Vrmx 500
Pyrantel Pamoate
Opmx Llc
Human Otc Drug
NDC 69729-141Vrmx 500 also known as Pyrantel Pamoate is a human otc drug labeled by 'Opmx Llc'. National Drug Code (NDC) number for Vrmx 500 is 69729-141. This drug is available in dosage form of Tablet. The names of the active, medicinal ingredients in Vrmx 500 drug includes Pyrantel Pamoate - 180 mg/1 . The currest status of Vrmx 500 drug is Active.
Drug Information:
| Drug NDC: | 69729-141 |
| 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: | Vrmx 500 |
| Also known as the trade name. It is the name of the product chosen by the labeler. |
| Product Type: | Human Otc 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: | Pyrantel Pamoate |
| Also known as the generic name, this is usually the active ingredient(s) of the product. |
| Labeler Name: | Opmx Llc |
| Name of Company corresponding to the labeler code segment of the ProductNDC. |
| Dosage Form: | Tablet |
| 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: | PYRANTEL PAMOATE - 180 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: | OTC MONOGRAPH FINAL |
| 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: | 10 Jun, 2022 |
| This is the date that the labeler indicates was the start of its marketing of the drug product. |
| Marketing End Date: | 22 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: | part357B |
| 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: | OPMX LLC
|
| Name of manufacturer or company that makes this drug product, corresponding to the labeler code segment of the NDC. |
| RxCUI: | 199107
|
| 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: | 0856828008625
|
| UPC stands for Universal Product Code. |
| UNII: | 81BK194Z5M
|
| 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. |
Packaging Information:
| Package NDC | Description | Marketing Start Date | Marketing End Date | Sample Available |
|---|
| 69729-141-10 | 1 BLISTER PACK in 1 CARTON (69729-141-10) / 10 TABLET in 1 BLISTER PACK | 10 Jun, 2022 | 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. |
Purpose:
Purpose antihelmintic
Product Elements:
Vrmx 500 pyrantel pamoate polyethylene glycol 6000 lactose monohydrate microcrystalline cellulose crospovidone croscarmellose sodium povidone, unspecified potassium sorbate pyrantel pamoate pyrantel silicon dioxide magnesium stearate talc g
Indications and Usage:
Use: for the treatment of pinworms
Warnings:
Warnings: do not exceed recommended dosage ask a doctor before use if: you're pregnant you're nursing a baby you have liver disease when using this product: abdominal cramps, nausea, vomiting, diarrhea, headache, or dizziness sometimes occur after taking this drug. if any of these symptoms persist consult a doctor. keep out of reach of children. in case of overdose, get medical help or contact a poison control center rightaway.
When Using:
When using this product: abdominal cramps, nausea, vomiting, diarrhea, headache, or dizziness sometimes occur after taking this drug. if any of these symptoms persist consult a doctor.
Dosage and Administration:
Directions: adults, children 12 years of age and over, and children 2 years to under 12 years: oral dossage is a single dose of 5 mg of pyrantel base per pound or 11 mg of pyrantel base per kilogram of body weight. do not exceed 1 gram (1000mg). children under 25lbs. or 2yrs: don't use unless directed by a doctor. read package insert carefully before taking this medication weight dosage (taken as a single dose) less than 25 lb. or under 2 yrs. old do not use unless directed by a doctor 25-37 lb. 2 tablets 38-62 lb. 4 tablets 63-87 lb. 6 tablets 88-112 lb. 8 tablets 113-137 lb. 10 tablets 138-162 lb. 12 tablets 163-187 lb. 14 tablets 188 lb & over 16 tablets
Package Label Principal Display Panel:
Ndc 69729-141-10 vrmx 500 pyrantel pamoate tablets 180 mg treatment for pinworms recommended by health care professionals forthe entire family â10 tablets vrmx 500 (pyrantel pamoate)