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NDC 00115-2011-02 Orphenadrine Citrate 100 mg/1 Details
Orphenadrine Citrate 100 mg/1
Orphenadrine Citrate is a ORAL TABLET, EXTENDED RELEASE in the HUMAN PRESCRIPTION DRUG category. It is labeled and distributed by Amneal Pharmaceuticals of New York LLC. The primary component is ORPHENADRINE CITRATE.
MedlinePlus Drug Summary
Orphenadrine is used with rest, physical therapy, and other measures to relieve pain and discomfort caused by strains, sprains, and other muscle injuries. Orphenadrine is in a class of medications called skeletal muscle relaxants. It works by changing the way the body senses muscle pain.
Related Packages: 00115-2011-02Last Updated: 11/30/2022
MedLinePlus Full Drug Details: Orphenadrine
Product Information
NDC | 00115-2011 |
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Product ID | 0115-2011_b32f83c1-81bd-46e2-8808-ea055c4418f9 |
Associated GPIs | 75100080107410 |
GCN Sequence Number | 004595 |
GCN Sequence Number Description | orphenadrine citrate TABLET ER 100 MG ORAL |
HIC3 | H6H |
HIC3 Description | SKELETAL MUSCLE RELAXANTS |
GCN | 17670 |
HICL Sequence Number | 001906 |
HICL Sequence Number Description | ORPHENADRINE CITRATE |
Brand/Generic | Generic |
Proprietary Name | Orphenadrine Citrate |
Proprietary Name Suffix | n/a |
Non-Proprietary Name | ORPHENADRINE CITRATE |
Product Type | HUMAN PRESCRIPTION DRUG |
Dosage Form | TABLET, EXTENDED RELEASE |
Route | ORAL |
Active Ingredient Strength | 100 |
Active Ingredient Units | mg/1 |
Substance Name | ORPHENADRINE CITRATE |
Labeler Name | Amneal Pharmaceuticals of New York LLC |
Pharmaceutical Class | Centrally-mediated Muscle Relaxation [PE], Muscle Relaxant [EPC] |
DEA Schedule | n/a |
Marketing Category | ANDA |
Application Number | ANDA040368 |
Listing Certified Through | 2023-12-31 |
Package
Package Images

NDC 00115-2011-02 (00115201102)
NDC Package Code | 0115-2011-02 |
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Billing NDC | 00115201102 |
Package | 500 TABLET, EXTENDED RELEASE in 1 BOTTLE (0115-2011-02) |
Marketing Start Date | 2000-06-23 |
NDC Exclude Flag | N |
Pricing Information | |
Price Per Unit | 0.53642 |
Pricing Unit | EA |
Effective Date | 2022-11-23 |
NDC Description | ORPHENADRINE ER 100 MG TABLET |
Pharmacy Type Indicator | C/I |
OTC | N |
Explanation Code | 1 |
Classification for Rate Setting | G |
As of Date | 2022-11-23 |
Standard Product Labeling (SPL)/Prescribing Information SPL 6e89e43d-a3fc-481e-8aed-d6955fa2a14b Details
DESCRIPTION
Orphenadrine citrate is the citrate salt of orphenadrine (2-dimethylaminoethyl-2-methylbenzhydryl ether citrate). It occurs as a white, crystalline powder having a bitter taste. It is practically odorless; sparingly soluble in water, slightly soluble in alcohol.
Each orphenadrine citrate extended-release tablet contains 100 mg orphenadrine citrate, USP. Orphenadrine citrate extended-release tablets also contain ethylcellulose NF, povidone USP, lactose monohydrate NF, and magnesium stearate NF.
CLINICAL PHARMACOLOGY
INDICATIONS AND USAGE
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
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.
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 citrate. It is also not know whether orphenadrine citrate can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. Orphenadrine citrate should be given to a pregnant woman only if clearly needed.
Pediatric Use
Safety and effectiveness in pediatric patients have not been established.
ADVERSE REACTIONS
Adverse reactions of orphenadrine are mainly due to the mild anti-cholinergic 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, dilation 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.
To report SUSPECTED ADVERSE REACTIONS, contact Amneal Pharmaceuticals at 1-877-835-5472 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
DRUG ABUSE AND DEPENDENCE
OVERDOSAGE
Orphenadrine is toxic when overdosed and typically induces anticholinergic effects.[3] In a review of orphenadrine toxicity, the minimum lethal dose was found to be 2 grams to 3 grams for adults; however, the range of toxicity is variable and unpredictable.[4] 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.[5]
DOSAGE AND ADMINISTRATION
HOW SUPPLIED
Orphenadrine Citrate Extended-release Tablets, 100 mg - Each round, white, convex tablet imprinted with “G” on one side and “2011” on the other side.
They are available as follows:
Bottles of 100: NDC 0115-2011-01
Bottles of 500: NDC 0115-2011-02
Store at controlled room temperature 15° to 30°C (59° to 86°F).
Dispense in tightly-closed, light-resistant container (USP).
Distributed by:
Amneal Pharmaceuticals LLC
Bridgewater, NJ 08807
124-05
Rev. 01-2019-00
PRINCIPAL DISPLAY PANEL - 100 mg Tablet Bottle Label
PRINCIPAL DISPLAY PANEL - 100 mg Tablet Bottle Label
INGREDIENTS AND APPEARANCE
ORPHENADRINE CITRATE
orphenadrine citrate tablet, extended release |
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Labeler - Amneal Pharmaceuticals of New York LLC (123797875) |
Establishment | |||
Name | Address | ID/FEI | Business Operations |
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Amneal Pharmaceuticals of New York, LLC | 123797875 | ANALYSIS(0115-2011) , MANUFACTURE(0115-2011) |
Establishment | |||
Name | Address | ID/FEI | Business Operations |
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Reed-Lane | 001819879 | PACK(0115-2011) |