NDC 0121-0775-08 Guaifenesin And Codeine Phosphate

Solution Oral

  1. Labeler Index
  2. Pharmaceutical Associates, Inc.
  3. 0121-0775
  4. NDC Package Code: 0121-0775-08 Guaifenesin And Codeine Phosphate

NDC Package Code 0121-0775-08

The NDC Code 0121-0775-08 is assigned to a package of 237 ml in 1 bottle of Guaifenesin And Codeine Phosphate, a human over the counter drug labeled by Pharmaceutical Associates, Inc.. The product's dosage form is solution and is administered via oral form.

Field Name Field Value
NDC Code 0121-0775-08
Package Description 237 mL in 1 BOTTLE
Product Code 0121-0775
Proprietary Name Guaifenesin And Codeine Phosphate 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 Guaifenesin And Codeine Phosphate 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 This product is used as active ingredients in each 5 ml (teaspoonful)purposescodeine phosphate, usp 10 mgcough suppressantguaifenesin, usp 100 mgexpectorant
11-Digit NDC Billing Format 00121077508 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 237 ML
NADAC Wholesale Price per Unit $0.04497
RxNorm Crosswalk
  • RxCUI: 995868
    • Product Type Human Otc 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 Pharmaceutical Associates, Inc.
    Dosage Form Solution - A clear, homogeneous liquid1 dosage form that contains one or more chemical substances dissolved in a solvent or mixture of mutually miscible solvents.
    Administration Route(s)
    • Oral - Administration to or by way of the mouth.
    Active Ingredient(s)
    Pharmacologic Class(es)
    DEA Schedule Schedule V (CV) Substances What is the Drug Enforcement Administration (DEA) CV Schedule?
    The controlled substances in the CV schedule have an abuse potential and dependence liability less than those listed in CIV and have an accepted medical use in the United States. Substances in schedule CV are often available without prescription, and include preparations containing limited quantities of certain narcotic drugs generally for antitussive and antidiarrheal purposes. Buprenorphine is also a CV schedule drug.
    Sample Package No Sample Package?
    This field Indicates whether this package is a sample packaging or not.
    Marketing Category OTC MONOGRAPH FINAL - A product marketed pursuant to a final Over-the-Counter (OTC) Drug Monograph. 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 part341 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 10-01-2006 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 12-31-2023 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

    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) wholesale price per unit for NDC 0121-0775-08 is $0.04497 and is up-to-date as of 08-03-2022. This product is billed per "ML" milliliter and contains an estimated amount of 237 billable units per package. The estimated wholesale price for the this package based on the lastest NADAC pricing survey is $.

    The NADAC survey price 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 $0.04497
    Effective Date 07-20-2022 Effective Date
    The effective date of the NADAC Per Unit cost.
    Pricing Unit ML 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.
    Code 5: The NADAC was calculated based on package size. 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 08-03-2022
    View Pricing Details

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    Other Product Packages

    The following packages are also available for Guaifenesin And Codeine Phosphate with product NDC 0121-0775.

    NDC Package CodePackage Description
    0121-0775-04118 mL in 1 BOTTLE
    0121-0775-16473 mL in 1 BOTTLE

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