NDC 0037-9001-05 Levsin

Hyoscyamine Sulfate

NDC Package Code 0037-9001-05

The NDC Code 0037-9001-05 is assigned to a package of 5 ampule in 1 carton > 1 ml in 1 ampule of Levsin, a human prescription drug labeled by Meda Pharmaceuticals Inc.. The product's dosage form is injection, solution and is administered via subcutaneous form.This product is billed per "ML" milliliter and contains an estimated amount of 5 billable units per package.

Field Name Field Value
NDC Code 0037-9001-05
Package Description 5 AMPULE in 1 CARTON > 1 mL in 1 AMPULE
Proprietary Name Levsin What is the Proprietary Name?
The proprietary name also known as the trade name is the name of the product chosen by the medication labeler for marketing purposes.
Non-Proprietary Name Hyoscyamine Sulfate 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.
Drug Uses 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.
11-Digit NDC Billing Format 00037900105 NDC Format for Billing
For insurance billing purposes the Centers for Medicare & Medicaid Services (CMS) created an 11 digit NDC derivative identifier. If the NDC Package code is less than 11 digits the code must be padded with leading zeros. The leading zeros must be added to the appropriate segment to create a 5-4-2 configuration.
Billing Unit ML - Billing unit of "milliliter" is used when a product is measured by its liquid volume.
Estimated Billable Units per Package 5 ML
RxNorm Crosswalk1047916 and 1047918 - RxCUI What is RxNorm?
The RxNorm crosswalk provides a normalized naming system for generic and branded drugs by assigning unique concept identifiers (RxCUI) to each NDC.
Product Type Human Prescription Drug 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.
Labeler Name Meda Pharmaceuticals Inc.
Dosage Form Injection, Solution - A liquid preparation containing one or more drug substances dissolved in a suitable solvent or mixture of mutually miscible solvents that is suitable for injection.
Administration Route(s)
  • Subcutaneous - Administration beneath the skin; hypodermic. Synonymous with the term SUBDERMAL.
Active Ingredient(s)
  • HYOSCYAMINE SULFATE .5 mg/mL
Sample Package No Sample Package?
This field Indicates whether this package is a sample packaging or not.
Marketing Category UNAPPROVED DRUG OTHER - 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.
Start Marketing Date 12-01-2008 What is the Start Marketing Date?
This is the date that the labeler indicates was the start of its marketing of the drug product.
End Marketing Date 01-01-2030 What is the End Marketing Date?
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.
Exclude Flag N 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 ("Y"), or because the listing certification is expired ("E"), or because the listing data was inactivated by FDA ("I"). Values = "Y", "N", "E", or "I".

NDC Code Structure

  • 0037 - Meda Pharmaceuticals Inc.
    • 0037-9001 - Levsin
      • 0037-9001-05 - 5 AMPULE in 1 CARTON

The NDC Directory contains ONLY information on final marketed drugs submitted to FDA electronically by labelers. A labeler might be a manufacturer, re-packager or re-labeler. The product information included in the NDC directory does not indicate that FDA has verified the information provided by the product labeler. Assigned NDC numbers are not in any way an indication of FDA approval of the product.

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NDC HCPCS Crosswalk

This crosswalk is intended to help the public understand which drug products (identified by NDCs) are assigned to which HCPCS billing codes.

NDC 0037-9001-05 HCPCS crosswalk information with package details and bill units information.

NDC Billing CodeHCPCS CodeHCPCS Code Desc.DosagePackage SizePackage QuantityBillable UnitsBillable Units / Pkg
00037900105J1980Hyoscyamine sulfate inj0.25 MG15210

* Please review the disclaimer below.