NDC 0115-3511-01 Pyridostigmine Bromide

Pyridostigmine Bromide

  1. Labeler Index
  2. Amneal Pharmaceuticals Of New York Llc
  3. 0115-3511
  4. NDC Package Code: 0115-3511-01 Pyridostigmine Bromide

NDC Package Code 0115-3511-01

The NDC Code 0115-3511-01 is assigned to a package of 100 tablet in 1 bottle of Pyridostigmine Bromide, a human prescription drug labeled by Amneal Pharmaceuticals Of New York Llc. The product's dosage form is tablet and is administered via oral form.

The National Average Drug Acquisition Cost (NADAC) wholesale price per unit for NDC 0115-3511-01 is $0.38041 and is up-to-date as of 07-28-2021.

Field Name Field Value
NDC Code 0115-3511-01
Package Description 100 TABLET in 1 BOTTLE
Proprietary Name Pyridostigmine Bromide 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 Pyridostigmine Bromide 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 Pyridostigmine is used to improve muscle strength in patients with a certain muscle disease (myasthenia gravis). It works by preventing the breakdown of a certain natural substance (acetylcholine) in your body. Acetylcholine is needed for normal muscle function.
11-Digit NDC Billing Format 00115351101 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 EA - Billing unit of "each" is used when the product is dispensed in discreet units.
RxNorm Crosswalk903857 - 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 Amneal Pharmaceuticals Of New York Llc
Dosage Form Tablet - A solid dosage form containing medicinal substances with or without suitable diluents.
Administration Route(s)
  • Oral - Administration to or by way of the mouth.
Active Ingredient(s)
  • PYRIDOSTIGMINE BROMIDE 60 mg/1
Pharmacological Class(es)
  • Cholinesterase Inhibitor - [EPC] (Established Pharmacologic Class)
  • Cholinesterase Inhibitors - [MoA] (Mechanism of Action)
Sample Package No Sample Package?
This field Indicates whether this package is a sample packaging or not.
Marketing Category ANDA - A product marketed under an approved Abbreviated New Drug Application. 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.
FDA Application Number ANDA040502 What is the FDA Application Number?
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.
Start Marketing Date 04-24-2003 What is the Start Marketing Date?
This is the date that the labeler indicates was the start of its marketing of the drug product.
Listing Expiration Date 12-31-2021 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.
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

  • 0115 - Amneal Pharmaceuticals Of New York Llc
    • 0115-3511 - Pyridostigmine Bromide
      • 0115-3511-01 - 100 TABLET in 1 BOTTLE

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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National Average Drug Acquisition Cost (NADAC)

The National Average Drug Acquisition Cost (NADAC) is the average drug invoice price paid by retail community pharmacies to wholesalers. The Centers for Medicare and Medicaid Services (CMS) compile the NADAC data based on random monthly surveys on more than 60,000 pharmacies from all 50 states and the District of Columbia. NADAC pricing information is NOT the price paid by end-customers but instead the price paid by pharmacies to drug wholesalers and distributors.

Field Name Field Value
Price per Unit $0.38041
Effective Date 07-21-2021 Effective Date
The effective date of the NADAC Per Unit cost.
Pricing Unit EA Pricing Unit
Indicates the pricing unit for the associated NDC (ML, GM or EA).
Pharmacy Type Indicator C/I - Chain or Independent Pharmacy Pharmacy Type Indicator
The source of pharmacy survey data used to calculate the NADAC. 'C/I' indicates data was collected from surveys of Chain/Independent pharmacies. Other pharmacy type indicators are not used at this time.
Explanation Code Code 1: The NADAC was calculated using information from the most recently completed pharmacy survey. Explanation Code
The source of pharmacy survey data used to calculate the NADAC. 'C/I' indicates data was collected from surveys of Chain/Independent pharmacies. Other pharmacy type indicators are not used at this time.
Classification for Rate Setting G - Generic Classification for Rate Setting
Indicates whether the NDC was considered brand (B) or generic (G) for the NADAC rate calculation process. If the NDC was considered brand (B) and approved under an Abbreviated New Drug Application (ANDA), the indicator is shown as (B-ANDA).
As of Date 07-28-2021
View Pricing Details

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Pill Identification

Pyridostigmine Bromide 60 MG Oral Tablet

Pyridostigmine Bromide 60 MG Oral Tablet
Image Labeler: Global Pharmaceuticals, Division of Impax Laboratories Inc.

Physical Characteristics

What does pyridostigmine bromide look like?
Pyridostigmine Bromide may look like a white round shaped tablet; approximately 10 millimeters in size. The medicine is imprinted with debossed code(s) G and 3511.

Shape: ROUND
Size: 10 mm
Color: WHITE
Imprint: G;3511
Imprint Type: DEBOSSED

Active and Inactive Ingredients

Active Ingredients: pyridostigmine bromide 60 mg

Inactive Ingredients: silicon dioxide, anhydrous lactose, magnesium stearate, stearic acid

Other Product Packages

The following packages are also available for Pyridostigmine Bromide with product NDC 0115-3511.

NDC Package CodePackage Description
0115-3511-02500 TABLET in 1 BOTTLE

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