NDC Package 53345-010-02 Acetaminophen (red)

Acetaminophen Capsule, Liquid Filled 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:
53345-010-02
Package Description:
1 BAG in 1 BOX / 4000 CAPSULE, LIQUID FILLED in 1 BAG
Product Code:
Proprietary Name:
Acetaminophen (red)
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:
53345001002
NDC to RxNorm Crosswalk:
  • RxCUI: 198436 - acetaminophen 325 MG Oral Capsule
  • RxCUI: 198436 - APAP 325 MG Oral Capsule
  • Product Type:
    Human Otc Drug
    Labeler Name:
    Humanwell Puracap Pharmaceutical (wuhan) Co., Ltd
    Dosage Form:
    Capsule, Liquid Filled - A solid dosage form in which the drug is enclosed within a soluble, gelatin shell which is plasticized by the addition of a polyol, such as sorbitol or glycerin, and is therefore of a somewhat thicker consistency than that of a hard shell capsule; typically, the active ingredients are dissolved or suspended in a liquid vehicle.
    Administration Route(s):
  • Oral - Administration to or by way of the mouth.
  • Oral - Administration to or by way of the mouth.
  • Sample Package:
    No
    FDA Application Number:
    part343
    Marketing Category:
    OTC MONOGRAPH NOT FINAL - A product marketed pursuant to an Over-the-Counter (OTC) Drug Monograph that is not final.
    Start Marketing Date:
    04-04-2016
    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
    53345-010-011 BAG in 1 BOX / 5000 CAPSULE, LIQUID FILLED in 1 BAG

    * Please review the disclaimer below.

    Frequently Asked Questions

    What is NDC 53345-010-02?

    The NDC Packaged Code 53345-010-02 is assigned to a package of 1 bag in 1 box / 4000 capsule, liquid filled in 1 bag of Acetaminophen (red), a human over the counter drug labeled by Humanwell Puracap Pharmaceutical (wuhan) Co., Ltd. The product's dosage form is capsule, liquid filled and is administered via oral form.

    Is NDC 53345-010 included in the NDC Directory?

    Yes, Acetaminophen (red) with product code 53345-010 is active and included in the NDC Directory. The product was first marketed by Humanwell Puracap Pharmaceutical (wuhan) Co., Ltd on April 04, 2016 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 53345-010-02?

    The 11-digit format is 53345001002. 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
    5-3-253345-010-025-4-253345-0010-02