Orphenadrine citrate 60 mg/2mL Injection
🆔 Identity & classification
Where does this data come from?
🏷️ RxNorm drug class
This medicine belongs to the Muscle Relaxant class.
Where does this data come from?
🏭 Manufacturer & labeler
Where does this data come from?
🩺 Clinical
- It's a common assumption, but orphenadrine actually doesn't directly relax tense muscles. Researchers believe its benefit comes from pain-relieving properties — so it helps you fee...
- What exactly does orphenadrine do — does it just relax my muscles?
- Take one extended-release tablet in the morning and one in the evening — that's twice a day. Try to stick to the same times each day. If you're unsure whether to take it with food...
- How should I take the extended-release tablet?
Patient education
Supplement & herbal interactions
Where does this data come from?
Ask a licensed pharmacist directly — free, answered by our team.
🧪 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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5.8 mg / 2 mL
UNII 451W47IQ8X
Sodium chloride is common table salt. It's used in medicines as a buffer to maintain proper pH, as a filler to add bulk, or to adjust the osmotic balance in liquid formulations.
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UNII 55X04QC32I
A strong alkaline chemical used to adjust and maintain the pH balance of liquid medicines. It helps keep the medicine stable and ensures it stays effective during storage.
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2 mg / 2 mL
UNII 4VON5FNS3C
Sodium metabisulfite is a preservative derived from sulfur compounds. It prevents microbial growth and oxidation in medicines, helping extend shelf life and maintain product stability.
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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.
4 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
Are inactive ingredients the same for every manufacturer?
Why might an inactive ingredient be missing?
Can inactive ingredients matter?
💲 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 mL | Per package |
|---|---|---|
| Retail pharmacies payNADAC · weekly | $7.074 | $3,537.20 / 500 ml |
| Medicaid paysCMS SDUD · 12 mo | $8.01 | $4,003.30 / 500 ml |
| Medicare drug plans payPart D · quarterly | No Part D plan price is available for this NDC in our data. | |
| Medicare Part B allowsASP · J2360 | $7.777 / J2360 unit | — |
Where does this data come from?
🧾 Billing & reimbursement
Where does this data come from?
🔁 Therapeutic equivalents
| Product | Labeler | Pack | NADAC/unit | TE | Status | Price vs. this |
|---|---|---|---|---|---|---|
| Orphenadrine Citrate 30 mg/mL 25021-0651-02 | Sagent | 10 vials | $5.710 | AP | Availability likely | save 19% |
| Orphenadrine citrate 60 mg/2mLthis 00641-6182-25 | Hikma | 10 vials | $7.074 | AP | Availability likely | — |
| Orphenadrine Citrate 30 mg/mL 00591-3222-47 | Actavis | 10 ampules | — | AP | FDA listed | — |
Where does this data come from?
⏳ Availability & generic status
This product is an FDA-approved generic. Other versions of the same drug are listed under Therapeutic equivalents, least expensive first.
Where does this data come from?
🗺️ Medicaid utilization & spend
💊 Medicaid utilization by pack size
📊 Medicare Part D spend CMS · PART D · 2026 (Q1)
🔬 Reported adverse events (FAERS)
Top reported reactions
Age at onset
Reporter sex
Serious outcomes
Where does this data come from?
📦 Packaging — all sizes for this product
| Package NDC | Description | Per unit | Per pack | Marketing start | Status |
|---|---|---|---|---|---|
| 00641-6182-10 | 10 VIAL in 1 BOX (0641-6182-10) / 2 mL in 1 VIAL (0641-6182-01) | $5.71 / mL | $114.19 | 2003-04-28 | Active |
| 00641-6182-25 You're viewing this | 25 BOX in 1 BOX (0641-6182-25) / 10 VIAL in 1 BOX (0641-6182-10) / 2 mL in 1 VIAL (0641-6182-01) | $7.07 / mL | $3,537.20 | 2003-04-28 | Active |
Per mL, this pack runs about 24% above the cheapest pack (NDC 00641-6182-10, $5.71 vs $7.07 NADAC).
This pack accounts for about 33% of this product's recent Medicaid fills; most go to a different pack size. See all packs ↓
Pack size FAQ
What quantity is in NDC 00641-6182-25?
What NDC number is used to bill for this package of Orphenadrine citrate 60 mg/2mL Injection?
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.
📄 Full prescribing information FDA SPL
🎯 Indications and Usage ▾
INDICATIONS AND USAGE Orphenadrine citrate is indicated as an adjunct to rest, physical therapy, and other measures for the relief of discomfort associated with acute painful musculoskeletal conditions.
⏱️ Dosage and Administration ▾
DOSAGE AND ADMINISTRATION Adults - One 2 mL vial (60 mg) intravenously or intramuscularly; may be repeated every 12 hours. Relief may be maintained by one (100 mg) orphenadrine citrate tablet twice daily. Parenteral drug products should be inspected visually for particulate matter, whenever solution and container permit.
⛔ Contraindications ▾
CONTRAINDICATIONS Contraindicated in patients with glaucoma, pyloric or duodenal obstruction, stenosing peptic ulcers, prostatic hypertrophy or obstruction of the bladder neck, cardio-spasm (megaesophagus) and myasthenia gravis. Contraindicated in patients who have demonstrated a previous hypersensitivity to the drug.
⚠️ Warnings ▾
WARNINGS Some patients may experience transient episodes of light-headedness, dizziness or syncope. Orphenadrine citrate may impair the ability of the patient to engage in potentially hazardous activities such as operating machinery or driving a motor vehicle; ambulatory patients should therefore be cautioned accordingly. Orphenadrine citrate injection contains sodium metabisulfite, a sulfite that may cause allergic-type reactions including anaphylactic symptoms and life-threatening or less severe asthmatic episodes in certain susceptible people.
The overall prevalence of sulfite sensitivity in the general population is unknown and probably low. Sulfite sensitivity is seen more frequently in asthmatic than nonasthmatic people.
🤒 Adverse Reactions ▾
ADVERSE REACTIONS Adverse reactions of orphenadrine are mainly due to the mild anticholinergic action of orphenadrine, and are usually associated with higher dosage. Dryness of the mouth is usually the first adverse effect to appear. When the daily dose is increased, possible adverse effects include: tachycardia, palpitation, urinary hesitancy or retention, blurred vision, dilatation of pupils, increased ocular tension, weakness, nausea, vomiting, headache, dizziness, constipation, drowsiness, hypersensitivity reactions, pruritus, hallucinations, agitation, tremor, gastric irritation, and rarely urticaria and other dermatoses.
Infrequently, an elderly patient may experience some degree of mental confusion. These adverse reactions can usually be eliminated by reduction in dosage. Very rare cases of aplastic anemia associated with the use of orphenadrine tablets have been reported.
No causal relationship has been established. Rare instances of anaphylactic reaction have been reported associated with the intramuscular injection of orphenadrine citrate.
🤰 Pregnancy ▾
Pregnancy Teratogenic Effects Pregnancy Category C Animal reproduction studies have not been conducted with orphenadrine. It is also not known whether orphenadrine can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. Orphenadrine should be given to a pregnant woman only if clearly needed.
🧒 Pediatric Use ▾
Pediatric Use Safety and effectiveness in children have not been established; therefore, this drug is not recommended for use in the pediatric age group.
🆘 Overdosage ▾
OVERDOSAGE Orphenadrine is toxic when overdosed and typically induces anticholinergic effects. In a review of orphenadrine toxicity, the minimum lethal dose was found to be 2 to 3 grams for adults; however, the range of toxicity is variable and unpredictable. Treatment for orphenadrine overdose is evacuation of stomach contents (when necessary), charcoal at repeated doses, intensive monitoring, and appropriate supportive treatment of any emergent anticholinergic effects.
🧬 Clinical Pharmacology ▾
CLINICAL PHARMACOLOGY The mode of therapeutic action has not been clearly identified, but may be related to its analgesic properties. Orphenadrine citrate does not directly relax tense muscles in man. Orphenadrine citrate also possesses anticholinergic actions.
📦 How Supplied / Storage and Handling ▾
HOW SUPPLIED Orphenadrine Citrate Injection, USP is supplied as follows: Cartons of 10 ( NDC 0641-6182-10 ) 2 mL vials, each vial containing 60 mg of orphenadrine citrate in aqueous solution. Cartons of 25 ( NDC 0641-6182-25 ) 2 mL vials, each vial containing 60 mg of orphenadrine citrate in aqueous solution. Storage Store at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature].
Protect from light. Single dose vial. Discard unused portion.
To report SUSPECTED ADVERSE REACTIONS, contact Hikma Pharmaceuticals USA Inc. at 1-877-845-0689, or the FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. For Product Inquiry call 1-877-845-0689. Manufactured by: Hikma Pharmaceuticals USA Inc.
Berkeley Heights, NJ 07922 Revised May 2023 462-734-02
📋 Description ▾
DESCRIPTION Orphenadrine citrate is the citrate salt of orphenadrine (±)- N , N -dimethyl-2-[( o -methyl-α-phenylbenzyl)oxy]-ethylamine citrate (1:1). It occurs as a white, crystalline powder having a bitter taste. It is practically odorless; sparingly soluble in water, slightly soluble in alcohol.
Each vial contains 60 mg of orphenadrine citrate in aqueous solution. Each vial also contains: sodium metabisulfite, 2 mg; sodium chloride, 5.8 mg; sodium hydroxide, to adjust pH; and water for injection, q.s. to 2 mL. The structural formula is: C 18 H 23 NO•C 6 H 8 O 7 MW 461.50 Structural Formula