NDC Package 54257-573-03 Acetaminophen Extended-release

Acetaminophen 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:
54257-573-03
Package Description:
200 TABLET in 1 BOTTLE
Product Code:
Proprietary Name:
Acetaminophen Extended-release
Non-Proprietary Name:
Acetaminophen
Substance Name:
Acetaminophen
Usage Information:
This drug is used to treat mild to moderate pain (from headaches, menstrual periods, toothaches, backaches, osteoarthritis, or cold/flu aches and pains) and to reduce fever.
11-Digit NDC Billing Format:
54257057303
NDC to RxNorm Crosswalk:
  • RxCUI: 1148399 - acetaminophen 650 MG 8HR Extended Release Oral Tablet
  • RxCUI: 1148399 - 8 HR acetaminophen 650 MG Extended Release Oral Tablet
  • RxCUI: 1148399 - 8 HR APAP 650 MG Extended Release Oral Tablet
  • RxCUI: 1148399 - acetaminophen 650 MG 8 HR Extended Release Oral Tablet
  • Product Type:
    Human Otc Drug
    Labeler Name:
    Magno-humphries, 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.
  • Active Ingredient(s):
    Sample Package:
    No
    FDA Application Number:
    ANDA211544
    Marketing Category:
    ANDA - A product marketed under an approved Abbreviated New Drug Application.
    Start Marketing Date:
    01-24-2020
    Listing Expiration Date:
    12-31-2024
    Exclude Flag:
    N
    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.

    * Please review the disclaimer below.

    Frequently Asked Questions

    What is NDC 54257-573-03?

    The NDC Packaged Code 54257-573-03 is assigned to a package of 200 tablet in 1 bottle of Acetaminophen Extended-release, a human over the counter drug labeled by Magno-humphries, Inc.. The product's dosage form is tablet and is administered via oral form.

    Is NDC 54257-573 included in the NDC Directory?

    Yes, Acetaminophen Extended-release with product code 54257-573 is active and included in the NDC Directory. The product was first marketed by Magno-humphries, Inc. on January 24, 2020 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 11-digit format for NDC 54257-573-03?

    The 11-digit format is 54257057303. 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
    5-3-254257-573-035-4-254257-0573-03