
| Hyoscyamine Sulfate .125 mg 39328-0050-10 | Patrin | 100 tablets | — | — | FDA listed | — |
| Hyoscyamine Sulfate TAB .125 mg 42708-0183-56 | QPharma, | 56 tablets | — | — | FDA listed | — |
| Hyoscyamine Sulfate .125 mg 51655-0764-52 | Northwind | 30 tablets | — | — | FDA listed | — |
| Hyoscyamine Sulfate TAB .125 mg 51655-0845-52 | Northwind | 30 tablets | — | — | FDA listed | — |
| Digenyx .125 mgthis 59088-0150-54 | PureTek | 30 tablets | — | — | FDA listed | — |
| Hyoscyamine Sulfate .125 mg 63629-1028-01 | Bryant | 100 tablets | — | — | Discontinued | — |
| Hyoscyamine Sulfate TAB .125 mg 63629-5911-01 | Bryant | 20 tablets | — | — | FDA listed | — |
| Hyoscyamine Sulfate .125 mg 69367-0677-01 | Westminster | 100 tablets | — | — | FDA listed | — |
| Hyoscyamine Sulfate TAB .125 mg 70518-3847-00 | REMEDYREPACK | 90 tablets | — | — | Discontinued | — |
| Hyoscyamine Sulfate .125 mg 70518-4436-00 | REMEDYREPACK | 180 tablets | — | — | FDA listed | — |
| Hyoscyamine Sulfate .125 mg 72162-1939-01 | Bryant | 100 tablets | — | — | FDA listed | — |
| Hyoscyamine Sulfate .125 mg 82804-0965-30 | Proficient | 30 tablets | — | — | FDA listed | — |
Where does this data come from?
⏳ Availability & generic status
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 |
|---|---|---|---|
| 59088-0150-54 You're viewing this | 30 TABLET in 1 BOTTLE (59088-150-54) | 2026-05-13 | Active |
🧭 About this NDC listing & data coverage
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. |
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📄 Full prescribing information FDA SPL
🎯 Indications and Usage ▾
INDICATIONS AND USAGE: Digenyx™ (Hyoscyamine Sulfate USP, 0.125 mg) tablets are an anticholinergic agent used as adjunctive therapy for a range of gastrointestinal and genitourinary conditions. Hyoscyamine reduces gastrointestinal motility and secretions and relieves smooth muscle spasm. Digenyx™ (Hyoscyamine Sulfate USP, 0.125 mg) tablets may be used as adjunctive therapy in conditions such as: -Peptic ulcer disease -Irritable bowel syndrome and functional gastrointestinal disorders (e.g., spastic colon, mucous colitis) -Acute enterocolitis -Neurogenic bladder and bladder spasms -Biliary and renal colic (in combination with narcotic analgesics)
⏱️ Dosage and Administration ▾
DOSAGE AND ADMINISTRATION: Dosage should be individualized according to the condition and severity of symptoms. Administer orally 30 to 60 minutes before meals and at bedtime, or as directed by licensed healthcare practitioner. Adults and pediatric patients 12 years of age and older: 1 to 2 tablets every four hours or as needed.
Do not exceed 12 tablets in 24 hours. Pediatric patients 2 to under 12 years of age: 1/2 to 1 tablet every four hours or as needed. Do not exceed 6 tablets in 24 hours.
Note: Geriatric patients may be more sensitive to the effects of the usual adult dose.
⛔ Contraindications ▾
CONTRAINDICATIONS: This product should not be used in patients with glaucoma, obstructive uropathy, obstructive gastrointestinal disease, paralytic ileus, severe ulcerative colitis, myasthenia gravis, or hypersensitivity to Hyoscyamine Sulfate, USP or any other ingredients in the formulation.
⚠️ Warnings ▾
WARNINGS: Digenyx™ (Hyoscyamine Sulfate USP, 0.125 mg) tablets may cause drowsiness, dizziness, or blurred vision, so patients should avoid activities that require mental alertness, such as driving or operating machinery. It should be used with caution in individuals with heart disease, high blood pressure, hyperthyroidism, or enlarged prostate, and is not recommended for patients with narrow-angle glaucoma. In hot environments, the use of this drug may lead to heat prostration (fever, heat stroke due to decreased sweating).
Diarrhea could be an early sign of incomplete intestinal obstruction, especially for patients with an ileostomy or colostomy, in which case using this product may be harmful. Psychosis has been reported in sensitive individuals given anticholinergic drugs including hyoscyamine sulfate. CNS signs and symptoms include confusion, disorientation, short-term memory loss, hallucinations, dysarthria, ataxia, coma, euphoria, anxiety, decreased anxiety, fatigue, insomnia, agitation and mannerisms and inappropriate affect.
These CNS signs and symptoms usually resolve within 12 to 48 hours after discontinuation of the drug.
🤒 Adverse Reactions ▾
ADVERSE REACTIONS: The following adverse reactions have been reported for hyoscyamine sulfate and for pharmacologically similar drugs with anticholinergic/antispasmodic action. Adverse reactions may include dryness of the mouth; urinary hesitancy and retention; blurred vision; tachycardia; palpitations; mydriasis; cycloplegia; increased ocular tension; loss of taste; headache; nervousness; drowsiness; weakness; fatigue; dizziness; insomnia; nausea; vomiting; impotence; suppression of lactation; constipation; bloated feeling; abdominal pain; diarrhea; allergic reactions or drug idiosyncrasies; urticaria and other dermal manifestations; ataxia; speech disturbance; some degree of mental confusion and/or excitement (especially in elderly persons); short-term memory loss; hallucinations; and decreased sweating.
To report SUSPECTED ADVERSE REACTIONS, contact PureTek Corporation at 1-877-921-7873 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
🔄 Drug Interactions ▾
Drug Interactions: Hyoscyamine may interact with anticholinergics, antihistamines, antidepressants, pain medications, and antacids, which can lead to increased side effects like constipation or confusion. Inform your healthcare provider of all medications and supplements you're taking. Antacids may interfere with the absorption of hyoscyamine sulfate. Administer hyoscyamine sulfate before meals; antacids after meals.
🤰 Pregnancy ▾
Pregnancy: Hyoscyamine is classified as Pregnancy Category C. There are no data on its effects during pregnancy. It should only be used if clearly needed and prescribed by a licensed healthcare practitioner, as it crosses the placenta.
🧒 Pediatric Use ▾
Pediatric Use: Infants and young children are especially sensitive to its effects, including increased body temperature in hot environments. Close supervision is required for children with brain conditions as they may react more strongly to the medication.
🧓 Geriatric Use ▾
Geriatric Use: Reported clinical experience has not identified differences in safety between patients aged 65 and over and younger patients. In general, dose selection for an elderly patient should be cautious, usually starting at the low end of the dosing range, reflecting the greater frequency of decreased hepatic, renal, or cardiac function and of concomitant disease or other drug therapy. This drug is known to be substantially excreted by the kidney, and the risk of toxic reactions to this drug may be greater in patients with impaired renal function.
Because elderly patients are more likely to have decreased renal function, care should be taken in dose selection, and it may be useful to monitor renal function.
🆘 Overdosage ▾
OVERDOSAGE: The signs and symptoms of overdose are headache, nausea, vomiting, blurred vision, dilated pupils, hot dry skin, dizziness, dryness of the mouth, difficulty in swallowing and CNS stimulation. Measures to be taken are immediate lavage of the stomach and 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 (tepid water sponge baths, hypothermic blanket).
Excitement to a degree which demands attention may be managed with sodium thiopental 2% solution given slowly intravenously or chloral hydrate (100-200 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. In rats, the LD50 for hyoscyamine is 375 mg/kg.
Hyoscyamine sulfate is dialyzable.
🧬 Clinical Pharmacology ▾
CLINICAL PHARMACOLOGY: Hyoscyamine sulfate is an anticholinergic agent that works by inhibiting the action of acetylcholine on muscarinic receptors in smooth muscle. By blocking acetylcholine, Hyoscyamine reduces gastrointestinal motility and secretions, alleviating symptoms associated with irritable bowel syndrome (IBS) and other gastrointestinal disorders such as spasms, cramping, and bloating. Hyoscyamine also decreases gastric acid secretion, resulting in a reduction in digestive tract activity.
It relaxes the muscles in the gut, improving the passage of food and preventing spasms. In addition, it reduces the secretion of fluids, including saliva, sweat, and digestive juices, which further aids in the management of conditions involving excess gastrointestinal secretions. Pharmacokinetically, hyoscyamine is rapidly absorbed after oral administration, with a peak plasma concentration occurring within 1 to 2 hours.
Its effects are generally noticeable within 30 to 60 minutes, and its half-life is about 2 to 3.5 hours. Hyoscyamine sulfate is partially hydrolyzed to tropic acid and tropine; however, the majority of the drug is excreted unchanged in the urine within the first 12 hours. It is metabolized in the placenta and liver and eliminated primarily via the kidneys, largely in unchanged form.
Hyoscyamine crosses the blood–brain barrier and may produce central nervous system effects, including drowsiness or dizziness.
📦 How Supplied / Storage and Handling ▾
HOW SUPPLIED: Digenyx™ (Hyoscyamine Sulfate USP, 0.125 mg) are off-white to light beige round tablets. Each bottle contains 30 tablets (NDC 59088-150-54). Dispense in a tight, light-resistant container as defined in the USP/NF with a child-resistant closure.
📦 Storage and Handling ▾
Store at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature]. Protect from light and moisture and avoid excessive heat. Do not use if bottle seal is broken. KEEP THIS AND ALL MEDICATIONS OUT OF THE REACH OF CHILDREN.
📋 Description ▾
DESCRIPTION: Digenyx™ (Hyoscyamine Sulfate USP, 0.125 mg) tablets are off-white to light beige round tablet containing 0.125 mg hyoscyamine sulfate formulated for oral administration. Each tablet also contains inactive ingredients: Lactose Monohydrate, Magnesium Stearate, Microcrystalline Cellulose, Stearic Acid, Sodium Starch Glycolate. Hyoscyamine sulfate is one of the principal anticholinergic/antispasmodic components of belladonna alkaloids.
The empirical formula is (C 17 H 23 NO 3 ) 2 • H 2 SO 4 • 2H 2 O and the molecular weight is 712.85. Chemically, it is benzeneacetic acid,α-(hydroxymethyl)-, 8-methyl-8-azabicyclo [3.2.1] oct-3-yl ester, [3(S)-endo]-, sulfate (2:1), dihydrate with the following structure: figure a
💬 Information for Patients ▾
Information for Patients: Digenyx™ (Hyoscyamine Sulfate USP, 0.125 mg) tablets can cause drowsiness, dizziness, and blurred vision. Avoid driving or operating machinery until you know how the medication affects you. During hot weather or exercise, be cautious as this medication can reduce sweating, increasing the risk of heat stroke.
Patients should observe caution before driving, using machinery or performing other tasks requiring mental alertness. Take the medication 30 minutes to 1 hour before meals and swallow the tablets whole.