Hyoscyamine Tablet, Extended Release
NDC 75929-057
View dosage, usage, ingredients, routes, and UNII mappings.
Product Information
Hyoscyamine (hyoscyamine sulfate) is a UNAPPROVED DRUG OTHER-approved product labeled by Pharma Packaging Solutions, Llc Dba Tjopack Llc. Hyoscyamine is used to treat a variety of stomach/intestinal problems such as cramps and irritable bowel syndrome. It is supplied as a white tablet, extended release for oral administration. This product entry covers the primary NDC 75929-057 and its associated package configuration. This profile includes active and inactive ingredient UNII references and FDA labeling data.
Primary Identification
NDC Product Code:
75929-057
Proprietary Name:
Hyoscyamine ER
Non-Proprietary Name: [1]
Hyoscyamine Sulfate
Substance Name: [2]
Hyoscyamine Sulfate
NDC Directory Status:
Human Prescription Drug
Product Type: [3]
ACTIVE PRODUCT INCLUDED in the NDC Directory
Code Navigator:
Clinical Specifications
Dosage Form:
Tablet, Extended Release
- A solid dosage form containing a drug which allows at least a reduction in dosing frequency as compared to that drug presented in conventional dosage form.
Administration Route(s): [4]
Oral - Administration to or by way of the mouth.
Labeler & Regulatory Data
Labeler Name: [5]
Labeler Code:
75929
Product Label ID:
Marketing Category: [8]
UNAPPROVED DRUG OTHER - An unapproved drug product in a marketing category that is not reflected on a particular list.
Marketing Timeline
Start Marketing Date: [9]
05-01-2016
Listing Expiration Date: [11]
12-31-2026
Exclude Flag: [12]
N
Product Characteristics
Color(s):
WHITE (C48325)
Shape:
OVAL (C48345)
Size(s):
15 MM
Imprint(s):
AP;115
Score:
1
Code Structure Chart
Product Details
What is NDC 75929-057?
The NDC code 75929-057 is assigned by the FDA to the product Hyoscyamine ER. It is commonly known by its generic name, hyoscyamine sulfate. This pharmaceutical product is labeled by Pharma Packaging Solutions, Llc Dba Tjopack Llc and is currently categorized as listed product. The medication is a tablet, extended release administered via oral route. In terms of distribution, this product is available in a single package configuration. The associated package NDC(s) include: 75929-057-10. Beyond standard identification, this entry provides technical data including pharmacologic classes, UNII ingredient references, and RxNorm cross-referencing for healthcare systems.
What are the uses of this product?
Hyoscyamine is used to treat a variety of stomach/intestinal problems such as cramps and irritable bowel syndrome. It is also used to treat other conditions such as bladder and bowel control problems, cramping pain caused by kidney stones and gallstones, and Parkinson's disease. In addition, it is used to decrease side effects of certain medications (drugs used to treat myasthenia gravis) and insecticides. This medication works by decreasing acid production in the stomach, slowing down the natural movements of the gut, and relaxing muscles in many organs (such as the stomach, intestines, bladder, kidney, gallbladder). Hyoscyamine also lessens the amount of certain body fluids (e.g., saliva, sweat). This medication belongs to a class of drugs known as anticholinergics/antispasmodics.
What are Active Ingredients of this product?
An active ingredient is the substance responsible for the medicinal effects of a product specified by the substance's molecular structure or if the molecular structure is not known, defined by an unambiguous definition that identifies the substance. Each active ingredient name is the preferred term of the UNII code submitted.
Which are the associated UNII Codes?
The UNII codes for the active ingredients in this product are:
- HYOSCYAMINE SULFATE (UNII: F2R8V82B84)
- HYOSCYAMINE (UNII: PX44XO846X) (Active Moiety)
What is the NDC to RxNorm Crosswalk for this product?
RxNorm is a normalized naming system for generic and branded drugs that assigns unique concept identifier(s) known as RxCUIs to NDC products.The NDC to RxNorm Crosswalk for this produdct indicates multiple concept unique identifiers (RXCUIs) are associated with this product:
- RxCUI: 1046770 - hyoscyamine sulfate 0.375 MG 12HR Extended Release Oral Tablet
- RxCUI: 1046770 - 12 HR hyoscyamine sulfate 0.375 MG Extended Release Oral Tablet
- RxCUI: 1046770 - hyoscyamine sulfate 0.375 MG 12 HR Extended Release Oral Tablet
- RxCUI: 1046770 - hyoscyamine sulfate 375 MCG 12 HR Extended Release Oral Tablet
* Please review the full disclaimer at the bottom of this page.
Product & Regulatory Definitions
What is the Non-Proprietary Name? The non-proprietary name is sometimes called the generic name. The generic name usually includes the active ingredient(s) of the product.
What is the Substance Name? An active ingredient is the substance responsible for the medicinal effects of a product specified by the substance's molecular structure or if the molecular structure is not known, defined by an unambiguous definition that identifies the substance. Each active ingredient name is the preferred term of the UNII code submitted.
What kind of product is this? Indicates the type of product, such as Human Prescription Drug or Human Over the Counter Drug. This data element matches the “Document Type” field of the Structured Product Listing.
What are the Administration Routes? The translation of the route code submitted by the firm, indicating route of administration.
What is the Labeler Name? Name of Company corresponding to the labeler code segment of the Product NDC.
What is the Marketing Category? Product types are broken down into several potential Marketing Categories, such as NDA/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.
What is the Start Marketing Date? This is the date that the labeler indicates was the start of its marketing of the drug product.
What is the Listing Expiration Date? This is the date when the listing record will expire if not updated or certified by the product labeler.
What is the NDC Exclude Flag? This field indicates whether the product has been removed/excluded from the NDC Directory for failure to respond to FDA"s requests for correction to deficient or non-compliant submissions, or because the listing certification is expired, or because the listing data was inactivated by FDA, or because it was discontinued by the labeler. Possible values in this field are: "D", "E", "I", "N", "U".
