NDC Package 63304-561-05 Acetaminophen And Codeine Phosphate

Tablet Oral - View Billable Units, 11-Digit Format, RxNorm

Package Information

Find all the important details about this NDC Package code, including the 11-Digit NDC Billing number, billing units, wholesale price, RxNorm crosswalk, active ingredients, pharmacologic clasess, etc.

NDC Package Code:
63304-561-05
Package Description:
500 TABLET in 1 BOTTLE
Product Code:
Proprietary Name:
Acetaminophen And Codeine Phosphate
Non-Proprietary Name:
Acetaminophen And Codeine Phosphate
Substance Name:
Acetaminophen; Codeine Phosphate
Usage Information:
Acetaminophen and Codeine Phosphate Tablets, USP are 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 Use Because of the risks of addiction, abuse, and misuse, with opioids, even at recommended doses [see WARNINGS], reserve Acetaminophen and Codeine Phosphate Tablets, USP for use in patients for whom alternative treatment options [e.g., non-opioid analgesics] •Have not provided adequate analgesia, or are not expected to provide adequate analgesia, •Have not been tolerated, or are not expected to be tolerated.
11-Digit NDC Billing Format:
63304056105
Billing Unit:
EA - Billing unit of "each" is used when the product is dispensed in discreet units.
NDC to RxNorm Crosswalk:
500 EA
NDC to RxNorm Crosswalk:
  • RxCUI: 993781 - codeine phosphate 30 MG / acetaminophen 300 MG Oral Tablet
  • RxCUI: 993781 - acetaminophen 300 MG / codeine phosphate 30 MG Oral Tablet
  • RxCUI: 993781 - APAP 300 MG / codeine phosphate 30 MG Oral Tablet
  • RxCUI: 993890 - codeine phosphate 60 MG / acetaminophen 300 MG Oral Tablet
  • RxCUI: 993890 - acetaminophen 300 MG / codeine phosphate 60 MG Oral Tablet
  • Product Type:
    Human Prescription Drug
    Labeler Name:
    Sun Pharmaceutical Industries, Inc.
    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.
  • DEA Schedule:
    Schedule III (CIII) Substances
    Sample Package:
    No
    FDA Application Number:
    ANDA087083
    Marketing Category:
    ANDA - A product marketed under an approved Abbreviated New Drug Application.
    Start Marketing Date:
    01-23-1980
    Listing Expiration Date:
    12-31-2024
    Exclude Flag:
    N

    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 this product:

    NDC Package CodePackage Description
    63304-561-01100 TABLET in 1 BOTTLE

    * Please review the disclaimer below.

    Frequently Asked Questions

    What is NDC 63304-561-05?

    The NDC Packaged Code 63304-561-05 is assigned to a package of 500 tablet in 1 bottle of Acetaminophen And Codeine Phosphate, a human prescription drug labeled by Sun Pharmaceutical Industries, Inc.. The product's dosage form is tablet and is administered via oral form.This product is billed for "EA" each discreet unit and contains an estimated amount of 500 billable units per package.

    Is NDC 63304-561 included in the NDC Directory?

    Yes, Acetaminophen And Codeine Phosphate with product code 63304-561 is active and included in the NDC Directory. The product was first marketed by Sun Pharmaceutical Industries, Inc. on January 23, 1980 and its listing in the NDC Directory is set to expire on December 31, 2024 if the product is not updated or renewed by the manufacturer.

    What is the NDC billing unit for package 63304-561-05?

    The contents of this package are billed per "each", products billed on a per each basis are usually products dispensed in discreet units. The calculated billable units for this package is 500.

    What is the 11-digit format for NDC 63304-561-05?

    The 11-digit format is 63304056105. The 11-digit billing format might be required by the Centers for Medicare & Medicaid Services (CMS) and other payers in billing claim forms.

    This package code is originally configured in a 5-3-2 segment 10-digit format and by adding a zero within the original NDC package code we can obtain the converted 11-digit format in a 5-4-2 segment configuration. The table below shows the 11-digit code conversion:

    10-Digit Format10-Digit Original Code11-Digit Format11-Digit Code
    5-3-263304-561-055-4-263304-0561-05