Opium Tincture Deodorized
Morphine Tincture
Bryant Ranch Prepack
Human Prescription Drug
NDC 63629-1965Opium Tincture Deodorized also known as Morphine Tincture is a human prescription drug labeled by 'Bryant Ranch Prepack'. National Drug Code (NDC) number for Opium Tincture Deodorized is 63629-1965. This drug is available in dosage form of Solution. The names of the active, medicinal ingredients in Opium Tincture Deodorized drug includes Morphine - 10 g/1000mL . The currest status of Opium Tincture Deodorized drug is Active.
Drug Information:
| Drug NDC: | 63629-1965 |
| 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: | Opium Tincture Deodorized |
| 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: | Morphine Tincture |
| Also known as the generic name, this is usually the active ingredient(s) of the product. |
| Labeler Name: | Bryant Ranch Prepack |
| Name of Company corresponding to the labeler code segment of the ProductNDC. |
| Dosage Form: | Solution |
| 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: | MORPHINE - 10 g/1000mL
|
| 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: | UNAPPROVED DRUG OTHER |
| 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: | 25 Feb, 2011 |
| This is the date that the labeler indicates was the start of its marketing of the drug product. |
| Marketing End Date: | 29 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. |
| 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: | Bryant Ranch Prepack
|
| Name of manufacturer or company that makes this drug product, corresponding to the labeler code segment of the NDC. |
| RxCUI: | 830196
|
| 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. |
| NUI: | N0000175684
N0000175690
|
| Unique identifier applied to a drug concept within the National Drug File Reference Terminology (NDF-RT). |
| UNII: | 76I7G6D29C
|
| 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 MOA: | Full Opioid Agonists [MoA]
|
| Mechanism of action of the drug—molecular, subcellular, or cellular functional activity—of the drug’s established pharmacologic class. Takes the form of the mechanism of action, followed by `[MoA]` (such as `Calcium Channel Antagonists [MoA]` or `Tumor Necrosis Factor Receptor Blocking Activity [MoA]`. |
| Pharmacologic Class EPC: | Opioid Agonist [EPC]
|
| Established pharmacologic class associated with an approved indication of an active moiety (generic drug) that the FDA has determined to be scientifically valid and clinically meaningful. Takes the form of the pharmacologic class, followed by `[EPC]` (such as `Thiazide Diuretic [EPC]` or `Tumor Necrosis Factor Blocker [EPC]`. |
| Pharmacologic Class: | Full Opioid Agonists [MoA]
Opioid Agonist [EPC]
|
| These are the reported pharmacological class categories corresponding to the SubstanceNames listed above. |
| DEA Schedule: | CII |
| This is the assigned DEA Schedule number as reported by the labeler. Values are CI, CII, CIII, CIV, and CV. |
Packaging Information:
| Package NDC | Description | Marketing Start Date | Marketing End Date | Sample Available |
|---|
| 63629-1965-1 | 118 mL in 1 BOTTLE (63629-1965-1) | 08 Feb, 2021 | 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:
Opium tincture deodorized morphine tincture morphine morphine alcohol water reddish-brown
Indications and Usage:
Indications and usage opium tincture is useful for the treatment of diarrhea.
Warnings:
Warnings addiction can result from opium usage. opium preparations should be given in the smallest effective dose and as infrequently as possible to minimize the development of tolerance and physical dependence.
Dosage and Administration:
Dosage and administration usual adult dose â 0.6 ml orally 4 times a day.
Contraindications:
Contraindications this preparation is not recommended for use in children. it should not be used in diarrhea caused by poisoning until the toxic material is eliminated from the gastrointestinal tract.
Adverse Reactions:
Adverse reactions constipation, nausea, and vomiting may occur in some patients. pruritus and urticaria have been observed.
Overdosage:
Overdosage signs and symptoms â symptoms of toxicity are those of morphine and alcohol, such as nausea, vomiting, miosis, cool and clammy skin, respiratory and cns depression, bradycardia, hypotension, and skeletal muscle flaccidity. noncardiogenic pulmonary edema may develop after opioid overdose and monitoring of heart filling pressure may be helpful. ethanol has been demonstrated to cause hypoglycemia in children or adults with limited glycogen stores. in severe overdosage, apnea, circulatory collapse, cardiac arrest, and death may occur. treatment â to obtain up-to-date information about the treatment of overdose, a good resource is your certified regional poison control center. telephone numbers of certified poison control centers are listed in the physiciansâ desk reference (pdr). in managing overdosage, consider the possibility of multiple drug overdoses, interaction among drugs, and unusual drug kinetics in your patient. initial management of opioid overdose should emphasize establishment of a secure airway and support of ventilation and perfusion. meticulously monitor and maintain, within acceptable limits, the patientâs vital signs, blood gases, serum electrolytes, blood glucose, etc. naloxone antagonizes most effects of opioids. protect the airway as naloxone may induce vomiting. since naloxone has a shorter duration of action than opioids, repeated doses may be needed. in patients who abuse opioids chronically, a withdrawal syndrome may be manifest on administration of naloxone. this may include yawning, tearing, restlessness, sweating, dilated pupils, piloerection, vomiting, diarrhea, and abdominal cramps. this syndrome usually abates quickly as the effect of naloxone dissipates. absorption of drugs from the gastrointestinal tract may be decreased by giving activated charcoal, which, in many cases, is more effective than emesis or lavage; consider charcoal instead of or in addition to gastric emptying. repeated doses of charcoal over time may hasten elimination of some drugs that have been absorbed. since opium tincture can delay gastric emptying, evacuation of the stomach may be beneficial. safeguard the patientâs airway when employing gastric emptying or charcoal. monitor for and treat hypoglycemia. the use of forced diuresis, peritoneal dialysis, hemodialysis or charcoal hemoperfusion has not been established to be beneficial.
Description:
Description opium tincture, usp (deodorized), is for oral administration. it is freed from unpleasant odor or nauseating substances by âdenarcotizationâ with a petroleum distillate. opium tincture is a clear, reddish-brown hydroalcoholic solution. each 100 ml contains 1 g of anhydrous morphine (represents the equivalent of 10 g of powdered opium, usp), alcohol, 19%, and water. opium has a very characteristic odor and a very bitter taste. the opiates are the most effective and prompt-acting nonspecific antidiarrheal agents.
Clinical Pharmacology:
Clinical pharmacology the opiates act by enhancing tone in the long segments of longitudinal muscle and by inhibiting propulsive contraction of both circular and longitudinal muscles. clinical evidence indicates that the analgesic activity of opium preparations is due to their morphine content. relatively small doses that do not produce significant analgesia are effective in controlling diarrhea. the papaverine content of the mixed alkaloids is too small to have demonstrable spasmolytic activity. following oral administration, morphine is well absorbed from the gastrointestinal tract. it is rapidly metabolized following oral administration, however, and plasma levels of unconjugated morphine are lower than those achieved after parenteral administration. like other narcotic analgesics, opium preparations are metabolized in the liver. morphine undergoes conjugation with glucuronic acid at the 3-hydroxyl group. secondary conjugation may also occur at the 6-hydroxyl group to form the 3,6-d
Read more...iglucuronide. morphine is excreted in the urine mainly as morphine-3-glucuronide and smaller amounts of morphine-3,6-diglucuronide and unchanged drug. approximately 75% of a dose of morphine is excreted in the urine within 48 hours.
How Supplied:
How supplied opium tincture, usp (deodorized), is supplied as: ndc 63629-1965-1 bottles of 4 fl oz dispense in tightly closed containers. store at controlled room temperature, 68° to 77°f (20° to 25°c) (see usp).
Package Label Principal Display Panel:
Morphine solution 10 mg/ml, #118 label