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  5. NDC Package Code: 25000-071-08 Acetaminophen Extended-release Tablets, 650 Mg

NDC Package 25000-071-08 Acetaminophen Extended-release Tablets, 650 Mg

Acetaminophen Tablet, Extended Release Oral - View Billable Units, 11-Digit Format, RxNorm

Table of Contents

    1. Package Information
    2. Other Packages
    3. Frequently Asked Questions

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:
25000-071-08
Package Description:
1 BOTTLE in 1 CARTON / 100 TABLET, EXTENDED RELEASE in 1 BOTTLE
Product Code:
25000-071
Proprietary Name:
Acetaminophen Extended-release Tablets, 650 Mg
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:
25000007108
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:
    Marksans Pharma Limited
    Dosage Form:
    Tablet, Extended Release - A solid dosage form containing a drug which allows at least a reduction in dosing frequency as compared to that drug presented in conventional dosage form.
    Administration Route(s):
  • Oral - Administration to or by way of the mouth.
    • Active Ingredient(s):
  • ACETAMINOPHEN 650 mg/1
    • Sample Package:
    No
    FDA Application Number:
    ANDA215486
    Marketing Category:
    ANDA - A product marketed under an approved Abbreviated New Drug Application.
    Start Marketing Date:
    09-02-2021
    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.

    Other Product Packages

    The following packages are also available for this product:

    NDC Package CodePackage Description
    25000-071-021 BOTTLE in 1 CARTON / 24 TABLET, EXTENDED RELEASE in 1 BOTTLE
    25000-071-101 BOTTLE in 1 CARTON / 225 TABLET, EXTENDED RELEASE in 1 BOTTLE
    25000-071-111 BOTTLE in 1 CARTON / 290 TABLET, EXTENDED RELEASE in 1 BOTTLE
    25000-071-45400 TABLET, EXTENDED RELEASE in 1 BOTTLE

    * Please review the disclaimer below.

    Frequently Asked Questions

    What is NDC 25000-071-08?

    The NDC Packaged Code 25000-071-08 is assigned to a package of 1 bottle in 1 carton / 100 tablet, extended release in 1 bottle of Acetaminophen Extended-release Tablets, 650 Mg, a human over the counter drug labeled by Marksans Pharma Limited. The product's dosage form is tablet, extended release and is administered via oral form.

    Is NDC 25000-071 included in the NDC Directory?

    Yes, Acetaminophen Extended-release Tablets, 650 Mg with product code 25000-071 is active and included in the NDC Directory. The product was first marketed by Marksans Pharma Limited on September 02, 2021 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 25000-071-08?

    The 11-digit format is 25000007108. 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
    5-3-225000-071-085-4-225000-0071-08