Trihexyphenidyl Hydrochloride 5 mg Tablet, 100-count
🆔 Identity & classification
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🏭 Manufacturer & labeler
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🩺 Clinical
Trihexyphenidyl is used along with other medications to treat the symptoms of Parkinson's disease (PD; a disorder of the nervous system that causes difficulties with movement, muscle control, and balance) and to control extrapyramidal symptoms (tremor, slurred speech) caused by certain medications. Trihexyphenidyl is in a class of medications called antimuscarinics. It works by relaxing muscles and nerve impulses that control the function of muscles.
Read the full MedlinePlus article ↗- Trihexyphenidyl is mainly used to treat parkinsonism — whether it developed on its own, after a brain infection, or from narrowing of blood vessels. It's often added to levodopa wh...
- What is trihexyphenidyl actually used for?
- It depends on how your body reacts. If it makes your mouth very dry, taking it before meals can help. If it causes nausea, take it after meals. If after-meal thirst is a problem, s...
- Should I take it before or after eating?
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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.
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UNII L11K75P92J
A mineral salt made from calcium and phosphate. It acts as a filler and binder in tablets to add bulk and help hold the medicine together in solid form.
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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 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 ETJ7Z6XBU4
Silicon dioxide is a naturally occurring mineral used as a glidant and anti-caking agent. It helps powder ingredients flow smoothly and prevents clumping during manufacturing and storage.
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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.
6 inactive ingredients listed in the exact product block matched to this NDC.
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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 ea | Per package |
|---|---|---|
| Retail pharmacies payNADAC · weekly | $0.120 | $12.03 / 100 tablets |
| Medicaid paysCMS SDUD · 12 mo | $0.2219 | $22.19 / 100 tablets |
| Medicare drug plans payPart D · Q2 2026 | $0.2046 | $20.46 / 100 tablets |
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🔁 Therapeutic equivalents
| Product | Labeler | Pack | NADAC/unit | TE | Status | Price vs. this |
|---|---|---|---|---|---|---|
| Trihexyphenidyl Hydrochloride 5 mgthis 00591-5337-01 | Actavis | 100 tablets | $0.120 | — | Availability likely | — |
| Trihexyphenidyl Hydrochloride 5 mg 70954-0211-10 | Novitium | 100 tablets | $0.120 | AA | Availability likely | — |
| Trihexyphenidyl Hydrochloride 5 mg 51407-0266-01 | Golden | 100 tablets | — | AA | FDA listed | — |
| Trihexyphenidyl Hydrochloride 5 mg 63850-0022-01 | Natco | 100 tablets | — | AA | FDA listed | — |
| Trihexyphenidyl Hydrochloride 5 mg 70518-1140-00 | REMEDYREPACK | 30 tablets | — | AA | FDA listed | — |
| Trihexyphenidyl Hydrochloride 5 mg 70518-1657-01 | REMEDYREPACK | 100 tablets | — | AA | FDA listed | — |
| Trihexyphenidyl Hydrochloride 5 mg 70518-2409-02 | REMEDYREPACK | 100 tablets | — | AA | FDA listed | — |
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⏳ Availability & generic status
FDA-approved generic versions are listed, and recent pricing/market data suggests they may be available — see Therapeutic equivalents.
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🗺️ Medicaid utilization & spend
💊 Medicaid utilization by pack size
📦 Packaging — all sizes for this product
| Package NDC | Description | Per unit | Per pack | Marketing start | Status |
|---|---|---|---|---|---|
| 00591-5337-01 You're viewing this | 100 TABLET in 1 BOTTLE, PLASTIC (0591-5337-01) | $0.1203 / ea | $12.03 | 1987-11-01 | Active |
| 00591-5337-10 | 1000 TABLET in 1 BOTTLE, PLASTIC (0591-5337-10) | $0.1203 / ea | $120.34 | 1987-11-01 | Active |
| 00591-5337-00 | 33000 TABLET in 1 BAG (0591-5337-00) | — | — | — | Active |
| 00591-5337-77 | 40008 TABLET in 1 CONTAINER (0591-5337-77) | — | — | — | Active |
You're viewing the smallest of 4 pack sizes for this product.
This pack has the lowest per-ea cost of the 2 priced pack sizes ($0.1203 NADAC).
In Medicaid, this is the most-dispensed pack of this product — about 83% of fills over the last four reported quarters. See all packs ↓
Pack size FAQ
What quantity is in NDC 00591-5337-01?
What is the difference between NDC 00591-5337-01 and NDC 00591-5337-10?
What NDC number is used to bill for this package of Trihexyphenidyl Hydrochloride 5 mg Tablet?
Prices are the latest CMS NADAC pharmacy acquisition cost per NDC; per-pack figures are per-unit × pack quantity, shown only when the pack is denominated in the same measure NADAC prices.
🧭 About this NDC listing & data coverage
What "drug for further processing" means
FDA lists this package under the "drug for further processing" marketing category: Actavis Pharma, Inc. supplies it to other companies for further processing or repackaging (blister cards that are later repackaged or co-packaged are a common example). The units themselves are a finished dosage form — which is why pricing or Medicaid data can still appear — but this exact package code may not be the presentation a retail pharmacy dispenses.
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) | ✓ Available |
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📄 Full FDA label FDA SPL
🎯 Indications and Usage ▾
INDICATIONS This drug is indicated as an adjunct in the treatment of all forms of parkinsonism (postencephalitic, arteriosclerotic, and idiopathic). It is often useful as adjuvant therapy when treating these forms of parkinsonism with levodopa. Additionally, it is indicated for the control of extrapyramidal disorders caused by central nervous system drugs such as the dibenzoxazepines, phenothiazines, thioxanthenes, and butyrophenones.
⏱️ Dosage and Administration ▾
DOSAGE AND ADMINISTRATION Dosage should be individualized. The initial dose should be low and then increased gradually, especially in patients over 60 years of age. Whether trihexyphenidyl HCl may best be given before or after meals should be determined by the way the patient reacts.
Postencephalitic patients, who are usually more prone to excessive salivation, may prefer to take it after meals and may, in addition, require small amounts of atropine which, under such circumstances, is sometimes an effective adjuvant. If trihexyphenidyl HCl tends to dry the mouth excessively, it may be better to take it before meals, unless it causes nausea. If taken after meals, the thirst sometimes induced can be allayed by mint candies, chewing gum or water.
Trihexyphenidyl HCl in Idiopathic Parkinsonism As initial therapy for parkinsonism, 1 mg may be administered the first day. The dose may then be increased by 2 mg increments at intervals of three to five days, until a total of 6 to 10 mg is given daily. The total daily dose will depend upon what is found to be the optimal level.
Many patients derive maximum benefit from this daily total of 6 to 10 mg, but some patients, chiefly those in the postencephalitic group, may require a total daily dose of 12 to 15 mg. Trihexyphenidyl HCl in Drug-Induced Parkinsonism The size and frequency of dose of trihexyphenidyl HCl needed to control extrapyramidal reactions to commonly employed tranquilizers, notably the phenothiazines, thioxanthenes, and butyrophenones, must be determined empirically. The total daily dosage usually ranges between 5 and 15 mg, although, in some cases, these reactions have been satisfactorily controlled on as little as 1 mg daily.
It may be advisable to commence therapy with a single 1 mg dose. If the extrapyramidal manifestations are not controlled in a few hours, the subsequent doses may be progressively increased until satisfactory control is achieved. Satisfactory control may sometimes be more rapidly achieved by temporarily reducing the dosage of the tranquilizer on instituting trihexyphenidyl HCl therapy and then adjusting dosage of both drugs until the desired ataractic effect is retained without onset of extrapyramidal reactions.
It is sometimes possible to maintain the patient on a reduced trihexyphenidyl HCl dosage after the reactions have remained under control for several days. Instances have been reported in which these reactions have remained in remission for long periods after trihexyphenidyl HCl therapy was discontinued. Concomitant Use of Trihexyphenidyl HCl with Levodopa When trihexyphenidyl HCl is used concomitantly with levodopa, the usual dose of each may need to be reduced.
Careful adjustment is necessary, depending on side effects and degree of symptom control. Trihexyphenidyl HCl dosage of 3 to 6 mg daily, in divided doses, is usually adequate. Concomitant Use of Trihexyphenidyl HCl with Other Parasympathetic Inhibitors Trihexyphenidyl HCl may be substituted, in whole or in part, for other parasympathetic inhibitors.
The usual technique is partial substitution initially, with progressive reduction in the other medication as the dose of trihexyphenidyl HCl is increased. Trihexyphenidyl Hydrochloride Tablets - The total daily intake of trihexyphenidyl HCl tablets is tolerated best if divided into 3 doses and taken at mealtimes. High doses (> 10 mg daily) may be divided into 4 parts, with 3 doses administered at meal times and the fourth at bedtime.
⚠️ Warnings ▾
WARNINGS Patients to be treated with trihexyphenidyl HCl should have a gonioscope evaluation and close monitoring of intraocular pressures at regular periodic intervals.
🤒 Adverse Reactions ▾
ADVERSE REACTIONS Minor side effects, such as dryness of the mouth, blurring of vision, dizziness, mild nausea, or nervousness, will be experienced by 30 to 50 percent of all patients. These sensations, however, are much less troublesome with trihexyphenidyl HCl than with belladonna alkaloids and are usually less disturbing than unalleviated parkinsonism. Such reactions tend to become less pronounced, and even to disappear, as treatment continues.
Even before these reactions have remitted spontaneously, they may often be controlled by careful adjustment of the dosage form, amount of drug, or interval between doses. Isolated instances of suppurative parotitis secondary to excessive dryness of the mouth, skin rashes, dilatation of the colon, paralytic ileus, and certain psychiatric manifestations such as delusions and hallucinations, plus one doubtful case of paranoia all of which may occur with any of the atropine-like drugs, have been rarely reported with trihexyphenidyl hydrochloride.
Patients with arteriosclerosis or with a history of idiosyncrasy to other drugs may exhibit reactions of mental confusion, agitation, disturbed behavior, or nausea and vomiting. Such patients should be allowed to develop a tolerance through the initial administration of a small dose and gradual increase in dose until an effective level is reached. If a severe reaction should occur, administration of the drug should be discontinued for a few days and then resumed at a lower dosage.
Psychiatric disturbances can result from indiscriminate use (leading to overdosage) to sustain continued euphoria. Potential side effects associated with the use of any atropine-like drugs include constipation, drowsiness, urinary hesitancy or retention, tachycardia, dilation of the pupil, increased intraocular tension, weakness, vomiting, and headache. The occurrence of angle-closure glaucoma due to long-term treatment with trihexyphenidyl hydrochloride has been reported.
To report SUSPECTED ADVERSE EVENTS, contact Teva at 1-888-838-2872 or FDA at 1-800-FDA-1088 or http://www.fda.gov/medwatch for voluntary reporting of adverse reactions.
🧬 Clinical Pharmacology ▾
CLINICAL PHARMACOLOGY Trihexyphenidyl HCl is the substituted piperidine salt, 3-(1-piperidyl)-1-phenylcyclohexyl-1-propanol hydrochloride, which exerts a direct inhibitory effect upon the parasympathetic nervous system. It also has a relaxing effect on smooth musculature; exerted both directly upon the muscle tissue itself and indirectly through an inhibitory effect upon the parasympathetic nervous system. Its therapeutic properties are similar to those of atropine, although undesirable side effects are ordinarily less frequent and severe than with the latter.
📦 How Supplied / Storage and Handling ▾
HOW SUPPLIED Trihexyphenidyl hydrochloride tablets USP, 2 mg are scored, round, white, flat faced, tablets imprinted DAN DAN and 5335 supplied in bottles of 100 (NDC 0591-5335-01) and 1000 (NDC 0591-5335-10). Trihexyphenidyl hydrochloride tablets USP, 5 mg are scored, round, white, tablets imprinted DAN DAN and 5337 supplied in bottles of 100 (NDC 0591-5337-01) and 1000 (NDC 0591-5337-10). Dispense in a tight container with child-resistant closure.
Store at 20° to 25° (68° to 77°F) [See USP Controlled Room Temperature]. Manufactured In India By: Watson Pharma Private Limited Verna, Salcette Goa 403 722 INDIA Manufactured For: Teva Pharmaceuticals Parsippany, NJ 07054 Rev. A 2/2024
📋 Description ▾
DESCRIPTION Trihexyphenidyl hydrochloride is a synthetic antispasmodic drug available in the following forms: Tablets, 2 mg and 5 mg. It is designated chemically 1-Piperidinepropanol,α-cyclohexyl-α-phenyl-, hydrochloride. The structural formula is represented below: C 20 H 31 NO•HCl M.W.
337.93 Trihexyphenidyl hydrochloride tablets USP, 2 mg and 5 mg contain the following inactive ingredients: colloidal silicon dioxide, dibasic calcium phosphate, lactose monohydrate, magnesium stearate, microcrystalline cellulose and sodium starch glycolate. 7066154a-figure-01