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Hyosyne Hyoscyamine Sulfate .125 mg/5mL Elixir, 473 mL — NDC 54838-0511-80 package photo
Label image from the product's FDA listing (DailyMed) — may show a different pack size or an older label revision.

Hyosyne Hyoscyamine Sulfate .125 mg/5mL Elixir, 473 mL — NDC 54838-511-80 (Billing 54838-0511-80)

by Lannett Company, Inc. · 473 mL in 1 BOTTLE, PLASTIC

This is a package of 473 mL of Hyosyne Hyoscyamine Sulfate .125 mg/5mL Elixir from Lannett Company, Inc., marketed since Nov 1997 and currently FDA-listed. It is this product's only package size.

NDC 54838-0511-80
🏷️ FDA NDC (as labeled) 54838-511-80 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 54838-511-80 alone.

Record
FDA NDC Directory package listing · Human prescription drug
Code segments
54838 labeler · 511 product · 80 package
Package marketed since
Nov 1, 1997
Sample package
No — commercial package
Listing certified through
Dec 31, 2026
Billing quantity
473 mL per package
Barcode (UPC-A, from the NDC)
3 5483851180 2
Medicaid fills, this package
81 prescriptions in the last four reported quarters
FDA record last changed
Jul 24, 2026

Identity & classification

Regulatory identifiers FDA, NLM and CMS codes for this package

FDA NDC (as labeled) 54838-511-80
Product NDC 54838-511
11-digit billing NDC 54838051180
NCPDP billing unit ML — per mL (volume)
RxCUI 1047881
UNII F2R8V82B84
SPL Set ID a0e8f7d7-9316-4b78-acc8-17519b9b3165
DEA schedule Non-controlled
Marketing category UNAPPROVED DRUG OTHER
Marketing status On market
FDA listing status Listed (active directory)
Marketing start 1997-11-01
Route ORAL
Dosage form ELIXIR
Substance HYOSCYAMINE SULFATE

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

GPI-14 49101030101055
GPI class Hyosyne
GCN Seq No 004862
GCN 18931
HICL code 002017
Ingredient (HICL) Hyoscyamine Sulfate
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 HYOSYNE 125 MCG/5 ML ELIXIR
FDB brand name Hyosyne
Legend status F — Federal legend — prescription drug or device
Quick answers
  • GSN (GCN sequence number): 004862
  • GCN: 18931
  • GPI-14 (Medi-Span): 49101030101055
  • HICL (First Databank): 002017
  • AHFS class code: 12:08.08.00
  • RxCUI (RxNorm): 1047881
Why two NDCs? The FDA registers this code as 54838-511-80 — 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 → 54838-0511-80. 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 HYOSYNE 125 MCG/5 ML ELIXIR Ingredient Hyoscyamine Sulfate
📗 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 mLPer package
Retail pharmacies payNADAC · weekly Not in the retail survey — common for institutional, discontinued, or low-volume packs.
Medicaid paysCMS SDUD · 12 mo $0.0569 $26.91 / 473 ml
Medicare drug plans payPart D · quarterly No Part D plan price is available for this NDC in our data.
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
54838-0511-80 You're viewing this Main listing 473 mL in 1 BOTTLE, PLASTIC 1997-11-01 — Active

Therapeutic equivalents

ProductLabelerPackNADAC/unitTEStatusPrice vs. this
Hyosyne .125 mg/5mL 17856-0511-02 ATLANTIC 72 cups — — FDA listed —
Hyosyne .125 mg/5mL 17856-0514-05 ATLANTIC 5 ml — — FDA listed —
Hyosyne .125 mg/5mLthis 54838-0511-80 Lannett 473 ml — — FDA listed —
Hyoscyamine Sulfate .125 mg/5mL 62135-0511-47 Chartwell 473 ml — — 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

🏛️
1997
On the market since
Nov 1997
📍
2026
Currently FDA-listed
29 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.

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 3K9958V90M
    A liquid solvent derived from fermentation or chemical synthesis. In medicines, alcohol dissolves active ingredients, helps preserve the product, and improves how the body absorbs certain drugs.
  • UNII XF417D3PSL
    Anhydrous citric acid is a sour, crystalline powder derived from citric acid with water removed. In medicines, it acts as a buffer to control pH, adds tartness to improve taste, and helps tablets disintegrate.
  • UNII WZB9127XOA
    A synthetic red dye used to color medications and make them easier to identify. It serves as a colorant in tablets, capsules, and liquid formulations.
  • UNII H77VEI93A8
    A synthetic yellow dye used to color medications. It helps identify the drug and make it visually distinctive, with no effect on how the medicine works.
  • UNII PDC6A3C0OX
    Glycerin is a clear, thick liquid derived from plant oils or fats. It acts as a humectant to retain moisture, a sweetener, and a solvent in medications.
  • UNII OJ245FE5EU
    Sodium benzoate is a salt derived from benzoic acid, a preservative. It's added to medicines to prevent growth of bacteria, fungi, and other microorganisms that could spoil the product.
  • UNII 1Q73Q2JULR
    Sodium citrate is a salt derived from citric acid. It works as a buffer to maintain the medicine's pH level and may also help improve taste or act as a preservative in the formulation.
  • UNII 506T60A25R
    Sorbitol is a natural sugar alcohol derived from glucose. It serves as a sweetener, humectant, and bulking agent in medications to improve taste and help maintain moisture in the product.
  • UNII C151H8M554
    A natural sugar derived from sugar cane or sugar beets. It's used as a sweetener, filler, and binder to improve taste, add bulk, and help hold tablet or capsule ingredients together.
  • UNII 059QF0KO0R
    Water is a liquid solvent that dissolves and mixes ingredients together in liquid medicines, syrups, and injections. It helps distribute the active drug evenly throughout the product.

10 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

LabelerLannett Company, Inc.
Labeler code54838
First marketedNov 1997
Product typeHuman Prescription Drug
Portfolio171 products on file

More NDCs from Lannett Company, Inc. labeler code 54838

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 🆘 Overdosage 🧬 Clinical Pharmacology 📦 How Supplied / Storage and Handling 📋 Description ⚠️ Precautions 📄 Package Label / Principal Display Panel
🎯 Indications and Usage 175 words ▾

INDICATIONS AND USAGE Hyoscyamine sulfate is effective as adjunctive therapy in the treatment of peptic ulcer. It can also be used to control gastric secretion, visceral spasm and hypermotility in spastic colitis, spastic bladder, cystitis, pylorospasm, and associated abdominal cramps. May be used in functional intestinal disorders to reduce symptoms such as those seen in mild dysenteries, diverticulitis, and acute enterocolitis.

For use as adjunctive therapy in the treatment of irritable bowel syndrome (irritable colon, spastic colon, mucous colitis) and functional gastrointestinal disorders. Also used as adjunctive therapy in the treatment of neurogenic bladder and neurogenic bowel disturbances (including the splenic flexure syndrome and neurogenic colon). Also used in the treatment of infant colic (elixir and drops).

Hyoscyamine sulfate is indicated along with morphine or other narcotics in symptomatic relief of biliary and renal colic; as a “drying agent” in the relief of symptoms of acute rhinitis; in the therapy of parkinsonism to reduce rigidity and tremors and to control associated sialorrhea and hyperhidrosis. May be used in the therapy of poisoning by anticholinesterase agents.

⏱️ Dosage and Administration ~2 min read ▾

DOSAGE AND ADMINISTRATION HYOSYNE ORAL DROPS (Hyoscyamine Sulfate Oral Solution) Dosage may be adjusted according to the conditions and severity of symptoms. Measure dosage very carefully. Adults and pediatric patients 12 years of age and older : 1 to 2 mL every four hours or as needed.

Do not exceed 12 mL in 24 hours. Pediatric patients 2 to under 12 years of age : 1/4 to 1 mL every four hours or as needed. Do not exceed 6 mL in 24 hours.

Pediatric patients under 2 years of age : The following dosage guide is based upon body weight. The doses may be repeated every four hours or as needed. Body Weight Usual Dose Do Not Exceed In 24 Hours 3.4 kg (7.5 lb.) 4 drops 24 drops 5 kg (11 lb.) 5 drops 30 drops 7 kg (15 lb.) 6 drops 36 drops 10 kg (22 lb.) 8 drops 48 drops Package of Hyoscyamine Sulfate Oral Drops is accompanied with a dropper having markings of 3, 4, 5 DROPS, and 0.25 mL.

The approximate equivalent amount of hyoscyamine sulfate drops (mL) and its equivalent amount of hyoscyamine sulfate (mg) for each marking are as follows: Approximate Equivalent Amount Marking on Dropper Hyoscyamine Sulfate Oral Drops Solution (mL) Hyoscyamine Sulfate (mg) 3 DROPS 0.08 mL 0.01 mg 4 DROPS 0.11 mL 0.01375 mg 5 DROPS 0.14 mL 0.0175 mg 0.25 mL 0.25 mL 0.03125 mg HYOSYNE ELIXIR (Hyoscyamine Sulfate Elixir) Dosage may be adjusted according to the conditions and severity of symptoms. Measure dosage very carefully.

Adults and pediatric patients 12 years of age and older : 1 to 2 teaspoonfuls every four hours or as needed. Do not exceed 12 teaspoonfuls in 24 hours. Pediatric patients 2 to under 12 years of age : Please see the following dosage guide is based on body weight.

The doses may be repeated every four hours or as needed. Do not exceed 6 teaspoonfuls in 24 hours. Body Weigh t Usual Dose 10 kg (22 lb.) 1/4 teaspoon (1.25 mL) 20 kg (44 lb.) 1/2 teaspoonful (2.5 mL) 40 kg (88 lb.) 3/4 teaspoonful (3.75 mL) 50 kg (110 lb.) 1 teaspoonful (5 mL)

⛔ Contraindications 49 words ▾

CONTRAINDICATIONS Glaucoma; obstructive uropathy (for example, bladder neck obstruction due to prostatic hypertrophy); obstructive disease of the gastrointestinal tract (as in achalasia, pyloroduodenal stenosis); paralytic ileus, intestinal atony of elderly or debilitated patients; unstable cardiovascular status in acute hemorrhage; severe ulcerative colitis; toxic megacolon complicating ulcerative colitis; myasthenia gravis.

⚠️ Warnings 153 words ▾

WARNINGS In the presence of high environmental temperature, heat prostration can occur with drug use (fever and heat stroke due to decreased sweating). 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.

Like other anticholinergic agents, Hyoscyamine sulfate may produce drowsiness, dizziness or blurred vision. In this event, the patient should be warned not to engage in activities requiring mental alertness such as operating a motor vehicle or other machinery or to perform hazardous work while taking this drug. Psychosis has been reported in sensitive individuals given anticholinergic drugs.

CNS signs and symptoms include confusion, disorientation, short term memory loss, hallucinations, dysarthria, ataxia, coma, euphoria, 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 84 words ▾

ADVERSE REACTIONS All of the following adverse reactions have been reported with hyoscyamine sulfate. Adverse reactions may include dryness of the mouth; urinary hesitancy and retention; blurred vision; tachycardia; palpitations; mydriasis; increased ocular tension; loss of taste; headache; nervousness; drowsiness; weakness; fatigue; dizziness; insomnia; nausea; vomiting; impotence; 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.

🆘 Overdosage 141 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 LD 50 for hyoscyamine is 375 mg/kg.

Hyoscyamine sulfate is dialyzable.

🧬 Clinical Pharmacology 175 words ▾

CLINICAL PHARMACOLOGY Hyoscyamine sulfate inhibits specifically the actions of acetylcholine on structures innervated by postganglionic cholinergic nerves and on smooth muscles that respond to acetylcholine but lack cholinergic innervation. These peripheral cholinergic receptors are present in the autonomic effector cells of the smooth muscle, cardiac muscle, the sinoatrial node, the atrioventricular node, and the exocrine glands. At therapeutic doses, it is completely devoid of any action on autonomic ganglia.

Hyoscyamine sulfate inhibits gastrointestinal propulsive motility and decreases gastric acid secretion. Hyoscyamine sulfate also controls excessive pharyngeal, tracheal and bronchial secretions. Hyoscyamine sulfate is absorbed totally and completely by oral administration.

Once absorbed, hyoscyamine sulfate disappears rapidly from the blood and is distributed throughout the entire body. The half-life of hyoscyamine sulfate is 2 to 3 1/2 hours. Hyoscyamine sulfate is partly hydrolyzed to tropic acid and tropine but the majority of the drug is excreted in the urine unchanged within the first 12 hours.

Only traces of this drug are found in breast milk. Hyoscyamine sulfate passes the blood brain barrier and the placental barrier.

📦 How Supplied / Storage and Handling 89 words ▾

HOW SUPPLIED HYOSYNE ORAL DROPS (Hyoscyamine Sulfate 0.125 mg per mL) is orange colored, flavored, and contains 5% alcohol. It is supplied in a 15 mL bottle with a calibrated dropper (NDC 54838-506-15). HYOSYNE ELIXIR (Hyoscyamine Sulfate 0.125 mg per 5 mL) is orange colored, flavored, and contains 20% alcohol.

It is supplied in a pint (473 mL) bottle (NDC 54838-511-80). Store at 20°-25°C (68°-77°F); excursions permitted between 15°-30°C (59°-86°F) [See USP Controlled Room Temperature]. Rx only.

Distributed by: Lannett Company, Inc. Philadelphia, PA 19136 Rev. 03/24 CIB72192A CG#2192A-2

📋 Description 157 words ▾

DESCRIPTION HYOSYNE ORAL DROPS (Hyoscyamine Sulfate Oral Solution) contain 0.125 mg hyoscyamine sulfate per mL with 5% v/v alcohol for oral administration. HYOSYNE ELIXIR (Hyoscyamine Sulfate Elixir) contains 0.125 mg hyoscyamine sulfate per 5 mL with 20% v/v alcohol for oral administration. 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: HYOSYNE ORAL DROPS also contain as inactive ingredients: Alcohol, citric acid, FD&C red #40, FD&C yellow #6, flavor, glycerin, sodium benzoate, sodium citrate, sorbitol solution, sucrose, and water. HYOSYNE ELIXIR also contain as inactive ingredients: Alcohol, citric acid, FD&C red #40, FD&C yellow #6, flavor, glycerin, purified water, sodium benzoate, sodium citrate, sorbitol solution, and sucrose.

Structure

⚠️ Precautions ~2 min read ▾

PRECAUTIONS General: Use with caution in patients with: autonomic neuropathy, hyperthyroidism, coronary heart disease, congestive heart failure, cardiac arrythmias, hypertension, and renal disease. Investigate any tachycardia before giving any anticholinergic drug since they may increase the heart rate. Use with caution in patients with hiatal hernia associated with reflux esophagitis.

Information for Patients: Like other anticholinergic agents, hyoscyamine sulfate may produce drowsiness, dizziness or blurred vision. In this event, the patient should be warned not to engage in activities requiring mental alertness such as operating a motor vehicle or other machinery or to perform hazardous work while taking this drug. Use of hyoscyamine sulfate may decrease sweating resulting in heat prostration, fever or heat stroke; febrile patients or those who may be exposed to elevated environmental temperatures should use caution.

Drug Interactions: Additive adverse effects resulting from cholinergic blockade may occur when hyoscyamine sulfate is administered concomitantly with other antimuscarinics, amantadine, haloperidol, phenothiazines, monoamine oxidase (MAO) inhibitors, tricyclic antidepressants or some antihistamines. Antacids may interfere with the absorption of hyoscyamine sulfate. Administer hyoscyamine sulfate before meals; antacids after meals.

Carcinogenesis, Mutagenesis, Impairment of Fertility: No long-term studies in animals have been performed to determine the carcinogenic, mutagenic or impairment of fertility potential of hyoscyamine sulfate; however, years of marketing experience with hyoscyamine sulfate shows no demonstrable evidence of a problem. Pregnancy - Pregnancy Category C: Animal reproduction studies have not been conducted with hyoscyamine sulfate. It is also not known whether hyoscyamine sulfate can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity.

Hyoscyamine sulfate should be given to a pregnant woman only if clearly needed. Nursing Mothers: Hyoscyamine sulfate is excreted in human milk. Caution should be exercised when hyoscyamine sulfate is administered to a nursing woman.

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.

📄 Package Label / Principal Display Panel 1 words ▾

label

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

Medicaid utilization & spend

📍 This exact package only: Medicaid data is reported per full 11-digit NDC — labeler, product and pack size — so every number here is for this package alone, not the drug overall. Other pack sizes report separately.
💊 Pharmacy benefit only: These are Medicaid outpatient pharmacy claims, billed by NDC. They exclude the medical benefit — clinic- or hospital-administered drugs billed under HCPCS J-codes — so drugs used mostly that way (e.g. Avastin, Lucentis, Keytruda) can look low or missing here. That’s expected, not an error.
📅 Q1 2025 – Q1 2026 · 5 quarters of data
ⓘ The newest quarter is usually incomplete when first published; states restate recent quarters in later CMS releases, so the latest figures typically revise upward. State coverage-policy changes can also shift quarter-to-quarter totals.
Prescriptions last 4 qtrs
81
Units reimbursed last 4 qtrs
12.7K
Gross reimbursed last 4 qtrs
$720.57
Avg / prescription
$8.90
Avg / unit
$0.0569
Latest quarter Q1 2026
17Rx
Fee-for-service vs managed care ⓘ
100% MCO
Fee-for-service · 0 Rx Managed care · 81 Rx
State Medicaid map
Alaska: no data reported AK Maine: no data reported ME Washington: no data reported WA Idaho: no data reported ID Montana: no data reported MT North Dakota: no data reported ND Minnesota: no data reported MN Wisconsin: no data reported WI Michigan: 9,695 units · 96.6 per 100k residents MI New York: no data reported NY Vermont: no data reported VT New Hampshire: no data reported NH Oregon: no data reported OR Nevada: no data reported NV Wyoming: no data reported WY South Dakota: no data reported SD Iowa: no data reported IA Illinois: no data reported IL Indiana: no data reported IN Ohio: no data reported OH Pennsylvania: no data reported PA New Jersey: no data reported NJ Massachusetts: no data reported MA California: no data reported CA Utah: no data reported UT Colorado: no data reported CO Nebraska: no data reported NE Missouri: no data reported MO Kentucky: no data reported KY West Virginia: no data reported WV Virginia: no data reported VA Maryland: no data reported MD Connecticut: no data reported CT Rhode Island: no data reported RI Arizona: no data reported AZ New Mexico: no data reported NM Kansas: no data reported KS Arkansas: no data reported AR Tennessee: no data reported TN North Carolina: no data reported NC South Carolina: no data reported SC Delaware: no data reported DE Oklahoma: 2,970 units · 73.3 per 100k residents OK Louisiana: no data reported LA Mississippi: no data reported MS Alabama: no data reported AL Georgia: no data reported GA D.C.: no data reported DC Hawaii: no data reported HI Texas: no data reported TX Florida: no data reported FL
Units reimbursed · per 100k residents
73.396.6
gray = no data reported ⓘ
Colors are per 100,000 residents, so big states don’t automatically dominate. Tap or hover a state for its actual totals.
Tap or hover a state
…for its Medicaid breakdown
🏆 Top states by units · per 100k residents
1 Michigan 96.6 /100k
2 Oklahoma 73.3 /100k
National units — by quarter
💵 About the dollar figures: “reimbursed” is what Medicaid paid pharmacies before confidential manufacturer rebates, so the program’s real net cost is lower than these numbers. Fee-for-service and managed-care claims are combined unless split above. Source: CMS State Drug Utilization Data; per-100k rates use 2023 Census population estimates.

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

Medicare Part D (outpatient prescription) spending for Hyoscyamine Sulfate (matched by generic name) — the program that covers self-administered drugs. 2 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 Hyoscyamine Sulfate. CMS lists 6 products for this generic; we show the highest-spend one. 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
$241.8K
Claims incl. refills
7K
Beneficiaries
5.5K
Spend / beneficiary
$43.58
Spend / claim
$34.68
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.

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 Hyosyne (this brand).

Top reported reactions

Nausea167
Diarrhoea147
Headache144
Fatigue138
Pain136
Dizziness125
Dyspnoea94

Age at onset

Child10
Adolescent16
Adult188
Elderly139

Reporter sex

1,902 reports
Male · 23%
Female · 76%
Unknown · 0%

Serious outcomes

Hospitalization511
Death120
Life-threatening18
Reports over time (by year) — tap or hover for the count & year
2019 2021 2023 2026 188 80
Most recent year is provisional (FAERS lags ~3 months).
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) — 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) ✓ Available
“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 Lannett Company, Inc.. Listing status can change — the directory data on this page refreshes weekly.
Who lists this product with the FDA?
Lannett Company, Inc. 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.
← 54838-0510-80 · Lannett 54838-0512-40 · Lannett →
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.