NDC Package 68071-3100-2 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:
68071-3100-2
Package Description:
20 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 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 UseBecause of the risks of addiction, abuse, and misuse, with opioids, even at recommended doses [see WARNINGS], reserve acetaminophen and codeine phosphate tablets 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 analgesiaHave not been tolerated, or are not expected to be tolerated
11-Digit NDC Billing Format:
68071310002
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
  • Product Type:
    Human Prescription Drug
    Labeler Name:
    Nucare Pharmaceuticals, 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:
    ANDA202800
    Marketing Category:
    ANDA - A product marketed under an approved Abbreviated New Drug Application.
    Start Marketing Date:
    01-05-2017
    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
    68071-3100-330 TABLET in 1 BOTTLE
    68071-3100-424 TABLET in 1 BOTTLE
    68071-3100-515 TABLET in 1 BOTTLE
    68071-3100-660 TABLET in 1 BOTTLE
    68071-3100-884 TABLET in 1 BOTTLE

    * Please review the disclaimer below.

    Frequently Asked Questions

    What is NDC 68071-3100-2?

    The NDC Packaged Code 68071-3100-2 is assigned to a package of 20 tablet in 1 bottle of Acetaminophen And Codeine Phosphate, a human prescription drug labeled by Nucare Pharmaceuticals, Inc.. The product's dosage form is tablet and is administered via oral form.

    Is NDC 68071-3100 included in the NDC Directory?

    Yes, Acetaminophen And Codeine Phosphate with product code 68071-3100 is active and included in the NDC Directory. The product was first marketed by Nucare Pharmaceuticals, Inc. on January 05, 2017 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 68071-3100-2?

    The 11-digit format is 68071310002. 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 5-4-1 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
    5-4-168071-3100-25-4-268071-3100-02