NDC 61825-999 Orphengesic Forte

Orphenadrine Citrate, Aspirin And Caffeine

NDC Product Code 61825-999

NDC Code: 61825-999

Proprietary Name: Orphengesic Forte What is the Proprietary Name?
The proprietary name also known as the trade name is the name of the product chosen by the medication labeler for marketing purposes.

Non-Proprietary Name: Orphenadrine Citrate, Aspirin And Caffeine What is the Non-Proprietary Name?
The non-proprietary name is sometimes called the generic name. The generic name usually includes the active ingredient(s) of the product.

Product Characteristics

Color(s):
WHITE (C48325 - WHITE AND GREEN)
Shape: CAPSULE (C48336)
Size(s):
6 MM
Imprint(s):
GA;473
Score: 2

NDC Code Structure

  • 61825 - Galt Pharmaceuticals, Llc
    • 61825-999 - Orphengesic Forte

NDC 61825-999-60

Package Description: 60 TABLET in 1 BOTTLE, PLASTIC

NDC Product Information

Orphengesic Forte with NDC 61825-999 is a a human prescription drug product labeled by Galt Pharmaceuticals, Llc. The generic name of Orphengesic Forte is orphenadrine citrate, aspirin and caffeine. The product's dosage form is tablet and is administered via oral form.

Labeler Name: Galt Pharmaceuticals, Llc

Dosage Form: Tablet - A solid dosage form containing medicinal substances with or without suitable diluents.

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.

Orphengesic Forte 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.

  • ORPHENADRINE CITRATE 50 mg/1
  • ASPIRIN 770 mg/1
  • CAFFEINE 60 mg/1

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.

  • ANHYDROUS LACTOSE (UNII: 3SY5LH9PMK)
  • SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
  • D&C YELLOW NO. 10 (UNII: 35SW5USQ3G)
  • FD&C BLUE NO. 1 (UNII: H3R47K3TBD)
  • MAGNESIUM STEARATE (UNII: 70097M6I30)
  • POVIDONE (UNII: FZ989GH94E)
  • STARCH, CORN (UNII: O8232NY3SJ)
  • STEARIC ACID (UNII: 4ELV7Z65AP)
  • WATER (UNII: 059QF0KO0R)

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)
  • Cyclooxygenase Inhibitors - [MoA] (Mechanism of Action)
  • Decreased Prostaglandin Production - [PE] (Physiologic Effect)
  • Nonsteroidal Anti-inflammatory Compounds - [Chemical/Ingredient]
  • Nonsteroidal Anti-inflammatory Drug - [EPC] (Established Pharmacologic Class)
  • Platelet Aggregation Inhibitor - [EPC] (Established Pharmacologic Class)
  • Decreased Platelet Aggregation - [PE] (Physiologic Effect)
  • Central Nervous System Stimulant - [EPC] (Established Pharmacologic Class)
  • Methylxanthine - [EPC] (Established Pharmacologic Class)
  • Xanthines - [CS]
  • Central Nervous System Stimulation - [PE] (Physiologic Effect)

Product Labeler Information

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

Labeler Name: Galt Pharmaceuticals, Llc
Labeler Code: 61825
FDA Application Number: ANDA075141 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: 06-17-2019 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: 12-31-2020 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 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. Values = ‘Y’ or ‘N’.

* Please review the disclaimer below.

Orphengesic Forte 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

Each Orphengesic


® Forte Tablet, for oral administration contains Orphenadrine Citrate 50 mg, Aspirin 770 mg and Caffeine 60 mg.


In addition, each tablet contains the following inactive ingredients: anhydrous lactose, colloidal silicon dioxide, D&C yellow #10, FD&C blue #1, magnesium stearate, povidone, pregelatinized starch, and stearic acid.Orphenadrine citrate is (2-dimethylaminoethyl 2-methylbenzhydryl ether citrate). It is a white, practically odorless, crystalline powder, having a bitter taste. It is sparingly soluble in water; slightly soluble in alcohol. It has the following structural formula:


Aspirin, salicylic acid acetate, is a non-opiate analgesic, anti-inflammatory and antipyretic agent It occurs as a white, crystalline tabular or needle-like powder and is odorless or has a faint odor. It is sparingly soluble in water, freely soluble in alcohol and chloroform. It has the following structural formula:


 


Caffeine is a central nervous system stimulant which occurs as a white powder or white glistening needles, usually matted together. It is sparingly soluble in alcohol, and freely soluble in chloroform. The chemical name for caffeine is, 1,3,7-Trimethylxanthine. It has the following structural formula:

Clinical Pharmacology

Orphenadrine citrate is a centrally acting (brain stem) compound which in animals selectively blocks facilitatory functions of the reticular formation. Orphenadrine does not produce myoneural block, nor does it affect crossed extensor reflexes. Orphenadrine prevents nicotine-induced convulsions but not those produced by strychnine.Chronic administration of Orphenadrine Citrate, Aspirin and Caffeine to dogs and rats has revealed no drug-related toxicity. No blood or urine changes were observed, nor were there any macroscopic or microscopic pathological changes detected. Extensive experience with combinations containing aspirin and caffeine has established them as safe agents. The addition of orphenadrine citrate does not alter the toxicity of aspirin and caffeine.The mode of therapeutic action of orphenadrine has not been clearly identified, but may be relegated to its analgesic properties. Orphenadrine citrate also possesses anti-cholinergic actions.

Indications & Usage

  • Orphengesic Forte (Orphenadrine Citrate, Aspirin and Caffeine 50 mg/ 770 mg/ 60 mg) Tablets are indicated in:Symptomatic relief of mild to moderate pain of acute musculoskeletal disorders.The orphenadrine component 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 orphenadrine has not been clearly identified, but may be related to its analgesic properties. Orphengesic Forte Tablets do not directly relax tense muscles in man.

Contraindications

Because of the mild anticholinergic effect of orphenadrine, Orphengesic Forte Tablets should not be used in patients with glaucoma, pyloric or duodenal obstruction, achalasia, prostatic hypertrophy or obstructions at the bladder neck. Orphengesic Forte Tablets are also contraindicated in patients with myasthenia gravis and in patients known to be sensitive to aspirin or caffeine.The drug is contraindicated in patients who have demonstrated a previous hypersensitivity to the drug.

Warnings

Reye’s Syndrome may develop in individuals who have chicken pox, influenza, or flu symptoms. Some studies suggest possible association between the development of Reye’s Syndrome and the use of medicines containing salicylate or aspirin. Orphengesic Forte Tablets (Orphenadrine Citrate, Aspirin and Caffeine Tablets 50 mg/ 770 mg/ 60 mg) contain aspirin and therefore are not recommended for use in patients with chicken pox, influenza, or flu symptoms.Orphengesic Forte 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.Aspirin should be used with extreme caution in the presence of peptic ulcers and coagulation abnormalities.

Usage In Pregnancy

Since safety of the use of this preparation in pregnancy, during lactation, or in the child-bearing age has not been established, use of the drug in such patients requires that the potential benefits of the drug be weighed against its possible hazard to the mother and child.

Usage In Children

The safe and effective use of this drug in children has not been established. Usage of this drug in children under 12 years of age is not recommended.

Precautions

Confusion, anxiety and tremors have been reported in a 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.Safety of continuous long term therapy with Orphengesic Forte Tablets has not been established; therefore, if Orphengesic Forte Tablets are prescribed for prolonged use, periodic monitoring of blood, urine and liver function values is recommended.

Adverse Reactions

Side effects of Orphengesic Forte Tablets are those seen with aspirin and caffeine or those usually associated with mild anti-cholinergic agents. These may include tachycardia, palpitation, urinary hesitancy or retention, dry mouth, blurred vision, dilation of the pupil, increased intraocular tension, weakness, nausea, vomiting, headache, dizziness, constipation, drowsiness, and rarely, urticaria and other dermatosis. Infrequently, an elderly patient may experience some degree of confusion. Mild central excitation and occasional hallucinations may be observed. These mild side effects can usually be eliminated by reduction in dosage. One case of aplastic anemia associated with the use of orphenadrine citrate, aspirin and caffeine has been reported. No causal relationship has been established. Rare G.I. hemorrhage due to aspirin content may be associated with the administration of Orphengesic Forte Tablets. Some patients may experience transient episodes of light-headedness, dizziness or syncope.

Dosage & Administration

Orphengesic Forte: Adults 1/2 to 1 tablet 3 to 4 times daily.

How Supplied

Orphengesic


® Forte Tablets (Orphenadrine Citrate 50 mg, Aspirin 770 mg, and Caffeine 60 mg): Two-layered, white/green capsule shaped, bisected tablets debossed “GA” and “473” with bisect on the white side and plain on the green side are available in bottles of 60 tablets (NDC 61825-999-60).


Store below 30°C (86°F).Rx OnlyManufactured for:


Galt Pharmaceuticals, LLC


Atlanta, GA  30339


500503-01


Rev. 09/2018

* Please review the disclaimer below.

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