NDC 0115-2011 Orphenadrine Citrate

Orphenadrine Citrate

NDC Product Code 0115-2011

NDC 0115-2011-01

Package Description: 100 TABLET, EXTENDED RELEASE in 1 BOTTLE

Price per Unit: $0.35642 per EA

NDC 0115-2011-02

Package Description: 500 TABLET, EXTENDED RELEASE in 1 BOTTLE

Price per Unit: $0.35642 per EA

NDC Product Information

Orphenadrine Citrate with NDC 0115-2011 is a a human prescription drug product labeled by Amneal Pharmaceuticals Of New York Llc. The generic name of Orphenadrine Citrate is orphenadrine citrate. The product's dosage form is tablet, extended release and is administered via oral form. The RxNorm Crosswalk for this NDC code indicates a single RxCUI concept is associated to this product: 994521.

Dosage Form: Tablet, Extended Release - A solid dosage form containing a drug which allows at least a reduction in dosing frequency as compared to that drug presented in conventional dosage form.

Product Type: Human Prescription Drug What kind of product is this?
Indicates the type of product, such as Human Prescription Drug or Human Over the Counter Drug. This data element matches the “Document Type” field of the Structured Product Listing.

Orphenadrine Citrate Active Ingredient(s)

What is the Active Ingredient(s) List?
This is the active ingredient list. Each ingredient name is the preferred term of the UNII code submitted.


Inactive Ingredient(s)

About the Inactive Ingredient(s)
The inactive ingredients are all the component of a medicinal product OTHER than the active ingredient(s). The acronym "UNII" stands for “Unique Ingredient Identifier” and is used to identify each inactive ingredient present in a product.

  • ETHYLCELLULOSES (UNII: 7Z8S9VYZ4B)
  • POVIDONE (UNII: FZ989GH94E)
  • LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X)
  • MAGNESIUM STEARATE (UNII: 70097M6I30)

Administration Route(s)

What are the Administration Route(s)?
The translation of the route code submitted by the firm, indicating route of administration.

  • Oral - Administration to or by way of the mouth.

Pharmacological Class(es)

What is a Pharmacological Class?
These are the reported pharmacological class categories corresponding to the SubstanceNames listed above.

  • Centrally-mediated Muscle Relaxation - [PE] (Physiologic Effect)
  • Muscle Relaxant - [EPC] (Established Pharmacologic Class)

Product Labeler Information

What is the Labeler Name?
Name of Company corresponding to the labeler code segment of the Product NDC.

Labeler Name: Amneal Pharmaceuticals Of New York Llc
Labeler Code: 0115
FDA Application Number: ANDA040368 What is the FDA Application Number?
This corresponds to the NDA, ANDA, or BLA number reported by the labeler for products which have the corresponding Marketing Category designated. If the designated Marketing Category is OTC Monograph Final or OTC Monograph Not Final, then the Application number will be the CFR citation corresponding to the appropriate Monograph (e.g. “part 341”). For unapproved drugs, this field will be null.

Marketing Category: ANDA - A product marketed under an approved Abbreviated New Drug Application. What is the Marketing Category?
Product types are broken down into several potential Marketing Categories, such as NDA/ANDA/BLA, OTC Monograph, or Unapproved Drug. One and only one Marketing Category may be chosen for a product, not all marketing categories are available to all product types. Currently, only final marketed product categories are included. The complete list of codes and translations can be found at www.fda.gov/edrls under Structured Product Labeling Resources.

Start Marketing Date: 06-23-2000 What is the Start Marketing Date?
This is the date that the labeler indicates was the start of its marketing of the drug product.

Listing Expiration Date: 12-31-2021 What is the Listing Expiration Date?
This is the date when the listing record will expire if not updated or certified by the product labeler.

Exclude Flag: N - NO What is the NDC Exclude Flag?
This field indicates whether the product has been removed/excluded from the NDC Directory for failure to respond to FDA"s requests for correction to deficient or non-compliant submissions ("Y"), or because the listing certification is expired ("E"), or because the listing data was inactivated by FDA ("I"). Values = "Y", "N", "E", or "I".

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Information for Patients

Orphenadrine

Orphenadrine is pronounced as (or fen' a dreen)

Why is orphenadrine medication prescribed?
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...
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Orphenadrine Citrate Product Labeling Information

The product labeling information includes all published material associated to a drug. Product labeling documents include information like generic names, active ingredients, ingredient strength dosage, routes of administration, appearance, usage, warnings, inactive ingredients, etc.

Product Labeling Index

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

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 skeletal muscles in man. Orphenadrine citrate also possesses anti-cholinergic actions.

Indications And Usage

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 musculo skeletal conditions.

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.PregnancyPregnancy 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

Orphenadrine has been chronically abused for its euphoric effects.[1] The mood elevating effects may occur at therapeutic doses of orphenadrine.[2]

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

Orphenadrine citrate extended-release tablets: Adults - Two tablets per day; one in the morning and one in the evening.

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 0115-2011-01Bottles of 500:                                    NDC 0115-2011-02Store at controlled room temperature 15° to 30°C (59° to 86°F).Dispense in tightly-closed, light-resistant container (USP).Distributed by:Amneal Pharmaceuticals LLCBridgewater, NJ 08807124-05Rev. 01-2019-00

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