Orphenadrine Citrate
Amneal Pharmaceuticals Of New York Llc
Human Prescription Drug
NDC 0115-2011Orphenadrine Citrate is a human prescription drug labeled by 'Amneal Pharmaceuticals Of New York Llc'. National Drug Code (NDC) number for Orphenadrine Citrate is 0115-2011. This drug is available in dosage form of Tablet, Extended Release. The names of the active, medicinal ingredients in Orphenadrine Citrate drug includes Orphenadrine Citrate - 100 mg/1 . The currest status of Orphenadrine Citrate drug is Active.
Drug Information:
| Drug NDC: | 0115-2011 |
| 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 |
| Also known as the trade name. It is the name of the product chosen by the labeler. |
| 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: | Amneal Pharmaceuticals Of New York 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: | 23 Jun, 2000 |
| 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: | ANDA040368 |
| 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: | Amneal Pharmaceuticals of New York 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. |
| Original Packager: | Yes
|
| Whether or not the drug has been repackaged for distribution. |
| 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 |
|---|
| 0115-2011-01 | 100 TABLET, EXTENDED RELEASE in 1 BOTTLE (0115-2011-01) | 23 Jun, 2000 | N/A | No |
| 0115-2011-02 | 500 TABLET, EXTENDED RELEASE in 1 BOTTLE (0115-2011-02) | 23 Jun, 2000 | 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 orphenadrine citrate orphenadrine citrate orphenadrine ethylcelluloses povidone lactose monohydrate magnesium stearate g;2011 convex
Indications and Usage:
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.
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.
Dosage and Administration:
Dosage and administration orphenadrine citrate extended-release tablets: adults - two tablets per day; one in the morning and one in the evening.
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.
Adverse Reactions:
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 pharmaceu
Read more...ticals at 1-877-835-5472 or fda at 1-800-fda-1088 or www.fda.gov/medwatch .
Description:
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.
Mechanism of Action:
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.
How Supplied:
How supplied orphenadrine citrate extended-release tablets, 100 mg - each round, white, convex tablet imprinted with âgâ on one side and â2011â 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
Package Label Principal Display Panel:
Principal display panel - 100 mg tablet bottle label ndc 0115-2011-02 orphenadrine citrate extended-release tablets 100 mg rx only 500 tablets 1