Orphenadrine Citrate Er
Orphenadrine Citrate
Advanced Rx Pharmacy Of Tennessee, Llc
Human Prescription Drug
NDC 80425-0117Orphenadrine Citrate Er also known as Orphenadrine Citrate is a human prescription drug labeled by 'Advanced Rx Pharmacy Of Tennessee, Llc'. National Drug Code (NDC) number for Orphenadrine Citrate Er is 80425-0117. This drug is available in dosage form of Tablet, Extended Release. The names of the active, medicinal ingredients in Orphenadrine Citrate Er drug includes Orphenadrine Citrate - 100 mg/1 . The currest status of Orphenadrine Citrate Er drug is Active.
Drug Information:
| Drug NDC: | 80425-0117 |
| The labeler code and product code segments of the National Drug Code number, separated by a hyphen. Asterisks are no longer used or included within the product code segment to indicate certain configurations of the NDC. |
| Proprietary Name: | Orphenadrine Citrate Er |
| Also known as the trade name. It is the name of the product chosen by the labeler. |
| Proprietary Name Base: | Orphenadrine Citrate |
| The base of the Brand/Proprietary name excluding its suffix. |
| Proprietary Name Suffix: | ER |
| A suffix to the proprietary name, a value here should be appended to the ProprietaryName field to obtain the complete name of the product. This suffix is often used to distinguish characteristics of a product such as extended release (“XR”) or sleep aid (“PM”). Although many companies follow certain naming conventions for suffices, there is no recognized standard. |
| Product Type: | Human Prescription Drug |
| Indicates the type of product, such as Human Prescription Drug or Human OTC Drug. This data element corresponds to the “Document Type” of the SPL submission for the listing. |
| Non Proprietary Name: | Orphenadrine Citrate |
| Also known as the generic name, this is usually the active ingredient(s) of the product. |
| Labeler Name: | Advanced Rx Pharmacy Of Tennessee, Llc |
| Name of Company corresponding to the labeler code segment of the ProductNDC. |
| Dosage Form: | Tablet, Extended Release |
| The translation of the DosageForm Code submitted by the firm. There is no standard, but values may include terms like `tablet` or `solution for injection`.The complete list of codes and translations can be found www.fda.gov/edrls under Structured Product Labeling Resources. |
| Status: | Active |
| FDA does not review and approve unfinished products. Therefore, all products in this file are considered unapproved. |
| Substance Name: | ORPHENADRINE CITRATE - 100 mg/1
|
| This is the active ingredient list. Each ingredient name is the preferred term of the UNII code submitted. |
| Route Details: | ORAL
|
| The translation of the Route Code submitted by the firm, indicating route of administration. The complete list of codes and translations can be found at www.fda.gov/edrls under Structured Product Labeling Resources. |
Marketing Information:
An openfda section: An annotation with additional product identifiers, such as NUII and UPC, of the drug product, if available.
| Marketing Category: | ANDA |
| Product types are broken down into several potential Marketing Categories, such as New Drug Application (NDA), Abbreviated New Drug Application (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. |
| Marketing Start Date: | 19 Jun, 1998 |
| This is the date that the labeler indicates was the start of its marketing of the drug product. |
| Marketing End Date: | 19 Dec, 2025 |
| This is the date the product will no longer be available on the market. If a product is no longer being manufactured, in most cases, the FDA recommends firms use the expiration date of the last lot produced as the EndMarketingDate, to reflect the potential for drug product to remain available after manufacturing has ceased. Products that are the subject of ongoing manufacturing will not ordinarily have any EndMarketingDate. Products with a value in the EndMarketingDate will be removed from the NDC Directory when the EndMarketingDate is reached. |
| Application Number: | ANDA040284 |
| 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. |
| Listing Expiration Date: | 31 Dec, 2023 |
| This is the date when the listing record will expire if not updated or certified by the firm. |
OpenFDA Information:
An openfda section: An annotation with additional product identifiers, such as NUII and UPC, of the drug product, if available.
| Manufacturer Name: | Advanced Rx Pharmacy of Tennessee, LLC
|
| Name of manufacturer or company that makes this drug product, corresponding to the labeler code segment of the NDC. |
| RxCUI: | 994521
|
| The RxNorm Concept Unique Identifier. RxCUI is a unique number that describes a semantic concept about the drug product, including its ingredients, strength, and dose forms. |
| UNII: | X0A40N8I4S
|
| Unique Ingredient Identifier, which is a non-proprietary, free, unique, unambiguous, non-semantic, alphanumeric identifier based on a substance’s molecular structure and/or descriptive information. |
| Pharmacologic Class: | Centrally-mediated Muscle Relaxation [PE]
Muscle Relaxant [EPC]
|
| These are the reported pharmacological class categories corresponding to the SubstanceNames listed above. |
Packaging Information:
| Package NDC | Description | Marketing Start Date | Marketing End Date | Sample Available |
|---|
| 80425-0117-1 | 30 TABLET, EXTENDED RELEASE in 1 BOTTLE (80425-0117-1) | 19 Jun, 1998 | N/A | No |
| Package NDC number, known as the NDC, identifies the labeler, product, and trade package size. The first segment, the labeler code, is assigned by the FDA. Description tells the size and type of packaging in sentence form. Multilevel packages will have the descriptions concatenated together. |
Product Elements:
Orphenadrine citrate er orphenadrine citrate orphenadrine citrate orphenadrine nl4
Indications and Usage:
3. indications and usage section 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 musculoskeletal conditions.
Warnings:
5. 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.
Dosage and Administration:
10. dosage and administration section dosage and administration adults two tablets per day; one in the morning and one in the evening.
Contraindications:
4. 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.
Adverse Reactions:
7. 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.
Overdosage:
9. 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:
1. 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 c18h23noâ¢c6h8o7 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. structure
Clinical Pharmacology:
2. 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 anti-cholinergic actions.
How Supplied:
11. how supplied/storage and handling 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: bottles of 30 tablets ndc: 80425-0117-01 store at 20°-25°c (68°-77°f) [see usp controlled room temperature]. dispense in a tight, light-resistant container. manufactured by novel laboratories, inc. somerset, nj 08873 manufactured for lupin pharmaceuticals, inc. baltimore, md 21202 pi4800000204 rev: 06/2017
Package Label Principal Display Panel:
Principal display panel label 1