NDC 0904-6465-09 All Nite
Acetaminophen, Dextromethorphan Hbr, Doxylamine Succinate Solution Oral

Package Information

The NDC Code 0904-6465-09 is assigned to a package of 237 ml in 1 bottle of All Nite, a human over the counter drug labeled by Major Pharmaceuticals. The product's dosage form is solution and is administered via oral form.

Field Name Field Value
NDC Code 0904-6465-09
Package Description 237 mL in 1 BOTTLE
Product Code 0904-6465
Proprietary Name 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.
All Nite
Non-Proprietary Name 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.
Acetaminophen, Dextromethorphan Hbr, Doxylamine Succinate
Usage Information Product Usage Information
The drug use information is a summary and does NOT have all possible information about this product. This information does not assure that this product is safe, effective, or appropriate. This information is not individual medical advice and does not substitute for the advice of a health care professional. Always ask a health care professional for complete information about this product and your specific health needs.
This product is used as Pain reliever/fever reducerCough suppressantAntihistamine. Temporarily relieves common cold/flu symptoms:•cough due to minor throat and bronchial irritation•sore throat•headache•minor aches and pains•fever•runny nose and sneezing
11-Digit NDC Billing Format 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.
00904646509
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 National Average Drug Acquisition Cost (NADAC)
The National Average Drug Acquisition Cost (NADAC) wholesale price per unit for NDC 0904-6465-09 is $0.01392 and is up-to-date as of 11-09-2022. 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 $3.30
$0.01392
Estimated Wholesale Price per Package $3.30
NDC to RxNorm Crosswalk
  • RxCUI: 1043400 - acetaminophen 650 MG / dextromethorphan HBr 30 MG / doxylamine succinate 12.5 MG in 30 mL Oral Solution
  • RxCUI: 1043400 - acetaminophen 21.7 MG/ML / dextromethorphan hydrobromide 1 MG/ML / doxylamine succinate 0.417 MG/ML Oral Solution
  • RxCUI: 1043400 - acetaminophen 325 MG / dextromethorphan HBr 15 MG / doxylamine succinate 6.25 MG per 15 ML Oral Solution
  • RxCUI: 1043400 - acetaminophen 650 MG / dextromethorphan HBr 30 MG / doxylamine succinate 12.5 MG per 30 ML Oral Solution
  • RxCUI: 1043400 - APAP 21.7 MG/ML / Dextromethorphan Hydrobromide 1 MG/ML / doxylamine succinate 0.417 MG/ML Oral Solution
  • Product Type 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.
    Human Otc Drug
    Labeler Name Major Pharmaceuticals
    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)
    Sample Package Sample Package?
    This field Indicates whether this package is a sample packaging or not.
    No
    Marketing Category 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.
    OTC MONOGRAPH FINAL - A product marketed pursuant to a final Over-the-Counter (OTC) Drug Monograph.
    FDA Application Number 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.
    part341
    Start Marketing Date What is the Start Marketing Date?
    This is the date that the labeler indicates was the start of its marketing of the drug product.
    11-19-2012
    Listing Expiration Date 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.
    12-31-2023
    Exclude Flag 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".
    N
    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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