Orphenadrine citrate
Tablet, Extended Release · Oral, Intramuscular, Intravenous
Uses
Orphenadrine citrate extended-release tablets are 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
Adults Two tablets per day; one in the morning and one in the evening.
Contraindications
Orphenadrine citrate extended-release tablets are contraindicated in patients with glaucoma, pyloric or duodenal obstruction, stenosing peptic ulcers, prostatic hypertrophy or obstruction of the bladder neck, cardio-spasm (mega-esophagus) and myasthenia gravis. Orphenadrine citrate tablets are contraindicated in patients who have demonstrated a previous hypersensitivity to the drug.
Warnings
Some patients may experience transient episodes of light-headedness, dizziness or syncope. Orphenadrine 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.
Precautions
Confusion, anxiety and tremors have been reported in few patients receiving propoxyphene and orphenadrine concomitantly. As these symptoms may be simply due to an additive effect, reduction of dosage and/or discontinuation of one or both agents is recommended in such cases. Orphenadrine citrate should be used with caution in patients with tachycardia, cardiac decompensation, coronary insufficiency, cardiac arrhythmias. Safety of continuous long-term therapy with orphenadrine has not been established. Therefore, if orphenadrine is prescribed for prolonged use, periodic monitoring of blood, urine and liver function values is recommended. Pregnancy 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 Safety and effectiveness in pediatric patients have not been established.
Side effects
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.
Pregnancy
Pregnancy 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 pediatric patients have not been established.
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.
Description
Orphenadrine citrate is the citrate salt of orphenadrine. It occurs as a white, crystalline powder having a bitter taste. It is practically odorless; sparingly soluble in water, slightly soluble in alcohol. The chemical name of orphenadrine citrate is (±) -N,N -Dimethyl-2-[( o -methyl-α-phenylbenzyl)oxy]ethylamine citrate (1:1) having molecular formula C 18 H 23 NO
• C 6 H 8 O 7 and molecular weight of 461.51. It has the following structural formula: Each tablet for oral administration contains 100 mg orphenadrine citrate. Each Orphenadrine citrate extended- release tablet contains the following inactive ingredients: hydroxypropyl methylcellulose, lactose monohydrate and magnesium stearate. Image
How supplied
Orphenadrine citrate extended-release tablets 100 mg are round, white to off-white tablets, debossed NL4 on one side and plain on the other side and are supplied as: NDC 43386-480-24 in bottles of 100 tablets NDC 43386-480-26 in bottles of 500 tablets NDC 43386-480-28 in bottles of 1000 tablets Store at 20°-25°C (68°-77°F) [see USP Controlled Room Temperature]. Dispense in a tight, light-resistant container. LUPIN and the are registered trademarks of Lupin Pharmaceuticals, Inc. Manufactured by Novel Laboratories, Inc. Somerset, NJ 08873 Manufactured For Lupin Pharmaceuticals, Inc. Naples FL, 34108 SAP Code: 276510 Rev: 10/2024 lupin symbol
Label text from the FDA structured product label by Lupin Pharmaceuticals, Inc. (revised Sep 10, 2025). Long sections are shortened; the complete label is on DailyMed.
Active ingredients
- Orphenadrine Citrate in 20 products
Orphenadrine citrate NDC products (20)
| NDC | Strength & form | Labeler | Type |
|---|---|---|---|
| 50090-0169 | Orphenadrine Citrate 100 mg/1 Tablet, Extended Release | A-S Medication Solutions | ANDA |
| 0591-3222 | Orphenadrine Citrate 30 mg/mL Injection | Actavis Pharma, Inc. | ANDA |
| 80425-0340 | Orphenadrine Citrate 100 mg/1 Tablet, Extended Release | Advanced Rx Pharmacy of Tennessee, LLC | ANDA |
| 80425-0117 | Orphenadrine Citrate 100 mg/1 Tablet, Extended Release | Advanced Rx Pharmacy of Tennessee, LLC | ANDA |
| 72162-2020 | Orphenadrine Citrate 100 mg/1 Tablet, Extended Release | Bryant Ranch Prepack | ANDA |
| 63629-1564 | Orphenadrine Citrate 100 mg/1 Tablet, Extended Release | Bryant Ranch Prepack | ANDA |
| 0641-6182 | Orphenadrine Citrate 60 mg/2mL Injection | Hikma Pharmaceuticals USA Inc. | ANDA |
| 49999-046 | Orphenadrine Citrate 100 mg/1 Tablet, Extended Release | Lake Erie Medical DBA Quality Care Products LLC | ANDA |
| 43386-480 | Orphenadrine Citrate 100 mg/1 Tablet, Extended Release | Lupin Pharmaceuticals, Inc. | ANDA |
| 82868-040 | Orphenadrine Citrate 100 mg/1 Tablet, Extended Release | Northwind Health Company, LLC | ANDA |
| 66267-158 | Orphenadrine Citrate 100 mg/1 Tablet, Extended Release | NuCare Pharmaceuticals, Inc. | ANDA |
| 43063-407 | Orphenadrine Citrate 100 mg/1 Tablet, Extended Release | PD-Rx Pharmaceuticals, Inc. | ANDA |
| 68788-9138 | Orphenadrine Citrate 100 mg/1 Tablet, Extended Release | Preferred Pharmaceuticals, Inc. | ANDA |
| 63187-632 | Orphenadrine Citrate 100 mg/1 Tablet, Extended Release | Proficient Rx LP | ANDA |
| 63187-122 | Orphenadrine Citrate 100 mg/1 Tablet, Extended Release | Proficient Rx LP | ANDA |
| 67296-1077 | Orphenadrine Citrate 100 mg/1 Tablet, Extended Release | RedPharm Drug | ANDA |
| 70518-4506 | Orphenadrine Citrate 100 mg/1 Tablet, Extended Release | REMEDYREPACK INC. | ANDA |
| 25021-651 | Orphenadrine Citrate 30 mg/mL Injection, Solution | Sagent Pharmaceuticals | ANDA |
| 0185-0022 | Orphenadrine Citrate 100 mg/1 Tablet, Extended Release | Sandoz Inc | ANDA |
| 60760-810 | Orphenadrine Citrate 100 mg/1 Tablet, Extended Release | St. Mary's Medical Park Pharmacy | ANDA |
Orphenadrine citrate recalls
- D-0753-2022 Apr 13, 2022 · Class II · Terminated
CGMP Deviations:Nitrosamine impurity (NMOA) above the acceptable daily limit. - D-1445-2014 Jul 30, 2014 · Class III · Terminated
Failed Dissolution Specifications: Product found to be out of specification (OOS) during stability testing.
Frequently asked questions
What is Orphenadrine citrate used for?
Orphenadrine citrate extended-release tablets are indicated as an adjunct to rest, physical therapy, and other measures for the relief of discomfort associated with acute painful musculoskeletal conditions.
What are the side effects of Orphenadrine citrate?
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… See the full label for the complete list.
Who makes Orphenadrine citrate?
Orphenadrine citrate is listed by 17 labelers in the FDA NDC directory, including A-S Medication Solutions, Actavis Pharma, Inc., Advanced Rx Pharmacy of Tennessee, LLC, Bryant Ranch Prepack.
Has Orphenadrine citrate been recalled?
The FDA enforcement database lists 2 recalls for Orphenadrine citrate, most recently D-0753-2022 (class ii): CGMP Deviations:Nitrosamine impurity (NMOA) above the acceptable daily limit.