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Digenyx Hyoscyamine Sulfate 0.125 mg .125 mg Tablet, 30-count — NDC 59088-0150-54 package photo
Label image from the product's FDA listing (DailyMed) — may show a different pack size or an older label revision.

Digenyx Hyoscyamine Sulfate 0.125 mg .125 mg Tablet, 30-count — NDC 59088-150-54 (Billing 59088-0150-54)

by PureTek Corporation · 30 TABLET in 1 BOTTLE

This is a package of 30 tablets of Digenyx Hyoscyamine Sulfate 0.125 mg .125 mg Tablet from PureTek Corporation, marketed since May 2026 and currently FDA-listed; retail pharmacies pay about $0.1459 per tablet (NADAC). It is this product's only package size.

NDC 59088-0150-54
🏷️ FDA NDC (as labeled) 59088-150-54 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 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

NDC database record

One package, one record: these facts belong to NDC 59088-150-54 alone.

Record
FDA NDC Directory package listing · Human prescription drug
Code segments
59088 labeler · 150 product · 54 package
Package marketed since
May 13, 2026
Sample package
No — commercial package
Listing certified through
Dec 31, 2027
Billing quantity
30 EA per package
Barcode (UPC)
0359088150542
FDA record last changed
Jul 24, 2026

Identity & classification

Regulatory identifiers FDA, NLM and CMS codes for this package

FDA NDC (as labeled) 59088-150-54
Product NDC 59088-150
11-digit billing NDC 59088015054
NCPDP billing unit EA — each (per item)
RxCUI 1047905, 2743192
UNII F2R8V82B84
UPC 0359088150542
SPL Set ID 512f3202-4ecf-1218-e063-6294a90a0544
DEA schedule Non-controlled
Marketing category UNAPPROVED DRUG OTHER
Marketing status On market
FDA listing status Listed (active directory)
Marketing start 2026-05-13
Route ORAL
Dosage form TABLET
Substance HYOSCYAMINE SULFATE

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

GPI-14 49101030100310
Quick answers
  • GPI-14 (Medi-Span): 49101030100310
  • RxCUI (RxNorm): 1047905
Why two NDCs? The FDA registers this code as 59088-150-54 — 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 → 59088-0150-54. 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

📖 What it is MedlinePlus · NLM

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.

Read the full MedlinePlus article ↗
📗 Our plain-language guide HelloPharmacist
  • Hyoscyamine calms spasms and slows secretions in the stomach, bowel and bladder. It is often an add-on for peptic ulcer or irritable bowel syndrome. Some products have additional u...
  • Many tablets are taken 30 to 60 minutes before meals and at bedtime, and some are taken as needed. Follow your label, since dissolving, under-the-tongue and extended-release forms...
  • Dry mouth, blurred vision, drowsiness, dizziness and constipation are common. Use caution driving until you know how it affects you. Call your doctor if you cannot urinate or feel...
  • Be careful. Hyoscyamine reduces sweating, so you can overheat and even get heat stroke. Stay cool and get help for fever or heat illness.
📖 Read our full Hyoscyamine guide →

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 eaPer package
Retail pharmacies payNADAC · weekly $0.146 $4.38 / 30 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 · quarterly No Part D plan price is available for this NDC in our data.
NADAC price history (per ea) — tap or hover for the price & month
Sep 2026 $0.146 $0.146
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
59088-0150-54 You're viewing this Main listing 30 TABLET in 1 BOTTLE 2026-05-13 — Active

Therapeutic equivalents

ProductLabelerPackNADAC/unitTEStatusPrice vs. this
Hyoscyamine Sulfate TAB .125 mg 42192-0340-01 Acella 100 tablets $0.146 — Availability likely —
Digenyx .125 mgthis 59088-0150-54 PureTek 30 tablets $0.146 — Availability likely —
Hyoscyamine sulfate .125 mg 62135-0512-12 Chartwell 120 tablets $0.146 — Availability likely —
Hyoscyamine Sulfate .125 mg 62559-0421-01 ANI 100 tablets $0.146 — Availability likely —
Oscimin .125 mg 68047-0252-01 Larken 100 tablets $0.146 — Availability likely —
Levsin .125 mg 68220-0112-10 Viatris 100 tablets $2.656 — Availability likely +1720%
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 —
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 —
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

🏛️
2026
On the market since
May 2026
📍
2026
Currently FDA-listed
listed with the FDA
🔒
·
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.

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.

🧪 Avoiding an ingredient? See Hyoscyamine inactive ingredients by manufacturer: every current product's list side by side, so you can ask your pharmacy for the version that does not list it.

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

  • 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 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.
  • 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?
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

LabelerPureTek Corporation
Labeler code59088
First marketedMay 2026
Product typeHuman Prescription Drug
Portfolio178 products on file

More NDCs from PureTek Corporation labeler code 59088

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. 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 💬 Information for Patients ⚠️ Precautions 🍼 Nursing Mothers 📄 Package Label / Principal Display Panel
🎯 Indications and Usage 85 words ▾

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 103 words ▾

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 36 words ▾

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 160 words ▾

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 110 words ▾

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 52 words ▾

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 37 words ▾

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 37 words ▾

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 116 words ▾

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 140 words ▾

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 203 words ▾

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 37 words ▾

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 41 words ▾

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 99 words ▾

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 79 words ▾

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.

⚠️ Precautions ~2 min read ▾

PRECAUTIONS: General: Use with caution in patients with autonomic neuropathy, hyperthyroidism, heart disease, heart failure, arrhythmias, high blood pressure, or kidney disease. Hyoscyamine may increase heart rate, so check for tachycardia before using anticholinergics. Patients with hiatal hernia and reflux esophagitis should also be monitored closely.

Prolonged use may decrease saliva, leading to dental issues. 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.

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: 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. Nursing Mothers: Hyoscyamine passes into breast milk. It should not be used while breastfeeding unless clearly necessary.

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: 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.

🍼 Nursing Mothers 17 words ▾

Nursing Mothers: Hyoscyamine passes into breast milk. It should not be used while breastfeeding unless clearly necessary.

📄 Package Label / Principal Display Panel 19 words ▾

Manufactured in the USA by: PureTek Corporation Panorama City, CA 91402 For questions or information Call toll-free: 1-877-921-7873 label

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

Reported adverse events (FAERS)

Read carefully: FAERS reports are voluntary and unverified. Counts are not incidence, do not establish causation, are subject to reporting bias, and cannot be used to compare one drug to another. Shown for signal context only. Reports for Digenyx (this brand).

Top reported reactions

Confusional State2
Dizziness2
Blood Pressure Decreased1
Breast Tenderness1
Dry Mouth1
Dysarthria1
Dysstasia1

Reporter sex

5 reports
Male · 20%
Female · 80%

Serious outcomes

Hospitalization1
Disabling1
Where does this data come from?
Adverse-event reports from the FDA Adverse Event Reporting System (FAERS) via openFDA. FAERS reports are voluntary and unverified — counts are not incidence and don’t establish causation.

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) ✓ Available
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.
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 PureTek Corporation. Listing status can change — the directory data on this page refreshes weekly.
Who lists this product with the FDA?
PureTek Corporation 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.
← 59088-0139-54 · PureTek 59088-0156-54 · PureTek →
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.