Phenazopyridine Hydrochloride 100 Mg
Phenazopyridine Hydrochloride
Graxcell Pharmaceutical, Llc
Human Prescription Drug
NDC 70795-1241Phenazopyridine Hydrochloride 100 Mg also known as Phenazopyridine Hydrochloride is a human prescription drug labeled by 'Graxcell Pharmaceutical, Llc'. National Drug Code (NDC) number for Phenazopyridine Hydrochloride 100 Mg is 70795-1241. This drug is available in dosage form of Tablet. The names of the active, medicinal ingredients in Phenazopyridine Hydrochloride 100 Mg drug includes Phenazopyridine Hydrochloride - 100 mg/1 . The currest status of Phenazopyridine Hydrochloride 100 Mg drug is Active.
Drug Information:
| Drug NDC: | 70795-1241 |
| 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: | Phenazopyridine Hydrochloride 100 Mg |
| Also known as the trade name. It is the name of the product chosen by the labeler. |
| Proprietary Name Base: | Phenazopyridine Hydrochloride |
| The base of the Brand/Proprietary name excluding its suffix. |
| Proprietary Name Suffix: | 100 mg |
| A suffix to the proprietary name, a value here should be appended to the ProprietaryName field to obtain the complete name of the product. This suffix is often used to distinguish characteristics of a product such as extended release (“XR”) or sleep aid (“PM”). Although many companies follow certain naming conventions for suffices, there is no recognized standard. |
| 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: | Phenazopyridine Hydrochloride |
| Also known as the generic name, this is usually the active ingredient(s) of the product. |
| Labeler Name: | Graxcell Pharmaceutical, 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: | PHENAZOPYRIDINE HYDROCHLORIDE - 100 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: | 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: | 12 Dec, 2020 |
| This is the date that the labeler indicates was the start of its marketing of the drug product. |
| Marketing End Date: | 22 Jan, 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. |
| 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: | GRAXCELL PHARMACEUTICAL, LLC
|
| Name of manufacturer or company that makes this drug product, corresponding to the labeler code segment of the NDC. |
| RxCUI: | 1094107
|
| 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: | 0370795124107
|
| UPC stands for Universal Product Code. |
| UNII: | 0EWG668W17
|
| 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 |
|---|
| 70795-1241-0 | 100 TABLET in 1 BOTTLE (70795-1241-0) | 12 Dec, 2020 | 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:
Phenazopyridine hydrochloride 100 mg phenazopyridine hydrochloride croscarmellose sodium silicon dioxide hypromellose, unspecified magnesium stearate starch, corn microcrystalline cellulose polyethylene glycol, unspecified povidone phenazopyridine hydrochloride phenazopyridine g15
Indications and Usage:
Indications and usage phenazopyridine is indicated for the symptomatic relief of pain, burning, urgency, frequency, and other discomforts arising from irritation of the lower urinary tract mucosa caused by infection, trauma, surgery, endoscopic procedures, or the passage of sounds or catheters. the use of phenazopyridine hcl for relief of symptoms should not delay definitive diagnosis and treatment of causative conditions. because it provides only symptomatic relief, prompt appropriate treatment of the cause of pain must be instituted and phenazopyridine hcl should be discontinued when symptoms are controlled. the analgesic action may reduce or eliminate the need for systemic analgesics or narcotics. it is, however, compatible with antibacterial therapy and can help to relieve pain and discomfort during the interval before antibacterial therapy controls the infection. treatment of a urinary tract infection with phenazopyridine hcl should not exceed two days because there is a lack of e
Read more...vidence that the combined administration of phenazopyridine hcl and an antibacterial provides greater benefit than administration of the antibacterial alone after two days. (see dosage and administration section.)
Dosage and Administration:
Dosage and administration 100 mg tablets: average adult dosage is two tablets 3 times a day after meals. when used concomitantly with an antibacterial agent for the treatment of a urinary tract infection, the administration of phenazopyridine hcl should not exceed 2 days.
Package Label Principal Display Panel:
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