Sunmark Urinary Pain Relief
Phenazopyridine Hydrochloride
Strategic Sourcing Services Llc
Human Otc Drug
NDC 49348-076Sunmark Urinary Pain Relief also known as Phenazopyridine Hydrochloride is a human otc drug labeled by 'Strategic Sourcing Services Llc'. National Drug Code (NDC) number for Sunmark Urinary Pain Relief is 49348-076. This drug is available in dosage form of Tablet. The names of the active, medicinal ingredients in Sunmark Urinary Pain Relief drug includes Phenazopyridine Hydrochloride - 95 mg/1 . The currest status of Sunmark Urinary Pain Relief drug is Active.
Drug Information:
| Drug NDC: | 49348-076 |
| 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: | Sunmark Urinary Pain Relief |
| 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: | Phenazopyridine Hydrochloride |
| Also known as the generic name, this is usually the active ingredient(s) of the product. |
| Labeler Name: | Strategic Sourcing Services 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 - 95 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: | 01 Jul, 2013 |
| 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: | Strategic Sourcing Services LLC
|
| Name of manufacturer or company that makes this drug product, corresponding to the labeler code segment of the NDC. |
| RxCUI: | 1094126
|
| 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: | 0010939679444
|
| 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 |
|---|
| 49348-076-44 | 1 BLISTER PACK in 1 CARTON (49348-076-44) / 30 TABLET in 1 BLISTER PACK | 01 Jul, 2013 | 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 urinary analgesic
Product Elements:
Sunmark urinary pain relief phenazopyridine hydrochloride phenazopyridine hydrochloride phenazopyridine magnesium stearate cellulose, microcrystalline shellac croscarmellose sodium sodium starch glycolate type a corn lactose magnesium silicate p95
Indications and Usage:
Uses fast relief from urinary pain,burning,urgency and frequency associated with urinary tract infections.
Warnings:
Warning do not exceed recommended dosage
When Using:
When using this product â when using this product stomach upset may occur, taking this product with or after meals may reduce stomach upset â your urine will become reddish-orange in color. this is not harmful, but care should be taken to avoid staining clothing or other items.
Dosage and Administration:
Directions â adults and children 12 and over: take 2 tablets 3 times daily with a full glass of water, with or after meals as needed â children under 12: consult a doctor â do not use for more than 2 days (12 tablets) without consulting a doctor
Stop Use:
Stop use and ask a doctor if â your symptoms last for more than 2 days â you suspect you are having an adverse reaction to the medication
Package Label Principal Display Panel: