Orphenadrine Citrate
Proficient Rx Lp
Human Prescription Drug
NDC 63187-632Orphenadrine Citrate is a human prescription drug labeled by 'Proficient Rx Lp'. National Drug Code (NDC) number for Orphenadrine Citrate is 63187-632. 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: | 63187-632 |
| 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: | Proficient Rx Lp |
| 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: | 15 Feb, 2000 |
| This is the date that the labeler indicates was the start of its marketing of the drug product. |
| Marketing End Date: | 18 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: | ANDA040327 |
| 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: | Proficient Rx LP
|
| 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 |
|---|
| 63187-632-30 | 30 TABLET, EXTENDED RELEASE in 1 BOTTLE (63187-632-30) | 01 Jan, 2016 | N/A | No |
| 63187-632-60 | 60 TABLET, EXTENDED RELEASE in 1 BOTTLE (63187-632-60) | 01 Jan, 2016 | N/A | No |
| 63187-632-90 | 90 TABLET, EXTENDED RELEASE in 1 BOTTLE (63187-632-90) | 01 Jan, 2016 | 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 calcium stearate ethylcellulose, unspecified lactose monohydrate orphenadrine citrate orphenadrine white round e;22
Indications and Usage:
Indications orphenadrine citrate is indicated as an adjunct to rest, physical therapy, and other measures for the relief of discomfort associated with acute painful musculo skeletal conditions. the mode of action of the drug has not been clearly identified, but may be related to its analgesic properties. orphenadrine citrate does not directly relax tense skeletal muscles in man.
Warnings:
Warnings some patients may experience transient episodes of light-headedness, dizziness or syncope. orphenadrine citrate extended-release tablets 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 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 citrate extended-release tablets are mainly due to the mild anti-cholinergic action of orphenadrine citrate extended-release tablets 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
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Use in Pregnancy:
Pregnancy pregnancy category c animal reproduction studies have not been conducted with orphenadrine citrate extended-release tablets. it is also not known whether orphenadrine citrate extended-release tablets can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. orphenadrine citrate extended-release tablets 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:
Overdosage orphenadrine citrate extended-release tablets are toxic when overdosed and typically induces anti-cholinergic effects.[3] 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.[4] treatment for orphenadrine citrate extended-release tablets overdose is evacuation of stomach contents (when necessary), charcoal at repeated doses, intensive monitoring and appropriate supportive treatment of any emergent anti-cholinergic effects.[5]
Description:
Description orphenadrine citrate is the citrate salt of orphenadrine: (2-dimethyl-aminoethyl 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 and has a molecular weight of 461.51. the molecular formula c 18 h 23 no ⢠c 6 h 8 o 7 is represented by the following structural formula: each orphenadrine citrate extended-release tablet contains 100 mg orphenadrine citrate. orphenadrine citrate extended-release tablets also contain: calcium stearate, ethylcellulose and lactose monohydrate. chemical structure
How Supplied:
How supplied orphenadrine citrate extended-release tablets, 100 mg, white, round-shaped tablets debossed âeâ over â22â on one side and plain on the other side and supplied as: ndc 63187-632-30 bottles of 30 ndc 63187-632-60 bottles of 60 ndc 63187-632-90 bottles of 90 store at 20° to 25°c (68° to 77°f)[see usp controlled room temperature]. dispense in tight, light-resistant containers as defined in the usp, with a child-resistant closure as required. keep tightly closed. keep this and all medication out of the reach of children. to report suspected adverse reactions, contact sandoz inc. at 1-800-525-8747 or fda at 1-800-fda-1088 or www.fda.gov/medwatch. sandoz inc. princeton, nj 08540 os8870 rev. 09/09 mf0022rev09/09 mg #14534 repackaged by: proficient rx lp thousand oaks, ca 91320
Package Label Principal Display Panel:
Orphenadrine citrate extended-release tablets, 100 mg x 100 tablets - label ndc 63187-632-30 orphenadrine citrate extended-release tablets 100 mg rx only 30 tablets 63187-632-30