Gen 7t
Lidocaine
7t Pharma Llc
Human Prescription Drug
NDC 70645-626Gen 7t also known as Lidocaine is a human prescription drug labeled by '7t Pharma Llc'. National Drug Code (NDC) number for Gen 7t is 70645-626. This drug is available in dosage form of Patch. The names of the active, medicinal ingredients in Gen 7t drug includes Lidocaine - 490 mg/1 . The currest status of Gen 7t drug is Active.
Drug Information:
| Drug NDC: | 70645-626 |
| 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: | Gen 7t |
| 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: | Lidocaine |
| Also known as the generic name, this is usually the active ingredient(s) of the product. |
| Labeler Name: | 7t Pharma Llc |
| Name of Company corresponding to the labeler code segment of the ProductNDC. |
| Dosage Form: | Patch |
| 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: | LIDOCAINE - 490 mg/1
|
| This is the active ingredient list. Each ingredient name is the preferred term of the UNII code submitted. |
| Route Details: | TOPICAL
|
| 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: | 01 Sep, 2019 |
| This is the date that the labeler indicates was the start of its marketing of the drug product. |
| Marketing End Date: | 17 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: | 7T Pharma LLC
|
| Name of manufacturer or company that makes this drug product, corresponding to the labeler code segment of the NDC. |
| RxCUI: | 2199665
|
| 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. |
| NUI: | N0000175682
M0000897
N0000175426
N0000175976
|
| Unique identifier applied to a drug concept within the National Drug File Reference Terminology (NDF-RT). |
| UNII: | 98PI200987
|
| 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 EPC: | Amide Local Anesthetic [EPC]
Antiarrhythmic [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 PE: | Local Anesthesia [PE]
|
| Physiologic effect or pharmacodynamic effect—tissue, organ, or organ system level functional activity—of the drug’s established pharmacologic class. Takes the form of the effect, followed by `[PE]` (such as `Increased Diuresis [PE]` or `Decreased Cytokine Activity [PE]`. |
| Pharmacologic Class CS: | Amides [CS]
|
| Chemical structure classification of the drug product’s pharmacologic class. Takes the form of the classification, followed by `[Chemical/Ingredient]` (such as `Thiazides [Chemical/Ingredient]` or `Antibodies, Monoclonal [Chemical/Ingredient]. |
| Pharmacologic Class: | Amide Local Anesthetic [EPC]
Amides [CS]
Antiarrhythmic [EPC]
Local Anesthesia [PE]
|
| 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 |
|---|
| 70645-626-10 | 10 PATCH in 1 BOX (70645-626-10) | 01 Sep, 2019 | N/A | No |
| 70645-626-35 | 15 PATCH in 1 BOX (70645-626-35) | 01 Sep, 2019 | 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:
Gen 7t lidocaine lidocaine lidocaine polyvinyl alcohol, unspecified sorbitol glycerin carboxymethylcellulose sodium silicon dioxide titanium dioxide propylene glycol tartaric acid magnesium hydroxide water polyacrylic acid (8000 mw) sodium polyacrylate (8000 mw)
Drug Interactions:
Drug interactions: antiarrhythmic drugs: gen7t patch ® should be used with caution in patients receiving class 1 antiarrhythmic drugs (such as tocainide and mexiletine) since the toxic effects are additive and potentially synergistic. local anesthetics: when gen7t patch ® is used concurrently with other products containing local anesthetic agents the amount absorbed from all formulations must be considered.
Warnings:
Warnings for external use only 1. do not use : more than 1 patch on your body at a time or on irritated or swollen skin on wounds, damaged or infected skin on eyes, mouth, genitals, or other mucous membranes with a heating pad 2. consult physician for children under 12 years of age 3. stop and consult your prescriber if condition or pain worsens if you are allergic to any of the ingredients in this product if using concurrently with any other external pain-relieving products if you are pregnant, planning to become pregnant, or breastfeeding if symptoms persist for more than 7 days, or symptoms clear up and occur again within 3 days call your healthcare provider right away if you get any of the following warning signs or any other unusual symptoms that concern you: shortness of breath swelling or numbness of the tongue or throat severe headache or vomiting dizziness or faintness changes in vision or speech excessive dosage, or short interval between doses, can result in high plasma leve
Read more...ls and serious adverse effects. patients should be instructed to strictly adhere to the recommended dosage and administration guidelines set forth in this literature and on your prescription label. the management of serious adverse reactions may require the use of resuscitative equipment, oxygen or other resuscitative drugs. general information about the safe and effective use gen7t patch ® medicines are sometimes prescribed for purposes other than those listed in a patient information leaflet. do not use this product for another indication unless instructed and prescribed by a physician. do not give this drug to anyone else, even if they have the same condition. this product is intended for use as prescribed by a physician. how should i store gen7t patch ® store product at room temperature at 68°f to 77°f (20°c to 25°c). keep away from heat or sunlight. protect from excessive moisture. safely discard product after expiration date posted on the product label. discard patches away from small children or animals. do not use the product after the expiration date printed on the box. what are the active ingredients in gen7t patch ® ? the patch consists of 3.5% lidocaine.
Contraindications:
Contraindications: gen7t patch ® is contraindicated in patients with a known hypersensitivity to lidocaine, or any of the topical amide-like local anesthetic preparations or to any other component of the product.
Adverse Reactions:
Adverse reactions: the most common adverse reactions are application site reactions, including dermatitis, itching or scaling. these tend to be dose-limiting and diminish with time. serious adverse experiences following the administration of gen7t patch ® are similar in nature to those observed in other amide anesthetic-containing agents. these adverse experiences are, in general, dose-related and may result from high plasma levels caused by excessive dosage, rapid absorption, or may result from hypersensitivity, idiosyncrasy, or a diminished tolerance on the part of the patient. serious adverse experiences are generally systemic in nature.
Drug Interactions:
Drug interactions: antiarrhythmic drugs: gen7t patch ® should be used with caution in patients receiving class 1 antiarrhythmic drugs (such as tocainide and mexiletine) since the toxic effects are additive and potentially synergistic. local anesthetics: when gen7t patch ® is used concurrently with other products containing local anesthetic agents the amount absorbed from all formulations must be considered.
Use in Pregnancy:
Pregnancy: the safety of gen7t patch ® has not been established during pregnancy. there are no well-controlled studies in pregnant women. gen7t patch ® should not be used during pregnancy unless absolutely needed and discussed with a physician.
Pediatric Use:
Pediatric / geriatric use: safety and effectiveness in pediatric and geriatric patients have not been established.
Overdosage:
Overdosage : there have been no reports of over-dosage with gen7t patch ® . signs of overdosage would include vomiting, drowsiness, coma, respiratory depression, and seizures. in the case of an overdosage, discontinue the product immediately, treat the patient symptomatically, and institute supportive measures.
Description:
Description : gen7t patch ® is a prescription topical patch containing 15 articulated patches or 10 articulated patches. lidocaine is present in a 3.5% concentration (w/w). it is chemically designated as 2-(diethylamino)-n-(2,6-dimethylphenyl) acetamide and has an empirical formula of c 14 h 22 n 2 o. the molecular weight of lidocaine is 234.34 g/mol. the structural formulas are: ** lidocaine ** lidocaine
Clinical Pharmacology:
Clinical pharmacology: lidocaine is a topical anesthetic and stabilizes the neuronal membrane by inhibiting the ionic fluxes required for the initiation and conduction of impulses, thereby effecting local anesthetic action.
Carcinogenesis and Mutagenesis and Impairment of Fertility:
Carc inogenesis , mutagenesis , impairment of fertility : a minor metabolite, 2,6-xylidine, has been found to be carcinogenic in rats. the blood concentration of this metabolite is negligible following application of topical lidocaine. the effect of gen7t patch ® on fertility has not been studied.
How Supplied:
How supplied: gen7t patch ® is supplied in the following dosage form: 15 patches [ (5 per re-sealable pouch) x 3 ] 3 15/16â x 5 1/2" (10 cm x 14 cm) made in usa rx only manufactured for: 7t pharma, llc 220 emerald vista way las vegas, nv 89144 800.941.2848 ndc: 70645-626-35 size: 15 patches gen7t patch ® is supplied in the following dosage form: 10 patches [ (5 per re-sealable pouch) x 2 ] rx only manufactured for: 7t pharma, llc 220 emerald vista way las vegas, nv 89144 800.941.2848 exclusively distributed by: alexso, inc los angeles, ca 90064 ndc: 70645-626-10 size: 10 patches
Package Label Principal Display Panel:
Principal display panel gen 7t patch lidocaine 3.5% patch rx only contains: 15 patches principal display panel gen 7t patch lidocaine 3.5% patch rx only contains: 15 patches
Principal display panel gen 7t patch lidocaine 3.5% patch dispense by prescription contains: 10 patches principal display panel gen 7t patch lidocaine 3.5% patch dispense by prescription contains: 10 patches