NDC 0121-0504-00 Acetaminophen And Codeine Phosphate

Package Information

The NDC Code 0121-0504-00 is assigned to a package of 10 tray in 1 case > 10 cup, unit-dose in 1 tray > 5 ml in 1 cup, unit-dose (0121-0504-05) of Acetaminophen And Codeine Phosphate, labeled by Pharmaceutical Associates, Inc.. The product's dosage form is and is administered via form.

Field Name Field Value
NDC Code 0121-0504-00
Package Description 10 TRAY in 1 CASE > 10 CUP, UNIT-DOSE in 1 TRAY > 5 mL in 1 CUP, UNIT-DOSE (0121-0504-05)
Product Code 0121-0504
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.
Acetaminophen And Codeine Phosphate
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.
Acetaminophen and codeine phosphate oral solution is indicated for the management of mild to moderate pain where treatment with an opioid is appropriate and for which alternative treatments are inadequate.Limitations of UseBecause of the risks of addiction, abuse, and misuse, with opioids, even at recommended doses [see WARNINGS], reserve acetaminophen and codeine phosphate oral solution for use in patients for whom alternative treatment options [e.g., non-opioid analgesics]: Have not been tolerated, or are not expected to be toleratedHave not provided adequate analgesia, or are not expected to provide adequate analgesia
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.
00121050400
Billing Unit ML - Billing unit of "milliliter" is used when a product is measured by its liquid volume.
Estimated Billable Units per Package 500 ML
NDC to RxNorm Crosswalk
  • RxCUI: 993755 - codeine phosphate 12 MG / acetaminophen 120 MG in 5 mL Oral Solution
  • RxCUI: 993755 - acetaminophen 24 MG/ML / codeine phosphate 2.4 MG/ML Oral Solution
  • RxCUI: 993755 - acetaminophen 120 MG / codeine phosphate 12 MG per 5 ML Oral Solution
  • RxCUI: 993755 - acetaminophen 300 MG / codeine phosphate 30 MG per 12.5 ML Oral Solution
  • RxCUI: 993755 - APAP 24 MG/ML / Codeine Phosphate 2.4 MG/ML Oral Solution
  • Labeler Name Pharmaceutical Associates, Inc.
    Sample Package Sample Package?
    This field Indicates whether this package is a sample packaging or not.
    No
    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.
    08-21-1981
    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.
    12-31-2020
    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".
    I
    NDC Code Structure
    This product is EXCLUDED from the official NDC directory because the listing data was inactivated by the FDA.

    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.

    * Please review the disclaimer below.

    Other Product Packages

    The following packages are also available for Acetaminophen And Codeine Phosphate with product NDC 0121-0504.

    NDC Package CodePackage Description
    0121-0504-04118 mL in 1 BOTTLE
    0121-0504-1210 TRAY in 1 CASE > 10 CUP, UNIT-DOSE in 1 TRAY > 12.5 mL in 1 CUP, UNIT-DOSE
    0121-0504-16473 mL in 1 BOTTLE

    * Please review the disclaimer below.