Orphenadrine Citrate
Akorn
Human Prescription Drug
NDC 17478-538Orphenadrine Citrate is a human prescription drug labeled by 'Akorn'. National Drug Code (NDC) number for Orphenadrine Citrate is 17478-538. This drug is available in dosage form of Injection. The names of the active, medicinal ingredients in Orphenadrine Citrate drug includes Orphenadrine Citrate - 30 mg/mL . The currest status of Orphenadrine Citrate drug is Active.
Drug Information:
| Drug NDC: | 17478-538 |
| 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: | Akorn |
| Name of Company corresponding to the labeler code segment of the ProductNDC. |
| Dosage Form: | Injection |
| 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 - 30 mg/mL
|
| This is the active ingredient list. Each ingredient name is the preferred term of the UNII code submitted. |
| Route Details: | INTRAMUSCULAR
INTRAVENOUS
|
| 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: | 17 Oct, 2006 |
| This is the date that the labeler indicates was the start of its marketing of the drug product. |
| Marketing End Date: | 18 Jun, 2026 |
| 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: | ANDA040484 |
| 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: | Akorn
|
| Name of manufacturer or company that makes this drug product, corresponding to the labeler code segment of the NDC. |
| RxCUI: | 994541
|
| 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. |
| UPC: | 0317478538028
|
| UPC stands for Universal Product Code. |
| 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 |
|---|
| 17478-538-02 | 10 VIAL in 1 CARTON (17478-538-02) / 2 mL in 1 VIAL | 17 Oct, 2006 | 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 sodium chloride sodium metabisulfite sodium hydroxide water
Indications and Usage:
Indications and usage: orphenadrine citrate injection is indicated as an adjunct to rest, physical therapy, and other measures for the relief of discomfort associated with acute painful musculoskeletal 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 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. orphenadrine citrate injection contains sodium metabisulfite, a sulfite that may cause allergic-type reactions including anaphylactic symptoms and life-threatening or less severe asthmatic episodes in certain susceptible people. the overall prevalence of sulfite sensitivity in the general population is unknown and probably low. sulfite sensitivity is seen more frequently in asthmatic than nonasthmatic people.
Dosage and Administration:
Dosage and administration: injection: adults - one 2 ml vial (60 mg) intravenously or intramuscularly; may be repeated every 12 hours.
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, 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. rare instances of anaphylactic reaction have been reported
Read more...associated with the intramuscular injection of orphenadrine citrate injection.
Use in Pregnancy:
Pregnancy: teratogenic effects: pregnancy category c. safe use of orphenadrine has not been established with respect to adverse effects upon fetal development. therefore, orphenadrine should be used in women of childbearing potential and particularly during early pregnancy only when in the judgment of the physician the potential benefits outweigh the possible hazards.
Pediatric Use:
Pediatric use: safety and effectiveness in children have not been established; therefore, this drug is not recommended for use in the pediatric age group.
Overdosage:
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:
Description: orphenadrine citrate is the citrate salt of orphenadrine ((±)-n, n-dimethyl- 2-[(o-methyl-a-phenylbenzyl)oxy]ethylamine citrate (1:1)) with a molecular weight of 461.50; empirical formula c 18 h 23 noâ¢c 6 h 8 o 7 . the structural formula of orphenadrine citrate is: it occurs as a white, crystalline powder having a bitter taste. it is practically odorless; sparingly soluble in water, slightly soluble in alcohol. orphenadrine citrate injection contains 60 mg of orphenadrine citrate in aqueous solution in each vial. orphenadrine citrate injection also contains: sodium chloride usp 5.8 mg; sodium metabisulfite nf, 2.0 mg; sodium hydroxide nf, to adjust ph (5.0 to 6.0); and water for injection usp, q.s. to 2 ml. structural formula
Clinical Pharmacology:
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:
How supplied: injection: boxes of 10 (ndc 17478-538-02) 2 ml vials, each vial containing 60 mg of orphenadrine citrate in aqueous solution. storage: store at 20° to 25°c (68° to 77°f) [see usp controlled room temperature]. protect from light. single-dose vial. discard unused portion. akorn manufactured by: akorn, inc. lake forest, il 60045 rf00n rev. 01/19
Package Label Principal Display Panel:
Principal display panel text for container label: ndc 17478-538-02 orphenadrine citrate injection, usp 60 mg (30 mg/ml) for i.m. or i.v. use. single-dose vial rx only 2 ml principal display panel text for container label
Principal display panel text for carton label: ndc 17478-538-02 orphenadrine citrate injection, usp 60 mg (30 mg/ml) for intravenous or intramuscular use single-dose vial 10 sterile vials (2 ml each) rx only akorn logo principal display panel text for carton label