Sennosides
Pd-rx Pharmaceuticals, Inc.
Human Otc Drug
NDC 72789-283Sennosides is a human otc drug labeled by 'Pd-rx Pharmaceuticals, Inc.'. National Drug Code (NDC) number for Sennosides is 72789-283. This drug is available in dosage form of Tablet. The names of the active, medicinal ingredients in Sennosides drug includes Sennosides A And B - 8.6 mg/1 . The currest status of Sennosides drug is Active.
Drug Information:
| Drug NDC: | 72789-283 |
| 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: | Sennosides |
| 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: | Sennosides |
| Also known as the generic name, this is usually the active ingredient(s) of the product. |
| Labeler Name: | Pd-rx Pharmaceuticals, Inc. |
| 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: | SENNOSIDES A AND B - 8.6 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 NOT 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: | 01 Aug, 2020 |
| This is the date that the labeler indicates was the start of its marketing of the drug product. |
| Marketing End Date: | 10 May, 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. |
| Application Number: | part334 |
| 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: | PD-Rx Pharmaceuticals, Inc.
|
| Name of manufacturer or company that makes this drug product, corresponding to the labeler code segment of the NDC. |
| RxCUI: | 312935
|
| 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. |
| UNII: | 1B5FPI42EN
|
| 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 |
|---|
| 72789-283-10 | 10 TABLET in 1 BOTTLE, PLASTIC (72789-283-10) | 22 Dec, 2022 | N/A | No |
| 72789-283-30 | 30 TABLET in 1 BOTTLE, PLASTIC (72789-283-30) | 24 Oct, 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 stimulant laxative
Product Elements:
Sennosides sennosides stearic acid croscarmellose sodium cellulose, microcrystalline hypromelloses magnesium stearate silicon dioxide sennosides a and b sennosides a and b light s5
Indications and Usage:
Uses relieve occasional constipation (irregularity) this product generally produces a bowel movement in 6 to 12 hours
Warnings:
Warnings do not use lasative products for longer than 1 week unless directed by a doctor
Dosage and Administration:
Directions take preferably at bedtime or as directed by a doctor do not exceed maximum dosage age starting dosage maximum dosage adults and children 12 years of age or older 2 tablets once a day 4 tablets twice a day children 6 to under 12 years 1 tablet once a day 2 tablets twice a day children 2 to under 6 years 1/2 tablet once a day 1 tablet twice a day children under 2 years ask a doctor ask a doctor
Stop Use:
Stop use and ask a doctor if you have rectal bleeding or fail to have a bowel movement after use of a laxative. these may indicate a serious condition.
How Supplied:
How supplied sennosides are round light brown and have a imprint of s5. they are available as follows: bottles of 10: 72789-283-10 bottles of 30: 72789-283-30 store at 20° to 25°c (68° to 77°f) [see usp controlled room temperature]. dispense in a well-closed, light-resistant container as defined in the usp. protect from light.
Package Label Principal Display Panel:
Sennosides 8.6 mg natural vegetable laxative *compare to the active ingredient in senokot® 72789283 label
Further Questions:
Questions or comments? call 516-341-0666 8:30am-4:30pm et. mon-fri